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Nitazoxanide: Drug information

Nitazoxanide: Drug information
(For additional information see "Nitazoxanide: Patient drug information" and see "Nitazoxanide: Pediatric drug information")

For abbreviations, symbols, and age group definitions used in Lexicomp (show table)
Brand Names: US
  • Alinia
Pharmacologic Category
  • Antiprotozoal
Dosing: Adult
Cryptosporidiosis

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

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]).

Dosing: Kidney Impairment: Adult

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

Dosing: Hepatic Impairment: Adult

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

Dosing: Pediatric

(For additional information see "Nitazoxanide: Pediatric drug information")

Balantidiasis

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

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

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

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; independent of HIV status

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

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.

Dosing: Kidney Impairment: Pediatric

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

Dosing: Hepatic Impairment: Pediatric

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

Dosing: Older Adult

Refer to adult dosing.

Dosage Forms: US

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 (allura red ac dye), sodium benzoate; strawberry flavor]

Tablet, Oral:

Alinia: 500 mg [contains corn starch, fd&c blue #2 (indigo carm) aluminum lake, fd&c yellow #6(sunset yellow)alumin lake, quinoline (d&c yellow #10) aluminum lake, soybean lecithin]

Generic: 500 mg

Generic Equivalent Available: US

May be product dependent

Administration: Adult

Administer with food. Shake suspension well prior to administration.

Administration: Pediatric

Oral: Administer with food. Shake suspension well prior to administration.

Use: Labeled Indications

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

Adverse Reactions

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

Contraindications

Hypersensitivity to nitazoxanide or any component of the formulation

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 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.

Metabolism/Transport Effects

None known.

Drug Interactions

There are no known significant interactions.

Food Interactions

Food increases AUC. Management: Take with food.

Pregnancy Considerations

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]).

Breastfeeding Considerations

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.

Dietary Considerations

Some formulations may contain sucrose.

Mechanism of Action

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.

Pharmacokinetics

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%).

Pricing: US

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

Disclaimer: A representative AWP (Average Wholesale Price) price or price range is provided as reference price only. A range is provided when more than one manufacturer's AWP price is available and uses the low and high price reported by the manufacturers to determine the range. The pricing data should be used for benchmarking purposes only, and as such should not be used alone to set or adjudicate any prices for reimbursement or purchasing functions or considered to be an exact price for a single product and/or manufacturer. Medi-Span expressly disclaims all warranties of any kind or nature, whether express or implied, and assumes no liability with respect to accuracy of price or price range data published in its solutions. In no event shall Medi-Span be liable for special, indirect, incidental, or consequential damages arising from use of price or price range data. Pricing data is updated monthly.

Brand Names: International
  • Adnix (BD);
  • Anelmin (PY);
  • Annita (BR);
  • Celectan (CO, VE);
  • Colufase (EC);
  • Daxon (CR, DO, GT, HN, MX, NI, PA, SV);
  • Dexidex (CR, DO, GT, HN, MX, NI, PA, SV);
  • Diar (BD);
  • Diasis (BD);
  • Givotan (PY);
  • Kidonax (MX);
  • Netazox (IN, VE);
  • Nidozox (BD);
  • Nitalet (BD);
  • Nitarid (IN);
  • Nitzix (IN);
  • Nixoran (AR);
  • Noxom (PY);
  • Nytaxin (VE);
  • Pacovanton (MX);
  • Paramix (MX);
  • Zoxaval (VE)


For country code abbreviations (show table)
  1. Ahlfors CE. Benzyl alcohol, kernicterus, and unbound bilirubin. J Pediatr. 2001;139(2):317-319. [PubMed 11487763]
  2. Alinia tablets and oral suspension (nitazoxanide) [prescribing information]. Tampa, FL: Romark, LC; January 2022.
  3. American Academy of Pediatrics (AAP). In: Kimberlin DW, Barnett ED, Lynfield R, Sawyer MH, eds. Red Book: 2021-2024 Report of the Committee on Infectious Diseases. 32nd ed. American Academy of Pediatrics; 2021.
  4. Bicart-Sée A, Massip P, Linas MD, Datry A. Successful treatment with nitazoxanide of Enterocytozoon bieneusi microsporidiosis in a patient with AIDS. Antimicrob Agents Chemother. 2000;44(1):167-168. doi:10.1128/aac.44.1.167-168.2000 [PubMed 10602740]
  5. Centers for Disease Control (CDC). Neonatal deaths associated with use of benzyl alcohol—United States. MMWR Morb Mortal Wkly Rep. 1982;31(22):290-291. http://www.cdc.gov/mmwr/preview/mmwrhtml/00001109.htm . [PubMed 6810084]
  6. Centers for Disease Control and Prevention (CDC). Parasites - Balantidiasis (also known as Balantidium coli infection). https://www.cdc.gov/parasites/balantidium/health_professionals/index.html. Updated May 20, 2020a. Accessed January 19, 2022.
  7. Centers for Disease Control and Prevention (CDC). Parasites - Blastocystis spp. infection. https://www.cdc.gov/parasites/blastocystis/health_professionals/index.html. Updated May 20, 2020b. Accessed January 19, 2022.
  8. Centers for Disease Control and Prevention (CDC). Parasites - Cryptosporidium (also known as "Crypto"). https://www.cdc.gov/parasites/crypto/treatment.html. Updated November 24, 2021. Accessed January 19, 2022.
  9. Centers for Disease Control and Prevention (CDC). Parasites - Hymenolepiasis (also known as Hymenolepis nana infection). https://www.cdc.gov/parasites/hymenolepis/health_professionals/index.html. Updated May 20, 2020c. Accessed January 19, 2022.
  10. Gamiño-Arroyo AE, Guerrero ML, McCarthy S, et al; Mexico Emerging Infectious Diseases Clinical Research Network (LaRed). Efficacy and safety of nitazoxanide in addition to standard of care for the treatment of severe acute respiratory illness. Clin Infect Dis. 2019;69(11):1903-1911. doi: 10.1093/cid/ciz100. [PubMed 30753384]
  11. Hadad GM, Abdel Salam RA, Emara S. Validated and optimized high-performance liquid chromatographic determination of tizoxanide, the main active metabolite of nitazoxanide in human urine, plasma and breast milk. J Chromatogr Sci. 2012;50(6):509-515. doi:10.1093/chromsci/bms041 [PubMed 22525879]
  12. "Inactive" ingredients in pharmaceutical products: update (subject review). American Academy of Pediatrics (AAP) Committee on Drugs. Pediatrics. 1997;99(2):268-278. [PubMed 9024461]
  13. La Hoz RM, Morris MI; AST Infectious Diseases Community of Practice. Intestinal parasites including Cryptosporidium, Cyclospora, Giardia, and Microsporidia, Entamoeba histolytica, Strongyloides, Schistosomiasis, and Echinococcus: guidelines from the American Society of Transplantation Infectious Diseases Community of Practice. Clin Transplant. 2019;33(9):e13618. doi:10.1111/ctr.13618 [PubMed 31145496]
  14. McDonald LC, Gerding DN, Johnson S, et al. Clinical practice guidelines for Clostridium difficile infection in adults and children: 2017 update by the Infectious Diseases Society of America (IDSA) and Society for Healthcare Epidemiology of America (SHEA). Clin Infect Dis. 2018;66(7):e1-e48. doi:10.1093/cid/cix1085 [PubMed 29462280]
  15. Meneses Calderón J, Figueroa Flores MDR, Paniagua Coria L, et al. Nitazoxanide against COVID-19 in three explorative scenarios. J Infect Dev Ctries. 2020;14(9):982-986. doi:10.3855/jidc.13274 [PubMed 33031085]
  16. Rossignol JF, Hidalgo H, Feregrino M, et al. A double-'blind' placebo-controlled study of nitazoxanide in the treatment of cryptosporidial diarrhoea in AIDS patients in Mexico. Trans R Soc Trop Med Hyg. 1998;92(6):663-666. doi:10.1016/s0035-9203(98)90804-5 [PubMed 10326116]
  17. Rossignol JF, Kabil SM, Said M, Samir H, Younis AM. Effect of nitazoxanide in persistent diarrhea and enteritis associated with Blastocystis hominis. Clin Gastroenterol Hepatol. 2005;3(10):987-991. doi:10.1016/s1542-3565(05)00427-1 [PubMed 16234044]
  18. Siberry GK, Abzug MJ, Nachman S, et al; Panel on Opportunistic Infections in HIV-Exposed and HIV-Infected Children, National Institutes of Health, Centers for Disease Control and Prevention, HIV Medicine Association of the Infectious Diseases Society of America, Pediatric Infectious Diseases Society, American Academy of Pediatrics. Guidelines for the prevention and treatment of opportunistic infections in HIV-exposed and HIV-infected children: recommendations from the National Institutes of Health, Centers for Disease Control and Prevention, the HIV Medicine Association of the Infectious Diseases Society of America, the Pediatric Infectious Diseases Society, and the American Academy of Pediatrics. Pediatr Infect Dis J. 2013;32(suppl 2):i-KK4. [PubMed 24569199]
  19. US Department of Health and Human Services (HHS) Panel on Adult and Adolescent Opportunistic Infection. Guidelines for the prevention and treatment of opportunistic infections in adults and adolescents with HIV: recommendations from the Centers for Disease Control and Prevention, the National Institutes of Health, and the HIV Medicine Association of the Infectious Diseases Society of America. https://clinicalinfo.hiv.gov/sites/default/files/guidelines/documents/adult-adolescent-oi/guidelines-adult-adolescent-oi.pdf. Updated May 26, 2020. Accessed November 9, 2020.
  20. US Department of Health and Human Services (HHS) Panel on Opportunistic Infections in HIV-Exposed and HIV-Infected Children. Guidelines for prevention and treatment of opportunistic infections in HIV-exposed and HIV-infected children. https://clinicalinfo.hiv.gov/en/guidelines/pediatric-opportunistic-infection/whats-new. Updated March 19, 2021. Accessed October 5, 2021.
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