In the U.S.—

• Antiprotozoal

Nitazoxanide ( nye-tah-ZOX-ah-nide) belongs to a group of medicines called antiprotozoals. It is used to treat diarrhea in children that is caused by protozoa (tiny, one-celled animals).

This medicine is available only with your healthcare professional's prescription, in the following dosage forms:

Oral
• Oral Suspension (U.S.)

In deciding to use a medicine, the risks of using the medicine must be weighed against the good it will do. This is a decision you and your healthcare professional will make. For nitazoxanide, the following should be considered:

Allergies—Tell your healthcare professional if you have ever had any unusual or allergic reaction to nitazoxanide. Also tell your healthcare professional if you are allergic to any other substances, such as foods, preservatives, or dyes.

Pregnancy—This medicine has not been studied in pregnant women. Before taking this medicine be sure your healthcare professional knows if you are pregnant or plan on becoming pregnant.

Breast-feeding—It is not known whether this medicine passes into breast milk. Although most medicines pass into breast milk in small amounts, many of them may be used safely while breast feeding. Mothers who are taking this medicine and wish to breast feed should discuss this with their healthcare professional.

Children—This medicine has been tested in children and it is not expected to cause different problems in children than it does in other age groups.This medicine is only approved for use in children who are 12 months of age to 11 years of age. It is not approved for use in children who are less than one year of age or greater than 11 years of age.

Older adults—Many medicines have not been specifically studied in older people. Therefore it may not be known whether they work the same way they do in younger adults or if they cause different side effects or problems in older people. There is no specific information comparing the use of nitazoxanide in the elderly with use in other age groups.

• Biliary (gallbladder) disease or
• Immune deficiency condition, including HIV or AIDS or
• Kidney disease or
• Liver disease—It is not known how this medicine will effect these conditions and it should be used with caution

• Diabetes mellitus (sugar diabetes)—The oral suspension of nitazoxanide contains 1.48 grams of sucrose per 5 milliliters (mL).

Dosing—

The dose of nitazoxanide will be different for different patients. Follow your healthcare professional's orders or the directions on the label. The following information includes only the average doses of nitazoxanide. If your dose is different, do not change it unless your healthcare professional tells you to do so.

It is important to take nitazoxanide with food.

It is very important to shake the medicine well before measuring each dose.

Use a specially marked measuring syringe or spoon to measure each dose accurately. The average household teaspoon may not hold the right amount of liquid.

• For oral dosage form (oral suspension):
  • For treatment of diarrhea caused by protozoal infections
    • Children—Ages 12 to 47 months: 5 milliliters (mL) every 12 hours for 3 days
    • Children—Ages 4 to 11 years: 10 milliliters (mL) every 12 hours for 3 days

Missed dose—

If you miss a dose of this medicine, take it as soon as possible. However, if it is almost time for your next dose, skip the missed dose and go back to your regular dosing schedule. Do not double doses.

Storage—

To store this medicine:

• The suspension may be stored for 7 days. Any unused suspension must be disposed of after 7 days.
• Store the suspension at room temperature.
• Do not store in the bathroom, near the kitchen sink, or in other damp places. Heat or moisture may cause the medicine to break down.
• Do not keep outdated medicine or medicine no longer needed. Ask your health care professional how you should dispose of any medicine you do not use. Be sure that any discarded medicine is out of the reach of children.

It is very important that your healthcare professional check you at regular visits

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

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. However, check with your healthcare professional if any of the following side effects continue or are bothersome.

• More common
  • Stomach pain 
  
  

• Less common
  • Diarrhea;  headache;  vomiting 
  
  

• Rare
  • Appetite increase;  bloated full feeling ;  discolored urine;  dizziness ;  enlarged salivary glands;  excess air or gas in stomach or intestines;  eye discoloration, pale yellow;  fever;  general feeling of discomfort or illness;  infection ;  itching skin;  loss of appetite;  nausea;  passing gas;  runny nose;  sneezing;  stuffy nose;  sweating;  unusual tiredness or weakness;  weight loss 
  
  

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

Once a medicine has been approved for marketing for a certain use, experience may show that it is also useful for other medical problems. Although this use is not included in product labeling, nitazoxanide is used in certain patients with the following medical condition:

• Intestinal parasitic infections

Other than the above information, there is no additional information relating to proper use, precautions, or side effects for this use.