MEDROXYPROGESTERONE ACETATE injection, suspension

국가: 미국

언어: 영어

출처: NLM (National Library of Medicine)

유효 성분:

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

제공처:

REMEDYREPACK INC.

관리 경로:

INTRAMUSCULAR

처방전 유형:

PRESCRIPTION DRUG

치료 징후:

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 Warnings and Precautions (5.7)] . - Undiagnosed vaginal bleeding [see Warnings and Precautions (5.10)] . Medroxyprogesterone acetate injectable suspension should not be administered during pregnancy [see  Contraindications (4)and Warnings and Precautions (5.17)]. Detectable amounts of drug have been identified in the milk of mothers receiving medroxyprogesterone acetate injectable suspension [see Warnings and Precautions (5.13) ]. Medroxyprogesterone acetate injectable suspension is not indicated before menarche. Use of medroxyprogesterone acetate injectable suspension is associated with significant loss of BMD. This loss of BMD is of particular concern during adolescence and early adulthood, a critical period of bone accretion. In adolescents, interpretation of BMD results should take into account patient age and skeletal maturity. It is unknown if use of medroxyprogesterone acetate injectable suspension by younger women will reduce peak bone mass and increase the risk of osteoporotic fractures in later life. Other than concerns about loss of BMD, the safety and effectiveness are expected to be the same for postmenarchal adolescents and adult women. This product has not been studied in post-menopausal women and is not indicated in this population. The effect of renal impairment on medroxyprogesterone acetate injectable suspension pharmacokinetics has not been studied. The effect of hepatic impairment on medroxyprogesterone acetate injectable suspension pharmacokinetics has not been studied. Medroxyprogesterone acetate injectable suspension should not be used by women with significant liver disease and should be discontinued if jaundice or disturbances of liver function occur [see  Contraindications (4) and Warnings and Precautions (5.7) ].

제품 요약:

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 packaged individually in a Carton with 22-gauge x 1 1/2 inch Terumo® SurGuardTM Needles NDC: 70518-3899-00 PACKAGING: 1 in 1 CARTON, 1 mL in 1 SYRINGE TYPE 2 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. Repackaged and Distributed By: Remedy Repack, Inc. 625 Kolter Dr. Suite #4 Indiana, PA 1-724-465-8762

승인 상태:

Abbreviated New Drug Application

제품 특성 요약

MEDROXYPROGESTERONE ACETATE- MEDROXYPROGESTERONE ACETATE INJECTION,
SUSPENSION
REMEDYREPACK 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 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)
Ac