misoprostol – oral, Cytotec
WARNING: Do not take this medication if you think you may be pregnant. It may cause abortion, premature birth, or birth defects. In rare cases, serious complications have occurred when misoprostol was used to start labor or in combination with another drug to cause abortion after the eighth week of pregnancy. These complications have resulted in harm to the unborn baby and mother. Avoid pregnancy while taking misoprostol and for at least one month after you have stopped treatment. If you become pregnant while taking misoprostol, contact your doctor immediately. If you are pregnant, do not take this medication to reduce the risk of stomach ulcers due to aspirin or other related drugs (non-steroidal anti-inflammatory drugs-NSAIDs such as ibuprofen). Also, if you are of childbearing age, do not use this drug to reduce the risk of ulcers from NSAIDs unless you are at high risk of having an ulcer or ulcer complications. Female patients must meet the following four requirements to use this drug: 1) test negative for pregnancy within two weeks before starting treatment; 2) use effective birth control to prevent pregnancy; 3) receive oral and written warnings on the dangers of using misoprostol while of childbearing age and the risks of possible birth control failure; 4) start taking misoprostol only on the second or third day of the next normal menstrual period. This medication must not be shared with others.
USES: This medication is used to prevent stomach ulcers while taking NSAIDs, especially if you are at risk for developing ulcers or have a history of ulcers. Misoprostol helps to decrease your risk of serious ulcer complications such as bleeding. It protects your stomach lining by lowering the amount of acid that comes in contact with it. This medication is also used in combination with another drug (mifepristone) to end a pregnancy (abortion). OTHER This section contains uses of this drug that are not listed in the approved professional labeling but may be prescribed by your healthcare professional. Use this drug for a condition that is listed in this section only if it has been so prescribed by your healthcare professional. This medication may also be used in the hospital to assist with childbirth only at the time of delivery (e.g., cervical ripening, induction of labor) and for the treatment of severe bleeding after delivery. When misoprostol is used vaginally for these purposes, it works by causing the womb muscles to contract.
HOW TO USE: This medicine comes with a patient information leaflet. Read it carefully. If you have any questions about this drug, ask your doctor, nurse, or pharmacist. Dosage is based on your medical condition and response to therapy. If you are taking this drug to prevent stomach ulcers, take it by mouth usually four times a day, after meals and at bedtime to minimize diarrhea, or as directed by your doctor. If you are taking this medication for abortion, take it by mouth exactly as directed by your doctor. If you are using this medication to start labor, your healthcare professional will insert it into your vagina. Avoid taking antacids that contain magnesium while using misoprostol because they may make the diarrhea it causes worse. If you need an antacid, consult your doctor or pharmacist to help you choose a product. For ulcer prevention, continue to take this drug for as long as you take NSAIDs. Use this medication regularly in order to get the most benefit from it. Remember to use it at the same times each day. Inform your doctor if your condition persists or worsens.
SIDE EFFECTS: Nausea or stomach cramps may occur. If any of these effects persist or worsen, notify your doctor or pharmacist promptly. Diarrhea is common with misoprostol and usually occurs about two weeks after you start taking it, and lasts for about a week. Be sure to keep up your intake of fluids and minerals/electrolytes to prevent dehydration. Persistent diarrhea may sometimes lead to a large loss of your body’s water and minerals. Tell your doctor immediately if you develop any of these serious signs of dehydration and mineral imbalance: severe dizziness, decreased amount of urine, mental/mood changes, muscle weakness, slow/irregular heartbeat. Tell your doctor immediately if any of these unlikely but serious side effects occur: menstrual problems or irregularities, unusual/heavy vaginal bleeding. A very serious allergic reaction to this drug is unlikely, but seek immediate medical attention if it occurs. Symptoms of a serious allergic reaction may include: rash, itching/swelling (especially of the face/tongue/throat), severe dizziness, trouble breathing. This is not a complete list of possible side effects. If you notice other effects not listed above, contact your doctor or pharmacist.
PRECAUTIONS: Before taking misoprostol, tell your doctor or pharmacist if you are allergic to it or if you have any other allergies. This product may contain inactive ingredients, which can cause allergic reactions or other problems. Talk to your pharmacist for more details. Before using this medication, tell your doctor or pharmacist your medical history, especially of: stomach/intestinal disease (e.g., inflammatory bowel disease), risk factors for uterine rupture when this drug is used vaginally (e.g., prior Cesarean delivery, uterine surgery, five or more previous pregnancies). Daily use of alcohol and tobacco may increase your risk for stomach bleeding. Limit alcohol beverages and stop smoking. Consult your doctor or pharmacist for more information. If you are taking this medication in combination with mifepristone to end a pregnancy, an incomplete abortion may rarely occur. It is very important for you to be closely monitored by your doctor and to keep your scheduled appointments to follow your progress. Be sure to have clear instructions from your doctor about who to call and what to do in case of an emergency. Expect vaginal bleeding after you take the combined medicine, however tell your doctor immediately if you develop any unlikely symptoms such as severe/prolonged vaginal bleeding, signs of infection (e.g., fever, chills), or fainting. This drug must not be used during pregnancy to prevent stomach ulcers because it could harm the unborn baby. If you are of childbearing age, use effective birth control methods while taking misoprostol and for at least one month after you stop taking it. If you become pregnant or think you may be pregnant, inform your doctor immediately. This medication passes into breast milk but is unlikely to harm a nursing infant. Consult your doctor before breast-feeding.
QUESTION
DRUG INTERACTIONS: See also the How to Use section. Your healthcare professionals may already be aware of any possible drug interactions and may be monitoring you for it. Do not start, stop or change the dosage of any medicine before checking with them first. Before using this medication, tell your doctor or pharmacist of all prescription and nonprescription/herbal products you may use. Keep a list of all your medications with you, and share the list with your doctor and pharmacist.
OVERDOSE: If overdose is suspected, contact a poison control center or emergency room immediately. US residents can call their local poison control center at 1-800-222-1222. Canada residents can call a provincial poison control center. Symptoms of overdose may include: severe drowsiness, seizures, severe dizziness, slow/irregular heartbeats.
NOTES: Do not share this medication with others.
MISSED DOSE: If you miss a dose, use it as soon as you remember. If it is near the time of the next dose, skip the missed dose and resume your usual dosing schedule. Do not double the dose to catch up.
STORAGE: Store at or below 77 degrees F (25 degrees C) in a dry place away from light and moisture. Do not store in the bathroom. Keep all medicines away from children and pets. Do not flush medications down the toilet or pour them into a drain unless instructed to do so. Properly discard this product when it is expired or no longer needed. Consult your pharmacist or local waste disposal company for more details about how to safely discard your product. Information last revised March 2013. Copyright(c) 2013 First Databank, Inc.
Report Problems to the Food and Drug Administration
You are encouraged to report negative side effects of prescription drugs to the FDA. Visit the FDA MedWatch website or call 1-800-FDA-1088.
Selected from data included with permission and copyrighted by First Databank, Inc. This copyrighted material has been downloaded from a licensed data provider and is not for distribution, except as may be authorized by the applicable terms of use.
CONDITIONS OF USE: The information in this database is intended to supplement, not substitute for, the expertise and judgment of healthcare professionals. The information is not intended to cover all possible uses, directions, precautions, drug interactions or adverse effects, nor should it be construed to indicate that use of a particular drug is safe, appropriate, or effective for you or anyone else. A healthcare professional should be consulted before taking any drug, changing any diet, or commencing or discontinuing any course of treatment.
