Nitazoxanide
Pronunciation: (nye-tah-ZOX-ah-nide)Class: Antiprotozoal
Trade Names:
Alinia
- Tablets 500 mg
- Oral suspension 100 mg per 5 mL
Pharmacology
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Interferes with pyruvate:ferredoxin oxidoreductase enzyme-dependent electron transfer reaction, which is essential to anaerobic energy metabolism.
Pharmacokinetics
Absorption
After ingestion, nitazoxanide is converted to the active metabolites tizoxanide and tizoxanide glucuronide. Bioavailability of the suspension is 70% compared with the tablet. Pharmacokinetics of tizoxanide following administration of nitazoxanide 500 mg tablet with food in adults or children 12 yr of age and older is: C max 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, corresponding values are: C max 10.5 and 7.3 mcg/mL, respectively; T max of 4.5 and 4 h, respectively; AUC of 63 and 46.5 mcg•h/mL, respectively. Absorption of tizoxanide following administration of the oral suspension with food to children 4 to 11 yr of age or 1 to 3 yr of age is: C max 3 and 3.11 mcg/mL, respectively; T max 2 and 3.5 h, respectively; AUC 13.5 and 11.7 mcg•h/mL, respectively. For tizoxanide glucuronide, corresponding values are: C max 2.84 and 3.64 mcg/mL, respectively; T max 4 h in both age groups; and AUC 16.9 and 19 mcg•h/mL, respectively.
Distribution
Tizoxanide is more than 99% protein bound.
Metabolism
Nitazoxanide is rapidly hydrolyzed to an active metabolite, tizoxanide, which then undergoes conjugation, primarily by glucuronidation, to an active metabolite.
Elimination
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.
Indications and Usage
Treatment of diarrhea caused by Giardia lamblia or Cryptosporidium parvum .
Contraindications
Standard considerations.
Dosage and Administration
Diarrhea caused by G. lambliaAdults and Children 12 yr of age and older
PO 500 mg every 12 h with food.
Children 4 to 11 yr of agePO 10 mL (200 mg) every 12 h with food.
Children 1 to 3 yr of agePO 5 mL (100 mg) every 12 h with food.
Diarrhea caused by C. parvumChildren 4 to 11 yr of age
PO 10 mL (200 mg) every 12 h with food.
Children 1 to 3 yr of agePO 5 mL (100 mg) every 12 h with food.
General Advice
- Nitazoxanide tablets and oral suspension are not bioequivalent. The relative bioavailability of the suspension compared to tablet is 70%.
- Administer with food to minimize GI adverse reactions and increase absorption.
- Shake suspension well before measuring dose.
Storage/Stability
Store tablets, unsuspended powder, and reconstituted oral suspension at controlled room temperature (59° to 86°F). Discard any unused suspension after 7 days.
Drug Interactions
Highly protein-bound drugs (eg, warfarin)May compete for binding sites, transiently increasing the effects of the displaced drug.
Laboratory Test Interactions
None well documented.
Adverse Reactions
CNS
Headache (3%).
GI
Abdominal pain (8%); diarrhea (4%); nausea (3%); vomiting (1%).
Precautions
Pregnancy
Category B .
Lactation
Not established.
Children
Safety and efficacy not established for treatment of C. parvum in patients 12 yr of age and older.
Oral suspensionSafety and efficacy not established in children younger than 1 yr of age.
TabletNot for use in children 11 yr of age or younger.
Elderly
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
Because nitazoxanide was not studied in patients with hepatic or renal function impairment, use with caution in patients with hepatic, biliary, or renal disease.
Tablet administration
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.
Patient Information
- 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; 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.
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More Nitazoxanide resources
nitazoxanide Drug Interactions
nitazoxanide - Includes detailed dosage instructions.
Compare Nitazoxanide with other medications for the treatment of:
Giardiasis, Cryptosporidiosis, Amebiasis, Ascariasis, Hymenolepis nana, Dwarf Tapeworm
