AMOXICILLIN-CLAVULANATE POTASS
  • AMOXICILLIN-CLAVULANATE POTASS (Generic for AUGMENTIN)

  • QTY 50 • 200-28.5/5 • Oral Suspension • Near 77381

AMOXICILLIN; CLAVULANIC ACID (a mox i SILL in; KLAV yoo lan ic AS id) treats infections caused by bacteria. It belongs to a group of medications called penicillin antibiotics. It will not treat colds, the flu, or infections caused by viruses.

AMOXICILLIN-CLAVULANATE POTASS (Generic for AUGMENTIN) Pediatric Monographs
  • General Administration Information
    For storage information, see the specific product information within the How Supplied section.

    Route-Specific Administration

    Oral Administration
    -The ratio of amoxicillin and clavulanic acid is not equivalent among different formulations; ratios vary from 14:1 to 2:1. Pay careful attention to dispense/administer the appropriate formulation. Excessive clavulanic acid causes adverse reactions (e.g., severe diarrhea).
    -All dosage forms: Ideally, administer at the beginning of a meal. While amoxicillin; clavulanic acid can be administered without regard to food, absorption is optimal when administered at the start of a light meal. Also, administration with food minimizes gastrointestinal irritation. Avoid administration with a high-fat meal because the absorption of clavulanic acid is decreased.
    Oral Solid Formulations
    -Chewable tablets: Chew well before swallowing; do not swallow whole.
    -Extended-release tablets: Do not crush or chew. Scored extended-release tablets are available for patients who have difficulty swallowing. Breaking the scored tablets in half does not affect the release characteristics.

    Oral Liquid Formulations
    -Shake well prior to each administration. Measure dosage with calibrated spoon, cup, or oral syringe.
    -For neonates and infants < 3 months of age, only the 125 mg/5 ml oral suspension is recommended in the FDA-approved labeling; the clavulanic acid content in this formulation is 1 mg clavulanic acid per 4 mg amoxicillin.
    -The various suspensions of amoxicillin; clavulanic acid are not interchangeable due to differences in the amount of clavulanic acid potassium contained in each product.

    Reconstitution
    -Review the reconstitution instructions for the particular product and package size, as the amount of water required for reconstitution varies from manufacturer to manufacturer.
    -Prior to reconstitution, tap the bottle several times to loosen the powder. Add approximately 2/3 of the total amount of water as instructed by the manufacturer and shake well. Add the remainder of the water and shake well.
    -Storage after reconstitution: Store under refrigeration for up to 10 days.

    Amoxicillin; clavulanic acid may cause severe cutaneous adverse reactions (SCAR), such as Stevens-Johnson syndrome (SJS), toxic epidermal necrolysis (TEN), drug reaction with eosinophilia and Systemic Symptoms (DRESS), and acute generalized exanthematous pustulosis (AGEP). Monitor persons who develop skin rash closely and discontinue amoxicillin; clavulanic acid if lesions progress. Other hypersensitivity and dermatologic reactions include contact dermatitis/diaper dermatitis (5% to 6%), rash (3%), and urticaria (3%). Postmarketing adverse reactions include hypersensitivity reactions, anaphylactoid reactions, anaphylactic shock, angioedema, serum sickness-like reactions (urticaria or skin rash accompanied by arthritis, arthralgia, myalgia, fever), hypersensitivity vasculitis, rash, pruritus, and exfoliative dermatitis. Fever was reported in 4% to 6% of patients.

    Crystalluria, hematuria, and interstitial nephritis have been reported during postmarketing experience with amoxicillin; clavulanic acid.

    In clinical trials with amoxicillin; clavulanate, diarrhea/loose stools was reported in 2% to 15% of patients. In pediatric trials (aged 2 months to 12 years) with the oral suspension, the incidence of diarrhea was significantly lower in patients receiving the twice daily regimen as compared to those using the every 8 hour regimen (14% vs. 34%, respectively). Also, the incidence of severe diarrhea and the number of patients who withdrew due to diarrhea was lower in the twice daily regimen (3% vs. 8%). In pediatric trials with the Augmentin ES suspension, diarrhea occurred in 4% to 13% of patients. Nausea (2% to 3%), abdominal discomfort/abdominal pain (less than 1%), flatulence (less than 1%), and vomiting (1%) were also reported. In pediatric trials, vomiting occurred in 7% of patients with the Augmentin ES suspension and 8% with regular amoxicillin; clavulanic acid. Gastrointestinal adverse events noted in postmarketing reports include indigestion (dyspepsia), gastritis, stomatitis, glossitis, tongue discoloration (black hairy tongue), and enterocolitis.

    Microbial overgrowth and superinfection can occur with antibiotic use. C. difficile-associated diarrhea (CDAD) or pseudomembranous colitis has been reported with amoxicillin; clavulanic acid. 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. Mucocutaneous candidiasis has been reported with the use of amoxicillin; clavulanic acid. In pediatric patients, candidal infection of the diaper areas has been reported in 4% to 6% of patients in clinical trials. Vaginitis has been reported in 1% of patients. In trials with the extended-release tablets, vaginal mycosis was reported in 3% of patients. Additionally, upper respiratory tract infection was reported in 3% to 9% of patients.

    Headache (less than 1%) has been reported with amoxicillin; clavulanic acid. Other central nervous system reactions reported with amoxicillin; clavulanic acid during postmarketing experience include agitation, anxiety, behavioral changes, aseptic meningitis, confusion, convulsions (seizures), dizziness, insomnia, and reversible hyperactivity. Seizures have been reported when large doses of penicillins were administered to patients with renal impairment; appropriate dosage adjustments should be observed in these patients.

    Hematologic effects reported with penicillins, such as amoxicillin; clavulanic acid, include anemia (including hemolytic anemia), thrombocytopenia, thrombotic thrombocytopenic purpura (TTP), eosinophilia, leukopenia, and agranulocytosis. These adverse hematologic effects are generally reversible after discontinuation of therapy and may be related to hypersensitivity. Thrombocytosis was reported in less than 1% of patients receiving amoxicillin; clavulanic acid in clinical studies. There have also been reports of increased prothrombin time in patients receiving amoxicillin; clavulanic acid and anticoagulant therapy.

    Hepatic dysfunction, including hepatitis, cholestatic jaundice (cholestasis), elevated hepatic enzymes (AST and/or ALT), increased serum bilirubin (hyperbilirubinemia), and/or increased alkaline phosphatase, has been infrequently reported with amoxicillin; clavulanic acid; it has been more commonly reported in males or in patients on prolonged treatment. Discontinue amoxicillin; clavulanic acid if signs or symptoms of hepatitis occur. Hepatotoxicity is usually reversible. Death has rarely been reported and has generally been cases associated with serious underlying diseases or concomitant medications. In a case series of 11 children (1 to 11 years) with hepatotoxicity associated with amoxicillin; clavulanic acid therapy, all cases had received normal doses of amoxicillin; clavulanic acid therapy with a duration of treatment ranging from 3 to 10 days. Hepatotoxicity was detected within 3 to 29 days in all patients and no correlation was found among the cases with regard to age distribution. As in adults, the majority of cases were males (n = 9). Elevated hepatic enzymes normalized within 8 weeks in most of the cases.

    Tooth discoloration (brown, yellow, or gray staining) has rarely been reported with amoxicillin therapy. The majority of reports have been in children. In most cases, discoloration was reduced or eliminated by brushing or dental cleaning. A follow-up study accessing fluoride intake and amoxicillin use reported a possible link to amoxicillin-associated dental fluorosis affecting permanent teeth. After adjusting for fluoride intake and otitis media, the study noted a significant increase in the risk of fluorosis with amoxicillin therapy. The highest risk for fluorosis was noted with amoxicillin use in the first year of life, especially in early infancy (first 6 months).

    Cough was reported in 7% to 12% of patients during clinical trials with amoxicillin; clavulanic acid.

    A false-positive reaction for glucose in the urine has been observed in patients receiving penicillins, such as amoxicillin; clavulanic acid, 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 amoxicillin; clavulanic acid treatment.

    Amoxicillin is a penicillin and should not be used in patients with a penicillin hypersensitivity; serious and occasionally fatal hypersensitivity reactions have occurred. Amoxicillin; clavulanic acid should be used cautiously in patients with cephalosporin hypersensitivity or carbapenem hypersensitivity. These patients are more susceptible to hypersensitivity reactions during therapy with amoxicillin; the incidence of true cross-sensitivity has been estimated at roughly 3-7%. Before initiating therapy, inquire about any previous allergic reactions to antibiotics. In addition, patients with allergies or atopic conditions including asthma, eczema, hives (urticaria), or hay fever may have a greater risk for hypersensitivity reactions to penicillins.

    Amoxicillin; clavulanic acid is contraindicated for use in patients with a previous history of drug-induced cholestasis, jaundice, or other hepatic dysfunction induced by this combination of drugs. Use amoxicillin; clavulanic acid with caution in patients with hepatic disease, and monitor liver function at regular intervals during therapy in these patients. Although hepatic dysfunction due to amoxicillin; clavulanic acid is usually reversible, deaths have been reported. Although data are limited, some evidence suggests that the incidence of hepatotoxicity may be lower in pediatric patients compared to adults.

    Amoxicillin; clavulanic acid extended-release tablets are contraindicated in patients with severe renal impairment (creatinine clearance < 30 ml/min), renal failure, and in hemodialysis (dialysis) patients. In general, other formulations of amoxicillin; clavulanic acid should be used with caution in patients with renal impairment or renal disease because the drug is eliminated via renal mechanisms. Adjust the dosage in patients with CrCl <= 30 ml/min, including those receiving dialysis.

    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 amoxicillin; clavulanic acid, 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.

    Patients with phenylketonuria should be warned that some amoxicillin; clavulanic acid chewable tablets and suspension formulations contain phenylalanine. The phenylalanine content varies with the manufacturer; consult the specific product labeling to determine phenylalanine content.

    According to the manufacturer, amoxicillin; clavulanic acid should not be used in patients with mononucleosis as a high incidence of skin rashes have been reported with amoxicillin in these patients.

    Serious rash events, such as Stevens-Johnson syndrome, toxic epidermal necrolysis, drug reaction with eosinophilia and systemic symptoms (DRESS), acute generalized exanthematous pustulosis (AGEP), erythema multiforme, and exfoliative dermatitis have been reported in patients receiving treatment with amoxicillin; clavulanic acid. If a skin rash occurs, monitor patients closely and discontinue amoxicillin; clavulanic acid if lesions progress.

    Description: Amoxicillin; clavulanic acid is a combination beta-lactam antibiotic. Clavulanic acid is a beta-lactamase inhibitor that possesses weak antibacterial activity. Combination with clavulanic acid reestablishes amoxicillin's activity against beta-lactamase-producing bacteria. This makes amoxicillin; clavulanic acid useful for treating infections due to beta-lactamase-producing H. influenzae and penicillinase-producing anaerobes. The drug is commonly used to treat infections such as acute otitis media, acute sinusitis, lower respiratory infections (e.g., pneumonia), skin and skin structure infections and urinary tract infections caused by susceptible organisms. To increase the efficacy of amoxicillin; clavulanic acid against penicillin-resistant S. pneumoniae in otitis media or lower respiratory infections, higher dosage regimens (e.g., 90 mg/kg/day) are recommended in pediatric patients. Formulations with higher clavulanic acid content (i.e., 4:1 vs. 7:1 and 14:1) are associated with more frequent and severe diarrhea in children; correct product selection is important to minimize occurrence of diarrhea. Amoxicillin; clavulanic acid (regular tablets, chewable tablets, suspension) is FDA-approved for use in pediatric patients as young as neonates. The ES-600 oral suspension formulation is FDA-approved for use in pediatric patients >= 3 months of age to 12 years of age (< 40 kg) and the extended-release tablet formulation is FDA-approved for use in pediatric patients >= 40 kg.

    General dosing information:
    -Dosages listed are based on the amoxicillin component; use the specified dosage forms as listed to ensure proper corresponding clavulanic acid dosage.
    -Carefully ensure that the correct amoxicillin; clavulanic acid product is selected. Many products are not interchangeable due to differences in clavulanic acid content. Incorrect product selection may lead to severe diarrhea from higher concentrations of clavulanic acid:-The 250 mg tablet and the 250 mg chewable tablet do not contain the same amount of clavulanic acid and are not interchangeable. The 250 mg tablet contains 125 mg of clavulanic acid, whereas the 250 mg chewable tablet contains 62.5 mg of clavulanic acid.
    -Immediate-release tablets (250 mg or 500 mg) cannot be used to provide the same dosages as extended-release tablets. The extended-release tablet contains 62.5 mg of clavulanic acid, while the immediate-release tablets each contain 125 mg of clavulanic acid. Also, the extended-release tablet provides an extended time course of plasma amoxicillin concentrations; therefore, two immediate-release 500 mg tablets are not equivalent to one extended-release 1000 mg tablet.
    -The ES-600 suspension (600 mg amoxicillin and 42.9 mg clavulanic acid per 5 ml suspension) does not contain the same amount of clavulanic acid (as the potassium salt) as any of the other suspensions of amoxicillin; clavulanic acid. Therefore, this suspension is not interchangeable with any other suspension.

    -Every 12 hour regimens are preferred over the every 8 hour regimens in children because they are associated with significantly less diarrhea.

    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: Bacteroides fragilis, Bacteroides sp., Eikenella corrodens, Enterobacter sp., Enterococcus faecalis, Escherichia coli, Fusobacterium nucleatum, Fusobacterium sp., Haemophilus influenzae (beta-lactamase negative), Haemophilus influenzae (beta-lactamase positive), Haemophilus parainfluenzae, Klebsiella pneumoniae, Klebsiella sp., Moraxella catarrhalis, Neisseria gonorrhoeae, Peptostreptococcus magnus, Peptostreptococcus micros, Peptostreptococcus sp., Proteus mirabilis, Staphylococcus aureus (MSSA), Staphylococcus epidermidis, Staphylococcus saprophyticus, Streptococcus pneumoniae, Streptococcus pyogenes (group A beta-hemolytic streptococci), 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: Burkholderia pseudomallei, Nocardia brasiliensis
    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 acute otitis media:
    NOTE: Amoxicillin; clavulanic acid is the preferred initial therapy for children who have received amoxicillin within the past 30 days, who have concurrent conjunctivitis, or those for whom coverage of beta-lactamase-positive H. influenzae and M. catarrhalis is desired.
    Oral dosage (immediate-release formulations and non-ES suspensions, standard dose therapy):
    Neonates: 30 mg/kg/day amoxicillin component PO divided every 12 hours. Due to limited data supporting the use of other formulations, the 125 mg/5 mL suspension for use in this age group.
    Infants 1 to 2 months: 30 mg/kg/day amoxicillin component PO divided every 12 hours. Due to limited data supporting the use of other formulations, the 125 mg/5 mL suspension is recommended for use in this age group.
    Infants 3 months and older, Children, and Adolescents weighing less than 40 kg: Due to the higher clavulanic acid content in regular formulations (i.e., chewable tablets, non-ES suspensions) and the need for high-dose therapy (i.e., 90 mg/kg/day), these formulations are not recommended for the treatment of AOM. The formulation containing 600 mg of amoxicillin and 42.9 mg of clavulanic acid per 5 mL (e.g., ES-600) is recommended for high-dose therapy. The FDA-approved dose is 45 mg/kg/day amoxicillin component PO divided every 12 hours (using 200 mg/5 mL or 400 mg/5 mL suspension; 200 mg or 400 mg chewable tablets) or 40 mg/kg/day amoxicillin component PO divided every 8 hours (using 125 mg/5 mL or 250 mg/5 mL suspension; 125 mg or 250 mg chewable tablets; or 500 mg regular tablets) for 10 days.
    Children and Adolescents weighing 40 kg or more: 500 mg amoxicillin with 125 mg clavulanic acid PO every 8 hours (using 500 mg regular tablets; 125 mg or 250 mg chewable tablets; or 125 mg/5 mL or 250 mg/5 mL suspension) or 875 mg amoxicillin with 125 mg clavulanic acid PO every 12 hours (using 875 mg tablet or 200 mg/5 mL or 400 mg/5 mL suspension) for 10 days.
    Oral dosage (ES-600; 600 mg amoxicillin and 42.9 mg clavulanic acid per 5 mL suspension, high-dose therapy):
    Infants 3 to 5 months: 90 mg/kg/day amoxicillin component PO divided every 12 hours for 10 days.
    Infants and Children 6 to 23 months: 90 mg/kg/day amoxicillin component PO divided every 12 hours for 10 days.
    Children 2 to 5 years: 90 mg/kg/day amoxicillin component PO divided every 12 hours for 7 days for mild to moderate disease and 10 days for severe disease.
    Children 6 years and older: 90 mg/kg/day amoxicillin component PO divided every 12 hours for 5 to 7 days for mild to moderate disease and 10 days for severe disease.

    For the treatment of acute bacterial sinusitis:
    Oral dosage (immediate-release formulations and non-ES suspensions, standard dose therapy):
    Neonates: 30 mg/kg/day amoxicillin component PO divided every 12 hours for 10 to 14 days as first-line therapy. Due to limited data supporting the use of other formulations, the 125 mg/5 mL suspension is recommended for use in this age group.
    Infants 1 to 2 months: 30 mg/kg/day amoxicillin component PO divided every 12 hours for 10 to 14 days as first-line therapy. Due to limited data supporting the use of other formulations, the 125 mg/5 mL suspension is recommended for use in this age group.
    Infants, Children, and Adolescents 3 months to 17 years weighing less than 40 kg: 40 mg/kg/day amoxicillin component PO divided every 8 hours (using 125 mg/5 mL or 250 mg/5 mL suspension; 125 mg or 250 mg chewable tablets; or 500 mg regular tablets) or 45 mg/kg/day amoxicillin component PO divided every 12 hours (using 200 mg/5 mL or 400 mg/5 mL suspension; 200 mg or 400 mg chewable tablets) for 10 to 14 days as first-line therapy for most patients. The every 12 hour regimen is preferred because it associated with less diarrhea than the every 8 hour regimen. High-dose therapy is recommended as initial empiric therapy for patients from geographic areas with high rates of penicillin-resistant S. pneumoniae, those with severe infection, children who attend daycare, children younger than 2 years, children with recent hospitalization, those with antibiotic use within the past month, and those who are immunocompromised. High-dose therapy is also recommended after initial treatment failure.
    Children and Adolescents weighing 40 kg or more: 500 mg amoxicillin with 125 mg clavulanic acid PO every 8 hours (using 500 mg regular tablets; 125 mg or 250 mg chewable tablets; or 125 mg/5 mL or 250 mg/5 mL suspension) or 875 mg amoxicillin with 125 mg clavulanic acid PO every 12 hours (using 875 mg tablet or 200 mg/5 mL or 400 mg/5 mL suspension) for 10 to 14 days as first-line therapy. The every 12 hour regimen is preferred because it associated with less diarrhea than the every 8 hour regimen. High-dose therapy is recommended as initial empiric therapy for patients from geographic areas with high rates of penicillin-resistant S. pneumoniae, those with severe infection, children who attend daycare, those with recent hospitalization, antibiotic use within the past month, and who are immunocompromised. High-dose therapy is also recommended after initial treatment failure.
    Oral dosage (extended-release tablets containing 1,000 mg amoxicillin and 62.5 mg clavulanate, high-dose therapy):
    Children and Adolescents weighing 40 kg or more: 2,000 mg amoxicillin with 125 mg clavulanic acid PO every 12 hours for 10 to 14 days as first-line therapy. High-dose therapy is recommended as initial empiric therapy for patients from geographic areas with high rates of penicillin-resistant S. pneumoniae, those with severe infection, children who attend daycare, those with recent hospitalization, antibiotic use within the past month, and who are immunocompromised. High-dose therapy is also recommended after initial treatment failure.
    Oral dosage (ES-600; 600 mg amoxicillin and 42.9 mg clavulanic acid per 5 mL suspension, high-dose therapy)*:
    Infants, Children, and Adolescents: 90 mg/kg/day amoxicillin component PO divided every 12 hours (Max: 2,000 mg amoxicillin/125 mg clavulanic acid/dose) for 10 to 14 days as first-line therapy. High-dose therapy is recommended as initial empiric therapy for patients from geographic areas with high rates of penicillin-resistant S. pneumoniae, those with severe infection, children who attend daycare, children younger than 2 years, children with recent hospitalization, those with antibiotic use within the past month, and those who are immunocompromised. High-dose therapy is also recommended after initial treatment failure.

    For the treatment of lower respiratory tract infections (LRTIs), including community-acquired pneumonia (CAP):
    -for the treatment of nonspecific lower respiratory tract infections (LRTIs):
    Oral dosage (immediate-release formulations and non-ES suspensions):
    Neonates: 30 mg/kg/day amoxicillin component PO divided every 12 hours. The 125 mg/5 mL suspension is recommended.
    Infants 1 to 2 months: 30 mg/kg/day amoxicillin component PO divided every 12 hours. The 125 mg/5 mL suspension is recommended.
    Infants, Children, and Adolescents 3 months to 17 years and weighing less than 40 kg: 45 mg/kg/day amoxicillin component PO divided every 12 hours or 40 mg/kg/day amoxicillin component PO divided every 8 hours. The every 12-hour regimen is associated with less diarrhea.
    Children and Adolescents weighing 40 kg or more: 875 mg amoxicillin with 125 mg clavulanate PO every 12 hours or 500 mg amoxicillin with 125 mg clavulanate PO every 8 hours.
    -for the treatment of community-acquired pneumonia (CAP):
    NOTE: For empiric therapy of CAP, high-dose therapy using either the suspension containing 600 mg of amoxicillin and 42.9 mg of clavulanate per 5 mL (e.g. Augmentin ES-600) or the XR tablet is recommended.
    Oral dosage (immediate-release formulations and non-ES suspensions):
    Neonates: 30 mg/kg/day amoxicillin component PO divided every 12 hours. The 125 mg/5 mL suspension is recommended. If a lower respiratory tract infection is suspected in a neonate, full evaluation and careful clinical workup are warranted. Neonates are likely to benefit from hospitalization.
    Infants 1 to 2 months: 30 mg/kg/day amoxicillin component PO divided every 12 hours. The 125 mg/5 mL suspension is recommended. If a lower respiratory tract infection is suspected in a young infant, full evaluation and careful clinical workup are warranted. Infants younger than 3 to 6 months are likely to benefit from hospitalization.
    Infants and Children 3 months to 12 years and weighing less than 40 kg: 45 mg/kg/day amoxicillin component PO divided every 8 hours for 7 to 10 days as an alternative to high-dose amoxicillin for mild infections or as step-down therapy for infections due to beta-lactamase-producing H. influenzae.
    Children weighing 40 kg or more: 500 mg amoxicillin with 125 mg clavulanate PO every 8 hours for 7 to 10 days as an alternative to high-dose amoxicillin for mild infections or as step-down therapy for infections due to beta-lactamase-producing H. influenzae.
    Adolescents weighing less than 40 kg: 45 mg/kg/day amoxicillin component PO divided every 8 hours for 5 to 10 days as an alternative to high-dose amoxicillin for mild infections or as step-down therapy for infections due to beta-lactamase-producing H. influenzae. In HIV-infected patients, amoxicillin; clavulanate is recommended as part of combination therapy for outpatients.
    Adolescents weighing 40 kg or more: 500 mg amoxicillin with 125 mg clavulanate PO every 8 hours for 5 to 10 days as an alternative to high-dose amoxicillin for mild infections or as step-down therapy for infections due to beta-lactamase-producing H. influenzae. In HIV-infected patients, amoxicillin; clavulanate is recommended as part of combination therapy for outpatients.
    Oral dosage (extended-release tablets containing 1,000 mg amoxicillin and 62.5 mg clavulanate per tablet):
    Children weighing 40 kg or more: 2,000 mg amoxicillin with 125 mg clavulanate PO every 12 hours for 7 to 10 days as an alternative to amoxicillin for empiric therapy in outpatients, for mild infections, or as step-down therapy for infections due to beta-lactamase-producing H. influenzae.
    Adolescents weighing 40 kg or more: 2,000 mg amoxicillin with 125 mg clavulanate PO every 12 hours for 5 to 10 days as an alternative to amoxicillin for empiric therapy in outpatients, for mild infections, or as step-down therapy for infections due to beta-lactamase-producing H. influenzae. In HIV-infected patients, amoxicillin; clavulanate is recommended as part of combination therapy for outpatients.
    Oral dosage (ES-600; suspension containing 600 mg amoxicillin and 42.9 mg clavulanate per 5 mL)*:
    Infants and Children 3 months to 12 years: 90 mg/kg/day amoxicillin component PO divided every 12 hours (Max: 2,000 mg amoxicillin with 125 mg clavulanate per dose) for 7 to 10 days as an alternative to amoxicillin for empiric therapy in outpatients, for mild infections, or as step-down therapy for infections due to beta-lactamase-producing H. influenzae.
    Adolescents: 90 mg/kg/day amoxicillin component PO divided every 12 hours (Max: 2,000 mg amoxicillin with 125 mg clavulanate per dose) for 5 to 10 days as an alternative to amoxicillin for empiric therapy in outpatients, for mild infections, or as step-down therapy for infections due to beta-lactamase-producing H. influenzae. In HIV-infected patients, amoxicillin; clavulanate is recommended as part of combination therapy for outpatients.

    For the treatment of skin and skin structure infections, including impetigo, cellulitis, erysipelas, and animal or human bite wounds:
    -for the treatment of impetigo:
    Oral dosage (immediate-release formulations and non-ES suspensions):
    Neonates: 30 mg/kg/day amoxicillin component PO divided every 12 hours for 5 to 7 days. Due to limited data supporting the use of other formulations, the FDA-approved labeling recommends the 125 mg/5 mL suspension for use in this age group.
    Infants 1 to 2 months: 30 mg/kg/day amoxicillin component PO divided every 12 hours for 5 to 7 days. Due to limited data supporting the use of other formulations, the FDA-approved labeling recommends the 125 mg/5 mL suspension for use in this age group.
    Infants, Children, and Adolescents 3 months to 17 years weighing less than 40 kg: 25 mg/kg/day amoxicillin component PO divided every 12 hours for 5 to 7 days.
    Children and Adolescents weighing 40 kg or more: 875 mg amoxicillin with 125 mg clavulanate PO every 12 hours for 5 to 7 days.
    -for the treatment of nonpurulent skin infections, such as cellulitis and erysipelas:
    Oral dosage (immediate-release formulations and non-ES suspensions):
    Neonates: 30 mg/kg/day amoxicillin component PO divided every 12 hours for 5 to 14 days. Due to limited data supporting the use of other formulations, the FDA-approved labeling recommends the 125 mg/5 mL suspension for use in this age group.
    Infants 1 to 2 months: 30 mg/kg/day amoxicillin component PO divided every 12 hours for 5 to 14 days. Due to limited data supporting the use of other formulations, the FDA-approved labeling recommends the 125 mg/5 mL suspension for use in this age group.
    Infants, Children, and Adolescents 3 months to 17 years weighing less than 40 kg: 25 to 45 mg/kg/day amoxicillin component PO divided every 12 hours or 20 to 40 mg/kg/day amoxicillin component PO divided every 8 hours for 5 to 14 days.
    Children and Adolescents weighing 40 kg or more: 875 mg amoxicillin with 125 mg clavulanate PO every 12 hours or 500 mg amoxicillin with 125 mg clavulanate PO every 8 to 12 hours or 250 mg amoxicillin with 125 mg clavulanate PO every 8 hours for 5 to 14 days.
    -for the treatment of animal bite wounds:
    Oral dosage (immediate-release formulations and non-ES suspensions):
    Neonates: 30 mg/kg/day amoxicillin component PO divided every 12 hours. Due to limited data supporting the use of other formulations, the FDA-approved labeling recommends the 125 mg/5 mL suspension for use in this age group. 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.
    Infants 1 to 2 months: 30 mg/kg/day amoxicillin component PO divided every 12 hours. Due to limited data supporting the use of other formulations, the FDA-approved labeling recommends the 125 mg/5 mL suspension for use in this age group. 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.
    Infants, Children, and Adolescents 3 months to 17 years weighing less than 40 kg: 25 to 45 mg/kg/day amoxicillin component PO divided every 12 hours. 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.
    Children and Adolescents weighing 40 kg or more: 875 mg amoxicillin with 125 mg clavulanate PO every 12 hours. 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 urinary tract infection (UTI):
    Oral dosage (immediate-release formulations and non-ES suspensions):
    Neonates and Infants 1 to 2 months: 30 mg/kg/day amoxicillin component PO divided every 12 hours is the FDA-approved dosage. Due to limited data supporting the use of other formulations, the FDA-approved labeling states that only the 125 mg/5 mL suspension is recommended for this age group. Neonates and infants younger than 2 to 3 months are at risk for systemic infection and rapid change in their clinical condition. UTIs should be treated as presumed pyelonephritis in these patients. 20 to 40 mg/kg/day amoxicillin component PO divided every 8 hours is recommended by the American Academy of Pediatrics (AAP) for the initial treatment of UTI in febrile infants 2 months and older.
    Infants 3 months and older, Children, and Adolescents weighing less than 40 kg (every 12 hour regimens): 25 mg/kg/day amoxicillin component PO divided every 12 hours for mild/moderate infections and 45 mg/kg/day amoxicillin component PO divided every 12 hours for severe infections (using 200 mg/5 mL or 400 mg/5 mL suspension; 200 mg and 400 mg chewable tablets). The every 12 hour regimen is preferred in children because it causes less diarrhea.
    Infants 3 months and older, Children, and Adolescents weighing less than 40 kg (every 8 hour regimens): 20 mg/kg/day amoxicillin component PO divided every 8 hours for mild/moderate infections and 40 mg/kg/day amoxicillin component PO divided every 8 hours for severe infections (using 125 mg/5 mL or 250 mg/5 mL suspension; 125 mg and 250 mg chewable tablets; 500 mg regular tablets). The every 12 hour regimen is preferred in children because it causes less diarrhea.
    Children and Adolescents weighing 40 kg or more (every 12 hour regimens): 500 mg amoxicillin with 125 mg clavulanic acid PO every 12 hours (using 500 mg regular tablets; 125 mg or 250 mg chewable tablets; 125 mg/5 mL or 250 mg/5 mL suspension) for mild/moderate infections and 875 mg amoxicillin with 125 mg clavulanic acid PO every 12 hours (using 875 mg regular tablets; 200 mg or 400 mg chewable tablets; 200 mg/5 mL or 400 mg/5 mL suspension) for severe infections.
    Children and Adolescents weighing 40 kg or more (every 8 hour regimens): 250 mg amoxicillin with 125 mg clavulanic acid PO every 8 hours (using 250 mg regular tablets) for mild/moderate infections and 500 mg PO with 125 mg clavulanic acid PO every 8 hours (using 500 mg regular tablets; 125 mg or 250 mg chewable tablets; 125 mg/5 mL or 250 mg/5 mL suspension) for severe infections.

    For the treatment of dental infection*, including dentoalveolar infection* and periodontitis*:
    Oral dosage (non-ES and non-XR formulations):
    Children and Adolescents: 20-40 mg/kg/day amoxicillin component PO divided every 8 hours (Max: 500 mg/dose) for 10 days.

    For group A streptococci chronic pharyngeal carriage eradication*:
    Oral dosage (immediate-release formulations and non-ES suspensions):
    Infants, Children, and Adolescents: 40 mg/kg/day amoxicillin component PO divided every 8 hours (Max: 2 g/day) for 10 days. Most chronic streptococcal carriers do not need antimicrobial therapy. Treatment may be considered during a community outbreak of acute rheumatic fever, acute poststreptococcal glomerulonephritis or invasive group A streptococcal (GAS) infection; during an outbreak of GAS pharyngitis in a closed or partially closed community; in the presence of a family or personal history of acute rheumatic fever; in a family with excessive anxiety about GAS infections; or when tonsillectomy is being considered only because of carriage.

    For use as oral maintenance therapy in the treatment of melioidosis* due to Burkholderia pseudomallei*:
    Oral dosage (chewable tablets [125 mg and 250 mg] and suspensions [125 mg/5 mL and 250 mg/5 mL]):
    Infants, Children, and Adolescents: 60 mg/kg/day amoxicillin with 15 mg/kg/day clavulanate PO divided every 8 hours to complete a total of 20 weeks of treatment after finishing the initial parenteral therapy. Amoxicillin; clavulanic acid is recommended as a first-line agent in children. Although a maximum dosage for this indication is not defined, the usual maximum dose of amoxicillin; clavulanic acid when given 3 times daily is 500 mg/dose.
    Oral dosage (500 mg/125 mg tablets):
    Children and Adolescents >= 40 kg: 60 mg/kg/day amoxicillin with 15 mg/kg/day clavulanate PO divided every 8 hours to complete a total of 20 weeks of treatment after finishing the initial parenteral therapy. Amoxicillin; clavulanic acid is recommended as a first-line agent in children. Although a maximum dosage for this indication is not defined, the usual maximum dose of amoxicillin; clavulanic acid when given 3 times daily is 500 mg/dose.

    For the treatment of drug-resistant tuberculosis infection* paired with a carbapenem as part of combination therapy:
    Oral dosage (immediate-release formulations and non-ES suspensions):
    Infants, Children, and Adolescents: 75 mg/kg/day amoxicillin component PO divided every 8 hours or 80 mg/kg/day amoxicillin component PO divided every 12 hours (Max: 3 g amoxicillin component/day).
    Oral dosage (ES-600; suspension containing 600 mg amoxicillin and 42.9 mg clavulanate per 5 mL):
    Infants, Children, and Adolescents: 80 mg/kg/day amoxicillin component PO divided every 12 hours (Max: 3 g amoxicillin component/day).

    For the oral step-down treatment of complicated intraabdominal infections*, including peritonitis*, appendicitis*, and intraabdominal abscess*:
    Oral dosage (immediate-release formulations and non-ES suspensions):
    Infants, Children, and Adolescents: 40 mg/kg/day amoxicillin component (Max: 1,500 mg/day) PO divided every 8 hours for a total treatment duration of 3 to 7 days. Complicated infections include peritonitis and appendicitis complicated by rupture, and intraabdominal abscess.

    For the treatment of bartonellosis*, including uncomplicated Oroya fever*:
    Oral dosage (immediate-release formulations and non-ES suspensions):
    Infants, Children, and Adolescents: 20 mg/kg/dose amoxicillin component (Max: 1 g amoxicillin component/dose) PO every 12 hours for 14 days with or without chloramphenicol as first-line therapy.

    Maximum Dosage Limits:
    -Neonates
    30 mg/kg/day amoxicillin component PO.
    -Infants
    < 3 months: 30 mg/kg/day amoxicillin component PO.
    >= 3 months: 90 mg/kg/day PO amoxicillin component using ES-600 suspension; 40-45 mg/kg/day amoxicillin component PO for regular suspension depending on formulation for most indications.
    -Children
    < 40 kg: 90 mg/kg/day PO amoxicillin component using ES-600 suspension; 40-45 mg/kg/day amoxicillin component PO for regular suspension and chewable tablets depending on formulation for most indications.
    >= 40 kg: regular tablets, chewable tablets, or suspension: up to 1750 mg/day amoxicillin component PO depending on formulation; XR tablets: 4 g/day amoxicillin component PO; ES-600 suspension: safety and efficacy have not been established; however, 90 mg/kg/day amoxicillin component PO (Max: 4 g/day amoxicillin component) is used off-label.
    -Adolescents
    < 40 kg: 90 mg/kg/day PO amoxicillin component using ES-600 suspension; 40-45 mg/kg/day amoxicillin component PO for regular suspension and chewable tablets depending on formulation for most indications.
    >= 40 kg: regular tablets, chewable tablets, or suspension: up to 1750 mg/day amoxicillin component PO depending on formulation; XR tablets: 4 g/day amoxicillin component PO; ES-600 suspension: safety and efficacy have not been established; however, 90 mg/kg/day amoxicillin component PO (Max: 4 g/day amoxicillin component) is used off-label.

    Patients with Hepatic Impairment Dosing
    Specific guidelines for dosage adjustment in hepatic impairment are not available; it appears that no dosage adjustments are needed.

    Patients with Renal Impairment Dosing
    The following dose adjustments are based on the usual dose in pediatric patients of 20-40 mg/kg/day amoxicillin component PO divided every 8 hours, 25-45 mg/kg/day amoxicillin component PO divided every 12 hours, or 80-90 mg/kg/day PO divided every 12 hours (high dose; ES-600 formulation) :
    CrCl >= 30 ml/min/1.73 m2: No dosage adjustment necessary.
    CrCl 10-29 ml/min/1.73 m2: 8-20 mg/kg/dose amoxicillin component (20 mg/kg/dose for high dose) PO every 12 hours.
    CrCl < 10 ml/min/1.73 m2: 8-20 mg/kg/dose amoxicillin component (20 mg/kg/dose for high dose) PO every 24 hours.

    FDA-approved dose adjustments (children and adolescents weighing > 40 kg):
    The following FDA-approved recommended dose adjustments are applicable for children and adolescents receiving the adult dosage:
    CrCl > 30 ml/min: No dosage adjustment needed.
    CrCl 10-30 ml/min: 250-500 mg amoxicillin component PO every 12 hours, depending on the severity of the infection.
    CrCl < 10 ml/min: 250-500 mg amoxicillin component PO every 24 hours, depending on the severity of the infection.
    NOTE: The 875-mg tablet is not recommended in patients with renal impairment. The extended-release formulation is contraindicated in patients with a CrCl <= 30 ml/min.

    Intermittent hemodialysis
    8-20 mg/kg/dose amoxicillin component (20 mg/kg/dose for high dose) PO every 24 hours, after dialysis. For children and adolescents receiving the adult dosage, 250-500 mg amoxicillin component PO every 24 hours, depending on the severity of the infection. According to the FDA-approved labeling, a supplemental dose should be administered both during and at the end of a dialysis session.

    Peritoneal dialysis
    8-20 mg/kg/dose amoxicillin component (20 mg/kg/dose for high dose) PO every 24 hours.

    *non-FDA-approved indication

    Monograph content under development

    Mechanism of Action: Amoxicillin is a semisynthetic antibacterial agent. Beta-lactam antibiotics such as amoxicillin are mainly bactericidal. Like other penicillins, amoxicillin 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 amoxicillin, as well as the other penicillins, against a particular organism depends on their ability to gain access to and bind with the necessary PBP. The aminopenicillins are able to penetrate gram-negative bacteria more readily than are the natural penicillins or penicillinase-resistant penicillins due to the presence of a free amino group within the structure. Like all beta-lactam antibiotics, amoxicillin'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. Prevention of the autolysin response to beta-lactam antibiotic exposure through loss of autolytic activity (mutation) or inactivation of autolysin (low-medium pH) by the microorganism can lead to tolerance to the beta-lactam antibiotic resulting in bacteriostatic activity.

    Clavulanic acid is a beta-lactam drug that acts as a competitive inhibitor of bacterial beta-lactamases. This protects amoxicillin from degradation and effectively extends the antibacterial spectrum of amoxicillin. It binds to the enzyme's active site, preventing the beta-lactamase from inactivating the beta-lactam antibiotic; clavulanic acid is also inactivated by this process, earning it the title "suicide" inhibitor. Clavulanic acid can bind with many plasmid- and chromosomally mediated bacterial beta-lactamases. Penetration of the cell wall allows clavulanic acid to bind both bound and extracellular beta-lactamases. Clavulanic acid does not alter the actions of the beta-lactam antibiotics.

    Beta-lactams 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 above MIC). 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. Penicillins require free drug concentrations to exceed the MIC for 30% of the dosing interval to achieve bacteriostatic activity and 50% of the dosing interval to achieve bactericidal activity.

    The susceptibility interpretive criteria for amoxicillin; clavulanic acid are delineated by pathogen. The MICs are defined for Enterobacterales as susceptible at 8/4 mcg/mL or less, intermediate at 16/8 mcg/mL, and resistant at 32/16 mcg/mL or more. The MICs are defined for S. pneumoniae (excluding meningitis) as susceptible at 2/1 mcg/mL or less, intermediate a 4/2 mcg/mL, and resistant at 8/4 mcg/mL or more. The Clinical and Laboratory Standards Institute (CLSI) and the FDA differ on MIC interpretation for H. influenzae. The MICs are defined for H. influenzae by the FDA as susceptible at 4/2 mcg/mL or less and resistant at 8/4 mcg/mL or more; however, the MICs are defined for H. influenzae and H. parainfluenzae by the CLSI as susceptible at 2/1 mcg/mL or less, intermediate at 4/2 mcg/mL, and resistant at 8/4 mcg/mL or more. The MICs are defined for anaerobes as susceptible at 4/2 mcg/mL or less, intermediate at 8/4 mcg/mL, and resistant at 16/8 mcg/mL or more. The breakpoints are based on a dosage of 875 mg amoxicillin with 125 mg clavulanic acid administered every 12 hours or 500 mg amoxicillin with 125 mg clavulanic acid administered every 8 hours when used for treatment of UTIs due to Enterobacterales, completion of therapy for Enterobacterales systemic infections, and for the treatment of S. pneumoniae, H. influenzae, and H. parainfluenzae. Enterococci susceptible to penicillin are predictably susceptible to amoxicillin; clavulanic acid for non-beta-lactamase producing enterococci. Oxacillin-susceptible staphylococci and beta-hemolytic streptococci can be considered susceptible to amoxicillin; clavulanic acid.

    Pharmacokinetics: Amoxicillin; clavulanic acid (clavulanate) is administered orally. Protein-binding is approximately 18% for amoxicillin and 25% for clavulanic acid. Amoxicillin and clavulanic acid are distributed into many tissues; however, minimal concentrations are attained in the CSF and brain. Approximately 50 to 80% of the amoxicillin dose is eliminated unchanged in the urine. Amoxicillin and its metabolites are excreted into the urine primarily via tubular secretion and glomerular filtration. Clearance of clavulanic acid has both a renal (25 to 50%) and a non-renal component. Clavulanic acid appears to be extensively metabolized, although the exact mechanism is not fully established. Co-administration of probenecid delays the excretion of amoxicillin but not that of clavulanic acid. In adult patients with normal renal function, the elimination half-lives of amoxicillin and clavulanic acid are roughly 1.3 hours and 1 hour, respectively.

    Affected cytochrome P450 isoenzymes: none


    -Route-Specific Pharmacokinetics
    Oral Route
    Amoxicillin; clavulanic acid is well absorbed after oral administration. Optimal absorption is achieved when the drug is administered at the beginning of a standard meal. Amoxicillin absorption may be reduced when administered in the fasted state, and clavulanic acid absorption is reduced by administration with a high-fat meal.

    Regular-release tablets and suspension
    Peak amoxicillin concentrations are reached approximately 1-2 hours after administration. Amoxicillin exposure achieved is similar to that produced by equivalent doses of amoxicillin alone.

    ES-600 suspension
    Peak amoxicillin concentrations are reached approximately 2 hours after administration, and peak clavulanic acid concentrations are achieved in approximately 1 hour. Amoxicillin exposure achieved is similar to that produced by equivalent doses of amoxicillin alone.

    Extended-release tablets
    Peak concentrations are reached approximately 1-2 hours after administration. Amoxicillin exposure achieved is similar to that produced by equivalent doses of amoxicillin alone; the extended-release tablets provide sustained plasma concentrations of amoxicillin.


    -Special Populations
    Pediatrics
    Neonates
    Pharmacokinetic data for amoxicillin; clavulanic acid are unavailable in neonates. Due to the immature renal function in neonates, it is expected that the clearance of amoxicillin; clavulanic acid is prolonged. A dosing interval of every 12 hours is recommended in neonates.

    Infants, Children, and Adolescents
    The elimination half-lives for amoxicillin and clavulanic acid are approximately 1-1.5 hours and 1 hour, respectively, in children. This is similar to what has been observed in adults. After administration of a 45/3.2 mg/kg dose of amoxicillin; clavulanic acid in fasting children, mean middle ear fluid (MEF) concentrations of amoxicillin at 2 hours were 3.3 mcg/ml; corresponding plasma concentrations were 15.7 mcg/ml. MEF concentrations of amoxicillin at 1-3 hours post-dose were > 1 mcg/ml in 18 specimens (90%) and > 4 mcg/ml in 8 specimens (40%), the amoxicillin MIC90 values for penicillin-intermediate and -resistant strains, respectively.

    Renal Impairment
    Pharmacokinetic data are unavailable in pediatric patients with renal impairment. Amoxicillin; clavulanic acid is primarily excreted renally and dosage adjustments are recommended in patients with renal impairment (CrCl <= 30 ml/min). Both amoxicillin and clavulanate are removed by hemodialysis.

DISCLAIMER: This drug information content is provided for informational purposes only and is not intended to be a substitute for professional medical advice, diagnosis, or treatment. Patients should always consult their physician with any questions regarding a medical condition and to obtain medical advice and treatment. Drug information is sourced from GSDD (Gold Standard Drug Database ) provided by Elsevier.

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