Nitazoxanide

Nitazoxanide is an antiprotozoal agent.

Nitazoxanide is used to treat diarrhea in adults and children caused by the protozoa Giardia lamblia. Nitazoxanide is also used to treat diarrhea caused by the protozoa Cryptosporidium parvum. These conditions are also sometimes referred to as travelers' diarrhea.

Nitazoxanide may also be used for purposes other than those listed in this medication guide.

Take nitazoxanide with food.

Talk to your doctor before taking other prescription or over-the-counter medications, including vitamins, minerals, and herbal products during treatment with nitazoxanide.

Talk to your doctor before taking nitazoxanide if you have

• liver disease;
• kidney disease; or
• HIV infection or problems with your immune system.

You may not be able to take nitazoxanide, or you may require a dosage adjustment or special monitoring during treatment if you have any of the conditions listed above.

The nitazoxanide oral suspension contains 1.48 grams of sucrose per 5 mL (teaspoon). Individuals with diabetes may need to monitor their intake of sucrose.

Nitazoxanide is in the FDA pregnancy category B. This means that it is not expected to be harmful to an unborn baby. Do not take nitazoxanide without first talking to your doctor if you are pregnant or could become pregnant during treatment.

It is not known whether nitazoxanide passes into breast milk. Do not take nitazoxanide without first talking to your doctor if you are breast-feeding a baby.

Pregnancy: No data with pregnant women to inform of drug-associated risk; No teratogenicity or fetotoxicity 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 maximum recommended human dose of 500 mg twice daily based on body surface area (BSA)

Lactation: Development and health benefits of breastfeeding should be considered along with the mother’s clinical need and any potential adverse effects on breastfed infant from therapy or from underlying maternal condition

Pregnancy Categories

A:Generally acceptable. Controlled studies in pregnant women show no evidence of fetal risk.

B:May be acceptable. Either animal studies show no risk but human studies not available or animal studies showed minor risks and human studies done and showed no risk.

C:Use with caution if benefits outweigh risks. Animal studies show risk and human studies not available or neither animal nor human studies done.

D:Use in LIFE-THREATENING emergencies when no safer drug available. Positive evidence of human fetal risk.

X:Do not use in pregnancy. Risks involved outweigh potential benefits. Safer alternatives exist.

NA:Information not available.

Oral Administration

Take with food

There are no restrictions on food, beverages, or activity during treatment with nitazoxanide unless otherwise directed by your doctor.

Nitazoxanide is a prescription medication used to treat diarrhea in children and adults caused by certain protozoa. Nitazoxanide belongs to a group of drugs called antiprotozoal agents. These work by stopping the growth of the protozoa that cause diarrhea. 

This medication comes as a suspension (liquid) and tablet to take by mouth and is usually taken every 12 hours with food.

Common side effects of nitazoxanide include stomach pain, diarrhea, headache, and nausea.

In the U.S.

• Alinia

Available Dosage Forms:

• Tablet
• Powder for Suspension

Therapeutic Class: Antiprotozoal

It is very important that your doctor check your progress at regular visits and to check for unwanted effects.

If your symptoms do not improve within a few days or if they become worse, check with your doctor.

Do not take other medicines unless they have been discussed with your doctor. This includes prescription or nonprescription (over-the-counter [OTC]) medicines and herbal or vitamin supplements.

Along with its needed effects, a medicine may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.

Check with your doctor immediately if any of the following side effects occur:

• Diarrhea

Some side effects may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. Also, your health care professional may be able to tell you about ways to prevent or reduce some of these side effects. Check with your health care professional if any of the following side effects continue or are bothersome or if you have any questions about them:

• Abdominal or stomach pain
• headache
• nausea
• urine changes

• Dizziness
• heartburn
• hives or welts, itching, or skin rash
• redness of the skin
• trouble breathing
• vomiting

Other side effects not listed may also occur in some patients. If you notice any other effects, check with your healthcare professional.

Call your doctor for medical advice about side effects. You may report side effects to the FDA at 1-800-FDA-1088.

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, sodium benzoate; strawberry flavor]

Tablet, Oral:

Alinia: 500 mg [contains corn starch, fd&c blue #2 aluminum lake, fd&c yellow #10 aluminum lake, fd&c yellow #6 aluminum lake, soybean lecithin]

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

There are no known significant interactions.

1% to 10%:

Central nervous system: Headache (>2%)

Gastrointestinal: Abdominal pain (>2%), nausea (>2%)

Genitourinary: Urine discoloration (>2%)

<1% (Limited to important or life-threatening): Diarrhea (exacerbation), dizziness, dyspnea, gastroesophageal reflux disease, skin rash, urticaria