Hemabate

Hemabate is a prescription medication used to abort pregnancy as well as stop bleeding after giving birth. Hemabate belongs to a group of medications called prostaglandins. These work by causing uterine contractions. 

Hemabate is available in an injectable form that is given directly into a muscle (IM) by a healthcare professional.

Common side effects of Hemabate include vomiting, diarrhea, and nausea. 

• Pharmacia and Upjohn Company

Hemabate is part of the drug class:

• Prostaglandin Oxytocics

Hemabate should be used only with strict adherence to recommended dosages like other potent oxytocic agents. Hemabate should be used by medically trained personnel in a hospital which can provide immediate intensive care and acute surgical facilities.

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

May increase activity of other oxytocic agents; concomitant use not recommended.1

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.

Pregnancy

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.

Interactions with 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.

Interactions with Food/Tobacco/Alcohol

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:

• Adrenal gland disease (history of)—Carboprost stimulates the body to produce steroids

• Anemia—In some patients, abortion with carboprost may result in loss of blood that may require a transfusion

• Asthma (or history of) or
• Lung disease—Carboprost 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, seizures have occurred with use of carboprost

• 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 during use of carboprost

• Heart or blood vessel disease (or history of) or
• High blood pressure (or history of) or
• Low blood pressure (or history of)—Carboprost 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 carboprost out of the bloodstream at the usual rate, which may make the medicine work longer or cause toxic effects

• If you have an allergy to carboprost tromethamine or any other part of Hemabate (carboprost tromethamine).
• If you are allergic to any drugs like this one, any other drugs, foods, or other substances. Tell your doctor about the allergy and what signs you had, like rash; hives; itching; shortness of breath; wheezing; cough; swelling of face, lips, tongue, or throat; or any other signs.
• If you have pelvic inflammatory disease.
• If you have any of these health problems: Heart problems, kidney problems, liver problems, or lung problems.
• If you are pregnant and do not want to end your pregnancy. This medicine is used to end pregnancy.

This is not a list of all drugs or health problems that interact with this medicine.

Tell your doctor and pharmacist about all of your drugs (prescription or OTC, natural products, vitamins) and health problems. You must check to make sure that it is safe for you to take Hemabate with all of your drugs and health problems. Do not start, stop, or change the dose of any drug without checking with your doctor.

Use Hemabate as ordered by your doctor. Read all information given to you. Follow all instructions closely.

• It is given as a shot into a muscle.
• You may be given another drug to lower certain side effects of this medicine.

All drugs may cause side effects. However, many people have no side effects or only have minor side effects. Call your doctor or get medical help if any of these side effects or any other side effects bother you or do not go away:

• Upset stomach or throwing up.
• Loose stools (diarrhea).
• Fever.
• Flushing.

These are not all of the side effects that may occur. If you have questions about side effects, call your doctor. Call your doctor for medical advice about side effects.

You may report side effects to the FDA at 1-800-FDA-1088. You may also report side effects at http://www.fda.gov/medwatch.

Hemabate Sterile Solution, an oxytocic, contains the tromethamine salt of the (15S)-15 methyl analogue of naturally occurring prostaglandin F2α in a solution suitable for intramuscular injection.

Carboprost tromethamine is the established name for the active ingredient in Hemabate. Four other chemical names are:

1. (15S)-15-methyl prostaglandin F2α tromethamine salt
2. 7-(3α,5α-dihydroxy-2ß-[(3S)-3-hydroxy-3-methyl-trans-1-octenyl]-1α-cyclopentyl]-cis-5-heptenoic acid compound with 2-amino-2-(hydroxymethyl)-1,3-propanediol
3. (15S)-9α,11α,15-trihydroxy-15-methylprosta-cis-5, trans-13-dienoic acid tromethamine salt
4. (15S)-15-methyl PGF2α-THAM

The structural formula is represented below:

The molecular formula is C25H47O8N. The molecular weight of carboprost tromethamine is 489.64. It is a white to slightly off-white crystalline powder. It generally melts between 95° and 105° C, depending on the rate of heating.

Carboprost tromethamine dissolves readily in water at room temperature at a concentration greater than 75 mg/mL.

Each mL of Hemabate Sterile Solution contains carboprost tromethamine equivalent to 250 mcg of carboprost, 83 mcg tromethamine, 9 mg sodium chloride, and 9.45 mg benzyl alcohol added as preservative. When necessary, pH is adjusted with sodium hydroxide and/or hydrochloric acid. The solution is sterile.

1 mL
NDC 0009-0856-05

Rx only

Hemabate®
carboprost tromethamine
injection, USP

250 mcg*

FOR INTRAMUSCULAR USE ONLY
Refrigerate at 2° to 8°C (36° to 46°F).
DOSAGE AND USE: See accompanying
prescribing information.
*Equivalent to 250 mcg carboprost.
Distributed by Pharmacia & Upjohn Co
Division of Pfizer Inc, NY, NY 10017

PAA043229

LOT
EXP

NDC 0009-0856-08
Contains 10 of NDC 0009-0856-05

Rx only

10–1 mL Single-Dose Ampoules

Hemabate®
carboprost tromethamine
injection, USP

250 mcg*

FOR INTRAMUSCULAR USE ONLY

Pfizer Injectables