pharmacopeia
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/api/v1/drug/carboprost

Mechanism of action

Sourced from openFDA

Mechanism-of-action class: Prostaglandin Receptor Agonists.

Prostaglandin Receptor

Indications

Sourced from openFDA
  • Carboprost tromethamine injection, USP is indicated for aborting pregnancy between the 13th and 20th weeks of gestation as calculated from the first day of the last normal menstrual period and in the following conditions related to second trimester abortion: 1. Failure of expulsion of the fetus during the course of treatment by another method; 2.

Contraindications

Sourced from openFDA
  • 1. Hypersensitivity (including anaphylaxis and angioedema) to carboprost tromethamine injection Sterile Solution [ see ADVERSE REACTIONS, Post-marketing Experience ] 2.contraindicated

Dosage & administration

Sourced from openFDA

1. Abortion and Indications 1-4 An initial dose of 1 mL of carboprost tromethamine injection sterile solution (containing the equivalent of 250 micrograms of carboprost) is to be administered deep in the muscle with a tuberculin syringe. Subsequent doses of 250 micrograms should be administered at 1½ to 3½ hour intervals depending on uterine response. An optional test dose of 100 micrograms (0.4 mL) may be administered initially. The dose may be increased to 500 micrograms (2 mL) if uterine contractility is judged to be inadequate after several doses of 250 micrograms (1 mL). The total dose administered of carboprost tromethamine should not exceed 12 milligrams and continuous administration of the drug for more than two days is not recommended. 2. For Refractory Postpartum Uterine Bleedin g: An initial dose of 250 micrograms of carboprost tromethamine injection sterile solution (1 mL of carboprost tromethamine injection) is to be given deep, intramuscularly. In clinical trials it was found that the majority of successful cases (73%) responded to single injections. In some selected cases, however, multiple dosing at intervals of 15 to 90 minutes was carried out with successful outcome. The need for additional injections and the interval at which these should be given can be determined only by the attending physicians as dictated by the course of clinical events. The total dose of carboprost tromethamine injection should not exceed 2 milligrams (8 doses).

Adverse reactions

Sourced from openFDA

The adverse effects of carboprost tromethamine 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 carboprost tromethamine. 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.

Use in specific populations

Sourced from openFDA

Pregnancy: Teratogenic Effects: Animal studies do not indicate that carboprost tromethamine is teratogenic, however, it has been shown to be embryotoxic in rats and rabbits and any dose which produces increased uterine tone could put the embryo or fetus at risk.

Approval history

Sourced from openFDA
  • Jan 9, 1979NDANDA017989Pfizer
  • Jul 2, 2019ANDAANDA211941Dr Reddys
  • Jan 27, 2022ANDAANDA215337Amneal
  • Aug 9, 2022ANDAANDA214499Long Grove Pharms
  • Feb 13, 2023ANDAANDA216882Caplin
  • May 19, 2023ANDAANDA216824Sola Pharms
  • May 25, 2023ANDAANDA216939Eugia Pharma
  • Jun 15, 2023ANDAANDA217198Alembic

FAERS reports

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Reference statistics only. FAERS reports are voluntarily submitted and are not incidence rates, safety signals, or causal evidence. Counts reflect reporting volume — how often a reaction was reported, not how often it occurs. For decision-grade use, consult openFDA and the FAERS Public Dashboard directly.
696 total reports matchedLatest report Share = reports listing the reaction ÷ total matched reports. Rows can sum to >100% because a single report often lists multiple reactions.
  1. 1Vomiting21130%
  2. 2Nausea19027%
  3. 3Off Label Use14120%
  4. 4Diarrhoea13519%
  5. 5Abdominal Pain Upper9714%
  6. 6Chest Discomfort8913%
  7. 7Abdominal Discomfort679.6%
  8. 8Abdominal Pain649.2%
  9. 9Dyspnoea649.2%
  10. 10Blood Pressure Increased598.5%
  11. 11Palpitations405.7%
  12. 12Gastrointestinal Disorder385.5%
  13. 13Hyperhidrosis385.5%
  14. 14Dizziness375.3%
  15. 15Headache365.2%

Literature

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Recent PubMed references pinned to Carboprost as a MeSH major topic. Citations link to pubmed.ncbi.nlm.nih.gov.

Clinical trials

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The 10 most recently updated of 13 ClinicalTrials.gov registrations naming Carboprost as an intervention. Registration is not evidence of efficacy or safety — reference crosswalk only.

Frequently asked questions

How does Carboprost work?
Mechanism-of-action class: Prostaglandin Receptor Agonists.
What is Carboprost used for?
According to FDA labeling, Carboprost carries indications including: Carboprost tromethamine injection, USP is indicated for aborting pregnancy between the 13th and 20th weeks of gestation as calculated from the first day of the last normal menstrual period and in the following conditions related to second trimester abortion: 1. Failure of expulsion of the fetus during the course of treatment by another method; 2.. This is a reference summary of labeled uses, not medical advice or a treatment recommendation.
What class of drug is Carboprost?
Carboprost is classified as Prostaglandins, Prostaglandin Analog, Prostaglandin Receptor Agonists, Increased GI Smooth Muscle Tone, Increased Prostaglandin Activity, Increased Uterine Smooth Muscle Contraction or Tone.
What are the brand names for Carboprost?
Carboprost is marketed under brand names including Hemabate.
What are the contraindications for Carboprost?
Carboprost labeling lists contraindications including: 1. Hypersensitivity (including anaphylaxis and angioedema) to carboprost tromethamine injection Sterile Solution [ see ADVERSE REACTIONS, Post-marketing Experience ] 2.. Always consult the full prescribing information and a clinician.
Note. Data for carboprost is illustrative MVP content compiled from public sources. pharmacopeia is for educational and informational use only and is not a substitute for professional medical advice.

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