Carboprost is a form of prostaglandin (a hormone-like substance that occurs naturally in the body). Prostaglandins help to control functions in the body such as blood pressure and muscle contractions.

Carboprost is used to treat severe bleeding after childbirth (postpartum).

Carboprost is also used to produce an abortion by causing uterine contractions. It is usually given between the 13th and 20th weeks of pregnancy, but may be given at other times for medical reasons. Carboprost is often used when another method of abortion has not completely emptied the uterus, or when a complication of pregnancy would cause the baby to be born too early to survive.

Carboprost may also be used for purposes not listed in this medication guide.

You should not receive carboprost if you have active pelvic inflammatory disease, a breathing disorder, heart disease, liver disease, or kidney disease.

This medicine in given in a hospital or clinic setting to quickly treat any serious side effects that occur.

Carboprost is given as an injection into a muscle. You will receive this injection in a clinic or hospital setting.

You may be given medication to prevent nausea, vomiting, or diarrhea while you are receiving carboprost.

To be sure this medication has been effective, your cervix (opening of the uterus) will need to be checked after the procedure. Do not miss any scheduled follow-up visits to your doctor.

In some cases, carboprost may not produce a complete abortion and the procedure must be repeated.

Usual Adult Dose for Abortion:

Initial dose: 250 mcg (1 mL) once by deep IM injection, with a tuberculin syringe

Subsequent doses of 250 mcg (1 mL) may be administered at 1.5 to 3.5 hour intervals depending on uterine response.

An optional test dose of 100 mcg (0.4 mL) may be administered initially. The dose may be increased to 500 mcg (2 mL) if uterine contractility is judged to be inadequate after several doses of 250 mcg (1 mL).

Maximum total dose: 12 mg

Duration of therapy: No more than 2 continuous days

Uses:
-Aborting pregnancy between the 13 th and 20 th weeks of gestation (calculated from the first day of the last normal menstrual period)
-Failure of expulsion of the fetus during the course of treatment by another method
-Premature rupture of membranes in intrauterine methods with loss of drug and insufficient or absent uterine activity
-Requirement of a repeat intrauterine instillation of drug for expulsion of the fetus
-Inadvertent or spontaneous rupture of membranes in the presence of a previable fetus and absence of adequate activity for expulsion

Usual Adult Dose for Postpartum Bleeding:

Initial dose: 250 mcg (1 mL) once by deep IM injection

Additional doses can be administered at intervals of 15 to 90 minutes, if necessary.

Maximum total dose: 2 mg (8 doses)

Comments: The need for additional injections and the administration interval should be determined by the attending physician as dictated by the course of clinical events.

Uses: Refractory postpartum hemorrhage due to uterine atony that has not responded to conventional methods of management.

You should not receive carboprost if you are allergic to it, or if you have:

• active pelvic inflammatory disease;

• a lung disorder or breathing problem;

• heart disease;

• kidney disease; or

• liver disease.

To make sure carboprost is safe for you, tell your doctor if you have:

• high or low blood pressure;

• diabetes;

• epilepsy or other seizure disorder;

• any scarring in your uterus;

• a history of asthma; or

• a history of heart, kidney, or liver disease.

It is not known whether carboprost passes into breast milk or if it could harm a nursing baby. Tell your doctor if you are breast-feeding a baby.

Because you will receive carboprost in a clinical setting, you are not likely to miss a dose.

Since this medication is given by a healthcare professional in a medical setting, an overdose is unlikely to occur.

Follow your doctor's instructions about any restrictions on food, beverages, or activity.

Get emergency medical help if you have any of these signs of an allergic reaction: hives; difficult breathing; swelling of your face, lips, tongue, or throat.

Carboprost may cause serious side effects. Call your doctor at once if you have:

• severe pelvic pain, cramping, or vaginal bleeding;

• high fever;

• a light-headed feeling, like you might pass out;

• shortness of breath

• severe nausea, vomiting, or diarrhea; or

• increased high blood pressure (severe headache, blurred vision, buzzing in your ears, anxiety, confusion, chest pain).

Common side effects of carboprost may include:

• mild nausea, vomiting, diarrhea;

• mild fever, chills;

• flushing (warmth, redness, or tingly feeling);

• cough, hiccups;

• headache; or

• mild pelvic pain or menstrual-type cramps.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.