Trade Names:Alinia- 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.
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.
Treatment of diarrhea caused by Giardia lamblia or Cryptosporidium parvum .
Hypersensitivity to nitazoxanide or any ingredient in the formulations.
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.
Store at 59° to 86°F. Discard any unused suspension after 7 days.
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.
Use with caution in patients with hepatic, biliary, or renal disease, or combined renal and hepatic disease.
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.
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