MEDROXYPROGESTERONE ACETATE injection, suspension, extended release

国: アメリカ合衆国

言語: 英語

ソース: NLM (National Library of Medicine)

有効成分:

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

から入手可能:

REMEDYREPACK INC.

投与経路:

INTRAMUSCULAR

処方タイプ:

PRESCRIPTION DRUG

適応症:

Medroxyprogesterone acetate 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 long-term [see Warnings and Precautions (5.1)] . The use of Medroxyprogesterone acetate 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 or any of its other ingredients [see Warnings and Precautions (5.5)] . - Significant liver disease [see Warnings and Precautions (5.6)]. - Undiagnosed vaginal bleeding [see Warnings and Precautions (5.9)] . Medroxyprogesterone acetate should not be administered during pregnancy. [See Contraindicationsand Warnings and Precautions (5.17).] Detectable amounts of drug have been identified in the milk of mothers receiving Medroxyprogesterone acetate. [See Warnings and Precautions (5.13).] Medroxyprogesterone acetate is not indicated before menarche. Use of Medroxyprogesterone acetate 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 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 pharmacokinetics has not been studied. The effect of hepatic impairment on Medroxyprogesterone acetate pharmacokinetics has not been studied. Medroxyprogesterone acetate 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).]

製品概要:

Medroxyprogesterone acetate injectable suspension, USP, 150 mg/mL is available as: NDC: 70518-3336-00 PACKAGING: 1 in 1 CARTON, 1 mL in 1 SYRINGE, TYPE 2 Syringe must be stored in carton at controlled room temperature 20° to 25°C (68° to 77°F) [see USP] until ready for use. Vials MUST be stored upright at controlled room temperature 20° to 25°C (68° to 77°F) [see USP]. Repackaged and Distributed By: Remedy Repack, Inc. 625 Kolter Dr. Suite #4 Indiana, PA 1-724-465-8762

認証ステータス:

Abbreviated New Drug Application

製品の特徴

MEDROXYPROGESTERONE ACETATE- MEDROXYPROGESTERONE ACETATE INJECTION,
SUSPENSION, EXTENDED RELEASE
REMEDYREPACK INC.
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HIGHLIGHTS OF PRESCRIBING INFORMATION
THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE
MEDROXYPROGESTERONE
ACETATE CONTRACEPTIVE INJECTION SAFELY AND EFFECTIVELY. SEE FULL
PRESCRIBING INFORMATION FOR
MEDROXYPROGESTERONE ACETATE CONTRACEPTIVE INJECTION.
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 CONTRACEPTIVE INJECTION 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 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)
MEDROXYPROGESTERONE ACETATE 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
Medroxyprogesterone acetate is a progestin indicated only for the
prevention of pregnancy. ( 1)
DOSAGE AND ADMINISTRATION
The recommended dose is 150 mg of Medroxyprogesterone acetate 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 Needle-Pro
EDGE™ Safety Device ( 3)
CONTRAINDICATIONS
Known or suspected pregnancy or as a diagnostic test for pregnancy. (
4)
Ac