Label: CARBOPROST TROMETHAMINE injection

  • NDC Code(s): 62559-900-01, 62559-900-11
  • Packager: ANI Pharmaceuticals, Inc.
  • Category: HUMAN PRESCRIPTION DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: Abbreviated New Drug Application

Drug Label Information

Updated December 20, 2024

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  • DESCRIPTION
    Carboprost Tromethamine Injection USP, an oxytocic, contains the tromethamine salt of the (15S)-15 methyl analogue of naturally occurring prostaglandin F2α in a solution suitable for intramuscular ...
  • CLINICAL PHARMACOLOGY
    Carboprost tromethamine administered intramuscularly stimulates in the gravid uterus myometrial contractions similar to labor contractions at the end of a full term pregnancy. Whether or not these ...
  • 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 ...
  • CONTRAINDICATIONS
    1. Hypersensitivity (including anaphylaxis and angioedema) to carboprost tromethamine injection sterile solution [see ADVERSE REACTIONS, Post-marketing Experience] 2. Acute pelvic inflammatory ...
  • WARNINGS
    Carboprost tromethamine injection sterile solution (carboprost tromethamine), like other potent oxytocic agents, should be used only with strict adherence to recommended dosages. Carboprost ...
  • PRECAUTIONS
    General - Animal studies lasting several weeks at high doses have shown that prostaglandins of the E and F series can induce proliferation of bone. Such effects have also been noted in newborn ...
  • ADVERSE REACTIONS
    The adverse effects of carboprost tromethamine injection sterile solution are generally transient and reversible when therapy ends. The most frequent adverse reactions observed are related to its ...
  • 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 ...
  • HOW SUPPLIED
    Carboprost Tromethamine Injection USP is available in the following packages:   1 mL single-dose vial NDC 62559-900-11 - 10 x 1 mL single-dose vials NDC 62559-900-01 - Each mL of Carboprost ...
  • PACKAGE/LABEL PRINCIPAL DISPLAY PANEL
    NDC 62559-900-01 - Contains 10 of NDC 62559-900-11 - Carboprost Tromethamine Injection USP - 250 mcg*/mL - FOR INTRAMUSCULAR USE ONLY - Discard unused portion. Rx only - 10 x 1 mL Single-Dose Vials
  • INGREDIENTS AND APPEARANCE
    Product Information