CARBOPROST TROMETHAMINE (Page 2 of 2)

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 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 injection.

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 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 perforation
Endometritis Weakness
Hiccough Diaphoresis
Dysmenorrhea-like 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 infection
Dryness of mouth Leg cramps
Hyperventilation Perforated uterus
Respiratory distress Anxiety
Hematemesis Chest pain
Taste alterations Retained placental fragment
Urinary tract infection Shortness of breath
Septic shock Fullness of throat
Torticollis Uterine sacculation
Lethargy Faintness, light- headedness
Hypertension Uterine rupture
Tachycardia
Pulmonary edema
Endometritis from IUCD

The most common complications when carboprost tromethamine injection 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).

DOSAGE & 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 Bleeding:
An initial dose of 250 micrograms of carboprost tromethamine injection sterile solution (1 mL of carboprost tromethamine injection, USP) 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).

Parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration, whenever solution and container permit.

HOW SUPPLIED

Carboprost tromethamine injection USP, 250 mcg/mL sterile solution is available in the following packages:

1 mL single-dose vial NDC 46708-777-01
10 x 1 mL single-dose vials NDC 46708-777-10

Each mL of carboprost tromethamine injection USP, 250 mcg/mL contains carboprost tromethamine equivalent to 250 mcg of carboprost.

Carboprost tromethamine injection USP, 250 mcg/mL must be refrigerated at 2° to 8° C (36° to 46° F).

Discard unused portion.

1 Duff, Sanders, and Gibbs; The course of labor in term patients with chorioamnionitis; Am. J. Obstet. Gynecol.; vol. 147, no. 4, October 15, 1983 pp 391–395.

Rx Only

Manufactured by:

Alembic Pharmaceuticals Limited
Karakhadi — 391450, Gujarat, India.

Issued: 01/2023

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Carboprost Tromethamine Injection USP 250 mcg/mL — Vial Label

carboprost-vial-label
(click image for full-size original)

Carboprost Tromethamine Injection USP 250 mcg/mL — 10’s Carton Label

carboprost-10-vials-carton
(click image for full-size original)
CARBOPROST TROMETHAMINE carboprost tromethamine injection, solution
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:46708-777
Route of Administration INTRAMUSCULAR DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
CARBOPROST TROMETHAMINE (CARBOPROST) CARBOPROST 250 ug in 1 mL
Inactive Ingredients
Ingredient Name Strength
BENZYL ALCOHOL 9.45 mg in 1 mL
SODIUM CHLORIDE 9 mg in 1 mL
TROMETHAMINE 83 ug in 1 mL
SODIUM HYDROXIDE
HYDROCHLORIC ACID
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:46708-777-10 10 VIAL in 1 CARTON contains a VIAL (46708-777-01)
1 NDC:46708-777-01 1 mL in 1 VIAL This package is contained within the CARTON (46708-777-10)
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA217198 06/15/2023
Labeler — Alembic Pharmaceuticals Limited (650574663)
Establishment
Name Address ID/FEI Operations
Alembic Pharmaceuticals Limited (F3) 675480734 MANUFACTURE (46708-777)

Revised: 03/2024 Alembic Pharmaceuticals Limited

Page 2 of 2 1 2

All MedLibrary.org resources are included in as near-original form as possible, meaning that the information from the original provider has been rendered here with only typographical or stylistic modifications and not with any substantive alterations of content, meaning or intent.

This site is provided for educational and informational purposes only, in accordance with our Terms of Use, and is not intended as a substitute for the advice of a medical doctor, nurse, nurse practitioner or other qualified health professional.

Privacy Policy | Copyright © 2024. All Rights Reserved.