Nitazoxanide

Diarrhea caused by Giardia lamblia or Cryptosporidium parvum: Nitazoxanide tablets (patients 12 years and older) are indicated for the treatment of diarrhea caused by Giardia lamblia or Cryptosporidium parvum . Limitations of Use Nitazoxanide tablets have not been shown to be effective for the treatment of diarrhea caused by Cryptosporidium parvum in HIV-infected or immunodeficient patients [see Clinical Studies (14.2) ] . Nitazoxanide tablets are antiprotozoal indicated for the treatment of diarrhea caused by Giardia lamblia or Cryptosporidium parvum (1 ). Limitations of Use: Nitazoxanide tablets have not been shown to be effective for the treatment of diarrhea caused by C. …

• Nitazoxanide tablets should not be administered to pediatric patient 11 years of age or younger . • Dosage for treatment of diarrhea caused by G.lamblia or C. parvum : Age Dosage Duration 12 years and older One 500 mg nitazoxanide tablet every 12 hours with food 3 days Recommended Dosage and Important Administration Instructions Important Administration Instructions for Pediatric Patients 11 years of Age or Younger: Nitazoxanide tablets should not be administered to pediatric patients 11 years of age or younger because a single tablet contains a greater amount of nitazoxanide than the recommended dosing in this pediatric age group
• Table 1
• Recommended Dosage Age Dosage Duration 12 years and older One 500 mg nitazoxanide tablet taken orally every 12 hours with food 3 days

Nitazoxanide tablets: 500 mg ( 3 ). 3.1 Nitazoxanide Tablets (500 mg) Green colored, round biconvex film-coated tablets debossed with “V1” on one side and “1” on the other side. Each tablet contains 500 mg of nitazoxanide.

• The safety and efficacy of nitazoxanide tablets
• For the treatment of diarrhea caused by G. lamblia or C. parvum
• In pediatric patients 12 to 17 years of age has been established based on three randomized controlled studies with 47 pediatric subjects treated with nitazoxanide tablets 500 mg
• A single nitazoxanide tablet contains a greater amount of nitazoxanide than is recommended for use
• In pediatric patients 11 years or younger. [see Dosage and Administration ]

Clinical studies of nitazoxanide tablets did not include sufficient numbers of subjects aged 65 and over to determine whether they respond differently from younger subjects. In general, the greater frequency of decreased hepatic, renal, or cardiac function, and of concomitant disease or other drug therapy in elderly patients should be considered when prescribing nitazoxanide tablets.

• Advise patients and parents/caregivers of pediatric patients taking nitazoxanide tablets of the following information: Dosage and Administration: Nitazoxanide tablets should be taken with food
• Drug-drug Interactions: Avoid concurrent warfarin use
• Manufactured for: Camber Pharmaceuticals, Inc
• Piscataway, NJ 08854 By: Annora Pharma Pvt
• Sangareddy - 502313, Telangana, India
• Revised: 05/2025 camberlogo

Hypersensitivity ( 4.1 ) 4.1 Hypersensitivity Nitazoxanide tablets are contraindicated in patients with a prior hypersensitivity to nitazoxanide or any other ingredient in the formulations.

Competition for binding sites may occur when administered concurrently with other highly plasma protein-bound drugs with narrow therapeutic indices. Monitor for adverse reactions ( 7 ). 7.1 Highly Protein Bound Drugs with Narrow Therapeutic Indices Tizoxanide (the active metabolite of nitazoxanide) is highly bound to plasma protein (>99.9%). Therefore, monitor for adverse reactions when administering nitazoxanide concurrently with other highly plasma protein-bound drugs with narrow therapeutic indices, as competition for binding sites may occur (e.g., warfarin).

The most common adverse reactions in ≥2% of patients were abdominal pain, headache, chromaturia, and nausea ( 6.1 ). To report SUSPECTED ADVERSE REACTIONS, contact Annora Pharma Private Limited at 1-866-495-1995 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch. 6.1 Clinical Trials Experience Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in practice. …

8.1 Pregnancy Risk Summary There are no data with nitazoxanide in pregnant women to inform a drug-associated risk. No teratogenicity or fetotoxicity was observed in animal reproduction studies with administration of nitazoxanide to pregnant rats and rabbits during organogenesis at exposures 30 and 2 times, respectively, the exposure at the maximum recommended human dose of 500 mg twice daily based on body surface area (BSA). In the U.S. …

Limited information on nitazoxanide overdosage is available. In the event of overdose, gastric lavage may be appropriate soon after oral administration. Patients should be observed and given symptomatic and supportive treatment. There is no specific antidote for overdose with nitazoxanide. Because tizoxanide is highly protein bound (>99.9%), dialysis is unlikely to significantly reduce plasma concentrations of the drug.

Take it when you remember, unless it is nearly time for the next dose. Then skip the missed one. Never take two doses at once to make up for it. Check your leaflet, as some medicines are different.