Carboprost tromethamine

Overview

A nonsteroidal abortifacient agent that is effective in both the first and second trimesters of pregnancy.

Indication

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. Premature rupture of membranes in intrauterine methods with loss of drug and insufficient or absent uterine activity; 3. Requirement of a repeat intrauterine instillation of drug for expulsion of the fetus; 4. Inadvertent or spontaneous rupture of membranes in the presence of a previable fetus and absence of adequate activity for expulsion. Also for the treatment of postpartum hemorrhage due to uterine atony which has not responded to conventional methods of management.

Associated Conditions

Unresponsive Postpartum Haemorrhage (PPH) caused by Uterine Atony

Clinical Trials

Title	Posted	Study ID	Phase	Status	Sponsor
Comparing the Dose-response Profiles of Uterotonics After Initial Carbetocin Administration - an Ex-vivo Study in Desensitized Human Myometrium	2024/02/29	NCT06285409	Not Applicable	Recruiting	Samuel Lunenfeld Research Institute, Mount Sinai Hospital
The Time Point of Carboprost Methylate Administration and Perioperative Complications	2023/04/28	NCT05834361	Not Applicable	Completed	Peking Union Medical College Hospital
Carboprost (Hemabate) for Fibroid Resection	2022/08/29	NCT05518812	Early Phase 1	Recruiting	Northwestern University
Early Usage of Bakri Ballon in Managing Postpartum Hemorrhage	2016/08/10	NCT02861482	Not Applicable	Completed	Dongyu Wang
Comparison of IV Ergonovine With IM Carboprost, With Oxytocin IV, During Cesarean Section for Failure to Progress	2013/06/05	NCT01869556	Not Applicable	Completed	Samuel Lunenfeld Research Institute, Mount Sinai Hospital
Impact of Uterotonic Agents on Isolated Human Myometrium	2009/10/02	NCT00989027	Not Applicable	Completed	Samuel Lunenfeld Research Institute, Mount Sinai Hospital

FDA Drug Approvals

Approved Product	Manufacturer	NDC Code	Route	Strength	Effective Date
Carboprost Tromethamine	Dr. Reddy's Laboratories Inc.	43598-179	INTRAMUSCULAR	250 ug in 1 mL	6/30/2023
Carboprost Tromethamine	Xellia Pharmaceuticals USA LLC	70594-112	INTRAMUSCULAR	250 ug in 1 mL	11/1/2023
carboprost tromethamine	Gland Pharma Limited	68083-584	INTRAMUSCULAR	250 ug in 1 mL	8/8/2023
CARBOPROST TROMETHAMINE	Caplin Steriles Limited	65145-132	INTRAMUSCULAR	250 ug in 1 mL	2/22/2023
carboprost tromethamine	Amneal Pharmaceuticals LLC	70121-1680	INTRAMUSCULAR	250 ug in 1 mL	12/23/2023
carboprost tromethamine	SOLA Pharmaceuticals, LLC	70512-859	INTRAMUSCULAR	250 ug in 1 mL	9/25/2023
CARBOPROST TROMETHAMINE	Alembic Pharmaceuticals Limited	46708-777	INTRAMUSCULAR	250 ug in 1 mL	3/15/2024
Carboprost Tromethamine	Long Grove Pharmaceuticals, LLC	81298-5010	INTRAMUSCULAR	250 ug in 1 mL	10/19/2022
CARBOPROST TROMETHAMINE	Alembic Pharmaceuticals Inc.	62332-777	INTRAMUSCULAR	250 ug in 1 mL	4/22/2022
Hemabate	Pharmacia & Upjohn Company LLC	0009-0856	INTRAMUSCULAR	250 ug in 1 mL	1/10/2022

EMA Drug Approvals

Approved Product	Authorization Holder	Status	Issued Date
No EMA approvals found for this drug.

HSA Drug Approvals

Approved Product	Manufacturer	Approval Number	Dosage Form	Strength	Approval Date
HEMABATE INJECTION 250 mcg/ml	Pharmacia & Upjohn LLC	SIN06722P	INJECTION	250 mcg/ml	11/29/1991

NMPA Drug Approvals

Approved Product	Company	Approval Number	Drug Type	Dosage Form	Approval Date
No NMPA approvals found for this drug.

PPB Drug Approvals

Approved Product	Registration No.	Company	Licence No.	Strength	Registration Date
No PPB approvals found for this drug.

TGA Drug Approvals

Approved Product	ARTG ID	Sponsor	Registration Type	Status	Registration Date
CARBOPROST-REACH carboprost (as trometamol) 250 microgram/1 mL solution for injection vial	394092	Reach Pharmaceuticals Pty Ltd	Medicine	A	6/30/2023
CARBOPROST DR.REDDY'S carboprost (as trometamol) 250 microgram /1 mL injection vial	387952	Dr Reddys Laboratories Australia Pty Ltd	Medicine	A	5/2/2023

Health Canada Drug Approvals

Approved Product	Company	DIN	Dosage Form	Strength	Market Date
No Health Canada approvals found for this drug.

CIMA AEMPS Drug Approvals

Approved Product	Company	Registration Number	Pharmaceutical Form	Prescription Type	Status
No CIMA AEMPS (Spain) approvals found for this drug.

Philippines FDA Drug Approvals

Approved Product	Company	License Number	Dosage Form	Strength	Approval Date
No Philippines FDA approvals found for this drug.

Saudi SFDA Drug Approvals

Approved Product	Company	License Number	Dosage Form	Strength	Approval Date
No Saudi SFDA approvals found for this drug.

Malaysia NPRA Drug Approvals

Approved Product	Company	Registration Number	Dosage Form	Strength	Approval Date
No Malaysia NPRA approvals found for this drug.

UK EMC Drug Information

Medicine Name	MA Holder	MA Number	Pharmaceutical Form	Active Ingredient	Authorization Date
No UK EMC drug information found for this drug.

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