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misoprostol

Pronunciation

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

What is misoprostol?

Misoprostol reduces stomach acid and helps protect the stomach from damage that can be caused by taking a nonsteroidal anti-inflammatory drug (NSAID) such as aspirin, ibuprofen (Advil, Motrin), naproxen (Aleve), celecoxib, diclofenac, indomethacin, meloxicam, and others.

Misoprostol is used to prevent stomach ulcers during treatment with aspirin or an NSAID.

Misoprostol may also be used for purposes not listed in this medication guide.

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

Misoprostol can cause birth defects, premature birth, uterine rupture, miscarriage, or incomplete miscarriage and dangerous uterine bleeding. Do not use misoprostol if you are pregnant.

If you are able to become pregnant, you will need to have a negative pregnancy test before starting this treatment. You will also need to use effective birth control to prevent pregnancy during treatment.

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

You should not use this medicine if you are allergic to misoprostol or other prostaglandins, or if you are pregnant.

To make sure misoprostol is safe for you, tell your doctor if you have:

  • inflammatory bowel disease (IBD), irritable bowel syndrome (IBS), or other intestinal problems;

  • heart disease; or

  • if you are dehydrated.

FDA pregnancy category X. Misoprostol can cause birth defects, premature birth, uterine rupture, miscarriage, or incomplete miscarriage and dangerous uterine bleeding. Do not use misoprostol if you are pregnant. Use effective birth control to prevent pregnancy while you are using this medicine, and for at least 1 month after your treatment ends.

If you are able to become pregnant, you will need to have a negative pregnancy test before you start taking misoprostol. Treatment with this medicine should begin on the second or third day of your menstrual period.

Stop taking this medicine and tell your doctor right away if you become pregnant during treatment.

It is not known whether misoprostol passes into breast milk or if it could harm a nursing baby. Tell your doctor if you are breast-feeding a baby.

How should I take misoprostol?

Follow all directions on your prescription label. Do not take this medicine in larger or smaller amounts or for longer than recommended.

Do not share this medicine with another person.

Misoprostol is usually taken with meals and at bedtime. Follow your doctor's instructions.

You may have nausea, stomach cramps, or diarrhea while taking this medicine, especially during the first few weeks after you start taking misoprostol. These symptoms usually last for about a week.

Call your doctor if you have severe nausea, stomach pain, or diarrhea lasting longer than 8 days.

Read all medication guides or patient instructions provided with this medicine each time your receive a new supply.

Store 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 or call the Poison Help line at 1-800-222-1222.

What should I avoid while taking misoprostol?

Ask your doctor before using an antacid, and use only the type your doctor recommends. Some antacids can increase your risk of diarrhea while you are taking misoprostol.

Misoprostol side effects

Get emergency medical help if you have any of these signs of an allergic reaction: hives; difficult breathing; swelling of your face, lips, tongue, or throat.

Call your doctor at once if you have:

  • severe ongoing stomach discomfort or diarrhea; or

  • dehydration symptoms--feeling very thirsty or hot, being unable to urinate, heavy sweating, or hot and dry skin.

Common side effects may include:

  • diarrhea;

  • stomach pain, nausea, upset stomach, gas;

  • vaginal bleeding or spotting, heavy menstrual flow; or

  • menstrual cramps.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

Misoprostol dosing information

Usual Adult Dose for Duodenal Ulcer:

200 mcg orally 4 times a day after meals and at bedtime
-Maintenance dose: 100 to 200 mcg orally 4 times a day

Comment: Treatment should be taken for the duration of non-steroidal anti-inflammatory drug (NSAID) therapy.

Use: Reducing the risk of NSAID-induced gastric ulcers in patients at high risk of complications from gastric ulcers (e.g., patients who are elderly, with concomitant debilitating disease) or at high risk of developing gastric ulceration (e.g., history of gastric ulcer)

Usual Adult Dose for Gastric Ulcer:

200 mcg orally 4 times a day after meals and at bedtime
-Maintenance dose: 100 to 200 mcg orally 4 times a day

Comment: Treatment should be taken for the duration of non-steroidal anti-inflammatory drug (NSAID) therapy.

Use: Reducing the risk of NSAID-induced gastric ulcers in patients at high risk of complications from gastric ulcers (e.g., patients who are elderly, with concomitant debilitating disease) or at high risk of developing gastric ulceration (e.g., history of gastric ulcer)

Usual Adult Dose for NSAID-Induced Ulcer Prophylaxis:

200 mcg orally 4 times a day after meals and at bedtime
-Maintenance dose: 100 to 200 mcg orally 4 times a day

Comment: Treatment should be taken for the duration of non-steroidal anti-inflammatory drug (NSAID) therapy.

Use: Reducing the risk of NSAID-induced gastric ulcers in patients at high risk of complications from gastric ulcers (e.g., patients who are elderly, with concomitant debilitating disease) or at high risk of developing gastric ulceration (e.g., history of gastric ulcer)

Usual Adult Dose for Cervical Ripening:

American College of Obstetricians and Gynecologists (ACOG) Recommendations:
25 mcg vaginally every 3 to 6 hours
-Some patients may require doses of 50 mcg every 6 hours

Comments:
-The manufacturer states that use outside of the approved indication should be reserved for hospital use only.
-Some experts state that this drug is a more efficient method of labor (compared to oxytocin) in patients before 28 weeks' gestation.
-Higher doses may be associated with a higher risk of adverse events (e.g., uterine tachysystole with fetal heart rate decelerations).
-Use should be avoided during the third trimester or in patients with a history of cesarean delivery or major uterine surgery.

Use: Cervical ripening and labor induction in women with premature rupture of membranes

Usual Adult Dose for Labor Induction:

American College of Obstetricians and Gynecologists (ACOG) Recommendations:
25 mcg vaginally every 3 to 6 hours
-Some patients may require doses of 50 mcg every 6 hours

Comments:
-The manufacturer states that use outside of the approved indication should be reserved for hospital use only.
-Some experts state that this drug is a more efficient method of labor (compared to oxytocin) in patients before 28 weeks' gestation.
-Higher doses may be associated with a higher risk of adverse events (e.g., uterine tachysystole with fetal heart rate decelerations).
-Use should be avoided during the third trimester or in patients with a history of cesarean delivery or major uterine surgery.

Use: Cervical ripening and labor induction in women with premature rupture of membranes

Usual Adult Dose for Postpartum Bleeding:

ACOG Recommendations:
800 to 1000 mcg rectally once

Use: Management of postpartum hemorrhage

International Federation of Gynecology Obstetrics (FIGO) Recommendations:
600 mcg orally OR 800 mcg sublingually once immediately after delivery

Comments:
-The manufacturer states that use outside of the approved indication should be reserved for hospital use only.
-Prior to administration of treatment, abdominal palpitation is recommended to confirm that there are no additional babies in utero.
-The dose is not based upon the patient's weight.
-The addition of this drug to oxytocin was not shown to provide additional benefit, but may increase the risk of adverse events.

Use: Prevention of postpartum hemorrhage in settings where oxytocin is not available

Usual Adult Dose for Abortion:

ACOG Recommendations:
First Trimester of Pregnancy:
-Early Pregnancy Loss: 800 mcg intravaginally once; a second dose may be given if there is no response to the first dose no sooner than 3 hours after the first dose, and usually within 7 days
-Incomplete Abortion: 600 mcg orally once
-Missed Abortion: 800 mcg intravaginally OR 600 mcg sublingually once; the dose may be repeated every 3 hours for 2 additional doses

Comments:
-Pain medications should be provided.
-Patients that are Rh(D) negative and unsensitized: Rh(D)-immune globulin should be given within 72 hours of administration of the initial dose.
-Follow-up treatment should be made within 7 to 14 days to ensure complete expulsion has occurred.
-If treatment fails, patients may opt for expectant management or suction curettage.

Use: Treatment of early pregnancy loss, incomplete abortion, or missed abortion

What other drugs will affect misoprostol?

Other drugs may interact with misoprostol, including prescription and over-the-counter medicines, vitamins, and herbal products. Tell each of your health care providers about all medicines you use now and any medicine you start or stop using.

See also: Side effects (in more detail)

Where can I get more information?

  • Your pharmacist can provide more information about misoprostol.
  • 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: 8.01.

Last reviewed: July 10, 2014
Date modified: September 05, 2017

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