Nitazoxanide (Oral route)
- Powder for Suspension
Uses of This Medicine:
Nitazoxanide is used to treat diarrhea that is caused by certain types of protozoa (tiny, one-celled animals). It belongs to a group of medicines called antiprotozoals.
This medicine is available only with your doctor's prescription.
Before Using This Medicine:
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 this medicine, the following should be considered:
Tell your doctor if you have ever had any unusual or allergic reaction to this medicine 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.
Appropriate studies performed to date have not demonstrated pediatric-specific problems that would limit the usefulness of nitazoxanide oral suspension in children 1 year of age and older, and nitazoxanide tablet in children 12 years of age and older. However, safety and efficacy of nitazoxanide oral suspension has not been established in children younger than 1 year of age.
Although appropriate studies on the relationship of age to the effects of nitazoxanide have not been performed in the geriatric population, geriatric-specific problems are not expected to limit the usefulness of nitazoxanide in the elderly. However, elderly patients are more likely to have age-related kidney, liver, or heart problems, which may require caution in patients receiving nitazoxanide.
|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.|
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.
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.
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 this medicine. Make sure you tell your doctor if you have any other medical problems, especially:
- Weak immune system (including HIV or AIDS)—It is not known how this medicine will effect these conditions and it should be used with caution.
Proper Use of This Medicine:
Take this medicine exactly as directed even if you feel well. Do not take more of this medicine and do not take it more often than your doctor ordered. This medicine works best if there is a constant amount in the blood. To keep blood levels constant, take this medicine at the same time each day and do not miss any doses.
Take this medicine with food.
Use only the form of this medicine that your doctor prescribed. The oral suspension and tablet contain different amounts of medicine.
Shake the oral suspension well before using. 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.
The dose of this medicine 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 this medicine. 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.
- For treatment of diarrhea caused by protozoal infections:
- For oral dosage form (oral suspension):
- Adults and children 12 years or older—25 milliliters (mL) every 12 hours, taken with food, for 3 days.
- Children 4 to 11 years of age—10 mL every 12 hours, taken with food, for 3 days.
- Children 1 to 3 years of age—5 mL every 12 hours, taken with food, for 3 days.
- Children younger than 1 year of age—Use and dose must be determined by your doctor.
- For oral dosage form (tablets):
- Adults and children 12 years of age and older—500 milligrams (mg) every 12 hours, taken with food, for 3 days.
- Children up to 11 years of age—Use of tablet is not recommended in these patients.
- For oral dosage form (oral suspension):
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.
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.
Store the medicine in a closed container at room temperature, away from heat, moisture, and direct light. Keep from freezing.
The mixed oral liquid can be stored at room temperature for 7 days. Throw away any unused medicine after 7 days.
Precautions While Using This Medicine:
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.
Side Effects of This Medicine:
- Incidence not known
- Less common
- Abdominal or stomach pain
- urine changes
- Incidence not known
- hives or welts, itching, or skin rash
- redness of the skin
- trouble breathing
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:
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:
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.
Last Updated: 9/4/2017