DEPO-PROVERA- medroxyprogesterone acetate injection, suspension

Țară: Statele Unite ale Americii

Limbă: engleză

Sursă: NLM (National Library of Medicine)

Ingredient activ:

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

Disponibil de la:

Pharmacia & Upjohn Company LLC

INN (nume internaţional):

MEDROXYPROGESTERONE ACETATE

Compoziție:

MEDROXYPROGESTERONE ACETATE 150 mg in 1 mL

Calea de administrare:

INTRAMUSCULAR

Tip de prescriptie medicala:

PRESCRIPTION DRUG

Indicații terapeutice:

Depo-Provera CI is indicated for use by females of reproductive potential to prevent pregnancy. Limitations of Use : The use of Depo-Provera CI 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 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 and Precautions (5.10)] . Depo-Provera CI

Rezumat produs:

Depo-Provera CI 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].

Statutul autorizaţiei:

New Drug Application

Caracteristicilor produsului

DEPO-PROVERA- MEDROXYPROGESTERONE ACETATE INJECTION, SUSPENSION
PHARMACIA & UPJOHN COMPANY LLC
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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 CI 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 CI 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)
RECENT MAJOR CHANGES
Indications and Usage (1)
12/2020
INDICATIONS AND USAGE
Depo-Provera CI is a progestin indicated for use by females of
reproductive potential to prevent pregnancy. (1)
Limitations of Use:
The use of Depo-Provera CI 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 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.
(3)
CONTRAINDICATIONS
Known or suspected pregnancy or as a diagnostic test for pregnancy.
(4)
Active thrombophlebitis, or current or past history of thromboembolic
diso