Nitazoxanide is an antiprotozoal medicine that treats infections caused by protozoa (single-cell parasites that live in moist places such as lakes, streams, and soil).

Nitazoxanide is used to treat diarrhea caused by Giardia or Cryptosporidium. These conditions are sometimes called "Traveler's diarrhea." Nitazoxanide is used in adults and children who are at least 1 year old.

Nitazoxanide may also be used for purposes not listed in this medication guide.

Follow all directions on your medicine label and package. Tell each of your healthcare providers about all your medical conditions, allergies, and all medicines you use.

Follow all directions on your prescription label. Do not take this medicine in larger or smaller amounts or for longer than recommended.

Take nitazoxanide with food.

Nitazoxanide is usually taken once every 12 hours for 3 days. Follow your doctor's dosing instructions very carefully.

Shake the oral suspension (liquid) well just before you measure a dose. Measure liquid medicine with the dosing syringe provided, or with a special dose-measuring spoon or medicine cup. If you do not have a dose-measuring device, ask your pharmacist for one.

Store at room temperature away from moisture and heat. Keep the bottle tightly closed when not in use. Throw away any unused liquid after 7 days.

Usual Adult Dose for Cryptosporidiosis:

500 mg orally every 12 hours for 3 days

Use: For the treatment of diarrhea due to Giardia lamblia or Cryptosporidium parvum

Usual Adult Dose for Giardiasis:

500 mg orally every 12 hours for 3 days

Use: For the treatment of diarrhea due to Giardia lamblia or Cryptosporidium parvum

Usual Pediatric Dose for Cryptosporidiosis:

1 to 3 years: 100 mg orally every 12 hours
4 to 11 years: 200 mg orally every 12 hours
12 years or older: 500 mg orally every 12 hours

Duration of Therapy: 3 days

Use: For the treatment of diarrhea due to G lamblia or C parvum

Usual Pediatric Dose for Giardiasis:

1 to 3 years: 100 mg orally every 12 hours
4 to 11 years: 200 mg orally every 12 hours
12 years or older: 500 mg orally every 12 hours

Duration of Therapy: 3 days

Use: For the treatment of diarrhea due to G lamblia or C parvum

You should not use nitazoxanide if you are allergic to it.

To make sure nitazoxanide is safe for you, tell your doctor if you have:

• liver or kidney disease;

• HIV or AIDS; or

• a weak immune system.

The tablet form of nitazoxanide should not be given to a child younger than 12 years old. Children ages 1 to 11 years should use only the oral suspension (liquid) form of nitazoxanide.

Nitazoxanide is not expected to be harmful to an unborn baby. Tell your doctor if you are pregnant.

It is not known whether nitazoxanide passes into breast milk or if it could harm a nursing baby. Tell your doctor if you are breast-feeding a baby.

Take the missed dose as soon as you remember. Skip the missed dose if it is almost time for your next scheduled dose. Do not take extra medicine to make up the missed dose.

Seek emergency medical attention or call the Poison Help line at 1-800-222-1222.

Keep this medication in the container it came in, tightly closed, and out of reach of children. Store it at room temperature and away from excess heat and moisture (not in the bathroom). Dispose of any unused nitazoxanide suspension after 7 days.

Unneeded medications should be disposed of in special ways to ensure that pets, children, and other people cannot consume them. However, you should not flush this medication down the toilet. Instead, the best way to dispose of your medication is through a medicine take-back program. Talk to your pharmacist or contact your local garbage/recycling department to learn about take-back programs in your community. See the FDA's Safe Disposal of Medicines website (http://goo.gl/c4Rm4p) for more information if you do not have access to a take-back program.

It is important to keep all medication out of sight and reach of children as many containers (such as weekly pill minders and those for eye drops, creams, patches, and inhalers) are not child-resistant and young children can open them easily. To protect young children from poisoning, always lock safety caps and immediately place the medication in a safe location – one that is up and away and out of their sight and reach. http://www.upandaway.org

To prevent dehydration caused by diarrhea, drink plenty of fluids.

Follow your doctor's instructions about any restrictions on food, beverages, or activity.

Get emergency medical help if you have signs of an allergic reaction: hives; difficult breathing; swelling of your face, lips, tongue, or throat.

Common side effects of nitazoxanide may include:

• nausea, stomach pain;

• headache; or

• discolored urine.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

Other drugs may interact with nitazoxanide, including prescription and over-the-counter medicines, vitamins, and herbal products. Tell each of your health care providers about all medicines you use now and any medicine you start or stop using.

Keep all appointments with your doctor.

Do not let anyone else take your medication. Your prescription is probably not refillable. If you still have diarrhea after you finish the nitazoxanide, call your doctor.

It is important for you to keep a written list of all of the prescription and nonprescription (over-the-counter) medicines you are taking, as well as any products such as vitamins, minerals, or other dietary supplements. You should bring this list with you each time you visit a doctor or if you are admitted to a hospital. It is also important information to carry with you in case of emergencies.