nitazoxanide (Oral route)

nye-ta-ZOX-a-nide

Commonly used brand name(s)

In the U.S.

  • Alinia

Available Dosage Forms:

  • Tablet
  • Powder for Suspension

Therapeutic Class: Antiprotozoal

Uses For nitazoxanide

Nitazoxanide belongs to a group of medicines called antiprotozoals. It is used to treat diarrhea that is caused by certain types of protozoa (tiny, one-celled animals).

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nitazoxanide is available only with your healthcare professional's prescription.

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

Before Using nitazoxanide

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

Allergies

Tell your doctor if you have ever had any unusual or allergic reaction to nitazoxanide or any other medicines. Also tell your health care professional if you have any other types of allergies, such as to foods, dyes, preservatives, or animals. For non-prescription products, read the label or package ingredients carefully.

Pediatric

nitazoxanide has been tested in children and it is not expected to cause different problems in children than it does in other age groups.

Geriatric

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.

Pregnancy

Pregnancy Category Explanation
All Trimesters B Animal studies have revealed no evidence of harm to the fetus, however, there are no adequate studies in pregnant women OR animal studies have shown an adverse effect, but adequate studies in pregnant women have failed to demonstrate a risk to the fetus.

Breast Feeding

There are no adequate studies in women for determining infant risk when using this medication during breastfeeding. Weigh the potential benefits against the potential risks before taking this medication while breastfeeding.

Interactions with Medicines

Although certain medicines should not be used together at all, in other cases two different medicines may be used together even if an interaction might occur. In these cases, your doctor may want to change the dose, or other precautions may be necessary. Tell your healthcare professional if you are taking any other prescription or nonprescription (over-the-counter [OTC]) medicine.

Interactions with Food/Tobacco/Alcohol

Certain medicines should not be used at or around the time of eating food or eating certain types of food since interactions may occur. Using alcohol or tobacco with certain medicines may also cause interactions to occur. Discuss with your healthcare professional the use of your medicine with food, alcohol, or tobacco.

Other Medical Problems

The presence of other medical problems may affect the use of nitazoxanide. Make sure you tell your doctor if you have any other medical problems, especially:

  • Biliary (gallbladder) disease or
  • Immune deficiency condition, including HIV or AIDS or
  • Kidney disease or
  • Liver disease—It is not known how nitazoxanide 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).

Proper Use of nitazoxanide

Dosing

The dose of nitazoxanide will be different for different patients. Follow your doctor'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 doctor tells you to do so.

The amount of medicine that you take depends on the strength of the medicine. Also, the number of doses you take each day, the time allowed between doses, and the length of time you take the medicine depend on the medical problem for which you are using the medicine.

It is important to take nitazoxanide with food.

It is very important to shake the oral suspension for of the medicine well before measuring each dose.

For the oral suspension dosage form: 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
      • Adults and adolescents—Ages 12 years or older: 25 milliliters (mL) every 12 hours for 3 days.
      • 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.
  • For oral dosage form (tablets):
    • For treatment of diarrhea caused by protozoal infections
      • Adults and adolescents—Ages 12 years or older: 500 milligrams (mg) every 12 hours for 3 days.
      • Children—Ages 11 months or younger: Tablet dosage form is not for use in children.

Missed Dose

If you miss a dose of nitazoxanide, 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

Store the medicine in a closed container at room temperature, away from heat, moisture, and direct light. Keep from freezing.

Keep out of the reach of children.

Do not keep outdated medicine or medicine no longer needed.

Ask your healthcare professional how you should dispose of any medicine you do not use.

The suspension may be stored for 7 days. Any unused suspension must be disposed of after 7 days.

Precautions While Using nitazoxanide

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.

nitazoxanide Side Effects

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:

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 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.

See also: Side effects (in more detail)

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