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:

Eugia US LLC

Administration route:

INTRAMUSCULAR

Prescription type:

PRESCRIPTION DRUG

Therapeutic indications:

Medroxyprogesterone acetate injectable suspension is indicated for use by females of reproductive potential to prevent pregnancy. Limitations of Use : The use of medroxyprogesterone acetate injectable suspension 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 medroxyprogesterone acetate injectable suspension 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 medroxyprogesterone acetate injectable suspension or any of its other ingredients [see Warnings and Precautions (5.5)] . - Significant liver disease [see Warn

Product summary:

Medroxyprogesterone acetate injectable suspension, USP is a sterile, white to off white aqueous suspension and is supplied in the following package configurations: 150 mg per mL: 1 mL prefilled syringe                                               NDC 55150-330-01 packaged individually in a Carton with 22-gauge x 1 1/2 inch Terumo® SurGuardTM  Needles Store at 20° to 25°C (68° to 77°F) [see USP Controlled Room Temperature]. The plunger rubber stopper is not made with natural rubber latex.

Authorization status:

Abbreviated New Drug Application

Summary of Product characteristics

MEDROXYPROGESTERONE ACETATE - MEDROXYPROGESTERONE
ACETATE INJECTION, SUSPENSION
EUGIA US LLC
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HIGHLIGHTS OF PRESCRIBING INFORMATION
THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE
MEDROXYPROGESTERONE ACETATE INJECTABLE SUSPENSION SAFELY AND
EFFECTIVELY. SEE FULL
PRESCRIBING INFORMATION FOR MEDROXYPROGESTERONE ACETATE INJECTABLE
SUSPENSION.
MEDROXYPROGESTERONE ACETATE INJECTABLE SUSPENSION, 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 INJECTABLE SUSPENSION 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 MEDROXYPROGESTERONE ACETATE INJECTABLE
SUSPENSION 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)
MEDROXYPROGESTERONE ACETATE INJECTABLE SUSPENSION 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)
INDICATIONS AND USAGE
Medroxyprogesterone acetate injectable suspension is a progestin
indicated for use by females of
reproductive potential to prevent pregnancy. (1)
Limitations of Use:
The use of medroxyprogesterone acetate injectable suspension 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 medroxyprogesterone acetate
injectable suspension every 3
months (13 weeks) administered by deep, intramuscular (IM) injection
in the gluteal or deltoid muscle.
(2.1)
DOSAGE FORMS AND STRENGTHS
Prefilled syringes are packaged with 22-gauge x 1 1/2 inch Terumo
SurGuard
Needles. (3)
CONTRAINDICATIONS
Known or suspected pregnancy or as a diagnostic test for pregnancy.
(4)
Active thrombo