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Brand Names: Cytotec

Generic Name: misoprostol (Pronunciation: mye so PRAH stole)

• What is misoprostol (Cytotec)?
• What are the possible side effects of misoprostol (Cytotec)?
• What is the most important information I should know about misoprostol (Cytotec)?
• What should I discuss with my healthcare provider before taking misoprostol (Cytotec)?
• How should I take misoprostol (Cytotec)?
• What happens if I miss a dose (Cytotec)?
• What happens if I overdose (Cytotec)?
• What should I avoid while taking misoprostol (Cytotec)?
• What other drugs will affect misoprostol (Cytotec)?
• Where can I get more information?

What is misoprostol (Cytotec)?

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.

Cytotec 100 mcg

round, white, imprinted with SEARLE, 1451

Cytotec 200 mcg

hexagonal, white, imprinted with LOGO STOMACH, SEARLE 1461

What are the possible side effects of misoprostol (Cytotec)?

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.

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

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.

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.