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Common uses
This medication is used to prevent stomach ulcers while you take NSAIDs (e.g., aspirin, ibuprofen, naproxen), 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. This medication 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 USES: This section contains uses of this drug that are not listed in the approved professional labeling for the drug but that may be prescribed by your health care professional. Use this drug for a condition that is listed in this section only if it has been so prescribed by your health care professional.
This medication may also be used 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.
Before using
Cytotec should not be used for reducing the risk of NSAID-induced ulcers in women of childbearing
potential unless the patient is at high risk of complications from gastric ulcers associated with use of the
NSAID, or is at high risk of developing gastric ulceration. In such patients, Cytotec may be prescribed if
the patient
• has had a negative serum pregnancy test within 2 weeks prior to beginning therapy.
• is capable of complying with effective contraceptive measures.
• has received both oral and written warnings of the hazards of misoprostol, the risk of possible
contraception failure, and the danger to other women of childbearing potential should the drug be
taken by mistake.
• will begin Cytotec only on the second or third day of the next normal menstrual period.
Directions
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.
Cautions
Since Cytotec may cause diarrhea, you should use Cytotec very cautiously if you have inflammatory bowel disease or any other condition in which the loss of fluid caused by diarrhea would be particularly dangerous.
To reduce the risk of diarrhea, take Cytotec with food and avoid taking it with a magnesium-containing antacid, such as Di-Gel, Gelusil, Maalox, Mylanta, and others. Have frequent medical checkups.
Never give Cytotec to anyone else; the dosage might be wrong, and if the other person is pregnant, the drug might harm the unborn baby or cause a miscarriage.
If you have a history of heart disease, you may not be able to use Cytotec. Be sure to tell your doctor about any heart problems.
Possible side effects
Cytotec may cause diarrhea, abdominal cramping, and/or nausea in some people. In most cases these
problems develop during the first few weeks of therapy and stop after about a week. You can minimize
possible diarrhea by making sure you take Cytotec with food.
Because these side effects are usually mild to moderate and usually go away in a matter of days, most
patients can continue to take Cytotec. If you have prolonged difficulty (more than 8 days), or if you have
severe diarrhea, cramping and/or nausea, call your doctor.
Take Cytotec only according to the directions given by your physician.
Do not give Cytotec to anyone else. It 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.
This information sheet does not cover all possible side effects of Cytotec. This patient information leaflet
does not address the side effects of your arthritis/pain medication. See your doctor if you have questions.
If you take too much
The toxic dose of Cytotec in humans has not been determined. Cumulative total daily doses of 1600 mcg
have been tolerated, with only symptoms of gastrointestinal discomfort being reported. In animals, the
acute toxic effects are diarrhea, gastrointestinal lesions, focal cardiac necrosis, hepatic necrosis, renal
tubular necrosis, testicular atrophy, respiratory difficulties, and depression of the central nervous system.
Clinical signs that may indicate an overdose are sedation, tremor, convulsions, dyspnea, abdominal pain,
diarrhea, fever, palpitations, hypotension, or bradycardia. Symptoms should be treated with supportive
therapy.
It is not known if misoprostol acid is dialyzable. However, because misoprostol is metabolized like a fatty acid, it is unlikely that dialysis would be appropriate treatment for overdosage.
Additional information
Cytotec is intended for administration along with nonsteroidal anti-inflammatory drugs (NSAIDs),
including aspirin, to decrease the chance of developing an NSAID-induced gastric ulcer.
Cytotec should be taken only according to the directions given by a physician.
If the patient has questions about or problems with Cytotec, the physician should be contacted
promptly.
THE PATIENT SHOULD NOT GIVE CYTOTEC TO ANYONE ELSE. Cytotec has been
prescribed for the patient’s specific condition, may not be the correct treatment for another person, and
may be dangerous to the other person if she is or were to become pregnant.
The Cytotec package the patient receives from the pharmacist will include a leaflet containing patient
information. The patient should read the leaflet before taking Cytotec and each time the prescription is
renewed because the leaflet may have been revised.
Keep Cytotec out of the reach of children.
Drug interactions
Cytotec has not been shown to interfere with the
beneficial effects of aspirin on signs and symptoms of rheumatoid arthritis. Cytotec does not exert
clinically significant effects on the absorption, blood levels, and antiplatelet effects of therapeutic doses
of aspirin. Cytotec has no clinically significant effect on the kinetics of diclofenac or ibuprofen.
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Cytotec
