Most recent update(s): The National Institutes of Health COVID-19 Treatment Guidelines recommend against the use of nitazoxanide for the treatment of COVID-19 outside of a clinical trial. As part of our response to the evolving COVID-19 pandemic, published literature and guidelines from major health organizations are continuously monitored for potential content updates. At this time, only investigational medications with data determined to be of relatively high quality and/or consistently showing positive clinical outcomes to support dosing recommendations will be included in the Lexicomp monograph, outside of this Special Alert field.
Further information may be found at:
Clinical trials.gov: https://www.clinicaltrials.gov/ct2/results?cond=covid-19&term=nitazoxanide&cntry=&state=&city=&dist=
IDSA: https://www.idsociety.org/practice-guideline/covid-19-guideline-treatment-and-management/
Cryptosporidiosis:
Immunocompetent patients: Oral: 500 mg every 12 hours for 3 days.
Patients with HIV (off-label use): Oral: 500 mg to 1 g twice daily for 14 days (must be used in conjunction with optimized antiretroviral therapy, electrolyte replacement, symptomatic treatment, and rehydration) (HHS [OI adult 2020]; Rossignol 1998).
Solid organ transplant recipients (off-label use): Oral: 500 mg to 1 g twice daily for 14 days, in combination with reduction of immunosuppression, when possible. In patients with severe diarrhea or treatment failure, consider 500 mg twice daily in combination with azithromycin (AST-IDCOP [La Hoz 2019]).
Giardiasis:
Oral: 500 mg every 12 hours for 3 days (AST-IDCOP [La Hoz 2019]; manufacturer's labeling). Note: Alternative agent for solid organ transplant recipients (AST-IDCOP [La Hoz 2019]).
There are no dosage adjustments provided in the manufacturer's labeling (has not been studied).
There are no dosage adjustments provided in the manufacturer's labeling (has not been studied).
(For additional information see "Nitazoxanide: Pediatric drug information")
Balantidiasis (Balantidium coli infection) (alternative agent): Limited data available (CDC 2020a; Red Book [AAP 2021]):
Children 1 to <4 years: Oral suspension: Oral: 100 mg twice daily for 3 days.
Children 4 to <12 years: Oral suspension: Oral: 200 mg twice daily for 3 days.
Children ≥12 years and Adolescents: Oral suspension, tablet: Oral: 500 mg twice daily for 3 days.
Blastocystis, symptomatic infection with persistent diarrhea: Note: Need for treatment is controversial as clinical significance of infection is unknown. Limited data available (CDC 2020b; Red Book [AAP 2021]; Rossignol 2005):
Children 1 to <4 years: Oral suspension: Oral: 100 mg twice daily for 3 days.
Children 4 to <12 years: Oral suspension: Oral: 200 mg twice daily for 3 days.
Children ≥12 years and Adolescents: Oral suspension, tablet: Oral: 500 mg twice daily for 3 days.
Cryptosporidiosis (Cryptosporidium parvum infection):
Note: Treatment duration is 3 days in immunocompetent patients (CDC 2021; Red Book [AAP 2021]; manufacturer's labeling). For immunocompromised patients, including those who are HIV-exposed/-infected, suggested treatment duration is 3 to 14 days or longer, despite uncertain efficacy; HIV-infected patients should also receive optimized combination antiretroviral therapy (HHS [OI pediatric 2021]; Red Book [AAP 2021]).
Children 1 to <4 years: Oral suspension: Oral: 100 mg every 12 hours.
Children 4 to <12 years: Oral suspension: Oral: 200 mg every 12 hours.
Children ≥12 years and Adolescents: Oral suspension, tablet: Oral: 500 mg every 12 hours.
Fascioliasis (Fasciola hepatica; sheep liver fluke infection): Limited data available (Red Book [AAP 2021]):
Children 1 to <4 years: Oral suspension: Oral: 100 mg every 12 hours for 7 days.
Children 4 to <12 years: Oral suspension: Oral: 200 mg every 12 hours for 7 days.
Children ≥12 years and Adolescents: Oral suspension, tablet: Oral: 500 mg every 12 hours for 7 days.
Giardiasis (Giardia duodenalis/intestinalis/lamblia infection); independent of HIV status (HHS [OI pediatric 2021]; Red Book [AAP 2021]; manufacturer's labeling):
Children 1 to <4 years: Oral suspension: Oral: 100 mg every 12 hours for 3 days.
Children 4 to <12 years: Oral suspension: Oral: 200 mg every 12 hours for 3 days.
Children ≥12 years and Adolescents: Oral suspension, tablet: Oral: 500 mg every 12 hours for 3 days.
Hymenolepiasis (Hymenolepis nana; dwarf tapeworm infection): Limited data available (CDC 2020c; Red Book [AAP 2021]):
Children 1 to <4 years: Oral suspension: Oral: 100 mg twice daily for 3 days.
Children 4 to <12 years: Oral suspension: Oral: 200 mg twice daily for 3 days.
Children ≥12 years and Adolescents: Oral suspension, tablet: Oral: 500 mg twice daily for 3 days.
There are no dosage adjustments provided in the manufacturer's labeling (has not been studied).
There are no dosage adjustments provided in the manufacturer's labeling (has not been studied).
Refer to adult dosing.
Excipient information presented when available (limited, particularly for generics); consult specific product labeling. [DSC] = Discontinued product
Suspension Reconstituted, Oral:
Alinia: 100 mg/5 mL (60 mL [DSC]) [contains fd&c red #40, sodium benzoate]
Alinia: 100 mg/5 mL (60 mL) [contains fd&c red #40, sodium benzoate; strawberry flavor]
Tablet, Oral:
Alinia: 500 mg [contains corn starch, fd&c blue #2 aluminum lake, fd&c yellow #10 aluminum lake, fd&c yellow #6 aluminum lake, soybean lecithin]
Generic: 500 mg
May be product dependent
Administer with food. Shake suspension well prior to administration.
Oral: Administer with food. Shake suspension well prior to administration.
Diarrhea, infectious: Treatment of diarrhea caused by Cryptosporidium parvum or Giardia lamblia
The following adverse drug reactions and incidences are derived from product labeling unless otherwise specified.
1% to 10%:
Central nervous system: Headache (>2%)
Gastrointestinal: Abdominal pain (>2%), nausea (>2%)
Genitourinary: Urine discoloration (>2%)
<1%, postmarketing, and/or case reports: Diarrhea (exacerbation), dizziness, dyspnea, gastroesophageal reflux disease, skin rash, urticaria
Hypersensitivity to nitazoxanide or any component of the formulation
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 patients with HIV.
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.
None known.
There are no known significant interactions.
Food increases AUC. Management: Take with food.
Information related to the use of nitazoxanide in pregnancy is limited (Meneses Calderón 2020).
Nitazoxanide may be used during pregnancy after the first trimester in women with severe symptoms of cryptosporidiosis (HHS [OI adult 2020]).
Tizoxanide, the active metabolite of nitazoxanide, is present in breast milk (Hadad 2012).
According to the manufacturer, the decision to breastfeed during therapy should consider the risk of exposure to the infant and the benefits of treatment to the mother.
Some formulations may contain sucrose.
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.
Protein binding: Tizoxanide: >99%.
Bioavailability: Relative bioavailability of suspension compared to tablet: 70%; tablet and suspension are not bioequivalent.
Half-life elimination: Tizoxanide: 1 to 1.6 hours.
Metabolism: Hepatic, to an active metabolite, tizoxanide. Tizoxanide undergoes conjugation to form tizoxanide glucuronide. Nitazoxanide is not detectable in the serum following oral administration.
Time to peak, plasma: Tizoxanide and tizoxanide glucuronide: 1 to 5 hours.
Excretion: Urine (~33%); feces (~67%).
Suspension (reconstituted) (Alinia Oral)
100 mg/5 mL (per mL): $10.44
Tablets (Alinia Oral)
500 mg (per each): $173.90
Tablets (Nitazoxanide Oral)
500 mg (per each): $165.21
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