MEDROXYPROGESTERONE ACETATE injection, suspension

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

MEDROXYPROGESTERONE ACETATE (UNII: C2QI4IOI2G) (MEDROXYPROGESTERONE - UNII:HSU1C9YRES)

Available from:

Physicians Total Care, Inc.

INN (International Name):

MEDROXYPROGESTERONE ACETATE

Composition:

MEDROXYPROGESTERONE 150 mg in 1 mL

Administration route:

INTRAMUSCULAR

Prescription type:

PRESCRIPTION DRUG

Therapeutic indications:

Medroxyprogesterone Acetate Injectable Suspension, USP is indicated only for the prevention of pregnancy. The loss of bone mineral density (BMD) in women of all ages and the impact on peak bone mass in adolescents should be considered, along with the decrease in BMD that occurs during pregnancy and/or lactation, in the risk/benefit assessment for women who use Medroxyprogesterone Acetate Injectable Suspension, USP long-term (see WARNINGS.) It is a long-term injectable contraceptive in women when administered at 3-month (13-week) intervals. Dosage does not need to be adjusted for body weight. In five clinical studies using Medroxyprogesterone Acetate Injectable Suspension, USP, the 12-month failure rate for the group of women treated with Medroxyprogesterone Acetate Injectable Suspension, USP was zero (no pregnancies reported) to 0.7 by Life-Table method. Pregnancy rates with contraceptive measures are typically reported for only the first year of use as shown in Table 1. Except for intrauterine devices (IUD)

Product summary:

Medroxyprogesterone Acetate Injectable Suspension, USP (Medroxyprogesterone Acetate sterile aqueous suspension 150 mg/mL) is available as: 1 mL vial                                   NDC 54868-5257-0 Store at controlled room temperature 20° to 25°C (68° to 77°F) [see USP].

Authorization status:

New Drug Application

Summary of Product characteristics

MEDROXYPROGESTERONE ACETATE - MEDROXYPROGESTERONE ACETATE INJECTION,
SUSPENSION
PHYSICIANS TOTAL CARE, INC.
----------
MEDROXYPROGESTERONE ACETATE INJECTABLE SUSPENSION, USP
PHYSICIAN INFORMATION
WOMEN WHO USE MEDROXYPROGESTERONE ACETATE INJECTABLE SUSPENSION, USP
MAY LOSE
SIGNIFICANT BONE MINERAL DENSITY. BONE LOSS IS GREATER WITH INCREASING
DURATION OF USE AND
MAY NOT BE COMPLETELY REVERSIBLE.
IT IS UNKNOWN IF USE OF MEDROXYPROGESTERONE ACETATE INJECTABLE
SUSPENSION, USP DURING
ADOLESCENCE OR EARLY ADULTHOOD, A CRITICAL PERIOD OF BONE ACCRETION,
WILL REDUCE PEAK BONE
MASS AND INCREASE THE RISK FOR OSTEOPOROTIC FRACTURE IN LATER LIFE.
MEDROXYPROGESTERONE ACETATE INJECTABLE SUSPENSION, USP SHOULD BE USED
AS A LONG-TERM
BIRTH CONTROL METHOD (E.G. LONGER THAN 2 YEARS) ONLY IF OTHER BIRTH
CONTROL METHODS ARE
INADEQUATE. (SEE WARNINGS.)
PATIENTS SHOULD BE COUNSELED THAT THIS PRODUCT DOES NOT PROTECT
AGAINST HIV INFECTION (AIDS) AND
OTHER SEXUALLY TRANSMITTED DISEASES.
DESCRIPTION
Medroxyprogesterone Acetate Injectable Suspension, USP contains
medroxyprogesterone acetate, a
derivative of progesterone, as its active ingredient.
Medroxyprogesterone Acetate is active by the
parenteral and oral routes of administration. It is a white to
off-white; odorless crystalline powder that
is stable in air and that melts between 200°C and 210°C. It is
freely soluble in chloroform, soluble in
acetone and dioxane, sparingly soluble in alcohol and methanol,
slightly soluble in ether, and insoluble
in water.
The chemical name for Medroxyprogesterone Acetate is
pregn-4-ene-3,20-dione, 17-(acetyloxy)-6-
methyl-, (6α-).
The structural formula is as follows:
MEDROXYPROG ESTERONE ACETATE
Medroxyprogesterone Acetate Injectable Suspension, USP for
intramuscular (IM) injection is available
in vials and prefilled syringes, each containing 1 mL of
Medroxyprogesterone Acetate sterile aqueous
suspension 150 mg/mL.
Each mL contains:
Medroxyprogesterone acetate
150 mg
Polyethylene glycol 3350
28.9 mg
Polysorbate 80
2.41 mg
Sodium chloride
8.68 mg