Brand Name

Nitazoxanide

View Brand Information
FDA approval date: November 27, 2020
Classification: Antiprotozoal
Form: Tablet

What is Nitazoxanide?

Diarrhea caused by Giardia lamblia or Cryptosporidium parvum: Nitazoxanide tablets 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 (1.

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Brand Information

Nitazoxanide (Nitazoxanide)
1INDICATIONS AND USAGE
Diarrhea caused by
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
2OVERDOSAGE
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.
3DESCRIPTION
Nitazoxanide tablets contain the active ingredient, nitazoxanide, a synthetic antiprotozoal for oral administration. Nitazoxanide is a pale yellow to yellow crystalline powder. It is poorly soluble in ethanol and practically insoluble in water. Chemically, nitazoxanide is 2-acetyloxy-
nitazoxanide-structure.jpg
Nitazoxanide tablets contain 500 mg of nitazoxanide and the following inactive ingredients: maize starch, partially pregelatinized maize starch, sodium starch glycolate, hypromellose, talc, magnesium stearate, soy lecithin, polyvinyl alcohol, xanthan gum, titanium dioxide, D&C Yellow No.10 Aluminum Lake, FD&C Yellow No. 6 Aluminum Lake and FD&C Blue No.2 Aluminum Lake.
4PATIENT COUNSELING INFORMATION
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:
Rising Pharma Holdings, Inc.
East Brunswick, NJ 08816

ALINIA for Oral Suspension is distributed by Lupin Pharmaceuticals, Inc. under license from Romark.
ALINIA is a registered trademark of Romark
Neutral code: 4323147/TS/DRUGS/2025
Revised: 09/2025

PIR52603-05
5PACKAGE LABEL.PRINCIPAL DISPLAY PANEL
Rising® NDC 64980-526-03
Nitazoxanide Tablets
30 Tablets
Rx only
nitazoxanide-30ct-label.jpg
Rising® NDC 64980-526-03
Nitazoxanide Tablets
30 Tablets
Rx only
nitazoxanide-30crt-label.jpg