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Hemabate

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Hemabate

Hemabate

Hemabate Side Effects Center

Medical Editor: John P. Cunha, DO, FACOEP

Hemabate (carboprost tromethamine) Sterile Solution is used to treat severe bleeding after childbirth (postpartum). Hemabate 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. Hemabate 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. It is a form of prostaglandin (a hormone-like substance that occurs naturally in the body). Common side effects include mild fever that may come and go, chills, numbness, or tingly feeling, mild nausea or diarrhea, cough, headache, breast pain or tenderness, menstrual type pain, or ringing in your ears.

To treat refractory postpartum uterine bleeding, an initial dose of 250 mcg of Hemabate Sterile Solution (1 mL) is given deep, intramuscularly. For abortion and other indications, an initial dose of 1 mL (250 mcg) is administered deep in the muscle. Subsequent doses of 250 mcg are administered at 1½ to 3½ hour intervals depending on uterine response. Hemabate may interact with dinoprostone, mifepristone, misoprostol, or oxytocin. Tell your doctor all medications you are taking. During pregnancy, Hemabate should be used only if prescribed. There is no information on this medication and whether it passes into breast milk. Consult your doctor before breast-feeding.

Our Hemabate (carboprost tromethamine) Side Effects Drug Center provides a comprehensive view of available drug information on the potential side effects when taking this medication.

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.

What is Patient Information in Detail?

Easy-to-read and understand detailed drug information and pill images for the patient or caregiver from Cerner Multum.

Hemabate in Detail - Patient Information: Side Effects

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

Call your doctor at once if you have any of these serious side effects:

  • severe pelvic pain, cramping, or vaginal bleeding;
  • high fever;
  • feeling light-headed or short of breath;
  • severe nausea, vomiting, or diarrhea; or
  • increased blood pressure (severe headache, blurred vision, trouble concentrating, chest pain, numbness, seizure).

Less serious side effects include:

  • mild fever that may come and go;
  • chills, numbness, or tingly feeling;
  • mild nausea or diarrhea;
  • cough;
  • headache;
  • breast pain or tenderness;
  • menstrual type pain; or
  • ringing in your ears.

This is not a complete list of side effects and others may occur. Tell your doctor about any unusual or bothersome side effect. You may report side effects to FDA at 1-800-FDA-1088.

Read the entire detailed patient monograph for Hemabate (Carboprost Tromethamine) »

What is Prescribing information?

The FDA package insert formatted in easy-to-find categories for health professionals and clinicians.

Hemabate FDA Prescribing Information: Side Effects
(Adverse Reactions)

SIDE EFFECTS

The adverse effects of HEMABATE Sterile Solution are generally transient and reversible when therapy ends. The most frequent adverse reactions observed are related to its contractile effect on smooth muscle.

In patients studied, approximately two-thirds experienced vomiting and diarrhea, approximately one-third had nausea, one-eighth had a temperature increase greater than 2° F, and one-fourteenth experienced flushing.

The pretreatment or concurrent administration of antiemetic and antidiarrheal drugs decreases considerably the very high incidence of gastrointestinal effects common with all prostaglandins used for abortion. Their use should be considered an integral part of the management of patients undergoing abortion with HEMABATE.

Of those patients experiencing a temperature elevation, approximately one-sixteenth had a clinical diagnosis of endometritis. The remaining temperature elevations returned to normal within several hours after the last injection.

Adverse effects observed during the use of HEMABATE for abortion and for hemorrhage, not all of which are clearly drug related, in decreasing order of frequency include:

Vomiting Nervousness
Diarrhea Nosebleed
Nausea Sleep disorders
Flushing or hot flashes Dyspnea
Chills or shivering Tightness in chest
Coughing Wheezing
Headaches Posterior cervical
Endometritis perforation
Hiccough Weakness
Dysmenorrhea-like Diaphoresis
pain Dizziness
Paresthesia Blurred vision
Backache Epigastric pain
Muscular pain Excessive thirst
Breast tenderness Twitching eyelids
Eye pain Gagging, retching
Drowsiness Dry throat
Dystonia Sensation of choking
Asthma Thyroid storm
Injection site pain Syncope
Tinnitus Palpitations
Vertigo Rash
Vaso-vagal syndrome Upper respiratory
Dryness of mouth infection
Hyperventilation Leg cramps
Respiratory distress Perforated uterus
Hematemesis Anxiety
Taste alterations Chest pain
Urinary tract infection Retained placental
Septic shock fragment
Torticollis Shortness of breath
Lethargy Fullness of throat
Hypertension Uterine sacculation
Tachycardia Faintness, light-
Pulmonary edema headedness
Endometritis from IUCD Uterine rupture

The most common complications when HEMABATE was utilized for abortion requiring additional treatment after discharge from the hospital were endometritis, retained placental fragments, and excessive uterine bleeding, occurring in about one in every 50 patients.

Post-marketing experience

Hypersensitivity reactions (e.g. Anaphylactic reaction, Anaphylactic shock, Anaphylactoid reaction, Angioedema).

Read the entire FDA prescribing information for Hemabate (Carboprost Tromethamine) »

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Report Problems to the Food and Drug Administration

 

You are encouraged to report negative side effects of prescription drugs to the FDA. Visit the FDA MedWatch website or call 1-800-FDA-1088.


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