CARBOPROST TROMETHAMINE (Page 3 of 3)

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 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 is available in the following packages:

1 mL single-dose vials NDC 43598-917-11

10 x 1 mL single-dose vials NDC 43598-917-58

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

Carboprost tromethamine injection must be refrigerated at 2° to 8° C (36° to 46° F).

Rx Only

Manufactured by: Dr. Reddy’s Laboratories Limited Visakhapatnam – 530 046 INDIA

NOVAPLUS is a registered trademark of Vizient, Inc.

Issued: 1119

To report SUSPECTED ADVERSE REACTIONS, contact Dr. Reddy’s Laboratories Inc., at 1-888-375-3784, or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch

PACKAGE LABEL PRINCIPAL DISPLAY PANEL

Vial Label:

Unvarnished Area Consists of: Lot Number and Expiry Date

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Carton Label:

Unvarnished Area Consists of: Lot Number and Expiry Date

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CARBOPROST TROMETHAMINE
carboprost tromethamine injection, solution
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:43598-917
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
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:43598-917-58 10 VIAL, SINGLE-DOSE in 1 CARTON contains a VIAL, SINGLE-DOSE (43598-917-11)
1 NDC:43598-917-11 1 mL in 1 VIAL, SINGLE-DOSE This package is contained within the CARTON (43598-917-58)
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA211941 02/04/2020
Labeler — Dr. Reddy’s Laboratories Inc. (802315887)
Registrant — Dr. Reddy’s Laboratories Limited (650446243)
Establishment
Name Address ID/FEI Operations
Dr. Reddy’s Laboratories Limited 650446243 manufacture (43598-917), analysis (43598-917)

Revised: 11/2019 Dr. Reddy’s Laboratories Inc.

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