nitazoxanide

Generic Name: nitazoxanide (nye tah ZOX ah nide)Brand Names: Alinia

What is 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.

What is the most important information I should know about nitazoxanide?

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.

What should I discuss with my healthcare provider before taking 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.

How should I take nitazoxanide?

Take nitazoxanide exactly as directed by your doctor. If you do not understand these instructions, ask your pharmacist, nurse, or doctor to explain them to you.

Take nitazoxanide with food. Shake the suspension well before measuring a dose. To ensure that you get the correct dose, measure the suspension with a dose-measuring spoon, dropper, or cup, not with a regular table spoon. If you do not have a dose-measuring device, ask your pharmacist where you can get one. Store the suspension at room temperature. The suspension may be stored for 7 days, after which any unused portion must be discarded.

See also: Nitazoxanide dosage in more detail

What happens if I miss a dose?

Take the missed dose as soon as you remember. If you do not remember until it is time for the next dose, skip the missed dose and take only the next regularly scheduled dose. Do not take a double dose of the medication.

What happens if I overdose?

Seek emergency medical attention.

Symptoms of a nitazoxanide overdose are not known.

What should I avoid while taking nitazoxanide?

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

Nitazoxanide side effects

Stop taking nitazoxanide and seek emergency medical attention if you experience a rare allergic reaction (difficulty breathing; closing of the throat; swelling of the lips, tongue, or face; or hives).

Other, less serious side effects may be more likely to occur. Continue to take the medication and talk to your doctor if you experience

• abdominal pain;

• nausea;

• diarrhea;

• vomiting; or

• headache.

Side effects other than those listed here may also occur. Talk to your doctor about any side effect that seems unusual or that is especially bothersome. You may report side effects to FDA at 1-800-FDA-1088.

Nitazoxanide Dosing Information

Usual Adult Dose for Amebiasis:

For diarrhea in immunocompetent patients: 500 mg twice daily with food for 3 days.For diarrhea in AIDS patients: 1000 mg twice daily with food for 14 days or until diarrhea resolves.

Usual Adult Dose for Cryptosporidiosis:

For diarrhea in immunocompetent patients: 500 mg twice daily with food for 3 days.For diarrhea in AIDS patients: 1000 mg twice daily with food for 14 days or until diarrhea resolves.

Usual Adult Dose for Giardiasis:

For diarrhea in immunocompetent patients: 500 mg twice daily with food for 3 days.For diarrhea in AIDS patients: 1000 mg twice daily with food for 14 days or until diarrhea resolves.

Usual Pediatric Dose for Cryptosporidiosis:

For diarrhea in immunocompetent patients:12 to 47 months: 100 mg (5 mL) by mouth with food every 12 hours for 3 days.4 to 11 years: 200 mg (10 mL) with food every 12 hours for 3 days.Greater than or equal to 12 years: 500 mg twice daily with food for 3 days.

Usual Pediatric Dose for Giardiasis:

For diarrhea in immunocompetent patients:12 to 47 months: 100 mg (5 mL) by mouth with food every 12 hours for 3 days.4 to 11 years: 200 mg (10 mL) with food every 12 hours for 3 days.Greater than or equal to 12 years: 500 mg twice daily with food for 3 days.

Usual Pediatric Dose for Ascariasis:

Study (n=105)Dosage given orally morning and evening for 3 consecutive days.2 to 3 years: 100 mg/5 mL4 to 11 years: 200 mg/10 mL

Usual Pediatric Dose for Hymenolepis nana (Dwarf Tapeworm):

Study (n=105)Dosage given orally morning and evening for 3 consecutive days.2 to 3 years: 100 mg/5 mL4 to 11 years: 200 mg/10 mL

Usual Pediatric Dose for Amebiasis:

Study (n=53):Greater than or equal to 12 years:For diarrhea in immunocompetent patients: 500 mg twice daily with food for 3 days.

What other drugs will affect nitazoxanide?

Many drugs may affect the way that nitazoxanide is metabolized ("broken down") in the body, leading to higher or lower than expected levels of the medication in the blood. Talk to your doctor before taking any other medicines during treatment with nitazoxanide.

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

Where can I get more information?

• Your pharmacist has additional information about nitazoxanide written for health professionals that you may read.

• Remember, keep this and all other medicines out of the reach of children, never share your medicines with others, and use this medication only for the indication prescribed.
• Every effort has been made to ensure that the information provided by Cerner Multum, Inc. ('Multum') is accurate, up-to-date, and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. Multum information has been compiled for use by healthcare practitioners and consumers in the United States and therefore Multum does not warrant that uses outside of the United States are appropriate, unless specifically indicated otherwise. Multum's drug information does not endorse drugs, diagnose patients or recommend therapy. Multum's drug information is an informational resource designed to assist licensed healthcare practitioners in caring for their patients and/or to serve consumers viewing this service as a supplement to, and not a substitute for, the expertise, skill, knowledge and judgment of healthcare practitioners. The absence of a warning for a given drug or drug combination in no way should be construed to indicate that the drug or drug combination is safe, effective or appropriate for any given patient. Multum does not assume any responsibility for any aspect of healthcare administered with the aid of information Multum provides. The information contained herein is not intended to cover all possible uses, directions, precautions, warnings, drug interactions, allergic reactions, or adverse effects. If you have questions about the drugs you are taking, check with your doctor, nurse or pharmacist.

Copyright 1996-2006 Cerner Multum, Inc. Version: 3.02. Revision Date: 4/12/2009 4:44:55 PM.