In the U.S.—

In Canada—

• Antiulcer agent
• Gastric mucosa protectant

Misoprostol (mye-soe-PROST-ole ) is taken to prevent stomach ulcers in patients taking anti-inflammatory drugs, including aspirin. Misoprostol may also be used for other conditions as determined by your doctor.

Misoprostol helps the stomach protect itself against acid damage. It also decreases the amount of acid produced by the stomach.

This medicine is available only with your doctor's prescription, in the following dosage form:

Oral
• Tablets (U.S. and Canada)

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 misoprostol, the following should be considered:

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

Pregnancy—Misoprostol must not be used during pregnancy when used to prevent stomach ulcers caused by anti-inflammatory medicines including aspirin. It has been shown to cause contractions and bleeding of the uterus. Misoprostol may also cause miscarriage.

Before starting to take this medicine you must have had a negative pregnancy test within the previous 2 weeks. Also, you must start taking misoprostol only on the second or third day of your next normal menstrual period. In addition, it will be necessary that you use an effective form of birth control while taking this medicine. Be sure that you have discussed this with your doctor before taking this medicine.

Breast-feeding—It is not known whether misoprostol passes into breast milk. However, misoprostol is not recommended for use during breast-feeding because it may cause diarrhea in nursing babies.

Children—Studies on this medicine have been done only in adult patients, and there is no specific information comparing use of misoprostol in children with use in other age groups.

Older adults—This medicine has been tested and has not been shown to cause different side effects or problems in older people than it does in younger adults.

Other 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 health care professional if you are taking any other prescription or nonprescription (over-the-counter [OTC]) medicine.

• Blood vessel disease—Medicines similar to misoprostol have been shown to make this condition worse

• Epilepsy (uncontrolled)—Medicines similar to misoprostol have been shown to cause convulsions (seizures)
• Inflammatory bowel disease—Misoprostol may worsen diarrhea, which could lead to dehydration

Misoprostol is best taken with or after meals and at bedtime, unless otherwise directed by your doctor. To help prevent loose stools, diarrhea, and abdominal cramping, always take this medicine with food or milk.

Dosing—

The dose of misoprostol 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 misoprostol. If your dose is different, do not change it unless your doctor tells you to do so.

• To prevent stomach ulcers in patients taking anti-inflammatory medicines including aspirin:
  • For oral dosage form (tablets):
    • Adults—200 micrograms (mcg) four times a day, with or after meals and at bedtime. Or, your dose may be 400 mcg two times a day with the last dose taken at bedtime. Your doctor may reduce the dose to 100 mcg if you are sensitive to high doses.
    • Children and teenagers—Dose must be determined by your doctor.

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:

• Keep out of the reach of children.
• Store away from heat and direct light.
• 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. Be sure that any discarded medicine is out of the reach of children.

Misoprostol may cause miscarriage if taken during pregnancy. Therefore, if you suspect that you may have become pregnant, stop taking this medicine immediately and check with your doctor.

This medicine may cause diarrhea, stomach cramps, or nausea in some people. These effects will usually disappear within a few days as your body adjusts to the medicine. However, check with your doctor if the diarrhea, cramps, or nausea is severe and/or does not stop after a week. Your doctor may have to lower the dose of misoprostol you are taking.

Along with its needed effects, a medicine may cause some unwanted 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. However, check with your doctor if any of the following side effects continue or are bothersome:

• More common
  • Abdominal or stomach pain (mild);  diarrhea  
  
  

• Less common or rare
  • Bleeding from vagina;  constipation;  cramps in lower abdomen or stomach area;  gas;  headache;  heartburn, indigestion, or acid stomach;  nausea and/or vomiting  
  
  

• Symptoms of overdose
  • Abdominal pain;  convulsions (seizures) ;  diarrhea;  drowsiness;  fast or pounding heartbeat;  fever;  low blood pressure;  slow heartbeat;  tremor;  troubled breathing 
  
  

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

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 these uses are not included in product labeling, misoprostol may be used in certain patients with the following medical conditions:

• Abortion, first trimester
• Abortion, second trimester
• Cervical ripening
• Induction of labor
• Postpartum hemorrhage

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