Misoprostol (Misoprostol) - Indications and Dosage

INDICATIONS AND USAGE

Misoprostol is indicated for reducing the risk of NSAID (nonsteroidal anti-inflammatory drugs, including aspirin)–induced gastric ulcers in patients at high risk of complications from gastric ulcer, eg, the elderly and patients with concomitant debilitating disease, as well as patients at high risk of developing gastric ulceration, such as patients with a history of ulcer. Misoprostol has not been shown to reduce the risk of duodenal ulcers in patients taking NSAIDs. Misoprostol should be taken for the duration of NSAID therapy. Misoprostol has been shown to reduce the risk of gastric ulcers in controlled studies of 3 months' duration. It had no effect, compared to placebo, on gastrointestinal pain or discomfort associated with NSAID use.

DOSAGE AND ADMINISTRATION

The recommended adult oral dose of misoprostol for reducing the risk of NSAID-induced gastric ulcers is 200 mcg four times daily with food. If this dose cannot be tolerated, a dose of 100 mcg can be used. (See Clinical Pharmacology: Clinical studies .) Misoprostol should be taken for the duration of NSAID therapy as prescribed by the physician. Misoprostol should be taken with a meal, and the last dose of the day should be at bedtime.

Renal impairment

Adjustment of the dosing schedule in renally impaired patients is not routinely needed, but dosage can be reduced if the 200-mcg dose is not tolerated. (See Clinical Pharmacology .)

HOW SUPPLIED

Misoprostol 100-mcg tablets are white, round, with G and 5007 debossed on one side; supplied as:

NDC Number              Size
59762-5007-1            unit-of-use bottle of 60
59762-5007-2            unit-of-use bottle of 120

Misoprostol 200-mcg tablets are white, hexagonal, with G debossed above and 5008 debossed below the line on one side; supplied as:

NDC Number              Size
59762-5008-1            unit-of-use bottle of 60
59762-5008-2            unit-of-use bottle of 100

Store at or below 25°C (77°F), in a dry area.

PATIENT INFORMATION

Read this leaflet before taking misoprostol and each time your prescription is renewed, because the leaflet may be changed.

Misoprostol is being prescribed by your doctor to decrease the chance of getting stomach ulcers related to the arthritis/pain medication that you take.

Do not take misoprostol to reduce the risk of NSAID-induced ulcers if you are pregnant. (See boxed WARNINGS.) Misoprostol can cause abortion (sometimes incomplete which could lead to dangerous bleeding and require hospitalization and surgery), premature birth, or birth defects. It is also important to avoid pregnancy while taking this medication and for at least one month or through one menstrual cycle after you stop taking it. Misoprostol has been reported to cause the uterus to rupture (tear) when given after the eighth week of pregnancy. Rupture (tearing) of the uterus can result in severe bleeding, hysterectomy, and/or maternal or fetal death.

If you become pregnant during misoprostol therapy, stop taking misoprostol and contact your physician immediately. Remember that even if you are on a means of birth control it is still possible to become pregnant. Should this occur, stop taking misoprostol and contact your physician immediately.

Misoprostol may cause diarrhea, abdominal cramping, and/or nausea in some people. In most cases these problems develop during the first few weeks of therapy and stop after about a week. You can minimize possible diarrhea by making sure you take misoprostol with food.

Because these side effects are usually mild to moderate and usually go away in a matter of days, most patients can continue to take misoprostol. If you have prolonged difficulty (more than 8 days), or if you have severe diarrhea, cramping and/or nausea, call your doctor.

Take misoprostol only according to the directions given by your physician.

Do not give misoprostol to anyone else. It has been prescribed for your specific condition, may not be the correct treatment for another person, and would be dangerous if the other person were pregnant.

This information sheet does not cover all possible side effects of misoprostol. This patient information leaflet does not address the side effects of your arthritis/pain medication. See your doctor if you have questions.

Keep out of reach of children.