misoprostol

Pronunciation

Generic Name: misoprostol (mye so PRAH stole)
Brand Name: Cytotec

What is misoprostol?

Misoprostol reduces stomach acid and replaces protective substances in the stomach that are inhibited by nonsteroidal anti-inflammatory drugs (NSAIDs) and aspirin.

Misoprostol is used to prevent the formation of ulcers in the stomach during treatment with aspirin or an NSAID such as ibuprofen (Motrin, Advil, Nuprin, others), ketoprofen (Orudis, Orudis KT, Oruvail), naproxen (Naprosyn, Aleve, Anaprox, Naprelan), oxaprozin (Daypro), indomethacin (Indocin), diclofenac (Voltaren, Cataflam), etodolac (Lodine), piroxicam (Feldene), meloxicam (Mobic), tolmetin (Tolectin), nabumetone (Relafen), and fenoprofen (Nalfon). NSAIDs and aspirin are used to treat pain, fever, arthritis, and inflammatory conditions.

Misoprostol may also be used for purposes other than those listed in this medication guide.

What is the most important information I should know about misoprostol?

Do not take misoprostol for the prevention of stomach ulcers if you are pregnant or if you might become pregnant during treatment. If you do become pregnant during treatment with misoprostol, stop taking the medication and contact your doctor immediately. Misoprostol is in the FDA pregnancy category X. This means that misoprostol is known to be harmful to an unborn baby. Misoprostol can cause miscarriage or spontaneous abortion (sometimes incomplete which could lead to dangerous bleeding and require hospitalization and surgery), premature birth, or birth defects. Misoprostol has also been reported to cause uterine rupture (tearing) when given after the eighth week of pregnancy, which can result in severe bleeding, hysterectomy, and/or maternal or fetal death. A pregnancy test with negative results will be required within 2 weeks of starting treatment with misoprostol, and treatment will begin only on the second or third day of a regular menstrual cycle. Also, appropriate contraception will be needed to prevent pregnancy during treatment and for one menstrual cycle following treatment. In some cases, misoprostol may be used under the supervision of a doctor for the induction of labor and delivery or abortion.

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Do not share this medication with anyone else. Misoprostol 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.

What should I discuss with my healthcare provider before taking misoprostol?

Before taking misoprostol, tell your doctor if you have inflammatory bowel disease, irritable bowel syndrome, or other intestinal problems. You may need a dosage adjustment or special monitoring during treatment with misoprostol.

Do not take misoprostol for the prevention of stomach ulcers if you are pregnant or if you might become pregnant during treatment. If you do become pregnant during treatment with misoprostol, stop taking the medication and contact your doctor immediately. Misoprostol is in the FDA pregnancy category X. This means that misoprostol is known to be harmful to an unborn baby. Misoprostol can cause miscarriage or spontaneous abortion (sometimes incomplete which could lead to dangerous bleeding and require hospitalization and surgery), premature birth, or birth defects. Misoprostol has also been reported to cause uterine rupture (tearing) when given after the eighth week of pregnancy, which can result in severe bleeding, hysterectomy, and/or maternal or fetal death. A pregnancy test with negative results will be required within 2 weeks of starting treatment with misoprostol, and treatment will begin only on the second or third day of a regular menstrual cycle. Also, appropriate contraception will be needed to prevent pregnancy during treatment and for one menstrual cycle following treatment. In some cases, misoprostol may be used under the supervision of a doctor for the induction of labor and delivery or abortion.

It is not known whether misoprostol passes into breast milk. Do not take misoprostol without first talking to your doctor if you are breast-feeding a baby.

How should I take misoprostol?

Take misoprostol exactly as directed by your doctor. If you do not understand these directions, ask your pharmacist, nurse, or doctor to explain them to you.

Take each dose with a full glass of water.

Misoprostol is usually taken four times a day, with meals and at bedtime. Follow your doctor's instructions.

Misoprostol may cause mild to moderate diarrhea, stomach cramps, and/or nausea. These problems usually occur during the first few weeks of treatment and stop after about a week. The occurrence of diarrhea may be minimized by taking misoprostol with food. Contact your doctor if these symptoms persist for longer than 8 days or if they are severe.

Take misoprostol for the full amount of time prescribed by your doctor. Treatment usually continues for as long as aspirin or an NSAID is taken.

Do not share this medication with anyone else. Misoprostol 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.

Store misoprostol at room temperature away from moisture and heat.

What happens if I miss a dose?

Take the missed dose as soon as you remember. However, if it is almost time for the next dose, skip the missed dose and take only the next regularly scheduled dose. Do not take a double dose of this medication.

What happens if I overdose?

Seek emergency medical attention.

The symptoms of a misoprostol overdose are not well known but might include stomach upset, stomach pain, diarrhea, drowsiness, tremor, seizures, difficulty breathing, fever, low blood pressure, and an irregular heart beat.

What should I avoid while taking misoprostol?

Do not share this medication with anyone else. Misoprostol 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.

The incidence of diarrhea may be reduced by avoiding antacids that contain magnesium. If an antacid is needed, one that contains aluminum or calcium may be a more appropriate choice.

There are no restrictions on food, beverages, or activities during treatment with misoprostol unless otherwise directed by your doctor.

Misoprostol side effects

Stop taking misoprostol and seek emergency medical attention if you experience an allergic reaction (difficulty breathing; closing of the throat; swelling of the lips, tongue, or face; or hives).

Misoprostol may cause mild to moderate diarrhea, stomach cramps, and/or nausea. These problems usually occur during the first few weeks of treatment and stop after about a week. The occurrence of diarrhea may be minimized by taking misoprostol with food. Contact your doctor if these symptoms persist for longer than 8 days or if they are severe.

Other, less serious side effects may also occur. Continue to take misoprostol and talk to your doctor if you experience

  • vomiting;

  • flatulence;

  • constipation;

  • headache; or

  • menstrual cramps, spotting, or increased or irregular menstruation.

Side effects other than those listed here may also occur. Talk to your doctor about any side effect that seems unusual or that is especially bothersome. You may report side effects to FDA at 1-800-FDA-1088.

See also: Side effects (in more detail)

Misoprostol dosing information

Usual Adult Dose for Duodenal Ulcer:

200 mcg orally 4 times a day after meals and at bedtime.

For duodenal ulcers: Alternatively, 400 mcg orally 2 times a day may be used.

Usual Adult Dose for Gastric Ulcer:

200 mcg orally 4 times a day after meals and at bedtime.

For duodenal ulcers: Alternatively, 400 mcg orally 2 times a day may be used.

Usual Adult Dose for NSAID-Induced Ulcer Prophylaxis:

200 mcg orally 4 times a day after meals and at bedtime.

For duodenal ulcers: Alternatively, 400 mcg orally 2 times a day may be used.

Usual Adult Dose for Labor Induction:

25 mcg vaginally every 4 to 6 hours.

Usual Adult Dose for Postpartum Bleeding:

Prophylaxis: 400 to 600 mcg orally or rectally after delivery of the baby, but before delivery of the placenta.

Usual Adult Dose for Cervical Ripening:

Before surgical abortion: 400 mcg vaginally, 3 to 4 hours before suction curettage.

Usual Adult Dose for Abortion:

First Trimester of Pregnancy: 400 mcg orally once as a single dose 48 hours after mifepristone administration. Alternatively, 800 mcg vaginally 48 hours after mifepristone administration. When used with methotrexate, 5 to 7 days later give 800 mcg vaginally (misoprostol dose may be repeated 24 hours later if needed).

In Failed Pregnancy or Fetal Death: 800 mcg vaginally once or twice (doses given 24 hours apart).

Second Trimester of Pregnancy: 600 mcg vaginally, 36 to 48 hours after mifepristone administration, followed by 400 mcg orally or vaginally every 3 hours to a maximum of 5 doses in the first 24 hours.

Third Trimester of Pregnancy - Fetal Death: 100 mcg vaginally every 12 hours.

Usual Adult Dose for Gynecologic Surgery:

Study (n=204) - Operative hysteroscopy: 400 mcg orally 12 to 24 hours before surgery.

Usual Pediatric Dose for NSAID-Induced Ulcer Prophylaxis:

Study (n=25)
>7 years: 9.8 mcg/kg/day, given in two equally divided doses daily, to a maximum of 800 mcg/day.

What other drugs will affect misoprostol?

The incidence of diarrhea may be reduced by avoiding antacids that contain magnesium. If an antacid is needed, one that contains aluminum or calcium may be a more appropriate choice.

Drugs other than those listed here may also interact with misoprostol. Talk to your doctor and pharmacist before taking any prescription or over-the-counter medicines, including herbal products.

Where can I get more information?

  • Your pharmacist has more information about misoprostol written for health professionals that you may read.
  • Remember, keep this and all other medicines out of the reach of children, never share your medicines with others, and use this medication only for the indication prescribed.
  • Disclaimer: Every effort has been made to ensure that the information provided by Cerner Multum, Inc. ('Multum') is accurate, up-to-date, and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. Multum information has been compiled for use by healthcare practitioners and consumers in the United States and therefore Multum does not warrant that uses outside of the United States are appropriate, unless specifically indicated otherwise. Multum's drug information does not endorse drugs, diagnose patients or recommend therapy. Multum's drug information is an informational resource designed to assist licensed healthcare practitioners in caring for their patients and/or to serve consumers viewing this service as a supplement to, and not a substitute for, the expertise, skill, knowledge and judgment of healthcare practitioners. The absence of a warning for a given drug or drug combination in no way should be construed to indicate that the drug or drug combination is safe, effective or appropriate for any given patient. Multum does not assume any responsibility for any aspect of healthcare administered with the aid of information Multum provides. The information contained herein is not intended to cover all possible uses, directions, precautions, warnings, drug interactions, allergic reactions, or adverse effects. If you have questions about the drugs you are taking, check with your doctor, nurse or pharmacist.

Copyright 1996-2012 Cerner Multum, Inc. Version: 7.03. Revision Date: 2010-12-15, 5:01:39 PM.

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