MEDROXYPROGESTERONE ACETATE- 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:

NuCare Pharmaceuticals,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 Injectable Suspension 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 long-term [ see 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)

Product summary:

NDC 68071-1818-5 BOX OF 1 Store at 20° to 25°C (68° to 77°F) [see USP Controlled Room Temperature].

Authorization status:

Abbreviated New Drug Application

Summary of Product characteristics

MEDROXYPROGESTERONE ACETATE- MEDROXYPROGESTERONE ACETATE INJECTION,
SUSPENSION
NUCARE PHARMACEUTICALS,INC.
----------
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 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
1. Dosage and Administration, Prevention of Pregnancy ( 2.1) 11/2016
Warnings and Precautions, Injection Site Reactions ( 5.6) 11/2016
INDICATIONS AND USAGE
Medroxyprogesterone Acetate Injectable Suspension is a progestin
indicated only for the prevention of pregnancy. ( 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
Vials containing sterile aqueous suspension: 150 mg per mL ( 3)
CONTRAINDICATIONS
Known or suspected pregnancy or as a diagnostic test for pregnancy. (
4)
Active thrombophlebitis, or current or past history of thromboembolic
disorders, or cerebral vascular