Hemabate

What is Hemabate used for?

Hemabate is a prescription medicine that is used to end a pregnancy. It is used to stop or treat bleeding that happens after a birth or an abortion. Hemabate may be given to you for other reasons.

Description

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.

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

Before taking Hemabate, tell your doctor:

• If you are allergic to Hemabate; any part of this medicine; or any other drugs, foods, or substances. Tell your doctor about the allergy and what signs you had.
• 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.

What are some things I need to know or do while I take Hemabate?

• Tell all of your health care providers that you take Hemabate. This includes your doctors, nurses, pharmacists, and dentists.
• A short-term fever may happen with Hemabate. Be sure you know when you need to call your doctor or get medical help if you get a fever after getting Hemabate.
• Tell your doctor if you are breast-feeding. You will need to talk about any risks to your baby.

How is Hemabate best taken?

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 Hemabate.

What do I do if I miss a dose?

• This medicine is given on an as needed basis.

What are the side effects of Hemabate that I need to call my doctor about immediately?

WARNING/CAUTION: Even though it may be rare, some people may have very bad and sometimes deadly side effects when taking a drug. Tell your doctor or get medical help right away if you have any of the following signs or symptoms that may be related to a very bad side effect:

• Signs of an allergic reaction, like rash; hives; itching; red, swollen, blistered, or peeling skin with or without fever; wheezing; tightness in the chest or throat; trouble breathing, swallowing, or talking; unusual hoarseness; or swelling of the mouth, face, lips, tongue, or throat.
• Signs of high blood pressure like very bad headache or dizziness, passing out, or change in eyesight.

What are some other side effects of Hemabate?

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.
• Diarrhea.
• 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 1-800-332-1088. You may also report side effects at https://www.fda.gov/medwatch.

If overdose is suspected:

If you think there has been an overdose, call your poison control center or get medical care right away. Be ready to tell or show what was taken, how much, and when it happened.

How do I store and/or throw out Hemabate?

• If you need to store Hemabate at home, talk with your doctor, nurse, or pharmacist about how to store it.

Label

PRINCIPAL DISPLAY PANEL – 1 ML AMPULE LABEL

• 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
• PAA093951
• LOT
  EXP

PRINCIPAL DISPLAY PANEL – 10 SINGLE-DOSE AMPOULE CARTON

• 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

 

SRC: NLM .