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Misoprostol (Oral route)

Pronunciation:

mye-soe-PROST-ol

Brand Names:

  • Cytotec

Dosage Forms:

  • Tablet

Warnings:

Oral route(Tablet)

Administration of misoprostol to women who are pregnant can cause birth defects, abortion, or premature birth. Uterine rupture has been reported when misoprostol was administered in pregnant women to induce labor or to induce abortion beyond the eighth week of pregnancy. Misoprostol should not be used for reducing the risk of NSAID-induced ulcers in women of childbearing potential unless the patient is at high risk of developing gastric ulcers or complications. Women must have a negative serum pregnancy test within 2 weeks prior to beginning therapy, use effective contraceptive measures, and initiate therapy only on the second or third day of the next normal menstrual period. Oral and written warnings of the hazards of misoprostol, including the risk of possible contraception failure, must be given to the patient prior to initiating therapy .

Classifications:

Therapeutic—

Endocrine-Metabolic Agent

Pharmacologic—

Prostaglandin

Uses of This Medicine:

Misoprostol 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.

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

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:

Allergies—

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.

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.

Pregnancy—

Pregnancy CategoryExplanation
All TrimestersXStudies in animals or pregnant women have demonstrated positive evidence of fetal abnormalities. This drug should not be used in women who are or may become pregnant because the risk clearly outweighs any possible benefit.

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.

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. When you are taking this medicine, it is especially important that your healthcare professional know if you are taking any of the medicines listed below. The following interactions have been selected on the basis of their potential significance and are not necessarily all-inclusive.

Using this medicine with any of the following medicines may cause an increased risk of certain side effects, but using both drugs may be the best treatment for you. If both medicines are prescribed together, your doctor may change the dose or how often you use one or both of the medicines.

  • Phenylbutazone

Other interactions—

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:

  • 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

Proper Use of This Medicine:

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 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.

  • 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—

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.

Precautions While Using This Medicine:

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.

Side Effects of This Medicine:

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.

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
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 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: 11/4/2014

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