DEPO-PROVERA- medroxyprogesterone acetate injection, suspension

국가: 미국

언어: 영어

출처: NLM (National Library of Medicine)

유효 성분:

MEDROXYPROGESTERONE ACETATE (UNII: C2QI4IOI2G) (MEDROXYPROGESTERONE - UNII:HSU1C9YRES)

제공처:

A-S Medication Solutions

INN (국제 이름):

MEDROXYPROGESTERONE ACETATE

구성:

MEDROXYPROGESTERONE ACETATE 150 mg in 1 mL

관리 경로:

INTRAMUSCULAR

처방전 유형:

PRESCRIPTION DRUG

치료 징후:

Depo-Provera CI 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 Depo-Provera CI long-term [see Warnings and Precautions (5.1) ]. The use of Depo-Provera CI 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 Depo-Provera CI (medroxyprogesterone acetate) or any of its other ingredients [see Warnings and Precautions (5.5)] . - Significant liver disease [see Warnings and Precautions (5.7)] . - Undiagnosed vaginal bleeding [see Warnings a

제품 요약:

Product: 50090-0665 NDC: 50090-0665-0 1 mL in a SYRINGE / 1 in a CARTON

승인 상태:

New Drug Application

제품 특성 요약

DEPO-PROVERA- MEDROXYPROGESTERONE ACETATE INJECTION, SUSPENSION
A-S MEDICATION SOLUTIONS
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HIGHLIGHTS OF PRESCRIBING INFORMATION
THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE
DEPO-PROVERA CI SAFELY AND EFFECTIVELY.
SEE FULL PRESCRIBING INFORMATION FOR DEPO-PROVERA CI.
DEPO-PROVERA CI (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 DEPO-PROVERA CONTRACEPTIVE INJECTION (DEPO-PROVERA CI)
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 DEPO-PROVERA CONTRACEPTIVE INJECTION 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)
DEPO-PROVERA CONTRACEPTIVE INJECTION 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
Dosage and Administration, Prevention of Pregnancy (2.1)
11/2016
Warnings and Precautions, Injection Site Reactions (5.6)
11/2016
INDICATIONS AND USAGE
Depo-Provera CI is a progestin indicated only for the prevention of
pregnancy. (1)
DOSAGE AND ADMINISTRATION
The recommended dose is 150 mg of Depo-Provera CI 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
or with 22 gauge × 1 1/2 inch BD SafetyGlide™ Needles. (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 cerebr