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Misoprostol

Pronunciation

Generic Name: misoprostol (MYE-soe-PROST-ol)
Brand Name: Cytotec

Do not take misoprostol to reduce the risk of stomach ulcers caused by nonsteroidal anti-inflammatory drugs (NSAIDs) if you are pregnant. Misoprostol may cause abortion, premature birth, or birth defects if taken during pregnancy. Life-threatening problems, such as uterine rupture (tear), have occurred in pregnant women who have taken misoprostol to cause abortion after the eighth week of pregnancy or to induce labor. Do not share misoprostol with others.

Women of childbearing potential should not take misoprostol to reduce the risk of stomach ulcers caused by NSAIDs unless there is a high risk of developing stomach ulcers or complications from stomach ulcers caused by the use of NSAIDs. If it is necessary for women of childbearing potential to take misoprostol, they must:

  • Have a negative serum pregnancy test within 2 weeks before beginning therapy
  • Comply with effective birth control measures
  • Receive written and oral warnings about the risks of taking misoprostol, the risks of possible failure of birth control methods, and the dangers to other women of childbearing potential who may take misoprostol by mistake
  • Agree to begin taking misoprostol only on the second or third day of the next normal menstrual period.

Misoprostol is used for:

Reducing the risk of stomach ulcers in certain patients who take nonsteroidal anti-inflammatory drugs (NSAIDs). It may also be used for other conditions as determined by your doctor.

Misoprostol is a prostaglandin. It works by reducing the amount of acid released by the stomach and protecting the stomach lining, which helps to reduce the risk of stomach ulcers.

Do NOT use misoprostol if:

  • you are allergic to any ingredient in misoprostol or to similar medicines (prostaglandins)
  • you are pregnant

Contact your doctor or health care provider right away if any of these apply to you.

Slideshow: 2014 Update: First Time Brand-to-Generic Switches

Before using misoprostol:

Some medical conditions may interact with misoprostol. Tell your doctor or pharmacist if you have any medical conditions, especially if any of the following apply to you:

  • if you are planning to become pregnant or are breast-feeding
  • if you are able to become pregnant
  • if you are taking any prescription or nonprescription medicine, herbal preparation, or dietary supplement
  • if you have allergies to medicines, foods, or other substances
  • if you have a history of heart disease, inflammatory bowel disease (eg, irritable bowel syndrome), dehydration, or other problems that may be worsened if you become dehydrated

Some MEDICINES MAY INTERACT with misoprostol. However, no specific interactions with misoprostol are known at this time.

Ask your health care provider if misoprostol may interact with other medicines that you take. Check with your health care provider before you start, stop, or change the dose of any medicine.

How to use misoprostol:

Use misoprostol as directed by your doctor. Check the label on the medicine for exact dosing instructions.

  • An extra patient leaflet is available with misoprostol. Talk to your pharmacist if you have questions about this information.
  • Take misoprostol by mouth with food unless your doctor tells you otherwise.
  • The last dose of the day should be taken at bedtime. Taking misoprostol after meals and at bedtime may decrease the risk of diarrhea.
  • Do not take an antacid that has magnesium in it within 1 hour before or 2 hours after you take misoprostol.
  • If you miss a dose of misoprostol, take it as soon as possible. If it is almost time for your next dose, skip the missed dose and go back to your regular dosing schedule. Do not take 2 doses at once.

Ask your health care provider any questions you may have about how to use misoprostol.

Important safety information:

  • Misoprostol may cause diarrhea, nausea, or stomach pain or cramps. If this occurs, it usually develops within the first few weeks after starting misoprostol. If these effects develop and last longer than 1 week, contact your health care provider.
  • Tell your doctor or dentist that you take misoprostol before you receive any medical or dental care, emergency care, or surgery.
  • Misoprostol should be used with extreme caution in CHILDREN; safety and effectiveness in children have not been confirmed.
  • If you may become pregnant, you must use an effective form of birth control while you take misoprostol. If you have questions about effective birth control, talk with your doctor.
  • PREGNANCY and BREAST-FEEDING: Do not take misoprostol if you are pregnant. It has been shown to cause harm to the fetus. Avoid becoming pregnant while you are taking it. Avoid becoming pregnant for at least 1 month or through 1 menstrual cycle after you stop taking it. If you think you may be pregnant, contact your doctor right away. Misoprostol is found in breast milk. If you are or will be breast-feeding while you use misoprostol, check with your doctor. Discuss any possible risks to your baby.

Possible side effects of misoprostol:

All medicines may cause side effects, but many people have no, or minor, side effects. Check with your doctor if any of these most COMMON side effects persist or become bothersome:

Diarrhea; stomach pain.

Seek medical attention right away if any of these SEVERE side effects occur:

Severe allergic reactions (rash; hives; itching; difficulty breathing; tightness in the chest; swelling of the mouth, face, lips, or tongue); black, tarry stools; blood in the urine; changes in hearing or deafness; changes in menstrual period; chest pain; fainting; fever; headache, dizziness, or blurred vision; irregular heartbeat; mood or mental changes (eg, anxiety, confusion, depression); persistent or severe diarrhea, nausea, or stomach pain or cramping; unusual bleeding or bruising; unusual tiredness or weakness; vomit that looks like coffee grounds; wheezing or shortness of breath.

This is not a complete list of all side effects that may occur. If you have questions about side effects, contact your health care provider. Call your doctor for medical advice about side effects. To report side effects to the appropriate agency, please read the Guide to Reporting Problems to FDA.

If OVERDOSE is suspected:

Contact 1-800-222-1222 (the American Association of Poison Control Centers), your local poison control center, or emergency room immediately. Symptoms may include difficulty breathing; fever; seizures; severe diarrhea; severe dizziness or drowsiness; slow or irregular heartbeat; stomach pain; tremors.

Proper storage of misoprostol:

Store misoprostol at or below 77 degrees F (25 degrees C). Store away from heat, moisture, and light. Do not store in the bathroom. Keep misoprostol out of the reach of children and away from pets.

General information:

  • If you have any questions about misoprostol, please talk with your doctor, pharmacist, or other health care provider.
  • Misoprostol is to be used only by the patient for whom it is prescribed. Do not share it with other people.
  • If your symptoms do not improve or if they become worse, check with your doctor.
  • Check with your pharmacist about how to dispose of unused medicine.

This information should not be used to decide whether or not to take misoprostol or any other medicine. Only your health care provider has the knowledge and training to decide which medicines are right for you. This information does not endorse any medicine as safe, effective, or approved for treating any patient or health condition. This is only a brief summary of general information about misoprostol. It does NOT include all information about the possible uses, directions, warnings, precautions, interactions, adverse effects, or risks that may apply to misoprostol. This information is not specific medical advice and does not replace information you receive from your health care provider. You must talk with your healthcare provider for complete information about the risks and benefits of using misoprostol.

Issue Date: September 3, 2014
Database Edition 14.3.1.003
Copyright © 2014 Wolters Kluwer Health, Inc.

Disclaimer: This information should not be used to decide whether or not to take this medicine or any other medicine. Only your health care provider has the knowledge and training to decide which medicines are right for you. This information does not endorse any medicine as safe, effective, or approved for treating any patient or health condition. This is only a brief summary of general information about this medicine. It does NOT include all information about the possible uses, directions, warnings, precautions, interactions, adverse effects, or risks that may apply to this medicine. This information is not specific medical advice and does not replace information you receive from your health care provider. You must talk with your healthcare provider for complete information about the risks and benefits of using this medicine.

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