Dosage Forms:

• Injectable
• Solution

Classifications:

Pharmacologic

Dinoprost

Uses of This Medicine:

Dinoprost is used to cause abortion during the second trimester of pregnancy. It may also be used for other purposes as determined by your doctor.

Dinoprost is to be administered only by or under the immediate care of your doctor.

Once a medicine has been approved for marketing for a certain use, experience may show that it is also useful for other medical problems. Although these uses are not specifically included in product labeling, dinoprost is used in certain patients for the following medical procedures:

• Angiography (x-ray pictures of the blood vessels)
• Inducing labor

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.

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. Tell your healthcare professional if you are taking any other prescription or nonprescription (over-the-counter [OTC]) medicine.

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:

• Anemia (history of) In some patients, abortion with dinoprost may result in loss of blood that may require a transfusion

• Asthma (or history of) or
• Lung disease Dinoprost may cause narrowing of the blood vessels in the lungs or narrowing of the lung passages

• Type 2 diabetes mellitus (history of)

• Epilepsy (or history of) Rarely, dinoprost has been reported to cause seizures in patients who have epilepsy

• Fibroid tumors of the uterus or
• Uterus surgery (history of) There is an increased risk of rupture of the uterus

• Glaucoma Rarely the pressure within the eye has increased and constriction of the pupils has occurred during the use of dinoprost

• Heart or blood vessel disease (or history of) or
• High blood pressure (history of) or
• Low blood pressure (history of) Dinoprost may cause changes in heart function or blood pressure changes

• Jaundice (history of)

• Kidney disease (or history of)

• Liver disease (or history of) The body may not get dinoprost out of the bloodstream at the usual rate, which may make the medicine work longer or cause toxic effects

Proper Use of This Medicine:

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 injection dosage form:
  • For aborting a pregnancy:
    • Adults Your doctor will slowly inject 40 milligrams (mg) into the amniotic sac (bag that surrounds the fetus). If needed, your doctor may give you another dose in twenty–four hours to complete the abortion.
  • For inducing labor:
    • Adults Your doctor will slowly inject 1 to 4 mg a day into a vein.

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:

Less common or rare

Chest pain

coughing (sudden)

cramping of the uterus (continuing and severe)

fast heartbeat

hives

numbness in legs or other body parts

pale, cool, or blotchy skin on arms or legs

pressing or painful feeling in chest

redness and itching of skin

shortness of breath

slow or irregular heartbeat

swelling of eyelids, face, or inside of nose

tightness in chest

trouble in breathing

weak or absent pulse in arms or legs

wheezing

Check with your doctor as soon as possible if any of the following side effects occur:

Less common or rare

Abdominal or stomach pain (severe or continuing)

blood in urine

constipation

decreased frequency of urination

difficult or painful urination

double vision or burning eyes

pain in legs, back, or shoulder

tender or mildly bloated abdomen

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

Diarrhea

nausea

stomach cramps or pain

vomiting

Less common

Anxiety

breast fullness or tenderness

burning feeling in breasts

chills or shivering

cough (continuing)

dizziness

drowsiness

fever (temporary)

flushing or redness of face

headache

hiccups

increased sweating

inflammation and pain at place of injection

unusual thirst

After the procedure has been completed, this procedure may still produce some side effects that need medical attention. Check with your doctor if you notice any of the following side effects:

Chills or shivering (continuing)

fever (continuing)

foul-smelling vaginal discharge

pain in lower abdomen

unusual increase in uterus bleeding

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.