Class: Antiprotozoals, Miscellaneous
VA Class: AP109
Chemical Name: 2-acetyloxy-N-(5-nitro-2-thiazolyl)benzamide
Molecular Formula: C12H9N3 O5 S
CAS Number: 55981-09-4
Uses for Nitazoxanide
Treatment of diarrhea caused by Cryptosporidium parvum in immunocompetent adults, adolescents, and children ≥1 year of age;1 12 designated an orphan drug by FDA for this use.13 A drug of choice for treatment of cryptosporidiosis in adults and pediatric patients who do not have HIV infection.12
Safety and efficacy not established for treatment of diarrhea caused by C. parvum in immunocompromised individuals (including HIV patients);1 has not been more effective than placebo in such patients.1 2 12 15 CDC, NIH, IDSA, and others state that the most appropriate treatment for cryptosporidiosis in HIV-infected individuals is the use of potent antiretroviral agents (to restore immune function) and symptomatic treatment of diarrhea.6 15 16
Treatment of diarrhea caused by Giardia lamblia (also known as G. duodenalis or G. intestinalis) in immunocompetent adults, adolescents, and children ≥1 year of age.1 Designated an orphan drug by FDA for treatment of intestinal giardiasis.13
Metronidazole, tinidazole, and nitazoxanide are drugs of choice for treatment of giardiasis.12
Safety and efficacy not established for treatment of giardiasis in immunocompromised individuals (including HIV patients).1
Nematode (Roundworm) Infections
Nitazoxanide Dosage and Administration
Administer orally twice daily with food.1
Reconstitute powder for oral suspension at the time of dispensing by adding the amount of water specified on the container in 2 portions; shake well after each addition.1
Reconstituted suspension contains 100 mg/5 mL.1
Shake suspension well prior to administration of each dose.1
Nitazoxanide tablets and oral suspension are not bioequivalent.1
Cestode (Tapeworm) Infections†
Hymenolepsis nana Infections†Oral
Children ≥12 years of age: 500 mg daily for 3 days.12
500 mg every 12 hours for 3 days.1
Cestode (Tapeworm) Infections†
Hymenolepsis nana Infections†Oral
500 mg daily for 3 days.12
Cautions for Nitazoxanide
Hypersensitivity to nitazoxanide or any ingredient in the formulation.1
Individuals with diabetes mellitus and/or their caregivers should be informed that reconstituted nitazoxanide oral suspension contains 1.48 g of sucrose/5 mL.1
Safety and efficacy for treatment of diarrhea caused by Giardia notestablished in immunocompromised individuals, including those with HIV infection.1
Safety and efficacy not established in children <1 year of age.1
Experience in those ≥65 years of age insufficient to determine whether they respond differently than younger adults.1
The greater frequency of decreased hepatic, renal, and/or cardiac function and of concomitant disease or drug therapy should be considered.1 Caution advised in geriatric patients with renal and/or hepatic impairment.1
Common Adverse Effects
Abdominal pain, diarrhea, nausea, vomiting, headache.1
Interactions for Nitazoxanide
Pharmacokinetic interaction possible with other highly protein-bound drugs; use with caution in patients receiving highly protein-bound drugs with a narrow therapeutic index (e.g., warfarin).1
Drugs Metabolized by Hepatic Microsomal Enzymes
Pharmacokinetic interaction unlikely; does not inhibit CYP isoenzymes.1
Peak plasma concentrations of tizoxanide and tizoxanide glucuronide attained within 1–4 hours; nitazoxanide undetectable in plasma.1
Food increases extent of absorption.1
Plasma Protein Binding
Pharmacokinetics not studied in patients with hepatic or renal impairment.1
25°C (may be exposed to 15–30°C).1
After reconstitution, store in tight container at 25°C (may be exposed to 15–30°C); discard after 7 days.1
25°C (may be exposed to 15–30°C).1
Both nitazoxanide and its metabolite, tizoxanide, have antiprotozoal activity.10
Antiprotozoal activity may be related principally to interference with the pyruvate:ferredoxin 2-oxidoreductase enzyme-dependent electron transfer reaction essential to anaerobic energy metabolism in susceptible organisms.1
Active against sporozoites and oocysts of Cryptosporidium parvum and trophozoites of Giardia lamblia (also known as G. duodenalis or G. intestinalis).1
Also active against some other organisms, including Entamoeba histolytica,10 Trichomonas vaginalis,10 and certain anaerobic and microaerophilic gram-positive and gram-negative bacteria (e.g., Helicobacter pylori).10
Advice to Patients
Importance of taking with food.1
Advise diabetic patients and/or their caregivers that the oral suspension contains sucrose.1
Importance of informing clinicians of existing or contemplated concomitant therapy, including prescription and OTC drugs, and any concomitant illnesses.1
Importance of women informing clinicians if they are or plan to become pregnant or plan to breast-feed.1
Importance of informing patients of other important precautionary information. (See Cautions.)
Excipients in commercially available drug preparations may have clinically important effects in some individuals; consult specific product labeling for details.
100 mg/5 mL
This pricing information is subject to change at the sole discretion of DS Pharmacy. This pricing information was updated 02/2013. Actual costs to patients will vary depending on the use of specific retail or mail-order locations and health insurance copays.
Alinia 500MG Tablets (ROMARK PHARMACEUTICALS): 60/$1,425.99 or 180/$4,006.97
This report on medications is for your information only, and is not considered individual patient advice. Because of the changing nature of drug information, please consult your physician or pharmacist about specific clinical use.
The American Society of Health-System Pharmacists, Inc. and Drugs.com represent that the information provided hereunder was formulated with a reasonable standard of care, and in conformity with professional standards in the field. The American Society of Health-System Pharmacists, Inc. and Drugs.com make no representations or warranties, express or implied, including, but not limited to, any implied warranty of merchantability and/or fitness for a particular purpose, with respect to such information and specifically disclaims all such warranties. Users are advised that decisions regarding drug therapy are complex medical decisions requiring the independent, informed decision of an appropriate health care professional, and the information is provided for informational purposes only. The entire monograph for a drug should be reviewed for a thorough understanding of the drug's actions, uses and side effects. The American Society of Health-System Pharmacists, Inc. and Drugs.com do not endorse or recommend the use of any drug. The information is not a substitute for medical care.
AHFS Drug Information. © Copyright, 1959-2013, Selected Revisions June 1, 2006. American Society of Health-System Pharmacists, Inc., 7272 Wisconsin Avenue, Bethesda, Maryland 20814.
1. Romark Pharmaceuticals. Alinia (nitazoxanide) tablets and for oral suspension prescribing information. Tampa, FL: 2005 Jun.
2. Amadi B, Mwiya M, Musuku J et al. Effect of nitazoxanide on morbidity and mortality in Zambian children with cryptosporidiosis: a randomised controlled study. Lancet. 2002; 360:1375-80. [IDIS 488791] [PubMed 12423984]
3. Rossignol J-F A, Ayoub A, Ayers MS. Treatment of diarrhea caused by Cryptosporidium parvum: a prospective randomized, double-blind, placebo-controlled study of nitazoxanide. J Infect Dis. 2001; 184:103-6. [IDIS 466301] [PubMed 11398117]
4. Committee on Infectious Diseases, American Academy of Pediatrics. Redbook: 2003 report of the Committee on Infectious Diseases. 26th ed. Elk Grove Village, IL: American Academy of Pediatrics; 2003:255-7, 283-5.
5. Scott K G-E, Meddings JB, Kirk DR et al. Intestinal infection with Giardia spp. reduces epithelial barrier function in a myosin light chain kinase-dependent fashion. Gastroenterol. 2002; 123:1179-90.
6. Chen XM, Keithly JS, Paya CV et al. Cryptosporidiosis. N Engl J Med. 2002; 346:1723-31. [PubMed 12037153]
7. Kosek M, Alcantara C, Lima AAM et al. Cryptosporidiosis: an update. Lancet Infect Dis. 2001; 1:262-9. [PubMed 11871513]
8. Guerrant RL, Gilder TV, Steiner TS et al. Practice guidelines for the management of infectious diarrhea. Clin Infect Dis. 2001; 32:331-50. [IDIS 466024] [PubMed 11170940]
9. Centers for Disease Control and Prevention. Diagnosis and management of foodborne illness. A primer for physicians. MMWR Morb Mortal Wkly Rep. 2001; 50(No. RR-2):1-69. [PubMed 11215787]
10. Adagu IS, Nolder D, Warhurst DC et al. In vitro activity of nitazoxanide and related compounds against isolates of Giardia intestinalis, Entamoeba histolytica, and Trichomonas vaginalis. J Antimicrob Chemother. 2002; 49:103-14. [PubMed 11751773]
11. Romark Laboratories, Tampa, FL: personal communication.
12. Anon. Drugs for parasitic infections. Med Lett Drugs Ther. Aug 2004. From the Medical Letter web site ().
13. Food and Drug Administration. Orphan designations pursuant to Section 526 of the Federal Food and Cosmetic Act as amended by the Orphan Drug Act (P.L. 97-414). Rockville, MD; 2002 Oct 15. From FDA web site (). Accessed 2003 Feb 24.
14. Juan JO, Lopez Chegne N, Gargala G et al. Comparative clinical studies of nitazoxanide, albendazole and praziquantel in the treatment of ascariasis, trichuriasis and hymenolepiasis in children from Peru. Trans R Soc Trop Med Hyg. 2002; 96:193-6. [PubMed 12055813]
15. Centers for Disease Control and Prevention. Treating opportunistic infections among HIV-infected adults and adolescents: recommendations from CDC, the National Institutes of Health, and the HIV Medicine Association/Infectious Diseases Society of America. MMWR Morb Mortal Wkly Rep. 2004; 53(No. RR-15):1-112.
16. Centers for Disease Control and Prevention. Treating opportunistic infections among HIV-exposed and infected children: recommendations from CDC, the National Institutes of Health, and the Infectious Diseases Society of America. MMWR Morb Mortal Wkly Rep. 2004; 53(No. RR-14):1-92.