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:

Greenstone LLC

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 for use by females of reproductive potential to prevent pregnancy. Limitations of Use : The use of MPA Injectable Suspension, USP is not recommended as a long-term (i.e., longer than 2 years) birth control method unless other options are considered inadequate [see Dosage and Administration (2.1) and 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 Injectable Suspension, USP (medroxyprogesterone acetate) or any of its other ingredients [see Warnings and Precautions (5.5)] . - Significant liver disease [see Warnings and Precautions (5.7)]

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
GREENSTONE LLC
----------
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 IS NOT RECOMMENDED AS A LONG-TERM
(I.E., LONGER
THAN 2 YEARS) BIRTH CONTROL METHOD UNLESS OTHER OPTIONS ARE CONSIDERED
INADEQUATE.
(1, 5.1)
RECENT MAJOR CHANGES
Indications and Usage (1)
12/2020
INDICATIONS AND USAGE
Medroxyprogesterone Acetate (MPA) Injectable Suspension, USP is a
progestin indicated for use by
females of reproductive potential to prevent pregnancy. (1)
Limitations of Use:
The use of MPA Injectable Suspension, USP is not recommended as a
long-term (i.e., longer than 2 years)
birth control method unless other options are considered inadequate.
(1, 5.1)
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)
C