(nye ta ZOX a nide)
Excipient information presented when available (limited, particularly for generics); consult specific product labeling.
Suspension Reconstituted, Oral:
Alinia: 100 mg/5 mL (60 mL) [contains fd&c red #40, sodium benzoate; strawberry flavor]
Alinia: 500 mg [contains fd&c blue #2 aluminum lake, fd&c yellow #10 aluminum lake, fd&c yellow #6 aluminum lake, soybean lecithin]
Brand Names: U.S.
Nitazoxanide is rapidly metabolized to the active metabolite tizoxanide in vivo. Activity may be due to interference with the pyruvate:ferredoxin oxidoreductase (PFOR) enzyme-dependent electron transfer reaction which is essential to anaerobic metabolism. In vitro, nitazoxanide and tizoxanide inhibit the growth of sporozoites and oocysts of Cryptosporidium parvum and trophozoites of Giardia lamblia.
Hepatic, to an active metabolite, tizoxanide. Tizoxanide undergoes conjugation to form tizoxanide glucuronide. Nitazoxanide is not detectable in the serum following oral administration.
Tizoxanide: Urine, bile, and feces; Tizoxanide glucuronide: Urine and bile
Time to Peak
Plasma: Tizoxanide and tizoxanide glucuronide: 1-4 hours
Use: Labeled Indications
Treatment of diarrhea caused by Cryptosporidium parvum or Giardia lamblia
Alternative treatment for Clostridium difficile-associated diarrhea (CDAD)
Hypersensitivity to nitazoxanide or any component of the formulation
Children: Diarrhea caused by Cryptosporidium parvum or Giardia lamblia:
Children 1 to 3 years: Oral suspension: 100 mg every 12 hours for 3 days; may consider increasing duration up to 14 days in HIV-exposed/-infected pediatric patients with cryptosporidiosis (CDC 2009)
Children 4 to 11 years: Oral suspension: 200 mg every 12 hours for 3 days; may consider increasing duration up to 14 days in HIV-exposed/-infected pediatric patients with cryptosporidiosis (CDC 2009)
Children ≥12 years: Refer to adult dosing.
Adolescents: Cryptosporidiosis-associated diarrhea in HIV-infected patients (off-label use): Refer to adult dosing.
Diarrhea caused by Cryptosporidium parvum or Giardia lamblia: Oral suspension or tablets: 500 mg every 12 hours for 3 days
Clostridium difficile-associated diarrhea (off-label use): Oral suspension or tablets: 500 mg every 12 hours for 7 to 10 days (Musher 2006; Musher 2009)
Cryptosporidiosis-associated diarrhea in HIV-infected patients (off-label use): Oral: 500 to 1,000 mg twice daily for 14 days (must be used in conjunction with optimized ART, electrolyte replacement, and symptomatic treatment and rehydration) (HHS [OI adult 2015])
Dosage adjustment in renal impairment: There are no dosage adjustments provided in the manufacturer’s labeling (has not been studied); use with caution.
Dosage adjustment in hepatic impairment: There are no dosage adjustments provided in the manufacturer’s labeling (has not been studied); use with caution.
For preparation at time of dispensing, add 48 mL incrementally to 60 mL bottle; shake vigorously. Resulting suspension is 20 mg/mL (100 mg per 5 mL).
Administer with food. Shake suspension well prior to administration.
Should be taken with food.
Suspension: Prior to and following reconstitution, store at 25°C (77°F); excursions permitted to 15°C to 30°C (59°F to 86°F). For preparation at time of dispensing, add 48 mL incrementally to 60 mL bottle; shake vigorously. Resulting suspension is 20 mg/mL (100 mg per 5 mL). Following reconstitution, discard unused portion of suspension after 7 days.
Tablet: Store at 25°C (77°F); excursions permitted to 15°C to 30°C (59°F to 86°F).
There are no known significant interactions.
Rates of adverse effects were similar to those reported with placebo.
1% to 10%:
Central nervous system: Headache (1% to 3%)
Gastrointestinal: Abdominal pain (7% to 8%), diarrhea (2% to 4%), nausea (3%), vomiting (1%)
<1% (Limited to important or life-threatening): Allergic reaction, ALT increased, anemia, anorexia, appetite increased, creatinine increased, diaphoresis, dizziness, eye discoloration (pale yellow), fever, flatulence, hypertension, infection, malaise, pruritus, rhinitis, salivary glands enlarged, tachycardia, urine discoloration
• Hepatic impairment: Use with caution in patients with hepatic impairment.
• HIV: Safety and efficacy have not been established in patients with HIV infection.
• Renal impairment: Use with caution in patients with renal impairment.
• Immunocompromised patients: Safety and efficacy have not been established in patients with immunodeficiency.
Dosage form specific issues:
• Benzyl alcohol and derivatives: Some dosage forms may contain sodium benzoate/benzoic acid; benzoic acid (benzoate) is a metabolite of benzyl alcohol; large amounts of benzyl alcohol (≥99 mg/kg/day) have been associated with a potentially fatal toxicity (“gasping syndrome”) in neonates; the “gasping syndrome” consists of metabolic acidosis, respiratory distress, gasping respirations, CNS dysfunction (including convulsions, intracranial hemorrhage), hypotension, and cardiovascular collapse (AAP ["Inactive" 1997]; CDC, 1982); some data suggests that benzoate displaces bilirubin from protein binding sites (Ahlfors, 2001); avoid or use dosage forms containing benzyl alcohol derivative with caution in neonates. See manufacturer’s labeling.
• Sucrose: Oral suspension contains sucrose; use caution in patients with diabetes mellitus.
Pregnancy Risk Factor
Adverse events have not been observed in animal reproduction studies. Human data is not available, however nitazoxanide may be used in during pregnancy after the first trimester in women with severe symptoms of cryptosporidiosis (HHS [opportunistic; adult] 2015).
• Discuss specific use of drug and side effects with patient as it relates to treatment. (HCAHPS: During this hospital stay, were you given any medicine that you had not taken before? Before giving you any new medicine, how often did hospital staff tell you what the medicine was for? How often did hospital staff describe possible side effects in a way you could understand?)
• Patient may experience headache, dyspepsia, or diarrhea. Have patient report immediately to prescriber severe nausea (HCAHPS).
• Educate patient about signs of a significant reaction (eg, wheezing; chest tightness; fever; itching; bad cough; blue skin color; seizures; or swelling of face, lips, tongue, or throat). Note: This is not a comprehensive list of all side effects. Patient should consult prescriber for additional questions.
Intended Use and Disclaimer: Should not be printed and given to patients. This information is intended to serve as a concise initial reference for healthcare professionals to use when discussing medications with a patient. You must ultimately rely on your own discretion, experience and judgment in diagnosing, treating and advising patients.
More about nitazoxanide
- Other brands: Alinia