Drug Profile

Breast-Feeding Warning

No information is available from either human or animal studies. However, it is likely that this drug, like many others, is excreted in human milk, and because of the potential for adverse effects in nursing infants, including serious diarrhea, you should not take this drug while nursing.

Pregnancy Warning

There are literature reports of skull defects, cranial nerve palsies, facial malformations and limb defects in women who took misoprostol during the first trimester of pregnancy. Because of the possibility of inducing an abortion, misoprostol should not be used by women who are pregnant. Patients must be advised of these properties and warned not to give the drug to others.

WARNING

MISOPROSTOL ADMINISTRATION TO WOMEN WHO ARE PREGNANT CAN CAUSE BIRTH DEFECTS, ABORTION, PREMATURE BIRTH OR UTERINE RUPTURE.

UTERINE RUPTURE HAS BEEN REPORTED WHEN MISOPROSTOL WAS ADMINISTERED TO PREGNANT WOMEN TO INDUCE LABOR OR TO INDUCE ABORTION. THE RISK OF UTERINE RUPTURE INCREASES WITH ADVANCING GESTATIONAL AGES AND WITH PRIOR UTERINE SURGERY, INCLUDING CESAREAN DELIVERY.

MISOPROSTOL TABLETS SHOULD NOT BE TAKEN IN PREGNANT WOMEN REDUCE THE RISK OF ULCERS INDUCED BY NONSTEROIDAL ANTI-INFLAMMATORY DRUGS (NSAIDs).

PATIENTS MUST BE ADVISED OF THE ABORTIFACIENT PROPERTY AND WARNED NOT TO GIVE THE DRUG TO OTHERS.

Misoprostol 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 NSAIDs or is at high risk of developing gastric ulceration. In such patients, misoprostol 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 using misoprostol only on the second or third day of the next normal menstrual period.

Do not use if you have or have had:

•   pregnancy or are breast-feeding

Tell your doctor if you have or have had:

•   allergies to prostaglandins or similar drugs
•   cerebral vascular disease, stroke, or transient ischemic attack
•   coronary artery disease
•   epilepsy heart problems
•   inflammatory bowel disease

Tell your doctor about any other drugs you take, including aspirin, herbs, vitamins, and other nonprescription products.

• Call your doctor immediately if you have black, tarry stools or if you vomit material that looks like coffee grounds. These are signs of a bleeding ulcer.
• Call your doctor if you have trouble swallowing or persistent abdominal pain.
• Check with your doctor if your symptoms do not improve or get worse.
• Do not drink alcohol or smoke.
• Avoid any food or drink that aggravates your ulcer.
• Stop medication immediately and check with your doctor if you suspect that you are pregnant.
• Consult your doctor if diarrhea lasts more than a week.
• Use antacids and laxatives that do not contain magnesium.
• Drink liquids to replace fluids lost by diarrhea.

• If you miss a dose, take it as soon as you remember, but skip it if it is almost time for the next dose. Do not take double doses.
• Do not share your medication with others.
• Take the drug at the same time(s) each day.
• Take with or after meals or at bedtime. Take with food or milk.
• Swallow tablets whole or break in half. Take with or after meals to lessen chance of diarrhea.
• Store at room temperature with lid on tightly. Do not store in the bathroom. Do not expose to heat, moisture, or strong light. Keep out of reach of children.

Evaluations of Drug Interactions 2003 lists no drugs, biologics (e.g., vaccines, therapeutic antibodies), or foods as causing “highly clinically significant” or “clinically significant” interactions when used together with the drugs in this section. We also found no interactions in the drugs’ FDA-approved professional package inserts. However, as the number of new drugs approved for marketing increases and as more experience is gained with these drugs over time, new interactions may be discovered.

Call your doctor if these symptoms continue:

•   abdominal or stomach cramps, or pain in lower abdomen or stomach
•   confusion[6]
•   constipation
•   diarrhea
•   gas
•   headache
•   heartburn, indigestion, or acid stomach
•   nausea and/or vomiting
•   urinary incontinence[7]
•   vaginal bleeding

Signs of overdose:

•   abdominal pain
•   blood pressure decrease
•   breathing difficulty
•   diarrhea
•   drowsiness
•   fever
•   heartbeat fast or pounding
•   heartbeat slow
•   seizures
•   tremor

If you suspect an overdose, call this number to contact your poison control center: (800) 222-1222.