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Brand Name

Nitazoxanide

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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.

Approved To Treat

Diarrhea

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Related Clinical Trials

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Study Drugs: Favipiravir, Monoclonal Antibodies, Ivermectin, Remdesivir, Fluoxetine, Molnupiravir, Nirmatrelvir/Ritonavir (e.g. PAXLOVID), Nitazoxanide

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Brand Information

Nitazoxanide (Nitazoxanide)

1INDICATIONS & USAGE

Diarrhea caused by

Nitazoxanide tablets (patients 12 years and older) are indicated for the treatment of diarrhea caused by

Limitations of Use

Nitazoxanide tablets have not been shown to be effective for the treatment of diarrhea caused by

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 light yellow crystalline powder. It is poorly soluble in ethanol and practically insoluble in water. Chemically, nitazoxanide is 2-acetyloxy-

Nitazoxanide tablets contain 500 mg of nitazoxanide and the following inactive ingredients: corn starch, sodium starch glycolate type A, sucrose, hydroxypropyl methylcellulose, talc, magnesium stearate, polyvinyl alcohol, titanium dioxide, D&C yellow #10 aluminum lake, lecithin (soy), xanthan gum, FD&C yellow #6 aluminum lake, FD&C blue #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.

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Rev. 09/2025

5PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Nitazoxanide Tablets, 500 mg

Bottles of 6 tablets NDC 13517-135-06