Cefotaxime is a parenteral third-generation cephalosporin and was the first of this group to be marketed. As with other agents in this group, cefotaxime is more active and has a broader spectrum against gram-negative species than earlier generations of cephalosporins. Although it is less active against gram-positive bacteria than first-generation agents, cefotaxime is often an effective agent for the treatment of infections due to methicillin-sensitive S. aureus and susceptible strains of nonenterococcal streptococci. The spectrum of activity of cefotaxime is similar to that of ceftizoxime and ceftriaxone; none of these cephalosporins is effective for the treatment of infections due to Pseudomonas aeruginosa. Clinically, cefotaxime is used in the treatment of enteric gram-negative meningitis, serious bacteremias, pneumonia, and community-acquired infections. Cefotaxime was approved by the FDA in 1981.
General Administration Information
For storage information, see the specific product information within the How Supplied section.
Route-Specific Administration
Injectable Administration
-Cefotaxime is administered intravenously or intramuscularly.
-One gram of cefotaxime in 14 mL of sterile water for injection is isotonic.
-Visually inspect parenteral products for particulate matter and discoloration prior to administration whenever solution and container permit.
Intravenous Administration
-Infusion bottles, bulk packages, and frozen bags are for IV use only.
IV Push
-Vials: reconstitute 500 mg, 1 g, or 2 g with 10 mL of sterile water for injection to give concentrations of 50, 95, or 180 mg/mL, respectively.
-Inject directly into a vein over 3-5 minutes or slowly into the tubing of a freely-flowing compatible IV solution.
Intermittent or continuous IV infusion
-Vials: the reconstituted powder (see above) may be further diluted with 50-1000 mL of a compatible IV solution.
-Infusion bottles: reconstitute bottles containing 1 or 2 g with 50-100 mL of 0.9% Sodium Chloride injection or 5% Dextrose injection.
-Frozen bags: thaw at room temperature. Do not force thaw. No reconstitution necessary.
-Pharmacy bulk packages: reconstitute 10 grams with 47 or 97 mL of a compatible solution to give concentrations of 200 mg/mL or 100 mg/mL, respectively. Withdraw appropriate dose and dilute in a compatible IV solution.
-ADD-Vantage vials: for IV infusion only. Reconstitute only with 0.9% Sodium Chloride injection or 5% Dextrose injection in the appropriate 50 or 100 mL flexible diluent container.
-Infuse appropriate dose over 20-60 minutes.
Intramuscular Administration
-Vials: reconstitute 500 mg, 1 g, or 2 g with 2, 3, 5 mL of sterile or bacteriostatic water for injection, respectively.
-Inject deeply into a large muscle (i.e., upper outer quadrant of the gluteus maximus or lateral part of the thigh).
Rapid administration (less than 60 seconds) of cefotaxime through a central venous catheter can result in potentially life-threatening arrhythmias. Avoid rapid bolus intravenous administration of cefotaxime.
A local injection site reaction has been reported in 4.3% of patients receiving cefotaxime. Reactions include injection site inflammation after intravenous administration and pain, induration and tenderness after intramuscular administration.
Hematologic adverse reactions that have been reported with cefotaxime include agranulocytosis, eosinophilia (2.4%), transient leukopenia (< 1%), neutropenia (< 1%), thrombocytopenia, pancytopenia, and bone marrow failure. Rare cases of hemolytic anemia have also been reported. Positive direct Coombs test have been reported in some patients receiving cefotaxime and other cephalosporins. If hematological testing is done in patients receiving cephalosporins, a positive Coombs test should be considered as being possibly due to the antibiotic. Aplastic anemia and bleeding (hemorrhage) have been reported with cephalosporin antibiotics in general.
Interstitial nephritis, a hypersensitivity reaction, has been reported with many of the cephalosporins including cefotaxime. Transient elevations in BUN (< 1%) and creatinine (azotemia) have also been occasionally reported. Renal failure (unspecified) has been reported in post-marketing surveillance. Other hypersensitivity reactions reported with cefotaxime, as well as with other cephalosporins, include anaphylactoid reactions (anaphylaxis), erythema multiforme, fever (2.4%), maculopapular rash (2.4%), pruritus (2.4%), Stevens-Johnson syndrome, toxic epidermal necrolysis, and urticaria. Angioedema has also been reported with cephalosporin use.
Seizures are rare, but a serious complication of cephalosporin therapy. More commonly associated with penicillins, the epileptogenic properties of both penicillins and cephalosporins are thought to be related to their beta-lactam ring. High doses and renal impairment are associated with an increased risk of seizures. Dizziness and headache (< 1%) have also been reported with cefotaxime.
Nausea/vomiting, colitis, and diarrhea are common gastrointestinal adverse effects of cefotaxime, occurring in 1.4% of patients. Other reported adverse effects include elevated hepatic enzymes (less than 1%), elevated LDH (less than 1%), malaise, abdominal pain. Hepatic impairment including cholestasis, cholecystitis, and cholelithiasis has also been reported with cefotaxime.
Cefotaxime has been associated with acute generalized exanthematous pustulosis (AGEP). The non-follicular, pustular, erythematous rash starts suddenly and is associated with fever above 38 degrees C. Drugs are the main cause of AGEP. A period of 2-3 weeks after an inciting drug exposure appears necessary for a first episode of AGEP. Unintentional reexposure may cause a second episode within 2 days.
The Jarisch-Herxheimer reaction is a self-limiting systemic reaction that has been reported in the setting of spirochete infections, such as Lyme disease, syphilis, relapsing fever, and leptospirosis, after the initiation of antimicrobial therapy. It is characterized by fever, chills, myalgias, headache, exacerbation of cutaneous lesions, tachycardia, hyperventilation, vasodilation with flushing, and mild hypotension. Less commonly, symptoms may include meningitis, pulmonary failure, hepatic and renal dysfunction, myocardial injury, premature uterine contractions in pregnant patients, and worsening cerebral function as well as strokes and seizures. The reaction has been noted in up to 30% of patients with early Lyme disease. The timing of the reaction varies by underlying infection but typically presents within a few hours after the initiation of antibiotics. For Lyme disease, the reaction usually begins within 1 to 2 hours after starting therapy and disappears within 12 to 24 hours. The reaction after treatment in syphilis usually starts at 4 hours, peaks at 8 hours, and subsides by 16 hours whereas it starts at about 1 to 2 hours, peaks at 4 hours, and subsides by 8 hours after treatment in relapsing fever. The pathogenesis of this reaction is unknown but may be due to the release of spirochetal heat-stable pyrogen. Fluids and antipyretics can be used to alleviate symptoms and duration of the reaction if severe.
Microbial overgrowth and superinfection can occur with antibiotic use. C. difficile-associated diarrhea (CDAD) or pseudomembranous colitis has been reported with cefotaxime. If pseudomembranous colitis is suspected or confirmed, ongoing antibacterial therapy not directed against C. difficile may need to be discontinued. Institute appropriate fluid and electrolyte management, protein supplementation, C. difficile-directed antibacterial therapy, and surgical evaluation as clinically appropriate. Candidiasis and vaginitis have also been reported in less than 1% of patients.
A false-positive reaction for glucose in the urine has been observed in patients receiving cephalosporins, such as cefotaxime, and using Benedict's solution, Fehling's solution, or Clinitest tablets for urine glucose testing. However, this reaction has not been observed with glucose oxidase tests (e.g., Tes-tape, Clinistix, Diastix). Patients with diabetes mellitus who test their urine for glucose should use glucose tests based on enzymatic glucose oxidase reactions while on cefotaxime treatment.
Positive direct Coombs tests have been reported during treatment with cefotaxime. In hematologic studies or in transfusion cross-matching procedures when antiglobulin tests are performed on the minor side or in Coombs test of newborns whose mothers received cefotaxime before delivery, clinicians should keep in mind that a positive Coombs test may be due to the drug.
Cefotaxime is contraindicated in patients with cephalosporin hypersensitivity or cephamycin hypersensitivity. Cefotaxime should be used cautiously in patients with hypersensitivity to penicillin. The structural similarity between cefotaxime and penicillin means that cross-reactivity can occur. Penicillins can cause a variety of hypersensitivity reactions ranging from mild rash to fatal anaphylaxis. Patients who have experienced severe penicillin hypersensitivity should not receive cefotaxime. Cross-reactivity to cephalosporins is approximately 3-7% with a documented history to penicillin.
Cefotaxime solutions containing dextrose may be contraindicated in patients with known corn hypersensitivity or hypersensitivity to corn products.
Cefotaxime should be used with caution in patients with renal disease or renal impairment since the drug is eliminated via renal mechanisms. Dosages may need to be reduced in these patients.
Consider pseudomembranous colitis in patients presenting with diarrhea after antibacterial use. Careful medical history is necessary as pseudomembranous colitis has been reported to occur over 2 months after the administration of antibacterial agents. Almost all antibacterial agents, including cefotaxime, have been associated with pseudomembranous colitis or C. difficile-associated diarrhea (CDAD) which may range in severity from mild to life-threatening. Treatment with antibacterial agents alters the normal flora of the colon leading to overgrowth of C. difficile.
All cephalosporins, including cefotaxime, may rarely cause hypothrombinemia and have the potential to cause bleeding. Cephalosporins which contain the NMTT side chain (e.g., cefoperazone, cefamandole, cefotetan) have been associated with an increased risk for bleeding. Cephalosporins should be used cautiously in patients with a preexisting coagulopathy (e.g., vitamin K deficiency) since these patients are at a higher risk for developing bleeding complications.
Use cefotaxime with caution in patients with hematological disease. Hematological abnormalities, such as leukopenia, neutropenia, thrombocytopenia, granulocytopenia, and more rarely, bone marrow failure, pancytopenia, or agranulocytosis, may occur during treatment with cefotaxime. Monitor blood counts for courses of therapy lasting longer than 10 days. Treatment discontinuation should be considered in cases of abnormal results.
Rapid administration (i.e., less than 60 seconds) of cefotaxime through a central venous catheter can result in infusion-related reactions that include potentially life-threatening arrhythmias. Avoid rapid bolus intravenous administration of cefotaxime.
Cefotaxime is classified as FDA pregnancy risk category B. Cefotaxime crosses the placenta. Animal data reveal no teratogenic or fetotoxic effects; however, a slight decrease in fetal and neonatal weight was observed. There are no adequate and well-controlled studies in pregnant women. Because animal studies are not always predictive of human response, this drug should be used during pregnancy only if clearly needed. Cefotaxime has not been studied for use during labor and delivery. Treatment should be given only if clearly needed.
Cefotaxime is excreted in breast milk in small quantities. The manufacturer recommends that it should be used with caution during breast-feeding, considering the benefit to the mother. Rare potential complications in the nursing infant include alterations of gut flora that might result in diarrhea or other related complications (e.g., dehydration). Cefotaxime is generally considered compatible for use for breast-feeding women by the American Academy of Pediatrics. Consider the benefits of breast-feeding, the risk of potential infant drug exposure, and the risk of an untreated or inadequately treated condition. If a breast-feeding infant experiences an adverse effect related to a maternally administered drug, healthcare providers are encouraged to report the adverse effect to the FDA.
Clinical trial and other reported clinical experience has not identified differences in responses between geriatric and younger adult patients, but greater sensitivity of some older individuals to cefotaxime cannot be ruled out. The federal Omnibus Budget Reconciliation Act (OBRA) regulates medication use in residents (e.g., geriatric adults) of long-term care facilities. According to OBRA, use of antibiotics should be limited to confirmed or suspected bacterial infections. Antibiotics are non-selective and may result in the eradication of beneficial microorganisms while promoting the emergence of undesired ones, causing secondary infections such as oral thrush, colitis, or vaginitis. Any antibiotic may cause diarrhea, nausea, vomiting, anorexia, and hypersensitivity reactions.
Per the manufacturer, this drug has been shown to be active against most strains of the following microorganisms either in vitro and/or in clinical infections: Acinetobacter sp., Bacteroides sp., Citrobacter sp., Clostridium sp., Enterobacter sp., Escherichia coli, Fusobacterium nucleatum, Fusobacterium sp., Haemophilus influenzae (beta-lactamase negative), Haemophilus influenzae (beta-lactamase positive), Haemophilus parainfluenzae, Klebsiella pneumoniae, Klebsiella sp., Morganella morganii, Neisseria gonorrhoeae, Neisseria meningitidis, Peptococcus sp., Peptostreptococcus sp., Proteus mirabilis, Proteus vulgaris, Providencia rettgeri, Providencia sp., Providencia stuartii, Pseudomonas sp., Salmonella enterica serotype Typhi , Salmonella sp., Serratia marcescens, Shigella sp., Staphylococcus aureus (MSSA), Staphylococcus epidermidis, Streptococcus pneumoniae, Streptococcus pyogenes (group A beta-hemolytic streptococci), Streptococcus sp., Viridans streptococci
NOTE: The safety and effectiveness in treating clinical infections due to organisms with in vitro data only have not been established in adequate and well-controlled clinical trials.
This drug may also have activity against the following microorganisms: Borrelia burgdorferi, Leptospira sp.
NOTE: Some organisms may not have been adequately studied during clinical trials; therefore, exclusion from this list does not necessarily negate the drug's activity against the organism.
For the treatment of bacteremia and sepsis:
-for the treatment of bacteremia:
Intravenous or Intramuscular dosage:
Adults: 2 g IV every 6 to 8 hours for severe infections and 2 g IV every 4 hours for life-threatening infections.
Children and Adolescents weighing 50 kg or more: 2 g IV every 6 to 8 hours for severe infections and 2 g IV every 4 hours for life-threatening infections.
Infants, Children, and Adolescents weighing less than 50 kg: 150 to 180 mg/kg/day (Max: 8 g/day) IV or IM divided every 6 to 8 hours.
Neonates 32 weeks gestation and older and 8 days and older: 50 mg/kg/dose IV or IM every 8 hours.
Neonates 32 weeks gestation and older and 0 to 7 days: 50 mg/kg/dose IV or IM every 12 hours.
Neonates younger than 32 weeks gestation and 7 days and older: 50 mg/kg/dose IV or IM every 8 hours.
Neonates younger than 32 weeks gestation and 0 to 6 days: 50 mg/kg/dose IV or IM every 12 hours.
-for the treatment of sepsis:
Intravenous dosage:
Adults: 2 g IV every 4 hours. Start within 1 hour for septic shock or within 3 hours for possible sepsis without shock. Duration of therapy is not well-defined and dependent on patient- and infection-specific factors. Assess patient daily for deescalation of antimicrobial therapy based on pathogen identification and/or adequate clinical response.
Children and Adolescents weighing 50 kg or more: 2 g IV every 4 hours. Start within 1 hour for septic shock or within 3 hours for sepsis-associated organ dysfunction without shock. Duration of therapy is not well-defined and dependent on patient- and infection-specific factors. Assess patient daily for deescalation of antimicrobial therapy based on pathogen identification and/or adequate clinical response.
Infants, Children, and Adolescents weighing less than 50 kg: 150 to 180 mg/kg/day (Max: 8 g/day) IV divided every 6 to 8 hours. Start within 1 hour for septic shock or within 3 hours for sepsis-associated organ dysfunction without shock. Duration of therapy is not well-defined and dependent on patient- and infection-specific factors. Assess patient daily for deescalation of antimicrobial therapy based on pathogen identification and/or adequate clinical response.
Neonates 32 weeks gestation and older and 8 days and older: 50 mg/kg/dose IV every 8 hours. Start within 1 hour for septic shock or within 3 hours for sepsis-associated organ dysfunction without shock. Duration of therapy is not well-defined and dependent on patient- and infection-specific factors. Assess patient daily for deescalation of antimicrobial therapy based on pathogen identification and/or adequate clinical response. Neonates younger than 37 weeks gestational age were excluded from guideline scope.
Neonates 32 weeks gestation and older and 0 to 7 days: 50 mg/kg/dose IV every 12 hours. Start within 1 hour for septic shock or within 3 hours for sepsis-associated organ dysfunction without shock. Duration of therapy is not well-defined and dependent on patient- and infection-specific factors. Assess patient daily for deescalation of antimicrobial therapy based on pathogen identification and/or adequate clinical response. Neonates younger than 37 weeks gestational age were excluded from guideline scope.
Neonates younger than 32 weeks gestation and 7 days and older: 50 mg/kg/dose IV every 8 hours.
Neonates younger than 32 weeks gestation and 0 to 6 days: 50 mg/kg/dose IV every 12 hours.
For the treatment of meningitis and ventriculitis:
NOTE: For gonococcal meningitis, see gonococcal infections. For neurologic Lyme infections, see Lyme borreliosis.
-for the treatment of meningococcal meningitis or ventriculitis as well as meningitis or ventriculitis due to H. influenzae:
Intravenous dosage:
Adults: 2 g IV every 4 to 6 hours for 7 days.
Children and Adolescents weighing 50 kg or more: 2 g IV every 4 to 6 hours for 7 days.
Infants, Children, and Adolescents weighing less than 50 kg: 200 to 300 mg/kg/day (Max: 12 g/day) IV divided every 4 to 6 hours for 7 days.
Neonates older than 7 days: 50 mg/kg/dose IV every 6 to 8 hours for 7 days.
Neonates 0 to 7 days: 50 mg/kg/dose IV every 8 to 12 hours for 7 days.
-for the treatment of pneumococcal meningitis or ventriculitis:
Intravenous dosage:
Adults: 2 g IV every 4 to 6 hours for 10 to 14 days; consider the addition of rifampin if dexamethasone is also given or ceftriaxone MIC is more than 2 mcg/mL.
Children and Adolescents weighing 50 kg or more: 2 g IV every 4 to 6 hours for 10 to 14 days; consider the addition of rifampin if dexamethasone is also given or ceftriaxone MIC is more than 2 mcg/mL.
Infants, Children, and Adolescents weighing less than 50 kg: 200 to 300 mg/kg/day (Max: 12 g/day) IV divided every 4 to 6 hours for 10 to 14 days; consider the addition of rifampin if dexamethasone is also given or ceftriaxone MIC is more than 2 mcg/mL.
Neonates older than 7 days: 50 mg/kg/dose IV every 6 to 8 hours for 10 to 14 days; consider the addition of rifampin if dexamethasone is also given or ceftriaxone MIC is more than 2 mcg/mL.
Neonates 0 to 7 days: 50 mg/kg/dose IV every 8 to 12 hours for 10 to 14 days; consider the addition of rifampin if dexamethasone is also given or ceftriaxone MIC is more than 2 mcg/mL.
-for the treatment of meningitis or ventriculitis due to aerobic gram-negative rods:
Intravenous dosage:
Adults: 2 g IV every 4 to 6 hours for 10 to 21 days.
Children and Adolescents weighing 50 kg or more: 2 g IV every 4 to 6 hours for 10 to 21 days.
Infants, Children, and Adolescents weighing less than 50 kg: 200 to 300 mg/kg/day (Max: 12 g/day) IV divided every 4 to 6 hours for 10 to 21 days.
Neonates older than 7 days: 50 mg/kg/dose IV every 6 to 8 hours for 2 weeks beyond the first sterile CSF culture or at least 21 days, whichever is longer.
Neonates 0 to 7 days: 50 mg/kg/dose IV every 8 to 12 hours for 2 weeks beyond the first sterile CSF culture or at least 21 days, whichever is longer.
-for the treatment of meningitis or ventriculitis due to C. acnes*:
Intravenous dosage:
Adults: 2 g IV every 4 to 6 hours for 10 to 14 days.
Infants, Children, and Adolescents: 200 to 300 mg/kg/day (Max: 12 g/day) IV divided every 4 to 6 hours for 10 to 14 days.
-for the treatment of meningitis due to S. agalactiae*:
Intravenous dosage:
Adults: 2 g IV every 4 to 6 hours for 14 to 21 days.
Infants, Children, and Adolescents: 200 to 300 mg/kg/day (Max: 12 g/day) IV divided every 4 to 6 hours for 14 to 21 days.
Neonates older than 7 days: 50 mg/kg/dose IV every 6 to 8 hours for 14 to 21 days.
Neonates 0 to 7 days: 50 mg/kg/dose IV every 8 to 12 hours for 14 to 21 days.
For the treatment of neurologic Lyme disease*, including Lyme meningitis*, cranial neuropathy*, and radiculoneuropathy/radiculoneuritis*:
-for the treatment of neurologic Lyme disease* without parenchymal involvement, including Lyme meningitis*, cranial neuropathy*, and radiculoneuropathy/radiculoneuritis*:
Intravenous dosage:
Adults: 2 g IV every 8 hours until clinical improvement, then switch to oral stepdown therapy for a total of 14 to 21 days as an alternative. For acutely ill patients or prior to confirmation of Lyme neuroborreliosis, IV therapy is preferred with appropriate stepdown to oral treatment.
Infants, Children, and Adolescents: 150 to 200 mg/kg/day (Max: 6 g/day) IV divided every 6 to 8 hours until clinical improvement, then switch to oral stepdown therapy for a total of 14 to 21 days as an alternative. For acutely ill patients or prior to confirmation of Lyme neuroborreliosis, IV therapy is preferred with appropriate stepdown to oral treatment.
-for the treatment of neurologic Lyme disease* with parenchymal involvement of the brain or spinal cord:
Intravenous dosage:
Adults: 2 g IV every 8 hours for 14 to 28 days. IV therapy is preferred.
Infants, Children, and Adolescents: 150 to 200 mg/kg/day (Max: 6 g/day) IV divided every 6 to 8 hours for 14 to 28 days. IV therapy is preferred.
For the treatment of gonorrhea, including ophthalmia neonatorum*:
-for the treatment of uncomplicated gonorrhea, including rectal infections in females, cervicitis, and urethritis:
Intramuscular dosage:
Adults: Not recommended by guidelines. The FDA-approved dosage is 500 mg IM as a single dose.
Children and Adolescents weighing 50 kg or more: Not recommended by guidelines. The FDA-approved dosage is 500 mg IM as a single dose.
-for the treatment of gonococcal proctitis:
Intramuscular dosage:
Adults: Not recommended by guidelines. The FDA-approved dosage is 1 g IM as a single dose.
Children and Adolescents weighing 50 kg or more: Not recommended by guidelines. The FDA-approved dosage is 1 g IM as a single dose.
-for the treatment of gonococcal arthritis* and arthritis-dermatitis syndrome*:
Intravenous dosage:
Adults: 1 g IV every 8 hours for 7 days as an alternative. If treating for arthritis-dermatitis syndrome, may switch to an oral agent 24 to 48 hours after clinical improvement for a total of at least 7 days.
Adolescents: 1 g IV every 8 hours for 7 days as an alternative. If treating for arthritis-dermatitis syndrome, may switch to an oral agent 24 to 48 hours after clinical improvement for a total of at least 7 days.
-for the treatment of gonococcal scalp abscesses and disseminated gonococcal infections in neonates*:
Intravenous or Intramuscular dosage:
Neonates: 25 mg/kg/dose IV or IM every 12 hours for 7 days as an alternative.
-for the treatment of neonatal gonococcal meningitis*:
Intravenous dosage:
Neonates: 25 mg/kg/dose IV every 12 hours for 10 to 14 days as an alternative.
-for the treatment of ophthalmia neonatorum* due to N. gonorrhoeae:
Intravenous or Intramuscular dosage:
Neonates: 100 mg/kg/dose IV or IM as a single dose for neonates unable to receive ceftriaxone.
For surgical infection prophylaxis:
Intravenous and Intramuscular dosage:
Adults: 1 g IV or IM as a single dose within 30 to 90 minutes prior to the surgical incision. For cesarean section, 1 g IV or IM as soon as the umbilical cord is clamped, then 1 g IV or IM every 6 hours for 2 more doses. Clinical practice guidelines suggest 1 g IV, or for obese patients, 2 g IV within 60 minutes prior to the surgical incision. Intraoperative redosing 3 hours from the first preoperative dose and duration of prophylaxis less than 24 hours are suggested by clinical practice guidelines. Cefotaxime is FDA-approved for surgical procedures that may be classified as contaminated or potentially contaminated (i.e., abdominal or vaginal hysterectomy, gastrointestinal and genitourinary tract surgery). However, clinical practice guidelines recommend cefotaxime only in combination with ampicillin for liver transplantation.
Infants*, Children*, and Adolescents* undergoing liver transplantation: 50 mg/kg IV or IM as a single dose (Max: 1 g/dose; 2 g/dose in obese patients) within 60 minutes prior to the surgical incision, in combination with ampicillin. Repeat dose intraoperatively 3 hours after preoperative dose if surgery still in progress. The duration should not exceed 24 hours.
For the treatment of infectious diarrhea and gastroenteritis, including salmonellosis* and yersiniosis*:
-for the empiric treatment of enteric bacterial infections* in persons living with HIV:
Intravenous dosage:
Adults: 1 g IV every 8 hours for 5 days. Routine use is not recommended.
Adolescents: 1 g IV every 8 hours for 5 days. Routine use is not recommended.
-for the treatment of salmonellosis* in persons living with HIV:
Intravenous dosage:
Adults: 1 g IV every 8 hours for 7 to 14 days as an alternative; treat for at least 14 days if concurrent bacteremia in persons with a CD4 count more than 200 cells/mm3. Treat for 2 to 6 weeks in persons with a CD4 count less than 200 cells/mm3. Follow with long-term suppressive therapy if recurrent bacteremia or gastroenteritis with a CD4 count less than 200 cells/mm3 and severe diarrhea.
Adolescents: 1 g IV every 8 hours for 7 to 14 days as an alternative; treat for at least 14 days if concurrent bacteremia in persons with a CD4 count more than 200 cells/mm3. Treat for 2 to 6 weeks in persons with a CD4 count less than 200 cells/mm3. Follow with long-term suppressive therapy if recurrent bacteremia or gastroenteritis with a CD4 count less than 200 cells/mm3 and severe diarrhea.
-for the treatment of yersiniosis*:
Intravenous dosage:
Adults: 1 g IV every 8 hours for 7 to 14 days; treat for 14 days if concurrent bacteremia.
For the treatment of leptospirosis*:
Intravenous dosage:
Adults: 1 g IV every 6 hours for 7 days as alternative therapy for severe disease.
Infants, Children, and Adolescents: 150 to 180 mg/kg/day (Max: 4 g/day) IV divided every 8 hours for 7 days as alternative therapy for severe disease.
For the treatment of acute bacterial sinusitis* in patients with severe infection requiring hospitalization:
Intravenous dosage:
Adults: 2 g IV every 4 to 6 hours for 5 to 10 days.
Infants, Children, and Adolescents: 100 to 200 mg/kg/day IV divided every 6 hours (Max: 8 g/day) for 10 to 14 days.
For the treatment of lower respiratory tract infections (LRTIs), including pneumonia, community-acquired pneumonia (CAP), and pleural empyema*:
-for the treatment of nonspecific lower respiratory tract infections (LRTIs), pneumonia, and pleural empyema*:
Intravenous or Intramuscular dosage:
Adults: 1 g IV or IM every 12 hours for uncomplicated infections, 1 to 2 g IV or IM every 8 hours for moderate to severe infections, 2 g IV every 6 to 8 hours for severe infections, and 2 g IV every 4 hours for life-threatening infections. Max: 12 g/day. For community-acquired empyema, guidelines recommend cefotaxime in combination with metronidazole for at least 2 weeks after drainage and defervescence.
Children and Adolescents weighing 50 kg or more: 1 g IV or IM every 12 hours for uncomplicated infections, 1 to 2 g IV or IM every 8 hours for moderate to severe infections, 2 g IV every 6 to 8 hours for severe infections, and 2 g IV every 4 hours for life-threatening infections. Max: 12 g/day.
Infants, Children, and Adolescents weighing less than 50 kg: 150 to 180 mg/kg/day IV or IM divided every 6 to 8 hours (Max: 2 g/dose).
Neonates 32 weeks gestation and older and 8 days and older: 50 mg/kg/dose IV or IM every 8 hours.
Neonates 32 weeks gestation and older and 0 to 7 days: 50 mg/kg/dose IV or IM every 12 hours.
Neonates younger than 32 weeks gestation and 7 days and older: 50 mg/kg/dose IV or IM every 8 hours.
Neonates younger than 32 weeks gestation and 0 to 6 days: 50 mg/kg/dose IV or IM every 12 hours.
-for the treatment of community-acquired pneumonia (CAP):
Intravenous dosage:
Adults: 1 to 2 g IV every 8 hours for at least 5 days as part of combination therapy for hospitalized patients.
Infants, Children, and Adolescents: 150 to 200 mg/kg/day (Max: 6 g/day) IV divided every 8 hours for 5 to 7 days. Guidelines recommend empiric therapy with cefotaxime for hospitalized patients who are not fully immunized, in regions where local epidemiology of invasive pneumococcal strains documents high-level penicillin resistance, and for life-threatening infection. Consider combination therapy with a macrolide for suspected atypical pneumonia or with clindamycin or vancomycin for suspected infection due to S. aureus.
For the treatment of multidrug-resistant severe typhoid fever* and quinolone-resistant severe typhoid fever*:
Intravenous dosage:
Adults: 40 to 80 mg/kg/day IV divided every 8 to 12 hours for 10 to 14 days. Usual dose: 2 to 4 g/day.
Infants, Children, and Adolescents: 40 to 80 mg/kg/day (Max: 4 g/day) IV divided every 8 to 12 hours for 10 to 14 days.
For the treatment of urinary tract infection (UTI), including pyelonephritis:
-for the treatment of nonspecific uncomplicated UTI:
Intravenous or Intramuscular dosage:
Adults: 1 g IV or IM every 12 hours.
Infants, Children, and Adolescents 2 months to 17 years: 150 to 180 mg/kg/day IV or IM divided every 6 to 8 hours (Max: 2 g/dose).
Infants 1 month: 150 to 180 mg/kg/day IV or IM divided every 6 to 8 hours. Infants younger than 2 to 3 months are at risk for systemic infection and rapid change in their clinical condition. Treat UTIs as presumed pyelonephritis in these patients.
Neonates 32 weeks gestation and older and 8 days and older: 50 mg/kg/dose IV or IM every 8 hours. Neonates are at risk for systemic infection and rapid change in their clinical condition. Treat UTIs should as presumed pyelonephritis in these patients.
Neonates 32 weeks gestation and older and 0 to 7 days: 50 mg/kg/dose IV or IM every 12 hours. Neonates are at risk for systemic infection and rapid change in their clinical condition. Treat UTIs as presumed pyelonephritis in these patients.
Neonates younger than 32 weeks gestation and 7 days and older: 50 mg/kg/dose IV or IM every 8 hours. Neonates are at risk for systemic infection and rapid change in their clinical condition. Treat UTIs as presumed pyelonephritis in these patients.
Neonates younger than 32 weeks gestation and 0 to 6 days: 50 mg/kg/dose IV or IM every 12 hours. Neonates are at risk for systemic infection and rapid change in their clinical condition. Treat UTIs as presumed pyelonephritis in these patients.
-for the treatment of moderate to severe UTI, including pyelonephritis:
Intravenous or Intramuscular dosage:
Adults: 1 to 2 g IV or IM every 8 hours for 7 to 14 days with or without an aminoglycoside.
Infants, Children, and Adolescents 2 months to 17 years: 150 to 180 mg/kg/day IV or IM divided every 6 to 8 hours (Max: 2 g/dose). Treat for 24 to 48 hours or until patient is clinically stable and afebrile, followed by oral antibiotics for a total duration of 7 to 14 days.
Infants 1 month: 150 to 180 mg/kg/day IV or IM divided every 6 to 8 hours. Infants younger than 2 to 3 months are at risk for systemic infection and rapid change in their clinical condition. Treat UTIs as presumed pyelonephritis in these patients.
Neonates 32 weeks gestation and older and 8 days and older: 50 mg/kg/dose IV or IM every 8 hours. Neonates are at risk for systemic infection and rapid change in their clinical condition. Treat UTIs as presumed pyelonephritis in these patients.
Neonates 32 weeks gestation and older and 0 to 7 days: 50 mg/kg/dose IV or IM every 12 hours. Neonates are at risk for systemic infection and rapid change in their clinical condition. Treat UTIs as presumed pyelonephritis in these patients.
Neonates younger than 32 weeks gestation and 7 days and older: 50 mg/kg/dose IV or IM every 8 hours. Neonates are at risk for systemic infection and rapid change in their clinical condition. Treat UTIs as presumed pyelonephritis in these patients.
Neonates younger than 32 weeks gestation and 0 to 6 days: 50 mg/kg/dose IV or IM every 12 hours. Neonates are at risk for systemic infection and rapid change in their clinical condition. Treat UTIs as presumed pyelonephritis in these patients.
For the treatment of intraabdominal infections, including peritonitis, appendicitis, intraabdominal abscess, neonatal necrotizing enterocolitis, spontaneous bacterial peritonitis*, and peritoneal dialysis-related peritonitis*:
-for the general treatment of intraabdominal infections:
Intravenous or Intramuscular dosage:
Adults: 1 to 2 g IV or IM every 8 hours for moderate to severe infections; 2 g IV every 6 to 8 hours for severe infections, and 2 g IV every 4 hours for life-threatening infections. The maximum dosage is 12 g/day.
Children and Adolescents weighing 50 kg or more: 1 to 2 g IV or IM every 8 hours for moderate to severe infections; 2 g IV every 6 to 8 hours for severe infections, and 2 g IV every 4 hours for life-threatening infections. The maximum dosage is 12 g/day.
Infants, Children, and Adolescents weighing less than 50 kg: 50 to 180 mg/kg/day IV or IM divided every 6 to 8 hours (Max: 2 g/dose).
Neonates 32 weeks gestation and older and 8 days and older: 50 mg/kg/dose IV or IM every 8 hours.
Neonates 32 weeks gestation and older and 0 to 7 days: 50 mg/kg/dose IV or IM every 12 hours.
Neonates younger than 32 weeks gestation and 7 days and older: 50 mg/kg/dose IV or IM every 8 hours.
Neonates younger than 32 weeks gestation and 0 to 6 days: 50 mg/kg/dose IV or IM every 12 hours.
-for the treatment of complicated community-acquired intraabdominal infections with adequate source control:
Intravenous dosage:
Adults: 1 to 2 g IV every 6 to 8 hours as part of combination therapy for 3 to 7 days. Complicated infections include peritonitis and appendicitis complicated by rupture, and intraabdominal abscess.
Children and Adolescents weighing 50 kg or more: 1 to 2 g IV every 6 to 8 hours as part of combination therapy for 3 to 7 days. Complicated infections include peritonitis and appendicitis complicated by rupture, and intraabdominal abscess.
Infants, Children, and Adolescents weighing less than 50 kg: 150 to 200 mg/kg/day IV divided every 6 to 8 hours (Max: 2 g/dose) as part of combination therapy for 3 to 7 days. Complicated infections include peritonitis and appendicitis complicated by rupture, and intraabdominal abscess.
Neonates 32 weeks gestation and older and 8 days and older: 50 mg/kg/dose IV every 8 hours as part of combination therapy for 7 to 10 days. Cefotaxime is an option for necrotizing enterocolitis.
Neonates 32 weeks gestation and older and 0 to 7 days: 50 mg/kg/dose IV every 12 hours as part of combination therapy for 7 to 10 days. Cefotaxime is an option for necrotizing enterocolitis.
Neonates younger than 32 weeks gestation and 7 days and older: 50 mg/kg/dose IV every 8 hours as part of combination therapy for 7 to 10 days. Cefotaxime is an option for necrotizing enterocolitis.
Neonates younger than 32 weeks gestation and 0 to 6 days: 50 mg/kg/dose IV every 12 hours as part of combination therapy for 7 to 10 days. Cefotaxime is an option for necrotizing enterocolitis.
-for the treatment of uncomplicated intraabdominal infections:
Intravenous dosage:
Adults: 1 to 2 g IV every 6 to 8 hours as part of combination therapy. Antibiotics should be discontinued within 24 hours. Uncomplicated infections include acute appendicitis without perforation, abscess, or local peritonitis; traumatic bowel perforations repaired within 12 hours; acute cholecystitis without perforation; and ischemic, non-perforated bowel.
Children and Adolescents weighing 50 kg or more: 1 to 2 g IV every 6 to 8 hours as part of combination therapy. Antibiotics should be discontinued within 24 hours. Uncomplicated infections include acute appendicitis without perforation, abscess, or local peritonitis; traumatic bowel perforations repaired within 12 hours; acute cholecystitis without perforation; and ischemic, non-perforated bowel.
Infants, Children, and Adolescents weighing less than 50 kg: 150 to 200 mg/kg/day IV divided every 6 to 8 hours (Max: 2 g/dose) as part of combination therapy. Antibiotics should be discontinued within 24 hours. Uncomplicated infections include acute appendicitis without perforation, abscess, or local peritonitis; traumatic bowel perforations repaired within 12 hours; acute cholecystitis without perforation; and ischemic, non-perforated bowel.
-for the treatment of spontaneous bacterial peritonitis*:
Intravenous dosage:
Adults: 2 g IV every 8 hours for at least 5 to 7 days.
-for the treatment of peritoneal dialysis-related peritonitis*:
Intermittent Intraperitoneal dosage*:
Adults: 0.5 to 1 g intraperitoneally every 24 hours for 21 days.
Infants, Children, and Adolescents: 30 mg/kg/dose (Max: 1 g/dose) intraperitoneally every 24 hours for 14 to 21 days.
Continuous Intraperitoneal dosage*:
Infants, Children, and Adolescents: 500 mg/L intraperitoneal loading dose, followed by 250 mg/L in each dialysate exchange. Treat for 14 to 21 days.
For the treatment of skin and skin structure infections, including necrotizing infections, animal bite wounds, and diabetic foot ulcer:
-for the treatment of unspecified uncomplicated skin infections:
Intravenous or Intramuscular dosage:
Adults: 1 g IV or IM every 8 to 12 hours.
Children and Adolescents weighing 50 kg or more: 1 g IV or IM every 8 to 12 hours.
Infants, Children, and Adolescents weighing less than 50 kg: 150 to 180 mg/kg/day IV or IM divided every 8 hours (Max: 1 g/dose). The FDA-approved dose is 50 to 180 mg/kg/day IV or IM divided every 4 to 6 hours (Max: 2 g/dose).
Neonates 32 weeks gestation and older and 8 days and older: 50 mg/kg/dose IV or IM every 8 hours.
Neonates 32 weeks gestation and older and 0 to 7 days: 50 mg/kg/dose IV or IM every 12 hours.
Neonates younger than 32 weeks gestation and 7 days and older: 50 mg/kg/dose IV or IM every 8 hours.
Neonates younger than 32 weeks gestation and 0 to 6 days: 50 mg/kg/dose IV or IM every 12 hours.
-for the treatment of unspecified moderate to severe skin infections:
Intravenous or Intramuscular dosage:
Adults: 1 to 2 g IV or IM every 8 hours.
Children and Adolescents weighing 50 kg or more: 1 to 2 g IV or IM every 8 hours.
Infants, Children, and Adolescents weighing less than 50 kg: 150 to 180 mg/kg/day IV or IM divided every 8 hours (Max: 2 g/dose). The FDA-approved dose is 50 to 180 mg/kg/day IV or IM divided every 4 to 6 hours (Max: 2 g/dose); use the higher doses for more severe infections.
Neonates 32 weeks gestation and older and 8 days and older: 50 mg/kg/dose IV or IM every 8 hours.
Neonates 32 weeks gestation and older and 0 to 7 days: 50 mg/kg/dose IV or IM every 12 hours.
Neonates younger than 32 weeks gestation and 7 days and older: 50 mg/kg/dose IV or IM every 8 hours.
Neonates younger than 32 weeks gestation and 0 to 6 days: 50 mg/kg/dose IV or IM every 12 hours.
-for the treatment of unspecified life-threatening skin infections:
Intravenous dosage:
Adults: 2 g IV every 4 hours.
Children and Adolescents weighing more than 50 kg: 2 g IV every 4 hours.
Infants, Children, and Adolescents weighing less than 50 kg: 150 to 180 mg/kg/day IV divided every 8 hours (Max: 12 g/day). The FDA-approved dose is 50 to 180 mg/kg/day IV divided every 4 to 6 hours (Max: 2 g/dose); use the higher doses for more severe infections.
Neonates 32 weeks gestation and older and 8 days and older: 50 mg/kg/dose IV every 8 hours.
Neonates 32 weeks gestation and older and 0 to 7 days: 50 mg/kg/dose IV every 12 hours.
Neonates younger than 32 weeks gestation and 7 days and older: 50 mg/kg/dose IV every 8 hours.
Neonates younger than 32 weeks gestation and 0 to 6 days: 50 mg/kg/dose IV every 12 hours.
-for the treatment of necrotizing infections of the skin, fascia, and muscle:
Intravenous dosage:
Adults: 2 g IV every 6 to 8 hours until further debridement is not necessary, the patient has improved clinically, and fever has been absent for 48 to 72 hours. Cefotaxime is recommended for mixed infections plus metronidazole or clindamycin and for Vibrio vulnificus infections plus doxycycline.
Infants, Children, and Adolescents: 50 mg/kg/dose (Max: 2 g/dose) IV divided every 6 hours until further debridement is not necessary, the patient has improved clinically, and fever has been absent for 48 to 72 hours. Cefotaxime is recommended for mixed infections plus metronidazole or clindamycin.
Neonates 32 weeks gestation and older and 8 days and older: 50 mg/kg/dose IV every 8 hours until further debridement is not necessary, the patient has improved clinically, and fever has been absent for 48 to 72 hours. Cefotaxime is recommended as for mixed infections plus metronidazole or clindamycin.
Neonates 32 weeks gestation and older and 0 to 7 days: 50 mg/kg/dose IV every 12 hours until further debridement is not necessary, the patient has improved clinically, and fever has been absent for 48 to 72 hours. Cefotaxime is recommended for mixed infections plus metronidazole or clindamycin.
Neonates younger than 32 weeks gestation and 7 days and older: 50 mg/kg/dose IV every 8 hours until further debridement is not necessary, the patient has improved clinically, and fever has been absent for 48 to 72 hours. Cefotaxime is recommended as for mixed infections plus metronidazole or clindamycin.
Neonates younger than 32 weeks gestation and 0 to 6 days: 50 mg/kg/dose IV every 12 hours until further debridement is not necessary, the patient has improved clinically, and fever has been absent for 48 to 72 hours. Cefotaxime is recommended for mixed infections plus metronidazole or clindamycin.
-for the treatment of animal bite wounds:
Intravenous dosage:
Adults: 1 to 2 g IV every 6 to 8 hours plus an anaerobic agent. In setting of a cat or dog bite, preemptive early antimicrobial therapy for 3 to 5 days is recommended for patients who are immunocompromised, asplenic, have advanced liver disease, have edema of the bite area, have moderate to severe injuries, particularly of the hand or face, or have penetrating injuries to the periosteum or joint capsule.
-for the treatment of diabetic foot ulcer:
Intravenous dosage:
Adults: 1 to 2 g IV every 8 hours for 7 to 14 days for moderate or severe infections in patients with recent antibiotic exposure or infections with no complicating features or with ischemic limb/necrosis/gas forming plus clindamycin or metronidazole. Continue treatment for up to 28 days if infection is improving but is extensive and resolving slower than expected or if patient has severe peripheral artery disease.
For the treatment of bone and joint infections, including osteomyelitis and infectious arthritis:
-for the treatment of osteomyelitis:
Intravenous dosage:
Adults: 2 g IV every 6 to 8 hours for 4 to 6 weeks.
Children and Adolescents weighing 50 kg or more: 2 g IV every 6 to 8 hours. Treat for 2 to 4 days or until clinically improved, followed by oral step-down therapy for a total duration of 3 to 4 weeks for uncomplicated cases. A longer course (i.e., 4 to 6 weeks or longer) may be needed for severe or complicated infections.
Children and Adolescents weighing less than 50 kg: 150 to 200 mg/kg/day (Max: 8 g/day) IV divided every 6 to 8 hours. Treat for 2 to 4 days or until clinically improved, followed by oral step-down therapy for a total duration of 3 to 4 weeks for uncomplicated cases. A longer course (i.e., 4 to 6 weeks or longer) may be needed for severe or complicated infections.
Infants 3 to 11 months: 150 to 200 mg/kg/day IV divided every 6 to 8 hours. Treat for 2 to 4 days or until clinically improved, followed by oral step-down therapy for a total duration of 3 to 4 weeks for uncomplicated cases. A longer course (i.e., 4 to 6 weeks or longer) may be needed for severe or complicated infections.
Infants 1 to 2 months: 150 to 200 mg/kg/day IV divided every 6 to 8 hours. Treat for 14 to 21 days or until clinically improved, followed by oral step-down therapy for a total duration of 4 to 6 weeks. A longer course (several months) may be needed for severe or complicated infections.
Neonates 32 weeks gestation and older and 8 days and older: 50 mg/kg/dose IV every 8 hours. Treat for 14 to 21 days or until clinically improved, followed by oral step-down therapy for a total duration of 4 to 6 weeks. A longer course (several months) may be needed for severe or complicated infections.
Neonates 32 weeks gestation and older and 0 to 7 days: 50 mg/kg/dose IV every 12 hours. Treat for 14 to 21 days or until clinically improved, followed by oral step-down therapy for a total duration of 4 to 6 weeks. A longer course (several months) may be needed for severe or complicated infections.
Neonates younger than 32 weeks gestation and 7 days and older: 50 mg/kg/dose IV every 8 hours. Treat for 14 to 21 days or until clinically improved, followed by oral step-down therapy for a total duration of 4 to 6 weeks. A longer course (several months) may be needed for severe or complicated infections.
Neonates younger than 32 weeks gestation and 0 to 6 days: 50 mg/kg/dose IV every 12 hours. Treat for 14 to 21 days or until clinically improved, followed by oral step-down therapy for a total duration of 4 to 6 weeks. A longer course (several months) may be needed for severe or complicated infections.
-for the treatment of infectious arthritis:
Intravenous dosage:
Adults: 2 g IV every 6 to 8 hours. Treat for 1 to 2 weeks or until clinically improved, followed by oral step-down therapy for 2 to 4 weeks.
Children and Adolescents weighing 50 kg or more: 2 g IV every 6 to 8 hours. Treat for 2 to 4 days or until clinically improved, followed by oral step-down therapy for a total duration of 2 to 3 weeks for uncomplicated cases. A longer course (i.e., 4 to 6 weeks or longer) may be needed for septic hip arthritis or severe or complicated infections.
Children and Adolescents weighing less than 50 kg: 150 to 200 mg/kg/day (Max: 8 g/day) IV divided every 6 to 8 hours. Treat for 2 to 4 days or until clinically improved, followed by oral step-down therapy for a total duration of 2 to 3 weeks for uncomplicated cases. A longer course (i.e., 4 to 6 weeks or longer) may be needed for septic hip arthritis or severe or complicated infections.
Infants 3 to 11 months: 150 to 200 mg/kg/day IV divided every 6 to 8 hours. Treat for 2 to 4 days or until clinically improved, followed by oral step-down therapy for a total duration of 2 to 3 weeks for uncomplicated cases. A longer course (i.e., 4 to 6 weeks or longer) may be needed for septic hip arthritis or severe or complicated infections.
Infants 1 to 2 months: 150 to 200 mg/kg/day IV divided every 6 to 8 hours. Treat for 14 to 21 days or until clinically improved, followed by oral step-down therapy for a total duration of 4 to 6 weeks. A longer course (several months) may be needed for severe or complicated infections.
Neonates 32 weeks gestation and older and 8 days and older: 50 mg/kg/dose IV every 8 hours. Treat for 14 to 21 days or until clinically improved, followed by oral step-down therapy for a total duration of 4 to 6 weeks. A longer course (several months) may be needed for severe or complicated infections.
Neonates 32 weeks gestation and older and 0 to 7 days: 50 mg/kg/dose IV every 12 hours. Treat for 14 to 21 days or until clinically improved, followed by oral step-down therapy for a total duration of 4 to 6 weeks. A longer course (several months) may be needed for severe or complicated infections.
Neonates younger than 32 weeks gestation and 7 days and older: 50 mg/kg/dose IV every 8 hours. Treat for 14 to 21 days or until clinically improved, followed by oral step-down therapy for a total duration of 4 to 6 weeks. A longer course (several months) may be needed for severe or complicated infections.
Neonates younger than 32 weeks gestation and 0 to 6 days: 50 mg/kg/dose IV every 12 hours. Treat for 14 to 21 days or until clinically improved, followed by oral step-down therapy for a total duration of 4 to 6 weeks. A longer course (several months) may be needed for severe or complicated infections.
For the treatment of gynecologic infections, including endometritis, pelvic cellulitis, pelvic inflammatory disease (PID), and tubo-ovarian abscess*:
Intravenous or Intramuscular dosage:
Adults: 1 to 2 g IV or IM every 8 hours for moderate to severe infections and 2 g IV every 6 to 8 hours for severe infections. Cefotaxime in combination with doxycycline may be effective for inpatient, intravenous treatment of PID; however, there is decreased anaerobic activity and the addition of metronidazole should be considered. Cefotaxime should be continued for at least 24 to 48 hours after clinical improvement, and then stepdown to oral doxycycline and metronidazole for a total of 14 days of therapy. Additionally, for outpatient PID therapy, cefotaxime may be administered IM with oral doxycycline and metronidazole for 14 days.
Children and Adolescents weighing 50 kg or more: 1 to 2 g IV or IM every 8 hours for moderate to severe infections and 2 g IV every 6 to 8 hours for severe infections. Cefotaxime in combination with doxycycline may be effective for inpatient, intravenous treatment of PID; however, there is decreased anaerobic activity and the addition of metronidazole should be considered. Cefotaxime should be continued for at least 24 to 48 hours after clinical improvement, and then stepdown to oral doxycycline and metronidazole for a total of 14 days of therapy. Additionally, for outpatient PID therapy, cefotaxime may be administered IM with oral doxycycline and metronidazole for 14 days.
For the treatment of infective endocarditis*:
Intravenous dosage:
Adults: 2 g IV every 6 to 8 hours for septicemia and 2 g IV every 4 hours for life-threatening infections are recommended in the FDA-approved labeling. Guidelines recommend cefotaxime as an alternate therapy for 4 weeks for native valve endocarditis (NVE) and for 6 weeks for prosthetic valve endocarditis (PVE) caused by HACEK microorganisms. In patients with penicillin-resistant streptococcal endocarditis with or without meningitis, high-dose cefotaxime is a reasonable option; if the isolate is cefotaxime-resistant, consider adding vancomycin and rifampin. Treat for 6 weeks for streptococcal PVE.
Children and Adolescents: 200 mg/kg/day IV divided every 6 hours (Max: 12 g/day). Guidelines recommend cefotaxime as a preferred therapy for 4 weeks for endocarditis caused by HACEK group organisms or for at least 6 weeks in combination with an aminoglycoside for other gram-negative microorganisms.
Infants: 150 to 180 mg/kg/day IV divided every 8 hours is the general dosage recommended by the American Academy of Pediatrics (AAP).
Neonates 32 weeks gestation and older and 8 days and older: 50 mg/kg/dose IV every 8 hours is the general dosage recommended by the American Academy of Pediatrics (AAP).
Neonates 32 weeks gestation and older and 0 to 7 days: 50 mg/kg/dose IV every 12 hours is the general dosage recommended by the American Academy of Pediatrics (AAP).
Neonates younger than 32 weeks gestation and 14 days and older: 50 mg/kg/dose IV every 8 hours is the general dosage recommended by the American Academy of Pediatrics (AAP).
Neonates younger than 32 weeks gestation and 0 to 13 days: 50 mg/kg/dose IV every 12 hours is the general dosage recommended by the American Academy of Pediatrics (AAP).
For gonorrhea prophylaxis* in high-risk neonates:
Intravenous or Intramuscular dosage:
Neonates: 100 mg/kg/dose IV or IM as a single dose for neonates unable to receive ceftriaxone and are at high risk for exposure (i.e., infants born to mothers at risk for gonococcal infection or with no prenatal care).
For the treatment of invasive vibriosis*:
Intravenous dosage:
Adults: 2 g IV every 8 hours in combination with doxycycline for 7 to 14 days.
Infants, Children, and Adolescents: 50 to 60 mg/kg/dose (Max: 2 g/dose) IV every 8 hours in combination with doxycycline for 7 to 14 days.
For the treatment of epiglottitis*:
Intravenous dosage:
Adults: 1 to 2 g IV every 8 hours for 5 to 10 days.
Infants, Children, and Adolescents: 150 to 200 mg/kg/day (Max: 8 g/day) IV divided every 6 to 8 hours for 5 to 10 days.
Maximum Dosage Limits:
-Adults
12 g/day IV/IM.
-Geriatric
12 g/day IV/IM.
-Adolescents
12 g/day IV/IM.
-Children
Weighing 50 kg or more: 12 g/day IV/IM.
Weighing less than 50 kg: 180 mg/kg/day IV/IM is FDA-approved maximum; however, doses up to 300 mg/kg/day (Max: 12 g/day) have been used off-label for meningitis.
-Infants
180 mg/kg/day IV/IM is FDA-approved maximum; however, doses up to 300 mg/kg/day have been used off-label for meningitis.
-Neonates
8 days and older: 150 mg/kg/day IV/IM is FDA-approved maximum; however, doses up to 200 mg/kg/day have been used off-label for meningitis.
0 to 7 days: 100 mg/kg/day IV/IM is FDA-approved maximum; however, doses up to 150 mg/kg/day have been used off-label for meningitis.
Patients with Hepatic Impairment Dosing
Cefotaxime is metabolized by the liver to an active metabolite, desacetylcefotaxime. Dosage adjustments in patients with hepatic impairment without concomitant renal insufficiency are usually not necessary since cefotaxime has a high therapeutic index. However, specific guidelines for dosage adjustment in patients with hepatic impairment are not available.
Patients with Renal Impairment Dosing
Adults
CrCl more than 20 mL/min: no dosage adjustment needed.
CrCl 20 mL/min or less: reduce recommended dose by 50%.
Pediatric patients
The following dose adjustments are based on a usual recommended dose in children of 100 to 200 mg/kg/day IV/IM divided every 8 hours.
CrCl more than 50 mL/min/1.73 m2: no dosage adjustment needed.
CrCl 30 to 50 mL/min/1.73 m2: 35 to 70 mg/kg/dose IV/IM every 8 to 12 hours.
CrCl 10 to 29 mL/min/1.73 m2: 35 to 70 mg/kg/dose IV/IM every 12 hours.
CrCl less than 10 mL/min/1.73 m2: 35 to 70 mg/kg/dose IV/IM every 24 hours.
Intermittent hemodialysis
Approximately 50% of the serum concentration of cefotaxime is removed during a standard hemodialysis session. Some clinicians recommend that 0.5 to 2 g be given as single daily doses and that a supplemental dose of cefotaxime be given after each hemodialysis session. For pediatric patients, the recommended dose is 35 to 70 mg/kg/dose IV/IM every 24 hours, given after hemodialysis on dialysis days.
Peritoneal dialysis
For adult patients, give 1 g IV/IM every 24 hours. For pediatric patients, the recommended dose is 35 to 70 mg/kg/dose IV/IM every 24 hours.
Continuous renal replacement therapy (CRRT)
For adult patients, give 1 g IV/IM every 12 hours. For pediatric patients, the recommended dose is 35 to 70 mg/kg/dose IV/IM every 12 hours.
*non-FDA-approved indication
Acetaminophen; Ibuprofen: (Minor) Cefotaxime's product label states that cephalosporins may potentiate the adverse renal effects of nephrotoxic agents, such as aminoglycosides, nonsteroidal antiinflammatory drugs (NSAIDs), and loop diuretics. Carefully monitor renal function, especially during prolonged therapy or use of high aminoglycoside doses. The majority of reported cases involve the combination of aminoglycosides and cephalothin or cephaloridine, which are associated with dose-related nephrotoxicity as singular agents. Limited but conflicting data with other cephalosporins have been noted.
Amikacin: (Minor) Cefotaxime's product label states that cephalosporins may potentiate the adverse renal effects of nephrotoxic agents, such as aminoglycosides and loop diuretics. Carefully monitor renal function, especially during prolonged therapy or use of high aminoglycoside doses. The majority of reported cases involve the combination of aminoglycosides and cephalothin or cephaloridine, which are associated with dose-related nephrotoxicity as singular agents. Limited but conflicting data with other cephalosporins have been noted.
Aminoglycosides: (Minor) Cefotaxime's product label states that cephalosporins may potentiate the adverse renal effects of nephrotoxic agents, such as aminoglycosides and loop diuretics. Carefully monitor renal function, especially during prolonged therapy or use of high aminoglycoside doses. The majority of reported cases involve the combination of aminoglycosides and cephalothin or cephaloridine, which are associated with dose-related nephrotoxicity as singular agents. Limited but conflicting data with other cephalosporins have been noted.
Amlodipine; Celecoxib: (Minor) Cefotaxime's product label states that cephalosporins may potentiate the adverse renal effects of nephrotoxic agents, such as aminoglycosides, nonsteroidal antiinflammatory drugs (NSAIDs), and loop diuretics. Carefully monitor renal function, especially during prolonged therapy or use of high aminoglycoside doses. The majority of reported cases involve the combination of aminoglycosides and cephalothin or cephaloridine, which are associated with dose-related nephrotoxicity as singular agents. Limited but conflicting data with other cephalosporins have been noted.
Bumetanide: (Minor) Nephrotoxicity associated with cephalosporins may be potentiated by concomitant therapy with loop diuretics. Clinicians should be aware that this may occur even in patients with minor or transient renal impairment.
Bupivacaine; Meloxicam: (Minor) Cefotaxime's product label states that cephalosporins may potentiate the adverse renal effects of nephrotoxic agents, such as aminoglycosides, nonsteroidal antiinflammatory drugs (NSAIDs), and loop diuretics. Carefully monitor renal function, especially during prolonged therapy or use of high aminoglycoside doses. The majority of reported cases involve the combination of aminoglycosides and cephalothin or cephaloridine, which are associated with dose-related nephrotoxicity as singular agents. Limited but conflicting data with other cephalosporins have been noted.
Celecoxib: (Minor) Cefotaxime's product label states that cephalosporins may potentiate the adverse renal effects of nephrotoxic agents, such as aminoglycosides, nonsteroidal antiinflammatory drugs (NSAIDs), and loop diuretics. Carefully monitor renal function, especially during prolonged therapy or use of high aminoglycoside doses. The majority of reported cases involve the combination of aminoglycosides and cephalothin or cephaloridine, which are associated with dose-related nephrotoxicity as singular agents. Limited but conflicting data with other cephalosporins have been noted.
Celecoxib; Tramadol: (Minor) Cefotaxime's product label states that cephalosporins may potentiate the adverse renal effects of nephrotoxic agents, such as aminoglycosides, nonsteroidal antiinflammatory drugs (NSAIDs), and loop diuretics. Carefully monitor renal function, especially during prolonged therapy or use of high aminoglycoside doses. The majority of reported cases involve the combination of aminoglycosides and cephalothin or cephaloridine, which are associated with dose-related nephrotoxicity as singular agents. Limited but conflicting data with other cephalosporins have been noted.
Chlorpheniramine; Ibuprofen; Pseudoephedrine: (Minor) Cefotaxime's product label states that cephalosporins may potentiate the adverse renal effects of nephrotoxic agents, such as aminoglycosides, nonsteroidal antiinflammatory drugs (NSAIDs), and loop diuretics. Carefully monitor renal function, especially during prolonged therapy or use of high aminoglycoside doses. The majority of reported cases involve the combination of aminoglycosides and cephalothin or cephaloridine, which are associated with dose-related nephrotoxicity as singular agents. Limited but conflicting data with other cephalosporins have been noted.
Desogestrel; Ethinyl Estradiol: (Moderate) It would be prudent to recommend alternative or additional contraception when oral contraceptives (OCs) are used in conjunction with antibiotics. It was previously thought that antibiotics may decrease the effectiveness of OCs containing estrogens due to stimulation of metabolism or a reduction in enterohepatic circulation via changes in GI flora. One retrospective study reviewed the literature to determine the effects of oral antibiotics on the pharmacokinetics of contraceptive estrogens and progestins, and also examined clinical studies in which the incidence of pregnancy with OCs and antibiotics was reported. It was concluded that the antibiotics ampicillin, ciprofloxacin, clarithromycin, doxycycline, metronidazole, ofloxacin, roxithromycin, temafloxacin, and tetracycline did not alter plasma concentrations of OCs. Antituberculous drugs (e.g., rifampin) were the only agents associated with OC failure and pregnancy. Based on the study results, these authors recommended that back-up contraception may not be necessary if OCs are used reliably during oral antibiotic use. Another review concurred with these data, but noted that individual patients have been identified who experienced significant decreases in plasma concentrations of combined OC components and who appeared to ovulate; the agents most often associated with these changes were rifampin, tetracyclines, and penicillin derivatives. These authors concluded that because females most at risk for OC failure or noncompliance may not be easily identified and the true incidence of such events may be under-reported, and given the serious consequence of unwanted pregnancy, that recommending an additional method of contraception during short-term antibiotic use may be justified. During long-term antibiotic administration, the risk for drug interaction with OCs is less clear, but alternative or additional contraception may be advisable in selected circumstances. Data regarding progestin-only contraceptives or for newer combined contraceptive deliveries (e.g., patches, rings) are not available.
Diclofenac: (Minor) Cefotaxime's product label states that cephalosporins may potentiate the adverse renal effects of nephrotoxic agents, such as aminoglycosides, nonsteroidal antiinflammatory drugs (NSAIDs), and loop diuretics. Carefully monitor renal function, especially during prolonged therapy or use of high aminoglycoside doses. The majority of reported cases involve the combination of aminoglycosides and cephalothin or cephaloridine, which are associated with dose-related nephrotoxicity as singular agents. Limited but conflicting data with other cephalosporins have been noted.
Diclofenac; Misoprostol: (Minor) Cefotaxime's product label states that cephalosporins may potentiate the adverse renal effects of nephrotoxic agents, such as aminoglycosides, nonsteroidal antiinflammatory drugs (NSAIDs), and loop diuretics. Carefully monitor renal function, especially during prolonged therapy or use of high aminoglycoside doses. The majority of reported cases involve the combination of aminoglycosides and cephalothin or cephaloridine, which are associated with dose-related nephrotoxicity as singular agents. Limited but conflicting data with other cephalosporins have been noted.
Dienogest; Estradiol valerate: (Moderate) It would be prudent to recommend alternative or additional contraception when oral contraceptives (OCs) are used in conjunction with antibiotics. It was previously thought that antibiotics may decrease the effectiveness of OCs containing estrogens due to stimulation of metabolism or a reduction in enterohepatic circulation via changes in GI flora. One retrospective study reviewed the literature to determine the effects of oral antibiotics on the pharmacokinetics of contraceptive estrogens and progestins, and also examined clinical studies in which the incidence of pregnancy with OCs and antibiotics was reported. It was concluded that the antibiotics ampicillin, ciprofloxacin, clarithromycin, doxycycline, metronidazole, ofloxacin, roxithromycin, temafloxacin, and tetracycline did not alter plasma concentrations of OCs. Antituberculous drugs (e.g., rifampin) were the only agents associated with OC failure and pregnancy. Based on the study results, these authors recommended that back-up contraception may not be necessary if OCs are used reliably during oral antibiotic use. Another review concurred with these data, but noted that individual patients have been identified who experienced significant decreases in plasma concentrations of combined OC components and who appeared to ovulate; the agents most often associated with these changes were rifampin, tetracyclines, and penicillin derivatives. These authors concluded that because females most at risk for OC failure or noncompliance may not be easily identified and the true incidence of such events may be under-reported, and given the serious consequence of unwanted pregnancy, that recommending an additional method of contraception during short-term antibiotic use may be justified. During long-term antibiotic administration, the risk for drug interaction with OCs is less clear, but alternative or additional contraception may be advisable in selected circumstances. Data regarding progestin-only contraceptives or for newer combined contraceptive deliveries (e.g., patches, rings) are not available.
Diflunisal: (Minor) Cefotaxime's product label states that cephalosporins may potentiate the adverse renal effects of nephrotoxic agents, such as aminoglycosides, nonsteroidal antiinflammatory drugs (NSAIDs), and loop diuretics. Carefully monitor renal function, especially during prolonged therapy or use of high aminoglycoside doses. The majority of reported cases involve the combination of aminoglycosides and cephalothin or cephaloridine, which are associated with dose-related nephrotoxicity as singular agents. Limited but conflicting data with other cephalosporins have been noted.
Diphenhydramine; Ibuprofen: (Minor) Cefotaxime's product label states that cephalosporins may potentiate the adverse renal effects of nephrotoxic agents, such as aminoglycosides, nonsteroidal antiinflammatory drugs (NSAIDs), and loop diuretics. Carefully monitor renal function, especially during prolonged therapy or use of high aminoglycoside doses. The majority of reported cases involve the combination of aminoglycosides and cephalothin or cephaloridine, which are associated with dose-related nephrotoxicity as singular agents. Limited but conflicting data with other cephalosporins have been noted.
Diphenhydramine; Naproxen: (Minor) Cefotaxime's product label states that cephalosporins may potentiate the adverse renal effects of nephrotoxic agents, such as aminoglycosides, nonsteroidal antiinflammatory drugs (NSAIDs), and loop diuretics. Carefully monitor renal function, especially during prolonged therapy or use of high aminoglycoside doses. The majority of reported cases involve the combination of aminoglycosides and cephalothin or cephaloridine, which are associated with dose-related nephrotoxicity as singular agents. Limited but conflicting data with other cephalosporins have been noted.
Drospirenone: (Moderate) It would be prudent to recommend alternative or additional contraception when oral contraceptives (OCs) are used in conjunction with antibiotics. It was previously thought that antibiotics may decrease the effectiveness of OCs containing estrogens due to stimulation of metabolism or a reduction in enterohepatic circulation via changes in GI flora. One retrospective study reviewed the literature to determine the effects of oral antibiotics on the pharmacokinetics of contraceptive estrogens and progestins, and also examined clinical studies in which the incidence of pregnancy with OCs and antibiotics was reported. It was concluded that the antibiotics ampicillin, ciprofloxacin, clarithromycin, doxycycline, metronidazole, ofloxacin, roxithromycin, temafloxacin, and tetracycline did not alter plasma concentrations of OCs. Antituberculous drugs (e.g., rifampin) were the only agents associated with OC failure and pregnancy. Based on the study results, these authors recommended that back-up contraception may not be necessary if OCs are used reliably during oral antibiotic use. Another review concurred with these data, but noted that individual patients have been identified who experienced significant decreases in plasma concentrations of combined OC components and who appeared to ovulate; the agents most often associated with these changes were rifampin, tetracyclines, and penicillin derivatives. These authors concluded that because females most at risk for OC failure or noncompliance may not be easily identified and the true incidence of such events may be under-reported, and given the serious consequence of unwanted pregnancy, that recommending an additional method of contraception during short-term antibiotic use may be justified. During long-term antibiotic administration, the risk for drug interaction with OCs is less clear, but alternative or additional contraception may be advisable in selected circumstances. Data regarding progestin-only contraceptives or for newer combined contraceptive deliveries (e.g., patches, rings) are not available.
Drospirenone; Estetrol: (Moderate) It would be prudent to recommend alternative or additional contraception when oral contraceptives (OCs) are used in conjunction with antibiotics. It was previously thought that antibiotics may decrease the effectiveness of OCs containing estrogens due to stimulation of metabolism or a reduction in enterohepatic circulation via changes in GI flora. One retrospective study reviewed the literature to determine the effects of oral antibiotics on the pharmacokinetics of contraceptive estrogens and progestins, and also examined clinical studies in which the incidence of pregnancy with OCs and antibiotics was reported. It was concluded that the antibiotics ampicillin, ciprofloxacin, clarithromycin, doxycycline, metronidazole, ofloxacin, roxithromycin, temafloxacin, and tetracycline did not alter plasma concentrations of OCs. Antituberculous drugs (e.g., rifampin) were the only agents associated with OC failure and pregnancy. Based on the study results, these authors recommended that back-up contraception may not be necessary if OCs are used reliably during oral antibiotic use. Another review concurred with these data, but noted that individual patients have been identified who experienced significant decreases in plasma concentrations of combined OC components and who appeared to ovulate; the agents most often associated with these changes were rifampin, tetracyclines, and penicillin derivatives. These authors concluded that because females most at risk for OC failure or noncompliance may not be easily identified and the true incidence of such events may be under-reported, and given the serious consequence of unwanted pregnancy, that recommending an additional method of contraception during short-term antibiotic use may be justified. During long-term antibiotic administration, the risk for drug interaction with OCs is less clear, but alternative or additional contraception may be advisable in selected circumstances. Data regarding progestin-only contraceptives or for newer combined contraceptive deliveries (e.g., patches, rings) are not available.
Drospirenone; Estradiol: (Moderate) It would be prudent to recommend alternative or additional contraception when oral contraceptives (OCs) are used in conjunction with antibiotics. It was previously thought that antibiotics may decrease the effectiveness of OCs containing estrogens due to stimulation of metabolism or a reduction in enterohepatic circulation via changes in GI flora. One retrospective study reviewed the literature to determine the effects of oral antibiotics on the pharmacokinetics of contraceptive estrogens and progestins, and also examined clinical studies in which the incidence of pregnancy with OCs and antibiotics was reported. It was concluded that the antibiotics ampicillin, ciprofloxacin, clarithromycin, doxycycline, metronidazole, ofloxacin, roxithromycin, temafloxacin, and tetracycline did not alter plasma concentrations of OCs. Antituberculous drugs (e.g., rifampin) were the only agents associated with OC failure and pregnancy. Based on the study results, these authors recommended that back-up contraception may not be necessary if OCs are used reliably during oral antibiotic use. Another review concurred with these data, but noted that individual patients have been identified who experienced significant decreases in plasma concentrations of combined OC components and who appeared to ovulate; the agents most often associated with these changes were rifampin, tetracyclines, and penicillin derivatives. These authors concluded that because females most at risk for OC failure or noncompliance may not be easily identified and the true incidence of such events may be under-reported, and given the serious consequence of unwanted pregnancy, that recommending an additional method of contraception during short-term antibiotic use may be justified. During long-term antibiotic administration, the risk for drug interaction with OCs is less clear, but alternative or additional contraception may be advisable in selected circumstances. Data regarding progestin-only contraceptives or for newer combined contraceptive deliveries (e.g., patches, rings) are not available.
Drospirenone; Ethinyl Estradiol: (Moderate) It would be prudent to recommend alternative or additional contraception when oral contraceptives (OCs) are used in conjunction with antibiotics. It was previously thought that antibiotics may decrease the effectiveness of OCs containing estrogens due to stimulation of metabolism or a reduction in enterohepatic circulation via changes in GI flora. One retrospective study reviewed the literature to determine the effects of oral antibiotics on the pharmacokinetics of contraceptive estrogens and progestins, and also examined clinical studies in which the incidence of pregnancy with OCs and antibiotics was reported. It was concluded that the antibiotics ampicillin, ciprofloxacin, clarithromycin, doxycycline, metronidazole, ofloxacin, roxithromycin, temafloxacin, and tetracycline did not alter plasma concentrations of OCs. Antituberculous drugs (e.g., rifampin) were the only agents associated with OC failure and pregnancy. Based on the study results, these authors recommended that back-up contraception may not be necessary if OCs are used reliably during oral antibiotic use. Another review concurred with these data, but noted that individual patients have been identified who experienced significant decreases in plasma concentrations of combined OC components and who appeared to ovulate; the agents most often associated with these changes were rifampin, tetracyclines, and penicillin derivatives. These authors concluded that because females most at risk for OC failure or noncompliance may not be easily identified and the true incidence of such events may be under-reported, and given the serious consequence of unwanted pregnancy, that recommending an additional method of contraception during short-term antibiotic use may be justified. During long-term antibiotic administration, the risk for drug interaction with OCs is less clear, but alternative or additional contraception may be advisable in selected circumstances. Data regarding progestin-only contraceptives or for newer combined contraceptive deliveries (e.g., patches, rings) are not available.
Drospirenone; Ethinyl Estradiol; Levomefolate: (Moderate) It would be prudent to recommend alternative or additional contraception when oral contraceptives (OCs) are used in conjunction with antibiotics. It was previously thought that antibiotics may decrease the effectiveness of OCs containing estrogens due to stimulation of metabolism or a reduction in enterohepatic circulation via changes in GI flora. One retrospective study reviewed the literature to determine the effects of oral antibiotics on the pharmacokinetics of contraceptive estrogens and progestins, and also examined clinical studies in which the incidence of pregnancy with OCs and antibiotics was reported. It was concluded that the antibiotics ampicillin, ciprofloxacin, clarithromycin, doxycycline, metronidazole, ofloxacin, roxithromycin, temafloxacin, and tetracycline did not alter plasma concentrations of OCs. Antituberculous drugs (e.g., rifampin) were the only agents associated with OC failure and pregnancy. Based on the study results, these authors recommended that back-up contraception may not be necessary if OCs are used reliably during oral antibiotic use. Another review concurred with these data, but noted that individual patients have been identified who experienced significant decreases in plasma concentrations of combined OC components and who appeared to ovulate; the agents most often associated with these changes were rifampin, tetracyclines, and penicillin derivatives. These authors concluded that because females most at risk for OC failure or noncompliance may not be easily identified and the true incidence of such events may be under-reported, and given the serious consequence of unwanted pregnancy, that recommending an additional method of contraception during short-term antibiotic use may be justified. During long-term antibiotic administration, the risk for drug interaction with OCs is less clear, but alternative or additional contraception may be advisable in selected circumstances. Data regarding progestin-only contraceptives or for newer combined contraceptive deliveries (e.g., patches, rings) are not available.
Elagolix; Estradiol; Norethindrone acetate: (Moderate) It would be prudent to recommend alternative or additional contraception when oral contraceptives (OCs) are used in conjunction with antibiotics. It was previously thought that antibiotics may decrease the effectiveness of OCs containing estrogens due to stimulation of metabolism or a reduction in enterohepatic circulation via changes in GI flora. One retrospective study reviewed the literature to determine the effects of oral antibiotics on the pharmacokinetics of contraceptive estrogens and progestins, and also examined clinical studies in which the incidence of pregnancy with OCs and antibiotics was reported. It was concluded that the antibiotics ampicillin, ciprofloxacin, clarithromycin, doxycycline, metronidazole, ofloxacin, roxithromycin, temafloxacin, and tetracycline did not alter plasma concentrations of OCs. Antituberculous drugs (e.g., rifampin) were the only agents associated with OC failure and pregnancy. Based on the study results, these authors recommended that back-up contraception may not be necessary if OCs are used reliably during oral antibiotic use. Another review concurred with these data, but noted that individual patients have been identified who experienced significant decreases in plasma concentrations of combined OC components and who appeared to ovulate; the agents most often associated with these changes were rifampin, tetracyclines, and penicillin derivatives. These authors concluded that because females most at risk for OC failure or noncompliance may not be easily identified and the true incidence of such events may be under-reported, and given the serious consequence of unwanted pregnancy, that recommending an additional method of contraception during short-term antibiotic use may be justified. During long-term antibiotic administration, the risk for drug interaction with OCs is less clear, but alternative or additional contraception may be advisable in selected circumstances. Data regarding progestin-only contraceptives or for newer combined contraceptive deliveries (e.g., patches, rings) are not available.
Estradiol; Levonorgestrel: (Moderate) It would be prudent to recommend alternative or additional contraception when oral contraceptives (OCs) are used in conjunction with antibiotics. It was previously thought that antibiotics may decrease the effectiveness of OCs containing estrogens due to stimulation of metabolism or a reduction in enterohepatic circulation via changes in GI flora. One retrospective study reviewed the literature to determine the effects of oral antibiotics on the pharmacokinetics of contraceptive estrogens and progestins, and also examined clinical studies in which the incidence of pregnancy with OCs and antibiotics was reported. It was concluded that the antibiotics ampicillin, ciprofloxacin, clarithromycin, doxycycline, metronidazole, ofloxacin, roxithromycin, temafloxacin, and tetracycline did not alter plasma concentrations of OCs. Antituberculous drugs (e.g., rifampin) were the only agents associated with OC failure and pregnancy. Based on the study results, these authors recommended that back-up contraception may not be necessary if OCs are used reliably during oral antibiotic use. Another review concurred with these data, but noted that individual patients have been identified who experienced significant decreases in plasma concentrations of combined OC components and who appeared to ovulate; the agents most often associated with these changes were rifampin, tetracyclines, and penicillin derivatives. These authors concluded that because females most at risk for OC failure or noncompliance may not be easily identified and the true incidence of such events may be under-reported, and given the serious consequence of unwanted pregnancy, that recommending an additional method of contraception during short-term antibiotic use may be justified. During long-term antibiotic administration, the risk for drug interaction with OCs is less clear, but alternative or additional contraception may be advisable in selected circumstances. Data regarding progestin-only contraceptives or for newer combined contraceptive deliveries (e.g., patches, rings) are not available.
Estradiol; Norethindrone: (Moderate) It would be prudent to recommend alternative or additional contraception when oral contraceptives (OCs) are used in conjunction with antibiotics. It was previously thought that antibiotics may decrease the effectiveness of OCs containing estrogens due to stimulation of metabolism or a reduction in enterohepatic circulation via changes in GI flora. One retrospective study reviewed the literature to determine the effects of oral antibiotics on the pharmacokinetics of contraceptive estrogens and progestins, and also examined clinical studies in which the incidence of pregnancy with OCs and antibiotics was reported. It was concluded that the antibiotics ampicillin, ciprofloxacin, clarithromycin, doxycycline, metronidazole, ofloxacin, roxithromycin, temafloxacin, and tetracycline did not alter plasma concentrations of OCs. Antituberculous drugs (e.g., rifampin) were the only agents associated with OC failure and pregnancy. Based on the study results, these authors recommended that back-up contraception may not be necessary if OCs are used reliably during oral antibiotic use. Another review concurred with these data, but noted that individual patients have been identified who experienced significant decreases in plasma concentrations of combined OC components and who appeared to ovulate; the agents most often associated with these changes were rifampin, tetracyclines, and penicillin derivatives. These authors concluded that because females most at risk for OC failure or noncompliance may not be easily identified and the true incidence of such events may be under-reported, and given the serious consequence of unwanted pregnancy, that recommending an additional method of contraception during short-term antibiotic use may be justified. During long-term antibiotic administration, the risk for drug interaction with OCs is less clear, but alternative or additional contraception may be advisable in selected circumstances. Data regarding progestin-only contraceptives or for newer combined contraceptive deliveries (e.g., patches, rings) are not available.
Estradiol; Norgestimate: (Moderate) It would be prudent to recommend alternative or additional contraception when oral contraceptives (OCs) are used in conjunction with antibiotics. It was previously thought that antibiotics may decrease the effectiveness of OCs containing estrogens due to stimulation of metabolism or a reduction in enterohepatic circulation via changes in GI flora. One retrospective study reviewed the literature to determine the effects of oral antibiotics on the pharmacokinetics of contraceptive estrogens and progestins, and also examined clinical studies in which the incidence of pregnancy with OCs and antibiotics was reported. It was concluded that the antibiotics ampicillin, ciprofloxacin, clarithromycin, doxycycline, metronidazole, ofloxacin, roxithromycin, temafloxacin, and tetracycline did not alter plasma concentrations of OCs. Antituberculous drugs (e.g., rifampin) were the only agents associated with OC failure and pregnancy. Based on the study results, these authors recommended that back-up contraception may not be necessary if OCs are used reliably during oral antibiotic use. Another review concurred with these data, but noted that individual patients have been identified who experienced significant decreases in plasma concentrations of combined OC components and who appeared to ovulate; the agents most often associated with these changes were rifampin, tetracyclines, and penicillin derivatives. These authors concluded that because females most at risk for OC failure or noncompliance may not be easily identified and the true incidence of such events may be under-reported, and given the serious consequence of unwanted pregnancy, that recommending an additional method of contraception during short-term antibiotic use may be justified. During long-term antibiotic administration, the risk for drug interaction with OCs is less clear, but alternative or additional contraception may be advisable in selected circumstances. Data regarding progestin-only contraceptives or for newer combined contraceptive deliveries (e.g., patches, rings) are not available.
Ethacrynic Acid: (Minor) Nephrotoxicity associated with cephalosporins may be potentiated by concomitant therapy with loop diuretics. Clinicians should be aware that this may occur even in patients with minor or transient renal impairment.
Ethinyl Estradiol; Norelgestromin: (Moderate) It would be prudent to recommend alternative or additional contraception when oral contraceptives (OCs) are used in conjunction with antibiotics. It was previously thought that antibiotics may decrease the effectiveness of OCs containing estrogens due to stimulation of metabolism or a reduction in enterohepatic circulation via changes in GI flora. One retrospective study reviewed the literature to determine the effects of oral antibiotics on the pharmacokinetics of contraceptive estrogens and progestins, and also examined clinical studies in which the incidence of pregnancy with OCs and antibiotics was reported. It was concluded that the antibiotics ampicillin, ciprofloxacin, clarithromycin, doxycycline, metronidazole, ofloxacin, roxithromycin, temafloxacin, and tetracycline did not alter plasma concentrations of OCs. Antituberculous drugs (e.g., rifampin) were the only agents associated with OC failure and pregnancy. Based on the study results, these authors recommended that back-up contraception may not be necessary if OCs are used reliably during oral antibiotic use. Another review concurred with these data, but noted that individual patients have been identified who experienced significant decreases in plasma concentrations of combined OC components and who appeared to ovulate; the agents most often associated with these changes were rifampin, tetracyclines, and penicillin derivatives. These authors concluded that because females most at risk for OC failure or noncompliance may not be easily identified and the true incidence of such events may be under-reported, and given the serious consequence of unwanted pregnancy, that recommending an additional method of contraception during short-term antibiotic use may be justified. During long-term antibiotic administration, the risk for drug interaction with OCs is less clear, but alternative or additional contraception may be advisable in selected circumstances. Data regarding progestin-only contraceptives or for newer combined contraceptive deliveries (e.g., patches, rings) are not available.
Ethinyl Estradiol; Norethindrone Acetate: (Moderate) It would be prudent to recommend alternative or additional contraception when oral contraceptives (OCs) are used in conjunction with antibiotics. It was previously thought that antibiotics may decrease the effectiveness of OCs containing estrogens due to stimulation of metabolism or a reduction in enterohepatic circulation via changes in GI flora. One retrospective study reviewed the literature to determine the effects of oral antibiotics on the pharmacokinetics of contraceptive estrogens and progestins, and also examined clinical studies in which the incidence of pregnancy with OCs and antibiotics was reported. It was concluded that the antibiotics ampicillin, ciprofloxacin, clarithromycin, doxycycline, metronidazole, ofloxacin, roxithromycin, temafloxacin, and tetracycline did not alter plasma concentrations of OCs. Antituberculous drugs (e.g., rifampin) were the only agents associated with OC failure and pregnancy. Based on the study results, these authors recommended that back-up contraception may not be necessary if OCs are used reliably during oral antibiotic use. Another review concurred with these data, but noted that individual patients have been identified who experienced significant decreases in plasma concentrations of combined OC components and who appeared to ovulate; the agents most often associated with these changes were rifampin, tetracyclines, and penicillin derivatives. These authors concluded that because females most at risk for OC failure or noncompliance may not be easily identified and the true incidence of such events may be under-reported, and given the serious consequence of unwanted pregnancy, that recommending an additional method of contraception during short-term antibiotic use may be justified. During long-term antibiotic administration, the risk for drug interaction with OCs is less clear, but alternative or additional contraception may be advisable in selected circumstances. Data regarding progestin-only contraceptives or for newer combined contraceptive deliveries (e.g., patches, rings) are not available.
Ethinyl Estradiol; Norgestrel: (Moderate) It would be prudent to recommend alternative or additional contraception when oral contraceptives (OCs) are used in conjunction with antibiotics. It was previously thought that antibiotics may decrease the effectiveness of OCs containing estrogens due to stimulation of metabolism or a reduction in enterohepatic circulation via changes in GI flora. One retrospective study reviewed the literature to determine the effects of oral antibiotics on the pharmacokinetics of contraceptive estrogens and progestins, and also examined clinical studies in which the incidence of pregnancy with OCs and antibiotics was reported. It was concluded that the antibiotics ampicillin, ciprofloxacin, clarithromycin, doxycycline, metronidazole, ofloxacin, roxithromycin, temafloxacin, and tetracycline did not alter plasma concentrations of OCs. Antituberculous drugs (e.g., rifampin) were the only agents associated with OC failure and pregnancy. Based on the study results, these authors recommended that back-up contraception may not be necessary if OCs are used reliably during oral antibiotic use. Another review concurred with these data, but noted that individual patients have been identified who experienced significant decreases in plasma concentrations of combined OC components and who appeared to ovulate; the agents most often associated with these changes were rifampin, tetracyclines, and penicillin derivatives. These authors concluded that because females most at risk for OC failure or noncompliance may not be easily identified and the true incidence of such events may be under-reported, and given the serious consequence of unwanted pregnancy, that recommending an additional method of contraception during short-term antibiotic use may be justified. During long-term antibiotic administration, the risk for drug interaction with OCs is less clear, but alternative or additional contraception may be advisable in selected circumstances. Data regarding progestin-only contraceptives or for newer combined contraceptive deliveries (e.g., patches, rings) are not available.
Ethynodiol Diacetate; Ethinyl Estradiol: (Moderate) It would be prudent to recommend alternative or additional contraception when oral contraceptives (OCs) are used in conjunction with antibiotics. It was previously thought that antibiotics may decrease the effectiveness of OCs containing estrogens due to stimulation of metabolism or a reduction in enterohepatic circulation via changes in GI flora. One retrospective study reviewed the literature to determine the effects of oral antibiotics on the pharmacokinetics of contraceptive estrogens and progestins, and also examined clinical studies in which the incidence of pregnancy with OCs and antibiotics was reported. It was concluded that the antibiotics ampicillin, ciprofloxacin, clarithromycin, doxycycline, metronidazole, ofloxacin, roxithromycin, temafloxacin, and tetracycline did not alter plasma concentrations of OCs. Antituberculous drugs (e.g., rifampin) were the only agents associated with OC failure and pregnancy. Based on the study results, these authors recommended that back-up contraception may not be necessary if OCs are used reliably during oral antibiotic use. Another review concurred with these data, but noted that individual patients have been identified who experienced significant decreases in plasma concentrations of combined OC components and who appeared to ovulate; the agents most often associated with these changes were rifampin, tetracyclines, and penicillin derivatives. These authors concluded that because females most at risk for OC failure or noncompliance may not be easily identified and the true incidence of such events may be under-reported, and given the serious consequence of unwanted pregnancy, that recommending an additional method of contraception during short-term antibiotic use may be justified. During long-term antibiotic administration, the risk for drug interaction with OCs is less clear, but alternative or additional contraception may be advisable in selected circumstances. Data regarding progestin-only contraceptives or for newer combined contraceptive deliveries (e.g., patches, rings) are not available.
Etodolac: (Minor) Cefotaxime's product label states that cephalosporins may potentiate the adverse renal effects of nephrotoxic agents, such as aminoglycosides, nonsteroidal antiinflammatory drugs (NSAIDs), and loop diuretics. Carefully monitor renal function, especially during prolonged therapy or use of high aminoglycoside doses. The majority of reported cases involve the combination of aminoglycosides and cephalothin or cephaloridine, which are associated with dose-related nephrotoxicity as singular agents. Limited but conflicting data with other cephalosporins have been noted.
Etonogestrel; Ethinyl Estradiol: (Moderate) It would be prudent to recommend alternative or additional contraception when oral contraceptives (OCs) are used in conjunction with antibiotics. It was previously thought that antibiotics may decrease the effectiveness of OCs containing estrogens due to stimulation of metabolism or a reduction in enterohepatic circulation via changes in GI flora. One retrospective study reviewed the literature to determine the effects of oral antibiotics on the pharmacokinetics of contraceptive estrogens and progestins, and also examined clinical studies in which the incidence of pregnancy with OCs and antibiotics was reported. It was concluded that the antibiotics ampicillin, ciprofloxacin, clarithromycin, doxycycline, metronidazole, ofloxacin, roxithromycin, temafloxacin, and tetracycline did not alter plasma concentrations of OCs. Antituberculous drugs (e.g., rifampin) were the only agents associated with OC failure and pregnancy. Based on the study results, these authors recommended that back-up contraception may not be necessary if OCs are used reliably during oral antibiotic use. Another review concurred with these data, but noted that individual patients have been identified who experienced significant decreases in plasma concentrations of combined OC components and who appeared to ovulate; the agents most often associated with these changes were rifampin, tetracyclines, and penicillin derivatives. These authors concluded that because females most at risk for OC failure or noncompliance may not be easily identified and the true incidence of such events may be under-reported, and given the serious consequence of unwanted pregnancy, that recommending an additional method of contraception during short-term antibiotic use may be justified. During long-term antibiotic administration, the risk for drug interaction with OCs is less clear, but alternative or additional contraception may be advisable in selected circumstances. Data regarding progestin-only contraceptives or for newer combined contraceptive deliveries (e.g., patches, rings) are not available.
Fenoprofen: (Minor) Cefotaxime's product label states that cephalosporins may potentiate the adverse renal effects of nephrotoxic agents, such as aminoglycosides, nonsteroidal antiinflammatory drugs (NSAIDs), and loop diuretics. Carefully monitor renal function, especially during prolonged therapy or use of high aminoglycoside doses. The majority of reported cases involve the combination of aminoglycosides and cephalothin or cephaloridine, which are associated with dose-related nephrotoxicity as singular agents. Limited but conflicting data with other cephalosporins have been noted.
Flurbiprofen: (Minor) Cefotaxime's product label states that cephalosporins may potentiate the adverse renal effects of nephrotoxic agents, such as aminoglycosides, nonsteroidal antiinflammatory drugs (NSAIDs), and loop diuretics. Carefully monitor renal function, especially during prolonged therapy or use of high aminoglycoside doses. The majority of reported cases involve the combination of aminoglycosides and cephalothin or cephaloridine, which are associated with dose-related nephrotoxicity as singular agents. Limited but conflicting data with other cephalosporins have been noted.
Furosemide: (Minor) Nephrotoxicity associated with cephalosporins may be potentiated by concomitant therapy with loop diuretics. Clinicians should be aware that this may occur even in patients with minor or transient renal impairment.
Gentamicin: (Minor) Cefotaxime's product label states that cephalosporins may potentiate the adverse renal effects of nephrotoxic agents, such as aminoglycosides and loop diuretics. Carefully monitor renal function, especially during prolonged therapy or use of high aminoglycoside doses. The majority of reported cases involve the combination of aminoglycosides and cephalothin or cephaloridine, which are associated with dose-related nephrotoxicity as singular agents. Limited but conflicting data with other cephalosporins have been noted.
Hydrocodone; Ibuprofen: (Minor) Cefotaxime's product label states that cephalosporins may potentiate the adverse renal effects of nephrotoxic agents, such as aminoglycosides, nonsteroidal antiinflammatory drugs (NSAIDs), and loop diuretics. Carefully monitor renal function, especially during prolonged therapy or use of high aminoglycoside doses. The majority of reported cases involve the combination of aminoglycosides and cephalothin or cephaloridine, which are associated with dose-related nephrotoxicity as singular agents. Limited but conflicting data with other cephalosporins have been noted.
Ibuprofen: (Minor) Cefotaxime's product label states that cephalosporins may potentiate the adverse renal effects of nephrotoxic agents, such as aminoglycosides, nonsteroidal antiinflammatory drugs (NSAIDs), and loop diuretics. Carefully monitor renal function, especially during prolonged therapy or use of high aminoglycoside doses. The majority of reported cases involve the combination of aminoglycosides and cephalothin or cephaloridine, which are associated with dose-related nephrotoxicity as singular agents. Limited but conflicting data with other cephalosporins have been noted.
Ibuprofen; Famotidine: (Minor) Cefotaxime's product label states that cephalosporins may potentiate the adverse renal effects of nephrotoxic agents, such as aminoglycosides, nonsteroidal antiinflammatory drugs (NSAIDs), and loop diuretics. Carefully monitor renal function, especially during prolonged therapy or use of high aminoglycoside doses. The majority of reported cases involve the combination of aminoglycosides and cephalothin or cephaloridine, which are associated with dose-related nephrotoxicity as singular agents. Limited but conflicting data with other cephalosporins have been noted.
Ibuprofen; Oxycodone: (Minor) Cefotaxime's product label states that cephalosporins may potentiate the adverse renal effects of nephrotoxic agents, such as aminoglycosides, nonsteroidal antiinflammatory drugs (NSAIDs), and loop diuretics. Carefully monitor renal function, especially during prolonged therapy or use of high aminoglycoside doses. The majority of reported cases involve the combination of aminoglycosides and cephalothin or cephaloridine, which are associated with dose-related nephrotoxicity as singular agents. Limited but conflicting data with other cephalosporins have been noted.
Ibuprofen; Pseudoephedrine: (Minor) Cefotaxime's product label states that cephalosporins may potentiate the adverse renal effects of nephrotoxic agents, such as aminoglycosides, nonsteroidal antiinflammatory drugs (NSAIDs), and loop diuretics. Carefully monitor renal function, especially during prolonged therapy or use of high aminoglycoside doses. The majority of reported cases involve the combination of aminoglycosides and cephalothin or cephaloridine, which are associated with dose-related nephrotoxicity as singular agents. Limited but conflicting data with other cephalosporins have been noted.
Indomethacin: (Minor) Cefotaxime's product label states that cephalosporins may potentiate the adverse renal effects of nephrotoxic agents, such as aminoglycosides, nonsteroidal antiinflammatory drugs (NSAIDs), and loop diuretics. Carefully monitor renal function, especially during prolonged therapy or use of high aminoglycoside doses. The majority of reported cases involve the combination of aminoglycosides and cephalothin or cephaloridine, which are associated with dose-related nephrotoxicity as singular agents. Limited but conflicting data with other cephalosporins have been noted.
Ketoprofen: (Minor) Cefotaxime's product label states that cephalosporins may potentiate the adverse renal effects of nephrotoxic agents, such as aminoglycosides, nonsteroidal antiinflammatory drugs (NSAIDs), and loop diuretics. Carefully monitor renal function, especially during prolonged therapy or use of high aminoglycoside doses. The majority of reported cases involve the combination of aminoglycosides and cephalothin or cephaloridine, which are associated with dose-related nephrotoxicity as singular agents. Limited but conflicting data with other cephalosporins have been noted.
Ketorolac: (Minor) Cefotaxime's product label states that cephalosporins may potentiate the adverse renal effects of nephrotoxic agents, such as aminoglycosides, nonsteroidal antiinflammatory drugs (NSAIDs), and loop diuretics. Carefully monitor renal function, especially during prolonged therapy or use of high aminoglycoside doses. The majority of reported cases involve the combination of aminoglycosides and cephalothin or cephaloridine, which are associated with dose-related nephrotoxicity as singular agents. Limited but conflicting data with other cephalosporins have been noted.
Leuprolide; Norethindrone: (Moderate) It would be prudent to recommend alternative or additional contraception when oral contraceptives (OCs) are used in conjunction with antibiotics. It was previously thought that antibiotics may decrease the effectiveness of OCs containing estrogens due to stimulation of metabolism or a reduction in enterohepatic circulation via changes in GI flora. One retrospective study reviewed the literature to determine the effects of oral antibiotics on the pharmacokinetics of contraceptive estrogens and progestins, and also examined clinical studies in which the incidence of pregnancy with OCs and antibiotics was reported. It was concluded that the antibiotics ampicillin, ciprofloxacin, clarithromycin, doxycycline, metronidazole, ofloxacin, roxithromycin, temafloxacin, and tetracycline did not alter plasma concentrations of OCs. Antituberculous drugs (e.g., rifampin) were the only agents associated with OC failure and pregnancy. Based on the study results, these authors recommended that back-up contraception may not be necessary if OCs are used reliably during oral antibiotic use. Another review concurred with these data, but noted that individual patients have been identified who experienced significant decreases in plasma concentrations of combined OC components and who appeared to ovulate; the agents most often associated with these changes were rifampin, tetracyclines, and penicillin derivatives. These authors concluded that because females most at risk for OC failure or noncompliance may not be easily identified and the true incidence of such events may be under-reported, and given the serious consequence of unwanted pregnancy, that recommending an additional method of contraception during short-term antibiotic use may be justified. During long-term antibiotic administration, the risk for drug interaction with OCs is less clear, but alternative or additional contraception may be advisable in selected circumstances. Data regarding progestin-only contraceptives or for newer combined contraceptive deliveries (e.g., patches, rings) are not available.
Levonorgestrel: (Moderate) It would be prudent to recommend alternative or additional contraception when oral contraceptives (OCs) are used in conjunction with antibiotics. It was previously thought that antibiotics may decrease the effectiveness of OCs containing estrogens due to stimulation of metabolism or a reduction in enterohepatic circulation via changes in GI flora. One retrospective study reviewed the literature to determine the effects of oral antibiotics on the pharmacokinetics of contraceptive estrogens and progestins, and also examined clinical studies in which the incidence of pregnancy with OCs and antibiotics was reported. It was concluded that the antibiotics ampicillin, ciprofloxacin, clarithromycin, doxycycline, metronidazole, ofloxacin, roxithromycin, temafloxacin, and tetracycline did not alter plasma concentrations of OCs. Antituberculous drugs (e.g., rifampin) were the only agents associated with OC failure and pregnancy. Based on the study results, these authors recommended that back-up contraception may not be necessary if OCs are used reliably during oral antibiotic use. Another review concurred with these data, but noted that individual patients have been identified who experienced significant decreases in plasma concentrations of combined OC components and who appeared to ovulate; the agents most often associated with these changes were rifampin, tetracyclines, and penicillin derivatives. These authors concluded that because females most at risk for OC failure or noncompliance may not be easily identified and the true incidence of such events may be under-reported, and given the serious consequence of unwanted pregnancy, that recommending an additional method of contraception during short-term antibiotic use may be justified. During long-term antibiotic administration, the risk for drug interaction with OCs is less clear, but alternative or additional contraception may be advisable in selected circumstances. Data regarding progestin-only contraceptives or for newer combined contraceptive deliveries (e.g., patches, rings) are not available.
Levonorgestrel; Ethinyl Estradiol: (Moderate) It would be prudent to recommend alternative or additional contraception when oral contraceptives (OCs) are used in conjunction with antibiotics. It was previously thought that antibiotics may decrease the effectiveness of OCs containing estrogens due to stimulation of metabolism or a reduction in enterohepatic circulation via changes in GI flora. One retrospective study reviewed the literature to determine the effects of oral antibiotics on the pharmacokinetics of contraceptive estrogens and progestins, and also examined clinical studies in which the incidence of pregnancy with OCs and antibiotics was reported. It was concluded that the antibiotics ampicillin, ciprofloxacin, clarithromycin, doxycycline, metronidazole, ofloxacin, roxithromycin, temafloxacin, and tetracycline did not alter plasma concentrations of OCs. Antituberculous drugs (e.g., rifampin) were the only agents associated with OC failure and pregnancy. Based on the study results, these authors recommended that back-up contraception may not be necessary if OCs are used reliably during oral antibiotic use. Another review concurred with these data, but noted that individual patients have been identified who experienced significant decreases in plasma concentrations of combined OC components and who appeared to ovulate; the agents most often associated with these changes were rifampin, tetracyclines, and penicillin derivatives. These authors concluded that because females most at risk for OC failure or noncompliance may not be easily identified and the true incidence of such events may be under-reported, and given the serious consequence of unwanted pregnancy, that recommending an additional method of contraception during short-term antibiotic use may be justified. During long-term antibiotic administration, the risk for drug interaction with OCs is less clear, but alternative or additional contraception may be advisable in selected circumstances. Data regarding progestin-only contraceptives or for newer combined contraceptive deliveries (e.g., patches, rings) are not available.
Levonorgestrel; Ethinyl Estradiol; Ferrous Bisglycinate: (Moderate) It would be prudent to recommend alternative or additional contraception when oral contraceptives (OCs) are used in conjunction with antibiotics. It was previously thought that antibiotics may decrease the effectiveness of OCs containing estrogens due to stimulation of metabolism or a reduction in enterohepatic circulation via changes in GI flora. One retrospective study reviewed the literature to determine the effects of oral antibiotics on the pharmacokinetics of contraceptive estrogens and progestins, and also examined clinical studies in which the incidence of pregnancy with OCs and antibiotics was reported. It was concluded that the antibiotics ampicillin, ciprofloxacin, clarithromycin, doxycycline, metronidazole, ofloxacin, roxithromycin, temafloxacin, and tetracycline did not alter plasma concentrations of OCs. Antituberculous drugs (e.g., rifampin) were the only agents associated with OC failure and pregnancy. Based on the study results, these authors recommended that back-up contraception may not be necessary if OCs are used reliably during oral antibiotic use. Another review concurred with these data, but noted that individual patients have been identified who experienced significant decreases in plasma concentrations of combined OC components and who appeared to ovulate; the agents most often associated with these changes were rifampin, tetracyclines, and penicillin derivatives. These authors concluded that because females most at risk for OC failure or noncompliance may not be easily identified and the true incidence of such events may be under-reported, and given the serious consequence of unwanted pregnancy, that recommending an additional method of contraception during short-term antibiotic use may be justified. During long-term antibiotic administration, the risk for drug interaction with OCs is less clear, but alternative or additional contraception may be advisable in selected circumstances. Data regarding progestin-only contraceptives or for newer combined contraceptive deliveries (e.g., patches, rings) are not available.
Levonorgestrel; Ethinyl Estradiol; Ferrous Fumarate: (Moderate) It would be prudent to recommend alternative or additional contraception when oral contraceptives (OCs) are used in conjunction with antibiotics. It was previously thought that antibiotics may decrease the effectiveness of OCs containing estrogens due to stimulation of metabolism or a reduction in enterohepatic circulation via changes in GI flora. One retrospective study reviewed the literature to determine the effects of oral antibiotics on the pharmacokinetics of contraceptive estrogens and progestins, and also examined clinical studies in which the incidence of pregnancy with OCs and antibiotics was reported. It was concluded that the antibiotics ampicillin, ciprofloxacin, clarithromycin, doxycycline, metronidazole, ofloxacin, roxithromycin, temafloxacin, and tetracycline did not alter plasma concentrations of OCs. Antituberculous drugs (e.g., rifampin) were the only agents associated with OC failure and pregnancy. Based on the study results, these authors recommended that back-up contraception may not be necessary if OCs are used reliably during oral antibiotic use. Another review concurred with these data, but noted that individual patients have been identified who experienced significant decreases in plasma concentrations of combined OC components and who appeared to ovulate; the agents most often associated with these changes were rifampin, tetracyclines, and penicillin derivatives. These authors concluded that because females most at risk for OC failure or noncompliance may not be easily identified and the true incidence of such events may be under-reported, and given the serious consequence of unwanted pregnancy, that recommending an additional method of contraception during short-term antibiotic use may be justified. During long-term antibiotic administration, the risk for drug interaction with OCs is less clear, but alternative or additional contraception may be advisable in selected circumstances. Data regarding progestin-only contraceptives or for newer combined contraceptive deliveries (e.g., patches, rings) are not available.
Loop diuretics: (Minor) Nephrotoxicity associated with cephalosporins may be potentiated by concomitant therapy with loop diuretics. Clinicians should be aware that this may occur even in patients with minor or transient renal impairment.
Meclofenamate Sodium: (Minor) Cefotaxime's product label states that cephalosporins may potentiate the adverse renal effects of nephrotoxic agents, such as aminoglycosides, nonsteroidal antiinflammatory drugs (NSAIDs), and loop diuretics. Carefully monitor renal function, especially during prolonged therapy or use of high aminoglycoside doses. The majority of reported cases involve the combination of aminoglycosides and cephalothin or cephaloridine, which are associated with dose-related nephrotoxicity as singular agents. Limited but conflicting data with other cephalosporins have been noted.
Mefenamic Acid: (Minor) Cefotaxime's product label states that cephalosporins may potentiate the adverse renal effects of nephrotoxic agents, such as aminoglycosides, nonsteroidal antiinflammatory drugs (NSAIDs), and loop diuretics. Carefully monitor renal function, especially during prolonged therapy or use of high aminoglycoside doses. The majority of reported cases involve the combination of aminoglycosides and cephalothin or cephaloridine, which are associated with dose-related nephrotoxicity as singular agents. Limited but conflicting data with other cephalosporins have been noted.
Meloxicam: (Minor) Cefotaxime's product label states that cephalosporins may potentiate the adverse renal effects of nephrotoxic agents, such as aminoglycosides, nonsteroidal antiinflammatory drugs (NSAIDs), and loop diuretics. Carefully monitor renal function, especially during prolonged therapy or use of high aminoglycoside doses. The majority of reported cases involve the combination of aminoglycosides and cephalothin or cephaloridine, which are associated with dose-related nephrotoxicity as singular agents. Limited but conflicting data with other cephalosporins have been noted.
Nabumetone: (Minor) Cefotaxime's product label states that cephalosporins may potentiate the adverse renal effects of nephrotoxic agents, such as aminoglycosides, nonsteroidal antiinflammatory drugs (NSAIDs), and loop diuretics. Carefully monitor renal function, especially during prolonged therapy or use of high aminoglycoside doses. The majority of reported cases involve the combination of aminoglycosides and cephalothin or cephaloridine, which are associated with dose-related nephrotoxicity as singular agents. Limited but conflicting data with other cephalosporins have been noted.
Naproxen: (Minor) Cefotaxime's product label states that cephalosporins may potentiate the adverse renal effects of nephrotoxic agents, such as aminoglycosides, nonsteroidal antiinflammatory drugs (NSAIDs), and loop diuretics. Carefully monitor renal function, especially during prolonged therapy or use of high aminoglycoside doses. The majority of reported cases involve the combination of aminoglycosides and cephalothin or cephaloridine, which are associated with dose-related nephrotoxicity as singular agents. Limited but conflicting data with other cephalosporins have been noted.
Naproxen; Esomeprazole: (Minor) Cefotaxime's product label states that cephalosporins may potentiate the adverse renal effects of nephrotoxic agents, such as aminoglycosides, nonsteroidal antiinflammatory drugs (NSAIDs), and loop diuretics. Carefully monitor renal function, especially during prolonged therapy or use of high aminoglycoside doses. The majority of reported cases involve the combination of aminoglycosides and cephalothin or cephaloridine, which are associated with dose-related nephrotoxicity as singular agents. Limited but conflicting data with other cephalosporins have been noted.
Naproxen; Pseudoephedrine: (Minor) Cefotaxime's product label states that cephalosporins may potentiate the adverse renal effects of nephrotoxic agents, such as aminoglycosides, nonsteroidal antiinflammatory drugs (NSAIDs), and loop diuretics. Carefully monitor renal function, especially during prolonged therapy or use of high aminoglycoside doses. The majority of reported cases involve the combination of aminoglycosides and cephalothin or cephaloridine, which are associated with dose-related nephrotoxicity as singular agents. Limited but conflicting data with other cephalosporins have been noted.
Nonsteroidal antiinflammatory drugs: (Minor) Cefotaxime's product label states that cephalosporins may potentiate the adverse renal effects of nephrotoxic agents, such as aminoglycosides, nonsteroidal antiinflammatory drugs (NSAIDs), and loop diuretics. Carefully monitor renal function, especially during prolonged therapy or use of high aminoglycoside doses. The majority of reported cases involve the combination of aminoglycosides and cephalothin or cephaloridine, which are associated with dose-related nephrotoxicity as singular agents. Limited but conflicting data with other cephalosporins have been noted.
Norethindrone Acetate; Ethinyl Estradiol; Ferrous fumarate: (Moderate) It would be prudent to recommend alternative or additional contraception when oral contraceptives (OCs) are used in conjunction with antibiotics. It was previously thought that antibiotics may decrease the effectiveness of OCs containing estrogens due to stimulation of metabolism or a reduction in enterohepatic circulation via changes in GI flora. One retrospective study reviewed the literature to determine the effects of oral antibiotics on the pharmacokinetics of contraceptive estrogens and progestins, and also examined clinical studies in which the incidence of pregnancy with OCs and antibiotics was reported. It was concluded that the antibiotics ampicillin, ciprofloxacin, clarithromycin, doxycycline, metronidazole, ofloxacin, roxithromycin, temafloxacin, and tetracycline did not alter plasma concentrations of OCs. Antituberculous drugs (e.g., rifampin) were the only agents associated with OC failure and pregnancy. Based on the study results, these authors recommended that back-up contraception may not be necessary if OCs are used reliably during oral antibiotic use. Another review concurred with these data, but noted that individual patients have been identified who experienced significant decreases in plasma concentrations of combined OC components and who appeared to ovulate; the agents most often associated with these changes were rifampin, tetracyclines, and penicillin derivatives. These authors concluded that because females most at risk for OC failure or noncompliance may not be easily identified and the true incidence of such events may be under-reported, and given the serious consequence of unwanted pregnancy, that recommending an additional method of contraception during short-term antibiotic use may be justified. During long-term antibiotic administration, the risk for drug interaction with OCs is less clear, but alternative or additional contraception may be advisable in selected circumstances. Data regarding progestin-only contraceptives or for newer combined contraceptive deliveries (e.g., patches, rings) are not available.
Norethindrone: (Moderate) It would be prudent to recommend alternative or additional contraception when oral contraceptives (OCs) are used in conjunction with antibiotics. It was previously thought that antibiotics may decrease the effectiveness of OCs containing estrogens due to stimulation of metabolism or a reduction in enterohepatic circulation via changes in GI flora. One retrospective study reviewed the literature to determine the effects of oral antibiotics on the pharmacokinetics of contraceptive estrogens and progestins, and also examined clinical studies in which the incidence of pregnancy with OCs and antibiotics was reported. It was concluded that the antibiotics ampicillin, ciprofloxacin, clarithromycin, doxycycline, metronidazole, ofloxacin, roxithromycin, temafloxacin, and tetracycline did not alter plasma concentrations of OCs. Antituberculous drugs (e.g., rifampin) were the only agents associated with OC failure and pregnancy. Based on the study results, these authors recommended that back-up contraception may not be necessary if OCs are used reliably during oral antibiotic use. Another review concurred with these data, but noted that individual patients have been identified who experienced significant decreases in plasma concentrations of combined OC components and who appeared to ovulate; the agents most often associated with these changes were rifampin, tetracyclines, and penicillin derivatives. These authors concluded that because females most at risk for OC failure or noncompliance may not be easily identified and the true incidence of such events may be under-reported, and given the serious consequence of unwanted pregnancy, that recommending an additional method of contraception during short-term antibiotic use may be justified. During long-term antibiotic administration, the risk for drug interaction with OCs is less clear, but alternative or additional contraception may be advisable in selected circumstances. Data regarding progestin-only contraceptives or for newer combined contraceptive deliveries (e.g., patches, rings) are not available.
Norethindrone; Ethinyl Estradiol: (Moderate) It would be prudent to recommend alternative or additional contraception when oral contraceptives (OCs) are used in conjunction with antibiotics. It was previously thought that antibiotics may decrease the effectiveness of OCs containing estrogens due to stimulation of metabolism or a reduction in enterohepatic circulation via changes in GI flora. One retrospective study reviewed the literature to determine the effects of oral antibiotics on the pharmacokinetics of contraceptive estrogens and progestins, and also examined clinical studies in which the incidence of pregnancy with OCs and antibiotics was reported. It was concluded that the antibiotics ampicillin, ciprofloxacin, clarithromycin, doxycycline, metronidazole, ofloxacin, roxithromycin, temafloxacin, and tetracycline did not alter plasma concentrations of OCs. Antituberculous drugs (e.g., rifampin) were the only agents associated with OC failure and pregnancy. Based on the study results, these authors recommended that back-up contraception may not be necessary if OCs are used reliably during oral antibiotic use. Another review concurred with these data, but noted that individual patients have been identified who experienced significant decreases in plasma concentrations of combined OC components and who appeared to ovulate; the agents most often associated with these changes were rifampin, tetracyclines, and penicillin derivatives. These authors concluded that because females most at risk for OC failure or noncompliance may not be easily identified and the true incidence of such events may be under-reported, and given the serious consequence of unwanted pregnancy, that recommending an additional method of contraception during short-term antibiotic use may be justified. During long-term antibiotic administration, the risk for drug interaction with OCs is less clear, but alternative or additional contraception may be advisable in selected circumstances. Data regarding progestin-only contraceptives or for newer combined contraceptive deliveries (e.g., patches, rings) are not available.
Norethindrone; Ethinyl Estradiol; Ferrous fumarate: (Moderate) It would be prudent to recommend alternative or additional contraception when oral contraceptives (OCs) are used in conjunction with antibiotics. It was previously thought that antibiotics may decrease the effectiveness of OCs containing estrogens due to stimulation of metabolism or a reduction in enterohepatic circulation via changes in GI flora. One retrospective study reviewed the literature to determine the effects of oral antibiotics on the pharmacokinetics of contraceptive estrogens and progestins, and also examined clinical studies in which the incidence of pregnancy with OCs and antibiotics was reported. It was concluded that the antibiotics ampicillin, ciprofloxacin, clarithromycin, doxycycline, metronidazole, ofloxacin, roxithromycin, temafloxacin, and tetracycline did not alter plasma concentrations of OCs. Antituberculous drugs (e.g., rifampin) were the only agents associated with OC failure and pregnancy. Based on the study results, these authors recommended that back-up contraception may not be necessary if OCs are used reliably during oral antibiotic use. Another review concurred with these data, but noted that individual patients have been identified who experienced significant decreases in plasma concentrations of combined OC components and who appeared to ovulate; the agents most often associated with these changes were rifampin, tetracyclines, and penicillin derivatives. These authors concluded that because females most at risk for OC failure or noncompliance may not be easily identified and the true incidence of such events may be under-reported, and given the serious consequence of unwanted pregnancy, that recommending an additional method of contraception during short-term antibiotic use may be justified. During long-term antibiotic administration, the risk for drug interaction with OCs is less clear, but alternative or additional contraception may be advisable in selected circumstances. Data regarding progestin-only contraceptives or for newer combined contraceptive deliveries (e.g., patches, rings) are not available.
Norgestimate; Ethinyl Estradiol: (Moderate) It would be prudent to recommend alternative or additional contraception when oral contraceptives (OCs) are used in conjunction with antibiotics. It was previously thought that antibiotics may decrease the effectiveness of OCs containing estrogens due to stimulation of metabolism or a reduction in enterohepatic circulation via changes in GI flora. One retrospective study reviewed the literature to determine the effects of oral antibiotics on the pharmacokinetics of contraceptive estrogens and progestins, and also examined clinical studies in which the incidence of pregnancy with OCs and antibiotics was reported. It was concluded that the antibiotics ampicillin, ciprofloxacin, clarithromycin, doxycycline, metronidazole, ofloxacin, roxithromycin, temafloxacin, and tetracycline did not alter plasma concentrations of OCs. Antituberculous drugs (e.g., rifampin) were the only agents associated with OC failure and pregnancy. Based on the study results, these authors recommended that back-up contraception may not be necessary if OCs are used reliably during oral antibiotic use. Another review concurred with these data, but noted that individual patients have been identified who experienced significant decreases in plasma concentrations of combined OC components and who appeared to ovulate; the agents most often associated with these changes were rifampin, tetracyclines, and penicillin derivatives. These authors concluded that because females most at risk for OC failure or noncompliance may not be easily identified and the true incidence of such events may be under-reported, and given the serious consequence of unwanted pregnancy, that recommending an additional method of contraception during short-term antibiotic use may be justified. During long-term antibiotic administration, the risk for drug interaction with OCs is less clear, but alternative or additional contraception may be advisable in selected circumstances. Data regarding progestin-only contraceptives or for newer combined contraceptive deliveries (e.g., patches, rings) are not available.
Norgestrel: (Moderate) It would be prudent to recommend alternative or additional contraception when oral contraceptives (OCs) are used in conjunction with antibiotics. It was previously thought that antibiotics may decrease the effectiveness of OCs containing estrogens due to stimulation of metabolism or a reduction in enterohepatic circulation via changes in GI flora. One retrospective study reviewed the literature to determine the effects of oral antibiotics on the pharmacokinetics of contraceptive estrogens and progestins, and also examined clinical studies in which the incidence of pregnancy with OCs and antibiotics was reported. It was concluded that the antibiotics ampicillin, ciprofloxacin, clarithromycin, doxycycline, metronidazole, ofloxacin, roxithromycin, temafloxacin, and tetracycline did not alter plasma concentrations of OCs. Antituberculous drugs (e.g., rifampin) were the only agents associated with OC failure and pregnancy. Based on the study results, these authors recommended that back-up contraception may not be necessary if OCs are used reliably during oral antibiotic use. Another review concurred with these data, but noted that individual patients have been identified who experienced significant decreases in plasma concentrations of combined OC components and who appeared to ovulate; the agents most often associated with these changes were rifampin, tetracyclines, and penicillin derivatives. These authors concluded that because females most at risk for OC failure or noncompliance may not be easily identified and the true incidence of such events may be under-reported, and given the serious consequence of unwanted pregnancy, that recommending an additional method of contraception during short-term antibiotic use may be justified. During long-term antibiotic administration, the risk for drug interaction with OCs is less clear, but alternative or additional contraception may be advisable in selected circumstances. Data regarding progestin-only contraceptives or for newer combined contraceptive deliveries (e.g., patches, rings) are not available.
Oral Contraceptives: (Moderate) It would be prudent to recommend alternative or additional contraception when oral contraceptives (OCs) are used in conjunction with antibiotics. It was previously thought that antibiotics may decrease the effectiveness of OCs containing estrogens due to stimulation of metabolism or a reduction in enterohepatic circulation via changes in GI flora. One retrospective study reviewed the literature to determine the effects of oral antibiotics on the pharmacokinetics of contraceptive estrogens and progestins, and also examined clinical studies in which the incidence of pregnancy with OCs and antibiotics was reported. It was concluded that the antibiotics ampicillin, ciprofloxacin, clarithromycin, doxycycline, metronidazole, ofloxacin, roxithromycin, temafloxacin, and tetracycline did not alter plasma concentrations of OCs. Antituberculous drugs (e.g., rifampin) were the only agents associated with OC failure and pregnancy. Based on the study results, these authors recommended that back-up contraception may not be necessary if OCs are used reliably during oral antibiotic use. Another review concurred with these data, but noted that individual patients have been identified who experienced significant decreases in plasma concentrations of combined OC components and who appeared to ovulate; the agents most often associated with these changes were rifampin, tetracyclines, and penicillin derivatives. These authors concluded that because females most at risk for OC failure or noncompliance may not be easily identified and the true incidence of such events may be under-reported, and given the serious consequence of unwanted pregnancy, that recommending an additional method of contraception during short-term antibiotic use may be justified. During long-term antibiotic administration, the risk for drug interaction with OCs is less clear, but alternative or additional contraception may be advisable in selected circumstances. Data regarding progestin-only contraceptives or for newer combined contraceptive deliveries (e.g., patches, rings) are not available.
Oxaprozin: (Minor) Cefotaxime's product label states that cephalosporins may potentiate the adverse renal effects of nephrotoxic agents, such as aminoglycosides, nonsteroidal antiinflammatory drugs (NSAIDs), and loop diuretics. Carefully monitor renal function, especially during prolonged therapy or use of high aminoglycoside doses. The majority of reported cases involve the combination of aminoglycosides and cephalothin or cephaloridine, which are associated with dose-related nephrotoxicity as singular agents. Limited but conflicting data with other cephalosporins have been noted.
Paromomycin: (Minor) Cefotaxime's product label states that cephalosporins may potentiate the adverse renal effects of nephrotoxic agents, such as aminoglycosides and loop diuretics. Carefully monitor renal function, especially during prolonged therapy or use of high aminoglycoside doses. The majority of reported cases involve the combination of aminoglycosides and cephalothin or cephaloridine, which are associated with dose-related nephrotoxicity as singular agents. Limited but conflicting data with other cephalosporins have been noted.
Piroxicam: (Minor) Cefotaxime's product label states that cephalosporins may potentiate the adverse renal effects of nephrotoxic agents, such as aminoglycosides, nonsteroidal antiinflammatory drugs (NSAIDs), and loop diuretics. Carefully monitor renal function, especially during prolonged therapy or use of high aminoglycoside doses. The majority of reported cases involve the combination of aminoglycosides and cephalothin or cephaloridine, which are associated with dose-related nephrotoxicity as singular agents. Limited but conflicting data with other cephalosporins have been noted.
Plazomicin: (Minor) Cefotaxime's product label states that cephalosporins may potentiate the adverse renal effects of nephrotoxic agents, such as aminoglycosides and loop diuretics. Carefully monitor renal function, especially during prolonged therapy or use of high aminoglycoside doses. The majority of reported cases involve the combination of aminoglycosides and cephalothin or cephaloridine, which are associated with dose-related nephrotoxicity as singular agents. Limited but conflicting data with other cephalosporins have been noted.
Probenecid: (Minor) Probenecid competitively inhibits renal tubular secretion of cefotaxime, thereby causing higher, prolonged serum levels of the drug.
Probenecid; Colchicine: (Minor) Probenecid competitively inhibits renal tubular secretion of cefotaxime, thereby causing higher, prolonged serum levels of the drug.
Relugolix; Estradiol; Norethindrone acetate: (Moderate) It would be prudent to recommend alternative or additional contraception when oral contraceptives (OCs) are used in conjunction with antibiotics. It was previously thought that antibiotics may decrease the effectiveness of OCs containing estrogens due to stimulation of metabolism or a reduction in enterohepatic circulation via changes in GI flora. One retrospective study reviewed the literature to determine the effects of oral antibiotics on the pharmacokinetics of contraceptive estrogens and progestins, and also examined clinical studies in which the incidence of pregnancy with OCs and antibiotics was reported. It was concluded that the antibiotics ampicillin, ciprofloxacin, clarithromycin, doxycycline, metronidazole, ofloxacin, roxithromycin, temafloxacin, and tetracycline did not alter plasma concentrations of OCs. Antituberculous drugs (e.g., rifampin) were the only agents associated with OC failure and pregnancy. Based on the study results, these authors recommended that back-up contraception may not be necessary if OCs are used reliably during oral antibiotic use. Another review concurred with these data, but noted that individual patients have been identified who experienced significant decreases in plasma concentrations of combined OC components and who appeared to ovulate; the agents most often associated with these changes were rifampin, tetracyclines, and penicillin derivatives. These authors concluded that because females most at risk for OC failure or noncompliance may not be easily identified and the true incidence of such events may be under-reported, and given the serious consequence of unwanted pregnancy, that recommending an additional method of contraception during short-term antibiotic use may be justified. During long-term antibiotic administration, the risk for drug interaction with OCs is less clear, but alternative or additional contraception may be advisable in selected circumstances. Data regarding progestin-only contraceptives or for newer combined contraceptive deliveries (e.g., patches, rings) are not available.
Segesterone Acetate; Ethinyl Estradiol: (Moderate) It would be prudent to recommend alternative or additional contraception when oral contraceptives (OCs) are used in conjunction with antibiotics. It was previously thought that antibiotics may decrease the effectiveness of OCs containing estrogens due to stimulation of metabolism or a reduction in enterohepatic circulation via changes in GI flora. One retrospective study reviewed the literature to determine the effects of oral antibiotics on the pharmacokinetics of contraceptive estrogens and progestins, and also examined clinical studies in which the incidence of pregnancy with OCs and antibiotics was reported. It was concluded that the antibiotics ampicillin, ciprofloxacin, clarithromycin, doxycycline, metronidazole, ofloxacin, roxithromycin, temafloxacin, and tetracycline did not alter plasma concentrations of OCs. Antituberculous drugs (e.g., rifampin) were the only agents associated with OC failure and pregnancy. Based on the study results, these authors recommended that back-up contraception may not be necessary if OCs are used reliably during oral antibiotic use. Another review concurred with these data, but noted that individual patients have been identified who experienced significant decreases in plasma concentrations of combined OC components and who appeared to ovulate; the agents most often associated with these changes were rifampin, tetracyclines, and penicillin derivatives. These authors concluded that because females most at risk for OC failure or noncompliance may not be easily identified and the true incidence of such events may be under-reported, and given the serious consequence of unwanted pregnancy, that recommending an additional method of contraception during short-term antibiotic use may be justified. During long-term antibiotic administration, the risk for drug interaction with OCs is less clear, but alternative or additional contraception may be advisable in selected circumstances. Data regarding progestin-only contraceptives or for newer combined contraceptive deliveries (e.g., patches, rings) are not available.
Sodium picosulfate; Magnesium oxide; Anhydrous citric acid: (Major) Prior or concomitant use of antibiotics with sodium picosulfate; magnesium oxide; anhydrous citric acid may reduce efficacy of the bowel preparation as conversion of sodium picosulfate to its active metabolite bis-(p-hydroxy-phenyl)-pyridyl-2-methane (BHPM) is mediated by colonic bacteria. If possible, avoid coadministration. Certain antibiotics (i.e., tetracyclines and quinolones) may chelate with the magnesium in sodium picosulfate; magnesium oxide; anhydrous citric acid solution. Therefore, these antibiotics should be taken at least 2 hours before and not less than 6 hours after the administration of sodium picosulfate; magnesium oxide; anhydrous citric acid solution.
Streptomycin: (Minor) Cefotaxime's product label states that cephalosporins may potentiate the adverse renal effects of nephrotoxic agents, such as aminoglycosides and loop diuretics. Carefully monitor renal function, especially during prolonged therapy or use of high aminoglycoside doses. The majority of reported cases involve the combination of aminoglycosides and cephalothin or cephaloridine, which are associated with dose-related nephrotoxicity as singular agents. Limited but conflicting data with other cephalosporins have been noted.
Sulindac: (Minor) Cefotaxime's product label states that cephalosporins may potentiate the adverse renal effects of nephrotoxic agents, such as aminoglycosides, nonsteroidal antiinflammatory drugs (NSAIDs), and loop diuretics. Carefully monitor renal function, especially during prolonged therapy or use of high aminoglycoside doses. The majority of reported cases involve the combination of aminoglycosides and cephalothin or cephaloridine, which are associated with dose-related nephrotoxicity as singular agents. Limited but conflicting data with other cephalosporins have been noted.
Sumatriptan; Naproxen: (Minor) Cefotaxime's product label states that cephalosporins may potentiate the adverse renal effects of nephrotoxic agents, such as aminoglycosides, nonsteroidal antiinflammatory drugs (NSAIDs), and loop diuretics. Carefully monitor renal function, especially during prolonged therapy or use of high aminoglycoside doses. The majority of reported cases involve the combination of aminoglycosides and cephalothin or cephaloridine, which are associated with dose-related nephrotoxicity as singular agents. Limited but conflicting data with other cephalosporins have been noted.
Tobramycin: (Minor) Cefotaxime's product label states that cephalosporins may potentiate the adverse renal effects of nephrotoxic agents, such as aminoglycosides and loop diuretics. Carefully monitor renal function, especially during prolonged therapy or use of high aminoglycoside doses. The majority of reported cases involve the combination of aminoglycosides and cephalothin or cephaloridine, which are associated with dose-related nephrotoxicity as singular agents. Limited but conflicting data with other cephalosporins have been noted.
Tolmetin: (Minor) Cefotaxime's product label states that cephalosporins may potentiate the adverse renal effects of nephrotoxic agents, such as aminoglycosides, nonsteroidal antiinflammatory drugs (NSAIDs), and loop diuretics. Carefully monitor renal function, especially during prolonged therapy or use of high aminoglycoside doses. The majority of reported cases involve the combination of aminoglycosides and cephalothin or cephaloridine, which are associated with dose-related nephrotoxicity as singular agents. Limited but conflicting data with other cephalosporins have been noted.
Torsemide: (Minor) Nephrotoxicity associated with cephalosporins may be potentiated by concomitant therapy with loop diuretics. Clinicians should be aware that this may occur even in patients with minor or transient renal impairment.
Warfarin: (Moderate) The concomitant use of warfarin with many classes of antibiotics, including cephalosporins, may increase the INR thereby potentiating the risk for bleeding. Inhibition of vitamin K synthesis due to alterations in the intestinal flora may be a mechanism; however, concurrent infection is also a potential risk factor for elevated INR. Additionally, certain cephalosporins (cefotetan, cefoperazone, cefamandole) are associated with prolongation of the prothrombin time due to the methylthiotetrazole (MTT) side chain at the R2 position, which disturbs the synthesis of vitamin K-dependent clotting factors in the liver. Monitor patients for signs and symptoms of bleeding. Additionally, increased monitoring of the INR, especially during initiation and upon discontinuation of the antibiotic, may be necessary.
Cefotaxime, like other beta-lactam antibiotics, is mainly bactericidal. It inhibits the third and final stage of bacterial cell wall synthesis by preferentially binding to specific penicillin-binding proteins (PBPs) that are located inside the bacterial cell wall. PBPs are responsible for several steps in the synthesis of the cell wall and are found in quantities of several hundred to several thousand molecules per bacterial cell. PBPs vary among different bacterial species. Thus, the intrinsic activity of cefotaxime as well as other cephalosporins and penicillins against a particular organism depends on its ability to gain access to and bind with the necessary PBP. Like all beta-lactam antibiotics, cefotaxime's ability to interfere with PBP-mediated cell wall synthesis ultimately leads to cell lysis. Lysis is mediated by bacterial cell wall autolytic enzymes (i.e., autolysins). The relationship between PBPs and autolysins is unclear, but it is possible that the beta-lactam antibiotic interferes with an autolysin inhibitor. Resistance to beta-lactam antibiotics can develop if there are changes in the PBPs, if cell wall permeability decreases, or if certain beta-lactamases are present. Cefotaxime retains activity against some beta-lactamase-producing isolates, including penicillinase and cephalosporinase; however, most extended spectrum beta-lactamase (ESBL)-producing and carbapenemase-producing isolates are resistant to the drug.
Beta-lactams, including cefotaxime, exhibit concentration-independent or time-dependent killing. In vitro and in vivo animal studies have demonstrated that the major pharmacodynamic parameter that determines efficacy for beta-lactams is the amount of time free (non-protein bound) drug concentrations exceed the minimum inhibitory concentration (MIC) of the organism (free T more than MIC).34145 This microbiological killing pattern is due to the mechanism of action, which is acylation of PBPs. There is a maximum proportion of PBPs that can be acylated; therefore, once maximum acylation has occurred, killing rates cannot increase. Free beta-lactam concentrations do not have to remain above the MIC for the entire dosing interval. The percentage of time required for both bacteriostatic and maximal bactericidal activity is different for the various classes of beta-lactams. Cephalosporins require free drug concentrations to be above the MIC for 35% to 40% of the dosing interval for bacteriostatic activity and 60% to 70% of the dosing interval for bactericidal activity.
The susceptibility interpretive criteria for cefotaxime are delineated by pathogen. The MICs are defined for Abiotrophia sp., Granulicatella sp., Aerococcus sp., Gemella sp., Corynebacterium sp., Vibrio sp., Aeromonas sp., Enterobacterales, and Viridans group Streptococcus as susceptible at 1 mcg/mL or less, intermediate at 2 mcg/mL, and resistant at 4 mcg/mL or more. The MICs for Vibrio sp., Aeromonas sp., and Enterobacterales are based on a dosage of 1 g IV every 8 hours. For non-meningitis infections, the MICs are defined for S. pneumoniae as susceptible at 1 mcg/mL or less, intermediate at 2 mcg/mL, and resistant at 4 mcg/mL or more. For meningitis, the MICs are defined for S. pneumoniae as susceptible at 0.5 mcg/mL or less, intermediate at 1 mcg/mL, and resistant at 2 mcg/mL or more (requires therapy with maximum doses). The MICs are defined for Aggregatibacter sp., Cardiobacterium sp., E. corrodens, Kingella sp., and M. catarrhalis as susceptible at 2 mcg/mL or less. The MICs are defined for E. rhusiopathiae as susceptible at 1 mcg/mL or less. The MICs are defined for beta-hemolytic Streptococcus sp. and N. gonorrhoeae as susceptible at 0.5 mcg/mL or less. The Clinical and Laboratory Standards Institute (CLSI) and the FDA differ on MIC interpretation for Acinetobacter sp. The MICs are defined for Acinetobacter sp. by the FDA as susceptible at 1 mcg/mL or less, intermediate at 2 mcg/mL, and resistant at 4 mcg/mL or more; however, the MICs are defined for Acinetobacter sp. by CLSI as susceptible at 8 mcg/mL or less, intermediate at 16 to 32 mcg/mL, and resistant at 64 mcg/mL or more. The MICs are defined for N. meningitidis as susceptible at 0.12 mcg/mL or less. The CLSI and the FDA differ on MIC interpretation for anaerobes. The MICs are defined for anaerobes by the FDA as susceptible at 1 mcg/mL or less, intermediate at 2 mcg/mL, and resistant at 4 mcg/mL or more; however, the MICs are defined for anaerobes by CLSI as susceptible at 16 mcg/mL or less, intermediate at 32 mcg/mL, and resistant at 64 mcg/mL or more. The CLSI and the FDA differ on MIC interpretation for H. influenzae and H. parainfluenzae. The MICs are defined for H. influenzae and H. parainfluenzae by the FDA as susceptible at 1 mcg/mL or less; however, the MICs are defined for H. influenzae and H. parainfluenzae by CLSI as susceptible at 2 mcg/mL or less. The CLSI and the FDA differ on MIC interpretation for other non-Enterobacterales. The MICs are defined for other non-Enterobacterales by the FDA as susceptible at 1 mcg/mL or less, intermediate at 2 mcg/mL, and resistant at 4 mcg/mL or more; however, the MICs are defined for other non-Enterobacterales by CLSI as susceptible at 8 mcg/mL or less, intermediate at 16 to 32 mcg/mL, and resistant at 64 mcg/mL or more. Oxacillin-susceptible staphylococci may be considered susceptible to cefotaxime.
Cefotaxime is administered intravenously and intramuscularly. It is not absorbed from the GI tract. Approximately 13 to 38% of the circulating drug is protein-bound. It is distributed into most body tissues and fluids including gallbladder; liver; kidney; bone; uterus; ovary; sputum; bile; and peritoneal, pleural, and synovial fluids. It penetrates inflamed meninges and reaches therapeutic levels within the CSF. It crosses the placenta. Cefotaxime is metabolized primarily by the liver to desacetylcefotaxime, an active metabolite that displays 10% of the parent drug's antibacterial activity. Cefotaxime and its metabolites are excreted into the urine primarily via tubular secretion. A small percentage is excreted in breast milk. In patients with normal renal function, the elimination half-lives of cefotaxime and desacetylcefotaxime are 1 to 1.5 hours and 1.5 to 2 hours, respectively.
-Route-Specific Pharmacokinetics
Intramuscular Route
Peak serum levels of cefotaxime occur within 30 minutes following an IM dose.
-Special Populations
Renal Impairment
The elimination half-life increases to up to 11.5 hours for cefotaxime and 56 hours for desacetylcefotaxime in patients with end-stage renal disease. Dosages should be adjusted accordingly. Cefotaxime and its metabolites are removed by hemodialysis.
Pediatrics
Infants and Children
Pharmacokinetics of cefotaxime are similar between children and adults. Peak concentrations of the active metabolite, desacetylcefotaxime, are reached approximately 1.5 to 3 hours after administration.The Vd and clearance of cefotaxime in infants and children is approximately 0.36 L/kg and 4.8 mL/kg/minute, respectively. The mean elimination half-lives of cefotaxime and desacetylcefotaxime in infants and children are 0.8 to 1.2 hours and 2 hours, respectively.
Neonates
The volume of distribution (Vd) and elimination half-life of cefotaxime are significantly greater in neonates compared with infants and children. In premature neonates (younger than 37 weeks gestational age), the Vd is approximately 0.5 to 0.7 L/kg, the clearance is approximately 1 to 1.5 mL/kg/minute, and the elimination half-life is approximately 3 to 6 hours. The elimination half-life of the desacetyl metabolite is approximately 8.4 to 9.4 hours, which is significantly longer compared to that reported in infants and children (about 2 hours). In term neonates, the Vd is similar to premature neonates, and values for clearance and elimination half-life are approximately 2 to 2.5 mL/kg/minute and 2 to 3 hours, respectively.