Pronunciation:

mye-soe-PROST-ol

Brand Names:

• Cytotec

Dosage Forms:

• Tablet

Warnings:

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 in 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 should not be taken by pregnant women to 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 NSAID, 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 misoprostol only on the second or third day of the next normal menstrual period .

Classifications:

Therapeutic—

Endocrine-Metabolic Agent

Pharmacologic—

Prostaglandin

Uses of This Medicine:

Misoprostol is used to decrease the chance of having stomach ulcers in patients taking nonsteroidal anti-inflammatory drugs (NSAIDs) including aspirin. This medicine works by helping the stomach protect itself against acid damage, and decreases the amount of acid produced by the stomach.

This medicine is available only with your doctor's prescription.

Before Using This Medicine:

In deciding to use a medicine, the risks of taking the medicine must be weighed against the good it will do. This is a decision you and your doctor will make. For this medicine, the following should be considered:

Allergies—

Tell your doctor if you have ever had any unusual or allergic reaction to this medicine or any other medicines. Also tell your health care professional if you have any other types of allergies, such as to foods, dyes, preservatives, or animals. For non-prescription products, read the label or package ingredients carefully.

Children—

Appropriate studies have not been performed on the relationship of age to the effects of misoprostol in the pediatric population. Safety and efficacy have not been established.

Older adults—

Appropriate studies performed to date have not demonstrated geriatric-specific problems that would limit the usefulness of misoprostol in the elderly.

Breast-feeding—

There are no adequate studies in women for determining infant risk when using this medication during breastfeeding. Weigh the potential benefits against the potential risks before taking this medication while breastfeeding.

Other medicines—

Although certain medicines should not be used together at all, in other cases two different medicines may be used together even if an interaction might occur. In these cases, your doctor may want to change the dose, or other precautions may be necessary. When you are taking this medicine, it is especially important that your healthcare professional know if you are taking any of the medicines listed below. The following interactions have been selected on the basis of their potential significance and are not necessarily all-inclusive.

Using this medicine with any of the following medicines may cause an increased risk of certain side effects, but using both drugs may be the best treatment for you. If both medicines are prescribed together, your doctor may change the dose or how often you use one or both of the medicines.

• Phenylbutazone

Other interactions—

Certain medicines should not be used at or around the time of eating food or eating certain types of food since interactions may occur. Using alcohol or tobacco with certain medicines may also cause interactions to occur. Discuss with your healthcare professional the use of your medicine with food, alcohol, or tobacco.

Other medical problems—

The presence of other medical problems may affect the use of this medicine. Make sure you tell your doctor if you have any other medical problems, especially:

• Dehydration or
• Heart or blood vessel problems or
• Inflammatory bowel disease or
• Stomach ulcers, history of—Use with caution. May make these conditions worse.

• Kidney disease—Use with caution. The effects may be increased because of the slower removal of the medicine from the body.

Proper Use of This Medicine:

For safe and effective use of this medicine, do not take more of it, do not take it more often, and do not take it for a longer time than ordered by your doctor. Taking too much of this medicine may increase the chance of unwanted effects. Do not change the dose or stop using this medicine without checking first with your doctor.

This medicine should come with a patient information leaflet. Read and follow these instructions carefully. Ask your doctor if you have any questions.

Misoprostol is best taken with or after meals and at bedtime, unless otherwise directed by your doctor. To help prevent loose stools, diarrhea, and abdominal cramping, always take this medicine with food or milk.

Do not give this medicine to another person.

Dosing—

The dose of this medicine will be different for different patients. Follow your doctor's orders or the directions on the label. The following information includes only the average doses of this medicine. If your dose is different, do not change it unless your doctor tells you to do so.

The amount of medicine that you take depends on the strength of the medicine. Also, the number of doses you take each day, the time allowed between doses, and the length of time you take the medicine depend on the medical problem for which you are using the medicine.

• For oral dosage form (tablets):
  • To prevent stomach ulcers in patients taking NSAIDs:
    • Adults—200 micrograms (mcg) four times a day with food. Other patients may need 100 mcg four times a day with food. Take the last dose of the day at bedtime.
    • Children—Use and dose must be determined by your doctor.

Missed dose—

If you miss a dose of this medicine, take it as soon as possible. However, if it is almost time for your next dose, skip the missed dose and go back to your regular dosing schedule. Do not double doses.

Storage—

Store the medicine in a closed container at room temperature, away from heat, moisture, and direct light. Keep from freezing.

Keep out of the reach of children.

Do not keep outdated medicine or medicine no longer needed.

Ask your healthcare professional how you should dispose of any medicine you do not use.

Precautions While Using This Medicine:

Do not use this medicine if you are pregnant or planning to become pregnant. This medicine can cause miscarriage, premature birth, or birth defects if taken during pregnancy. You will need to have a negative pregnancy test within 2 weeks before you start using this medicine. Continue to use birth control for at least 1 month after you stop using this medicine. Tell your doctor right away if you become pregnant.

Begin using this medicine on the 2nd or 3rd day of your next monthly period. This is to make sure you are not pregnant.

This medicine may cause diarrhea, stomach cramps, or nausea in some people. These effects will usually disappear within a few days as your body adjusts to the medicine. However, check with your doctor if the diarrhea, cramps, or nausea is severe and/or does not stop after a week. Your doctor may have to lower the dose of misoprostol you are taking.

Side Effects of This Medicine:

Along with its needed effects, a medicine may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.

Check with your doctor immediately if any of the following side effects occur:

Rare

Cramps

heavy bleeding

painful menstruation

Incidence not known

Bladder pain

bloody nose

bloody or black, tarry stools

bloody or cloudy urine

blurred vision

body aches or pain

chest pain

chills

confusion

constipation

cough

difficult, burning, or painful urination

difficulty with breathing

difficulty with moving

difficulty with swallowing

dizziness

dizziness, faintness, or lightheadedness when getting up suddenly from a lying or sitting position

ear congestion

feeling unusually cold

fever

frequent urge to urinate

headache

hives, itching, or skin rash

loss of voice

lower back or side pain

muscle pain or stiffness

nasal congestion

nervousness

pain in the joints

pale skin

pounding in the ears

puffiness or swelling of the eyelids or around the eyes, face, lips, or tongue

runny nose

severe stomach pain

shivering

slow or fast heartbeat

sneezing

sore throat

sweating

tightness in the chest

troubled breathing with exertion

unusual bleeding or bruising

unusual tiredness or weakness

vomiting of blood or material that looks like coffee grounds

Some side effects may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. Also, your health care professional may be able to tell you about ways to prevent or reduce some of these side effects. Check with your health care professional if any of the following side effects continue or are bothersome or if you have any questions about them:

More common

Abdominal or stomach pain

diarrhea

Less common

Acid or sour stomach

belching

bloated

excess air or gas in the stomach or intestines

full feeling

heartburn

indigestion

passing gas

stomach discomfort or upset

Incidence not known

Blistering, crusting, irritation, itching, or reddening of the skin

breast pain

burning, dry, or itching eyes

change in taste

continuing ringing or buzzing or other unexplained noise in the ears

cracked, dry, scaly skin

depression

discharge, excessive tearing

hair loss or thinning of the hair

hearing loss

lack or loss of strength

paleness of the skin

redness, pain, swelling of the eye, eyelid, or inner lining of the eyelid

weight changes

Other side effects not listed may also occur in some patients. If you notice any other effects, check with your healthcare professional.

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