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Nitazoxanide

Pronunciation

(nye ta ZOX a nide)

Index Terms

  • NTZ

Dosage Forms

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]

Tablet, Oral:

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.

  • Alinia

Pharmacologic Category

  • Antiprotozoal

Pharmacology

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.

Metabolism

Hepatic, to an active metabolite, tizoxanide. Tizoxanide undergoes conjugation to form tizoxanide glucuronide. Nitazoxanide is not detectable in the serum following oral administration.

Excretion

Urine (~33%); feces (~67%)

Time to Peak

Plasma: Tizoxanide and tizoxanide glucuronide: 1-4 hours

Half-Life Elimination

Tizoxanide: 1 to 1.6 hours

Protein Binding

Tizoxanide: >99%

Use: Labeled Indications

Diarrhea, infectious: Treatment of diarrhea caused by Cryptosporidium parvum or Giardia lamblia

Use: Unlabeled

Alternative treatment for Clostridium difficile-associated diarrhea (CDAD)

Contraindications

Hypersensitivity to nitazoxanide or any component of the formulation

Dosing: Adult

Diarrhea, infectious 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])

Dosing: Geriatric

Refer to adult dosing.

Dosing: Pediatric

Diarrhea, infectious caused by Cryptosporidium parvum or Giardia lamblia: Oral:

Children 1 to 3 years: Oral suspension: 100 mg every 12 hours for 3 days

Children 4 to 11 years: Oral suspension: 200 mg every 12 hours for 3 days

Children ≥12 years and Adolescents: Refer to adult dosing.

Cryptosporidiosis-associated diarrhea in HIV-infected patients (off-label use): Note: Used in conjunction with ART (HHS [OI pediatric] 2013)

Children 1 to 3 years: Oral suspension: 100 mg twice daily for 3 to 14 days (HHS [OI pediatric] 2013)

Children 4 to 11 years: Oral suspension: 200 mg twice daily for 3 to 14 days (HHS [OI pediatric] 2013)

Children ≥ 12 years: Oral tablet: 500 mg twice daily for 3 to 14 days (HHS [OI pediatric] 2013)

Adolescents: Refer to adult dosing.

Dosing: Renal Impairment

There are no dosage adjustments provided in the manufacturer's labeling (has not been studied).

Dosing: Hepatic Impairment

There are no dosage adjustments provided in the manufacturer's labeling (has not been studied).

Reconstitution

For preparation at time of dispensing, add 48 mL of water incrementally to 60 mL bottle; shake vigorously. Resulting suspension is 20 mg/mL (100 mg per 5 mL).

Administration

Administer with food. Shake suspension well prior to administration.

Dietary Considerations

Some formulations may contain sucrose.

Storage

Store at 25°C (77°F); excursions permitted to 15°C to 30°C (59°F to 86°F). Following reconstitution of oral suspension, discard unused portion after 7 days.

Drug Interactions

There are no known significant interactions.

Adverse Reactions

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): Anemia, anorexia, diaphoresis, dizziness, enlargement of salivary glands, fever, flatulence, hypersensitivity reaction, hypertension, increased appetite, increased serum ALT, increased serum creatinine, infection, malaise, ocular discoloration (pale yellow), pruritus, rhinitis, tachycardia, urine discoloration

Warnings/Precautions

Disease-related concerns:

• HIV: Nitazoxanide had not been studied for treatment of diarrhea caused by G. lamblia in patients with HIV infection. Nitazoxanide has not been shown to be superior to placebo for treatment of diarrhea caused by C. parvum in HIV-infected patients.

Special populations:

• Immunocompromised patients: Nitazoxanide had not been studied for treatment of diarrhea caused by G. lamblia in patients with immunodeficiency. Nitazoxanide has not been shown to be superior to placebo for treatment of diarrhea caused by C. parvum 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 suggest 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.

Pregnancy Considerations

Adverse events have not been observed in animal reproduction studies. Human data is not available; however, nitazoxanide may be used during pregnancy after the first trimester in women with severe symptoms of cryptosporidiosis (HHS [opportunistic; adult] 2015).

Patient Education

• 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, abdominal pain, nausea, or urine discoloration (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.

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