Cytotec

DRUG DESCRIPTION

Cytotec (misoprostol) oral tablets contain either 100 mcg or 200 mcg of misoprostol, a synthetic prostaglandin E1 analog.

Misoprostol contains approximately equal amounts of the two diastereomers presented below with their enantiomers indicated by (±):

Cytotec®
  (misoprostol) Structural Formula Illustration

Misoprostol is a water-soluble, viscous liquid.

Inactive ingredients of tablets are hydrogenated castor oil, hypromellose, microcrystalline cellulose, and sodium starch glycolate.

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...

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What are the precautions when taking misoprostol (Cytotec)?

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...

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Cytotec Consumer (continued)

SIDE EFFECTS: Nausea or stomach cramps may occur. If any of these effects persist or worsen, notify your doctor or pharmacist promptly.

Remember that your doctor has prescribed this medication because he or she has judged that the benefit to you is greater than the risk of side effects. Many people using this medication do not have serious side effects.

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.

In the US -

Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

In Canada - Call your doctor for medical advice about side effects. You may report side effects to Health Canada at 1-866-234-2345.

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 of possible harm to an unborn baby (see also Warnings). If you are of childbearing age, use effective birth control methods while taking misoprostol and for at least one month or one completed menstrual cycle 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. However, this drug is unlikely to harm a nursing infant. Consult your doctor before breast-feeding.


Cytotec Patient Information Including Side Effects

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.

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.

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