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:

REMEDYREPACK INC.

INN (International Name):

MEDROXYPROGESTERONE ACETATE

Composition:

MEDROXYPROGESTERONE ACETATE 150 mg in 1 mL

Administration route:

INTRAMUSCULAR

Prescription type:

PRESCRIPTION DRUG

Therapeutic indications:

Medroxyprogesterone Acetate (MPA) 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 MPA Injectable Suspension, USP long-term [see Warnings and Precautions (5.1)] . The use of MPA Injectable Suspension, USP is contraindicated in the following conditions: - Known or suspected pregnancy or as a diagnostic test for pregnancy. - Active thrombophlebitis, or current or past history of thromboembolic disorders, or cerebral vascular disease [see Warnings and Precautions (5.2)] . - Known or suspected malignancy of breast [see Warnings and Precautions (5.3)] . - Known hypersensitivity to MPA Injecta

Product summary:

Medroxyprogesterone Acetate Injectable Suspension, USP (Medroxyprogesterone Acetate sterile aqueous suspension 150 mg/mL) is supplied in the following strengths and package configurations: Vials MUST be stored upright at controlled room temperature 20° to 25°C (68° to 77°F) [see USP].

Authorization status:

New Drug Application Authorized Generic

Summary of Product characteristics

MEDROXYPROGESTERONE ACETATE- MEDROXYPROGESTERONE ACETATE INJECTION,
SUSPENSION
REMEDYREPACK INC.
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HIGHLIGHTS OF PRESCRIBING INFORMATION
THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE
MEDROXYPROGESTERONE ACETATE
(MPA) INJECTABLE SUSPENSION, USP SAFELY AND EFFECTIVELY. SEE FULL
PRESCRIBING INFORMATION FOR MPA
INJECTABLE SUSPENSION, USP.
MEDROXYPROGESTERONE ACETATE (MPA) INJECTABLE SUSPENSION, USP, FOR
INTRAMUSCULAR USE
INITIAL U.S. APPROVAL: 1959
WARNING: LOSS OF BONE MINERAL DENSITY
_SEE FULL PRESCRIBING INFORMATION FOR COMPLETE BOXED WARNING_.
WOMEN WHO USE MEDROXYPROGESTERONE ACETATE (MPA) INJECTABLE SUSPENSION,
USP MAY LOSE SIGNIFICANT
BONE MINERAL DENSITY. BONE LOSS IS GREATER WITH INCREASING DURATION OF
USE AND MAY NOT BE COMPLETELY
REVERSIBLE. ( 5.1)
IT IS UNKNOWN IF USE OF MPA 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. ( 5.1)
MPA INJECTABLE SUSPENSION, USP SHOULD NOT BE USED AS A LONG-TERM BIRTH
CONTROL METHOD (I.E., LONGER
THAN 2 YEARS) UNLESS OTHER BIRTH CONTROL METHODS ARE CONSIDERED
INADEQUATE. ( 5.1)
RECENT MAJOR CHANGES
Dosage and Administration, Prevention of Pregnancy ( 2.1)
1/2017
Warnings and Precautions, Injection Site Reactions ( 5.6)
1/2017
INDICATIONS AND USAGE
Medroxyprogesterone Acetate (MPA) Injectable Suspension, USP is a
progestin injectable contraceptive indicated only
for the prevention of pregnancy. ( 1)
DOSAGE AND ADMINISTRATION
The recommended dose is 150 mg of MPA Injectable Suspension, USP every
3 months (13 weeks) administered by
deep, intramuscular (IM) injection in the gluteal or deltoid muscle. (
2.1)
DOSAGE FORMS AND STRENGTHS
Vials containing sterile aqueous suspension: 150 mg per mL ( 3)
Prefilled syringes: prefilled syringes are available packaged with
22-gauge × 1 1/2 inch Terumo® SurGuard™ Needles
( 3)
CONTRAINDICATIONS
Known or suspected pregnancy or as a diagnostic test for pregnancy. (
4)