Nchi: Marekani
Lugha: Kiingereza
Chanzo: NLM (National Library of Medicine)
medroxyprogesterone acetate (UNII: C2QI4IOI2G) (medroxyprogesterone - UNII:HSU1C9YRES)
Preferred Pharmaceuticals, Inc
medroxyprogesterone acetate
medroxyprogesterone 150 mg in 1 mL
INTRAMUSCULAR
PRESCRIPTION DRUG
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
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].
New Drug Application Authorized Generic
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 Soma hati kamili