- Tablets 500 mg
- Suspension, oral 100 mg per 5 mL
Interferes with pyruvate:ferredoxin oxidoreductase enzyme-dependent electron transfer reaction, which is essential to anaerobic energy metabolism.
After ingestion, nitazoxanide is converted to the active metabolites tizoxanide and tizoxanide glucuronide. Bioavailability of the suspension is 70% compared with the tablet.Adults and children 12 yr of age and older
Following administration of nitazoxanide 500 mg tablet with food in adults or children 12 yr of age and older, C max is 10.6 and 9.1 mcg/mL, respectively; T max is 3 and 4 h, respectively; AUC is 41.9 and 39.5 mcg•h/mL. For tizoxanide glucuronide, C max is 10.5 and 7.3 mcg/mL, respectively; T max is 4.5 and 4 h, respectively; AUC is 63 and 46.5 mcg•h/mL, respectively.Children 1 to 11 yr of age
Following administration of nitazoxanide 500 mg tablet with food in children 4 to 11 yr of age or 1 to 3 yr of age, C max is 3 and 3.11 mcg/mL, respectively; T is max 2 and 3.5 h, respectively; AUC is 13.5 and 11.7 mcg•h/mL, respectively. For tizoxanide glucuronide, C is max is 2.84 and 3.64 mcg/mL, respectively; T max is 4 h in both age groups; and AUC is 16.9 and 19 mcg•h/mL, respectively.
Tizoxanide is more than 99% protein bound.
Nitazoxanide is rapidly hydrolyzed to an active metabolite, tizoxanide, which then undergoes conjugation, primarily by glucuronidation, to an active metabolite.
Approximately 67% of the oral dose of nitazoxanide is excreted in the feces and 33% in the urine. Tizoxanide is excreted in the urine, bile, and feces, while tizoxanide glucuronide is excreted in the urine and bile.
Special PopulationsRenal Function Impairment
The pharmacokinetics in patients with impaired renal function have not been studied.Hepatic Function Impairment
The pharmacokinetics in patients with impaired hepatic function have not been studied.
Indications and Usage
Treatment of diarrhea caused by Giardia lamblia or Cryptosporidium parvum .
Hypersensitivity to nitazoxanide or any ingredient in the formulations.
Dosage and AdministrationDiarrhea
Adults and Children 12 yr of age and older
PO 500 mg every 12 h for 3 days.Children 4 to 11 yr of age
PO 10 mL (200 mg) every 12 h for 3 days.Children 1 to 3 yr of age
PO 5 mL (100 mg) every 12 h for 3 days.
- Nitazoxanide tablets and oral suspension are not bioequivalent. The relative bioavailability of the suspension compared with the tablet is 70%.
- Do not use administer tablets in children 11 yr of age and younger.
- Administer with food to minimize GI adverse reactions and increase absorption.
- Shake suspension well before measuring dose.
Store at 59° to 86°F. Discard any unused suspension after 7 days.
Drug InteractionsHighly protein-bound drugs (eg, warfarin)
May compete for binding sites, transiently increasing the effects of the displaced drug.
Abdominal pain (8%); diarrhea (4%); nausea (3%); vomiting (1%).
Category B .
Safety and efficacy not established in children younger than 1 yr of age. Do not administer the tablets in children 11 yr of age or younger.
Use with caution because of the greater frequency of decreased hepatic, renal, or cardiac function, and concomitant diseases or other drug therapy.
Special Risk Patients
Use with caution in patients with hepatic, biliary, or renal disease, or combined renal and hepatic disease.
HIV-infected or immunodeficient patients
Nitazoxanide tablets and oral suspension have not been studied for the treatment of diarrhea cause by G. Iamblia in HIV-infected or immunodeficient patients. Nitazoxanide tablets and oral suspension have not been shown to be superior to placebo for the treatment of diarrhea caused by C. parvum in HIV-infected or immunodeficient patients.
A single tablet contains a greater amount of nitazoxanide than recommended for dosing in children and should not be used in patients 11 yr of age or younger.
- Instruct patient to take exactly as prescribed and not to change the dose or discontinue therapy unless advised by health care provider.
- Advise patient to take prescribed dose with food to minimize GI adverse reactions and increase absorption.
- Advise patient or caregiver using oral suspension to shake suspension well before measuring dose; measure and administer prescribed dose using dosing syringe, dosing spoon, or dosing cup; and discard any remaining suspension after 7 days.
- Instruct patient or caregiver to notify health care provider if diarrhea does not improve or worsens.
- Advise patient to report any other bothersome adverse reactions to health care provider.
- Advise diabetic patients and caregivers that the oral suspension contains 1.48 g of sucrose per 5 mL.
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