Nitazoxanide is an oral synthetic antiprotozoal agent indicated for the treatment of diarrhea due to Giardia lamblia and Cryptosporidium parvum; however, nitazoxanide has not been shown to be effective for the treatment of diarrhea caused by C. parvum in persons living with HIV or immunodeficiency. Nitazoxanide has also been effective in treating diarrhea due to other protozoa such as Giardia duodenalis, G. intestinalis, and Entamoeba histolytica. In a comparative study, nitazoxanide was as effective as metronidazole in the treatment of giardiasis due to G. intestinalis. Nitazoxanide is used off-label for the treatment of Clostridioides difficile-associated diarrhea (CDAD). Nitazoxanide has also been used for shortening the duration of diarrhea in children with rotavirus infection.
General Administration Information
For storage information, see the specific product information within the How Supplied section.
Route-Specific Administration
Oral Administration
-Nitazoxanide is administered orally. Give with food.
Oral Liquid Formulations
-Shake well prior to each administration.
-Measure dosage with calibrated spoon, cup, or oral syringe.
-Diabetic patients and caregivers should be aware that the oral suspension contains 1.48 g of sucrose per 5 ml.
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 half of the total amount of water as listed and shake vigorously to suspend the powder. Add the remainder of the water and again shake vigorously. After reconstitution, the oral suspension contains nitazoxanide 100 mg/5 ml.
-Storage: Store reconstituted suspension at controlled room temperature. Discard any unused portion after 7 days.
Gastrointestinal adverse events associated with nitazoxanide therapy include abdominal pain (6.6% adults; 7.8% pediatrics), diarrhea (4.2% adults; 2.1% pediatrics), nausea (3% adults; < 1% pediatrics), and vomiting (< 1% adults; 1.1% pediatrics). Other adverse reactions occurring in < 1% of patients in clinical trials include anorexia, appetite stimulation, flatulence, enlarged salivary glands in pediatric patients, dyspepsia, constipation, xerostomia, and thirst. Gastroesophageal reflux disease has been reported during post-marketing use. Due to the voluntary nature of post-marketing reports, neither a frequency nor a definitive causal relationship can be established.
Headache was reported in 1.1% of pediatric patients and 3.1% of adult patients receiving nitazoxanide during clinical trials. Other nervous system adverse events reported in < 1% of patients during clinical trials include dizziness, somnolence (drowsiness), insomnia, tremor, and hypoesthesia.
General adverse events occurring in < 1% of patients during nitazoxanide clinical trials include fever, infection, malaise, asthenia, unspecified pain, allergic reaction, pelvic pain, back pain, chills, influenza syndrome.
Urogenital adverse events reported in < 1% of patients during clinical trials with nitazoxanide include urine discoloration, dysuria, amenorrhea, metrorrhagia, kidney pain, and labial edema.
Metabolic and nutritional adverse events reported in < 1% of patients during nitazoxanide clinical trials includes elevated serum creatinine and elevated hepatic enzymes (SGPT).
Dermatologic adverse events reported in < 1% of patients during nitazoxanide trials include diaphoresis, rash (unspecified), and pruritus. Urticaria has been reported during post-marketing use. Due to the voluntary nature of post-marketing reports, neither a frequency nor a definitive causal relationship can be established.
Eye discolorations/iridal discoloration (pale yellow) and otalgia were reported in < 1% of patients during nitazoxanide clinical trials.
Respiratory adverse events reported in < 1% of patients during nitazoxanide clinical trials include rhinitis, epistaxis, lung disease, and pharyngitis.
Hematologic adverse events reported in < 1% of patients during trials with nitazoxanide include anemia and leukocytosis.
Cardiovascular adverse events reported in < 1% of patients during nitazoxanide clinical trials include sinus tachycardia, syncope, and hypertension.
Musculoskeletal adverse events reported in < 1% of patients during nitazoxanide clinical trials include myalgia, leg cramps/muscle cramps, and spontaneous bone fractures.
Nitazoxanide is contraindicated in patients with a prior hypersensitivity to nitazoxanide or any component of the formulation.
Nitazoxanide has not been studied in patients with compromised renal or hepatic function. Therefore, nitazoxanide should be administered with caution to patients with biliary tract disease, hepatic disease, renal disease, renal failure, renal impairment, or combined renal and hepatic disease.
Patients with diabetes mellitus or caregivers of these patients should be aware that the nitazoxanide oral suspension contains 1.48 g of sucrose per 5 ml.
Because nitazoxanide may cause dizziness, patients should be advised to use caution if driving or operating machinery or performing other potentially hazardous tasks until the effects of the drug are known.
There are no data with nitazoxanide in human pregnancy to inform a drug-associated risk. Animal reproductive studies performed in rats and rabbits at doses up to 2 and 30 times the recommended daily human dose demonstrated no evidence of teratogenicity or fetotoxicity due to nitazoxanide.
There is no information about the presence of nitazoxanide in human milk, the effects on the breast-fed infant, or the effects on milk production. The developmental and health benefits of breast-feeding should be considered along with the mother's clinical need for nitazoxanide and any potential adverse effects on the breast-fed infant from nitazoxanide or the mother's underlying condition.
A single nitazoxanide tablet contains more drug than is recommended in children younger than 11 years of age; therefore, the suspension should be used for patients under the age of 11 years. The safety and efficacy of the oral suspension have not been established in neonates and infants younger than 1 year of age.
Nitazoxanide has not been shown to be superior to placebo for the treatment of diarrhea due to Cryptosporidium parvum in patients with human immunodeficiency virus (HIV) infection , patients with acquired immunodeficiency syndrome (AIDS), patients receiving immunosuppression, or immunodeficient patients.
Clinical studies of nitazoxanide did not include sufficient numbers of geriatric patients to determine whether they respond differently from younger patients; however, elderly patients have a greater frequency of decreased hepatic, renal, or cardiac function. Therefore, nitazoxanide should be administered with caution in geriatric patients.
Administration of nitazoxanide may result in laboratory test interference. Antimicrobials are known to suppress H. pylori; thus, ingestion of these agents within 4 weeks of performing diagnostic tests for H. pylori may lead to false negative results. At a minimum, instruct the patient to avoid the use of nitazoxanide in the 4 weeks prior to the test.
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: Cryptosporidium parvum, Giardia lamblia
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: Clostridioides difficile, Cystoisospora belli, Entamoeba dispar, Entamoeba histolytica, Enterocytozoon bieneusi, Giardia intestinalis, Helicobacter pylori, rotavirus
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 infectious diarrhea and gastroenteritis, including, amebiasis*, ascariasis* (roundworm infection*), cryptosporidiosis, cystoisosporiasis*, giardiasis, microsporidiosis*, and rotavirus infection*:
-for the treatment of amebiasis*:
Oral dosage:
Adults: 500 mg PO every 12 hours for 3 days.
Children and Adolescents 12 to 17 years: 500 mg PO every 12 hours for 3 days.
Children 4 to 11 years: 200 mg PO every 12 hours for 3 days.
Children 1 to 3 years: 100 mg PO every 12 hours for 3 days.
-for the treatment of ascariasis* (roundworm infection*):
Oral dosage:
Adults: 500 mg PO every 12 hours for 3 days as an alternative.
Children and Adolescents 12 to 17 years: 500 mg PO every 12 hours for 3 days as an alternative.
Children 4 to 11 years: 200 mg PO every 12 hours for 3 days as an alternative.
Children 1 to 3 years: 100 mg PO every 12 hours for 3 days as an alternative.
-for the treatment of cryptosporidiosis in persons without HIV:
Oral dosage:
Adults: 500 mg PO every 12 hours 3 days.
Children and Adolescents 12 to 17 years: 500 mg PO every 12 hours for 3 days.
Children 4 to 11 years: 200 mg PO every 12 hours for 3 days.
Children 1 to 3 years: 100 mg PO every 12 hours for 3 days.
-for the treatment of cryptosporidiosis in persons living with HIV*:
Oral dosage:
Adults: 500 to 1,000 mg PO every 12 hours for at least 14 days. Give in combination with optimized antiretroviral therapy, symptomatic treatment, rehydration, and electrolyte replacement.
Adolescents: 500 to 1,000 mg PO every 12 hours for at least 14 days. Give in combination with optimized antiretroviral therapy, symptomatic treatment, rehydration, and electrolyte replacement.
Children 12 years: 500 mg PO every 12 hours for 3 to 14 days.
Children 4 to 11 years: 200 mg PO every 12 hours for 3 to 14 days.
Children 1 to 3 years: 100 mg PO every 12 hours for 3 to 14 days.
-for the treatment of cystoisosporiasis* in persons living with HIV:
Oral dosage:
Adults: 500 mg PO every 12 hours for 3 days as an alternative followed by long-term suppressive therapy.
Children and Adolescents 12 to 17 years: 500 mg PO every 12 hours for 3 days as an alternative followed by long-term suppressive therapy.
Children 4 to 11 years: 200 mg PO every 12 hours for 3 days as an alternative followed by long-term suppressive therapy.
Children 1 to 3 years: 100 mg PO every 12 hours for 3 days as an alternative followed by long-term suppressive therapy.
-for the treatment of giardiasis:
Oral dosage:
Adults: 500 mg PO every 12 hours for 3 days.
Children and Adolescents 12 to 17 years: 500 mg PO every 12 hours for 3 days.
Children 4 to 11 years: 200 mg PO every 12 hours for 3 days.
Children 1 to 3 years: 100 mg PO every 12 hours for 3 days.
-for the treatment of microsporidiosis* in persons living with HIV:
Oral dosage:
Adults: 1,000 mg PO every 12 hours as an alternative; however, effects may be minimal for persons with a low CD4 count.
Adolescents: 1,000 mg PO every 12 hours as an alternative; however, effects may be minimal for patients with a low CD4 count.
-for the treatment of rotavirus infection*:
Oral dosage:
Children 4 to 11 years: 200 mg PO every 12 hours for 3 days. In clinical trials in pediatric subjects (n = 163), treatment with nitazoxanide significantly reduced time to resolution of symptoms/diarrhea and duration of hospitalization compared with control treatments.
Children 1 to 3 years: 100 mg PO every 12 hours for 3 days. In clinical trials in pediatric subjects (n = 163), treatment with nitazoxanide significantly reduced time to resolution of symptoms/diarrhea and duration of hospitalization compared with control treatments.
Infants: 7.5 mg/kg/dose PO every 12 hours for 3 days. In clinical trials in pediatric subjects (n = 163), treatment with nitazoxanide significantly reduced time to resolution of symptoms/diarrhea and duration of hospitalization compared with control treatments.
For the treatment of pseudomembranous colitis* due to C. difficile infection*:
Oral dosage:
Adults: 500 mg PO twice daily for 10 days as an alternative for the treatment of the primary episode of C. difficile infection.
For Helicobacter pylori (H. pylori) eradication* as part of levofloxacin-based quadruple therapy:
Oral dosage:
Adults: 500 mg PO twice daily in combination with levofloxacin, doxycycline, and a proton pump inhibitor (PPI) for 7 to 10 days.
Maximum Dosage Limits:
-Adults
1,000 mg/day PO per FDA-approved labeling; however, doses up to 2,000 mg/day PO have been used off-label.
-Geriatric
1,000 mg/day PO per FDA-approved labeling; however, doses up to 2,000 mg/day PO have been used off-label.
-Adolescents
1,000 mg/day PO per FDA-approved labeling; however, doses up to 2,000 mg/day PO have been used off-label.
-Children
12 years: 1,000 mg/day PO.
4 to 11 years: 400 mg/day PO.
1 to 3 years: 200 mg/day PO.
-Infants
Safety and efficacy have not been established; however, doses up to 15 mg/kg/day PO have been used off-label.
-Neonates
Safety and efficacy have not been established.
Patients with Hepatic Impairment Dosing
Nitazoxanide has not been studied in patients with hepatic impairment.
Patients with Renal Impairment Dosing
Nitazoxanide has not been studied in patients with renal impairment.
*non-FDA-approved indication
Acetaminophen; Aspirin, ASA; Caffeine: (Moderate) The active metabolite of nitazoxanide, tizoxanide, is highly bound to plasma proteins. Caution should be exercised when administering nitazoxanide concurrently with other highly plasma protein-bound drugs with narrow therapeutic indices because competition for binding sites may occur.
Acetaminophen; Aspirin: (Moderate) The active metabolite of nitazoxanide, tizoxanide, is highly bound to plasma proteins. Caution should be exercised when administering nitazoxanide concurrently with other highly plasma protein-bound drugs with narrow therapeutic indices because competition for binding sites may occur.
Acetaminophen; Aspirin; Diphenhydramine: (Moderate) The active metabolite of nitazoxanide, tizoxanide, is highly bound to plasma proteins. Caution should be exercised when administering nitazoxanide concurrently with other highly plasma protein-bound drugs with narrow therapeutic indices because competition for binding sites may occur.
Aminosalicylate sodium, Aminosalicylic acid: (Moderate) The active metabolite of nitazoxanide, tizoxanide, is highly bound to plasma proteins. Caution should be exercised when administering nitazoxanide concurrently with other highly plasma protein-bound drugs with narrow therapeutic indices because competition for binding sites may occur.
Aspirin, ASA: (Moderate) The active metabolite of nitazoxanide, tizoxanide, is highly bound to plasma proteins. Caution should be exercised when administering nitazoxanide concurrently with other highly plasma protein-bound drugs with narrow therapeutic indices because competition for binding sites may occur.
Aspirin, ASA; Butalbital; Caffeine: (Moderate) The active metabolite of nitazoxanide, tizoxanide, is highly bound to plasma proteins. Caution should be exercised when administering nitazoxanide concurrently with other highly plasma protein-bound drugs with narrow therapeutic indices because competition for binding sites may occur.
Aspirin, ASA; Caffeine: (Moderate) The active metabolite of nitazoxanide, tizoxanide, is highly bound to plasma proteins. Caution should be exercised when administering nitazoxanide concurrently with other highly plasma protein-bound drugs with narrow therapeutic indices because competition for binding sites may occur.
Aspirin, ASA; Caffeine; Orphenadrine: (Moderate) The active metabolite of nitazoxanide, tizoxanide, is highly bound to plasma proteins. Caution should be exercised when administering nitazoxanide concurrently with other highly plasma protein-bound drugs with narrow therapeutic indices because competition for binding sites may occur.
Aspirin, ASA; Carisoprodol; Codeine: (Moderate) The active metabolite of nitazoxanide, tizoxanide, is highly bound to plasma proteins. Caution should be exercised when administering nitazoxanide concurrently with other highly plasma protein-bound drugs with narrow therapeutic indices because competition for binding sites may occur.
Aspirin, ASA; Citric Acid; Sodium Bicarbonate: (Moderate) The active metabolite of nitazoxanide, tizoxanide, is highly bound to plasma proteins. Caution should be exercised when administering nitazoxanide concurrently with other highly plasma protein-bound drugs with narrow therapeutic indices because competition for binding sites may occur.
Aspirin, ASA; Dipyridamole: (Moderate) The active metabolite of nitazoxanide, tizoxanide, is highly bound to plasma proteins. Caution should be exercised when administering nitazoxanide concurrently with other highly plasma protein-bound drugs with narrow therapeutic indices because competition for binding sites may occur.
Aspirin, ASA; Omeprazole: (Moderate) The active metabolite of nitazoxanide, tizoxanide, is highly bound to plasma proteins. Caution should be exercised when administering nitazoxanide concurrently with other highly plasma protein-bound drugs with narrow therapeutic indices because competition for binding sites may occur.
Aspirin, ASA; Oxycodone: (Moderate) The active metabolite of nitazoxanide, tizoxanide, is highly bound to plasma proteins. Caution should be exercised when administering nitazoxanide concurrently with other highly plasma protein-bound drugs with narrow therapeutic indices because competition for binding sites may occur.
Benzoic Acid; Hyoscyamine; Methenamine; Methylene Blue; Phenyl Salicylate: (Moderate) The active metabolite of nitazoxanide, tizoxanide, is highly bound to plasma proteins. Caution should be exercised when administering nitazoxanide concurrently with other highly plasma protein-bound drugs with narrow therapeutic indices because competition for binding sites may occur.
Bismuth Subsalicylate: (Moderate) The active metabolite of nitazoxanide, tizoxanide, is highly bound to plasma proteins. Caution should be exercised when administering nitazoxanide concurrently with other highly plasma protein-bound drugs with narrow therapeutic indices because competition for binding sites may occur.
Bismuth Subsalicylate; Metronidazole; Tetracycline: (Moderate) The active metabolite of nitazoxanide, tizoxanide, is highly bound to plasma proteins. Caution should be exercised when administering nitazoxanide concurrently with other highly plasma protein-bound drugs with narrow therapeutic indices because competition for binding sites may occur.
Butalbital; Aspirin; Caffeine; Codeine: (Moderate) The active metabolite of nitazoxanide, tizoxanide, is highly bound to plasma proteins. Caution should be exercised when administering nitazoxanide concurrently with other highly plasma protein-bound drugs with narrow therapeutic indices because competition for binding sites may occur.
Choline Salicylate; Magnesium Salicylate: (Moderate) The active metabolite of nitazoxanide, tizoxanide, is highly bound to plasma proteins. Caution should be exercised when administering nitazoxanide concurrently with other highly plasma protein-bound drugs with narrow therapeutic indices because competition for binding sites may occur.
Fosphenytoin: (Moderate) No interactions with other drugs have been reported by patients using nitazoxanide. The active metabolite of nitazoxanide, tizoxanide, is highly bound to plasma proteins (> 99%). No studies have been performed to determine if there are interactions with other drugs that exhibit high protein binding (e.g., hydantoins like phenytoin or fosphenytoin). Therefore, caution should be exercised when administering nitazoxanide concurrently with other highly plasma protein-bound drugs with narrow therapeutic indices because competition for binding sites may occur.
Glimepiride: (Moderate) The active metabolite of nitazoxanide, tizoxanide, is highly bound to plasma proteins. Caution should be exercised when administering nitazoxanide concurrently with other highly plasma protein-bound drugs with narrow therapeutic indices because competition for binding sites may occur.
Glipizide: (Moderate) The active metabolite of nitazoxanide, tizoxanide, is highly bound to plasma proteins. Caution should be exercised when administering nitazoxanide concurrently with other highly plasma protein-bound drugs with narrow therapeutic indices because competition for binding sites may occur.
Glipizide; Metformin: (Moderate) The active metabolite of nitazoxanide, tizoxanide, is highly bound to plasma proteins. Caution should be exercised when administering nitazoxanide concurrently with other highly plasma protein-bound drugs with narrow therapeutic indices because competition for binding sites may occur.
Glyburide: (Moderate) The active metabolite of nitazoxanide, tizoxanide, is highly bound to plasma proteins. Caution should be exercised when administering nitazoxanide concurrently with other highly plasma protein-bound drugs with narrow therapeutic indices because competition for binding sites may occur.
Glyburide; Metformin: (Moderate) The active metabolite of nitazoxanide, tizoxanide, is highly bound to plasma proteins. Caution should be exercised when administering nitazoxanide concurrently with other highly plasma protein-bound drugs with narrow therapeutic indices because competition for binding sites may occur.
Hyoscyamine; Methenamine; Methylene Blue; Phenyl Salicylate; Sodium Biphosphate: (Moderate) The active metabolite of nitazoxanide, tizoxanide, is highly bound to plasma proteins. Caution should be exercised when administering nitazoxanide concurrently with other highly plasma protein-bound drugs with narrow therapeutic indices because competition for binding sites may occur.
Magnesium Salicylate: (Moderate) The active metabolite of nitazoxanide, tizoxanide, is highly bound to plasma proteins. Caution should be exercised when administering nitazoxanide concurrently with other highly plasma protein-bound drugs with narrow therapeutic indices because competition for binding sites may occur.
Methenamine; Sodium Salicylate: (Moderate) The active metabolite of nitazoxanide, tizoxanide, is highly bound to plasma proteins. Caution should be exercised when administering nitazoxanide concurrently with other highly plasma protein-bound drugs with narrow therapeutic indices because competition for binding sites may occur.
Phenytoin: (Moderate) No interactions with other drugs have been reported by patients using nitazoxanide. The active metabolite of nitazoxanide, tizoxanide, is highly bound to plasma proteins (> 99%). No studies have been performed to determine if there are interactions with other drugs that exhibit high protein binding (e.g., hydantoins like phenytoin or fosphenytoin). Therefore, caution should be exercised when administering nitazoxanide concurrently with other highly plasma protein-bound drugs with narrow therapeutic indices because competition for binding sites may occur.
Pioglitazone; Glimepiride: (Moderate) The active metabolite of nitazoxanide, tizoxanide, is highly bound to plasma proteins. Caution should be exercised when administering nitazoxanide concurrently with other highly plasma protein-bound drugs with narrow therapeutic indices because competition for binding sites may occur.
Salicylates: (Moderate) The active metabolite of nitazoxanide, tizoxanide, is highly bound to plasma proteins. Caution should be exercised when administering nitazoxanide concurrently with other highly plasma protein-bound drugs with narrow therapeutic indices because competition for binding sites may occur.
Salsalate: (Moderate) The active metabolite of nitazoxanide, tizoxanide, is highly bound to plasma proteins. Caution should be exercised when administering nitazoxanide concurrently with other highly plasma protein-bound drugs with narrow therapeutic indices because competition for binding sites may occur.
Sulfonylureas: (Moderate) The active metabolite of nitazoxanide, tizoxanide, is highly bound to plasma proteins. Caution should be exercised when administering nitazoxanide concurrently with other highly plasma protein-bound drugs with narrow therapeutic indices because competition for binding sites may occur.
Warfarin: (Moderate) No interactions with other drugs have been reported by patients using nitazoxanide. The active metabolite of nitazoxanide, tizoxanide, is highly bound to plasma proteins (> 99%). The manufacturer has reported that nitazoxanide does not affect the pharmacokinetics or anticoagulant effects of warfarin in healthy volunteers. No studies have been performed to determine if there are interactions with other drugs that exhibit high protein binding (e.g., hydantoins like phenytoin or fosphenytoin, the sulfonylureas, or salicylates). Therefore, caution should be exercised when administering nitazoxanide concurrently with other highly plasma protein-bound drugs with narrow therapeutic indices because competition for binding sites may occur. No other clinical studies have been conducted to specifically exclude the possibility of interactions between nitazoxanide and other medicinal products which are not highly-protein bound.
Nitazoxanide exhibits antiprotozoal activity. Nitazoxanide and its metabolite, tizoxanide, are active in vitro in inhibiting the growth of sporozoites and oocysts of Cryptosporidium parvum and the trophozoites of Giardia lamblia. The exact mechanism of action of nitazoxanide is unknown. It is believed that the antiprotozoal effects of nitazoxanide are due to interference with the pyruvate:ferredoxin oxidoreductase (PFOR) enzyme-dependent electron transfer reaction which is essential to anaerobic energy metabolism. Studies of Giardia lamblia have shown that the PFOR enzyme from this organism directly reduces nitazoxanide by transfer of electrons in the absence of ferredoxin. The DNA-derived PFOR protein sequence of Cryptosporidium parvum appears to be similar to that of Giardia lamblia. It is suggested that interference with the PFOR enzyme-dependent electron transfer reaction may not be the only pathway by which nitazoxanide exhibits antiprotozoal activity. Nitazoxanide has also exhibited activity against other protozoa such as Giardia duodenalis, G. intestinalis and Entamoeba histolytica. Nitazoxanide also has some antiviral activity; it is being studied for rotavirus infection and chronic hepatitis B and C infections.
Resistance mechanisms to nitazoxanide by Cryptosporidium parvum, Giardia lamblia or other protozoa have not been examined.
Nitazoxanide is administered orally as a suspension. The pharmacokinetic parameters of nitazoxanide listed are from studies performed in the pediatric population from 12 months to 11 years of age. The parent drug nitazoxanide is not detected in plasma. Once in the systemic circulation, the active metabolite, tizoxanide, is > 99% bound to plasma proteins. Tizoxanide is excreted in the urine, bile, and feces, and tizoxanide glucuronide is excreted in urine and bile.
-Route-Specific Pharmacokinetics
Oral Route
Following oral administration of a single dose of nitazoxanide with food, the drug is rapidly hydrolyzed to the active metabolite, tizoxanide (desacetyl-nitazoxanide) which then undergoes conjugation primarily to tizoxanide glucuronide. Maximum plasma concentrations (Cmax) of tizoxanide and tizoxanide glucuronide occur within 1-4 hours (Tmax). No studies have been performed to determine if administration of the drug in the fasted state affects the pharmacokinetics of tizoxanide and tizoxanide glucuronide compared to administration with food.
-Special Populations
Hepatic Impairment
The pharmacokinetics of nitazoxanide have not been studied in patients with impaired hepatic function.
Renal Impairment
The pharmacokinetics of nitazoxanide have not been studied in patients with impaired renal function.
Pediatrics
The pharmacokinetics of nitazoxanide have not been studied in infants.
Elderly
The pharmacokinetics of nitazoxanide have not been studied in the elderly.