MEDROXYPROGESTERONE ACETATE injection, suspension

Land: USA

Språk: engelska

Källa: NLM (National Library of Medicine)

Aktiva substanser:

medroxyprogesterone acetate (UNII: C2QI4IOI2G) (medroxyprogesterone - UNII:HSU1C9YRES)

Tillgänglig från:

Preferred Pharmaceuticals, Inc

INN (International namn):

medroxyprogesterone acetate

Sammansättning:

medroxyprogesterone 150 mg in 1 mL

Administreringssätt:

INTRAMUSCULAR

Receptbelagda typ:

PRESCRIPTION DRUG

Terapeutiska indikationer:

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 and Precautions (5.1) ]. The use of Medroxyprogesterone Acetate 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 Medroxyprogesterone Acetate Injectable Suspension, USP (medroxyprogesterone acetate) or any of its other ingredie

Produktsammanfattning:

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]. Store at controlled room temperature 20° to 25°C (68° to 77°F) [see USP].

Bemyndigande status:

New Drug Application Authorized Generic

Produktens egenskaper

MEDROXYPROGESTERONE ACETATE- MEDROXYPROGESTERONE ACETATE INJECTION,
SUSPENSION
PREFERRED PHARMACEUTICALS, INC
----------
HIGHLIGHTS OF PRESCRIBING INFORMATION
THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE
MEDROXYPROGESTERONE ACETATE INJECTABLE
SUSPENSION, USP SAFELY AND EFFECTIVELY. SEE FULL PRESCRIBING
INFORMATION FOR MEDROXYPROGESTERONE ACETATE
INJECTABLE SUSPENSION, USP.
MEDROXYPROGESTERONE ACETATE 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 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 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. (5.1)
MEDROXYPROGESTERONE ACETATE 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
Boxed Warning: Loss of Bone Mineral Density
10/2010
Warnings and Precautions; Loss of Bone Mineral Density (5.1)
10/2010
INDICATIONS AND USAGE
Medroxyprogesterone Acetate 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 Medroxyprogesterone Acetate
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 BD SafetyGlide Needles (3)
CONTRAINDICATIONS
Known or s