DrugindexOnline^{2nd edition}

Generic Name: Misoprostol (MY-so-PRAHST-ole)
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 due to 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.

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 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 inflammatory bowel disease (IBS), 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.
• 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 drowsiness or dizziness. These effects may be worse if you take it with alcohol or certain medicines. Use Misoprostol with caution. Do not drive or perform other possibly unsafe tasks until you know how you react to it.
• 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.
• This medicine 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 use 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. It is not known if Misoprostol is found in breast milk. Do not breast-feed while taking Misoprostol .

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:

Constipation; diarrhea; gas; headache; indigestion; nausea; vomiting.

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; persistent or severe vomiting or diarrhea; vomit that looks like coffee grounds.

This is not a complete list of all side effects that may occur. If you have questions or need medical advice about side effects, contact your doctor or health care provider. You may report side effects to the FDA at 1-800-FDA-1088 (1-800-332-1088) or at http://www.fda.gov/medwatch.

If OVERDOSE is suspected:

Contact 1-800-222-1222 (the American Association of Poison Control Centers), your local poison control center (http://www.aapcc.org/findyour.htm), or emergency room immediately. Symptoms may include difficulty breathing; fever; seizures; 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.

This information is a summary only. It does not contain all information about Misoprostol . If you have questions about the medicine you are taking or would like more information, check with your doctor, pharmacist, or other health care provider.