Carboprost Tromethamine 250 ug/mL
Carboprost Tromethamine · INJECTION, SOLUTION · Sagent Pharmaceuticals
Carboprost tromethamine is an injection used to treat postpartum hemorrhage (excessive bleeding after childbirth) and to manage incomplete abortion or miscarriage. It works by causing the uterus to contract, which helps control bleeding.
Key Facts
- Brand Name
- Carboprost Tromethamine
- Generic Name
- Carboprost Tromethamine
- NDC Code (Product)
25021-477- Manufacturer
- Sagent Pharmaceuticals
- Strength
- 250 ug/mL
- Dosage Form
- INJECTION, SOLUTION
- Route
- INTRAMUSCULAR
- Marketing Status
- Application #
- ANDA217198
- Marketing Start
- 12/01/2025
Recall History
No Recall HistorySide Effects Reported to FDA
FDA FAERS database · These are reported events, not confirmed side effects
Full Prescribing Information
Indications & Usage
INDICATIONS AND USAGE 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. 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. Carboprost tromethamine injection is indicated for the treatment of postpartum hemorrhage due to uterine atony which has not responded to conventional methods of management. Prior treatment should include the use of intravenously administered oxytocin, manipulative techniques such as uterine massage and, unless contraindicated, intramuscular ergot preparations. Studies have shown that in such cases, the use of carboprost tromethamine injection has resulted in satisfactory control o…
Dosage & Administration
DOSAGE AND ADMINISTRATION 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…
Contraindications
CONTRAINDICATIONS 1. Hypersensitivity (including anaphylaxis and angioedema) to carboprost tromethamine injection Sterile Solution [ see ADVERSE REACTIONS, Post-marketing Experience ] 2. Acute pelvic inflammatory disease 3. Patients with active cardiac, pulmonary, renal or hepatic disease WARNINGS Carboprost tromethamine injection sterile solution (carboprost tromethamine), like other potent oxytocic agents, should be used only with strict adherence to recommended dosages. Carboprost tromethamine injection should be used by medically trained personnel in a hospital which can provide immediate intensive care and acute surgical facilities Carboprost tromethamine does not appear to directly affect the fetoplacental unit. Therefore, the possibility does exist that the previable fetus aborted by carboprost tromethamine could exhibit transient life signs. Carboprost tromethamine is not indicated if the fetus in utero has reached the stage of viability. Carboprost tromethamine injection should not be considered a feticidal agent. Evidence from animal studies has suggested that certain other prostaglandins have some teratogenic potential. Although these studies do not indicate that carbopr…
Drug Interactions
Drug Interactions Carboprost tromethamine may augment the activity of other oxytocic agents. Concomitant use with other oxytocic agents is not recommended.
Adverse Reactions
ADVERSE REACTIONS 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. Adverse effects observed during the use of carboprost tromethamine injection for abortion and for hemorrhage, not all of which are clearly drug related, in decreasing order of fr…
Frequently Asked Questions
What is Carboprost Tromethamine used for?
Carboprost tromethamine is an injection used to treat postpartum hemorrhage (excessive bleeding after childbirth) and to manage incomplete abortion or miscarriage. It works by causing the uterus to contract, which helps control bleeding.
Is Carboprost Tromethamine a controlled substance?
Carboprost Tromethamine is not classified as a controlled substance by the DEA.
What is the generic name for Carboprost Tromethamine?
The generic name for Carboprost Tromethamine is Carboprost Tromethamine. There are 6 other brand versions of Carboprost Tromethamine.
What is the NDC code for Carboprost Tromethamine 250 ug/mL?
The NDC (National Drug Code) for Carboprost Tromethamine 250 ug/mL is 25021-477, listed by Sagent Pharmaceuticals.