DEPO-PROVERA- medroxyprogesterone acetate injection, suspension

Land: USA

Språk: engelsk

Kilde: NLM (National Library of Medicine)

Aktiv ingrediens:

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

Tilgjengelig fra:

Pharmacia and Upjohn Company LLC

Administreringsrute:

INTRAMUSCULAR

Resept typen:

PRESCRIPTION DRUG

Indikasjoner:

Adjunctive therapy and palliative treatment of inoperable, recurrent, and metastatic endometrial or renal carcinoma. - Active thrombophlebitis, or current or past history of thromboembolic disorders, or cerebral vascular disease - Known sensitivity to DEPO-PROVERA (medroxyprogesterone acetate or any of its other ingredients).

Produkt oppsummering:

DEPO-PROVERA Sterile Aqueous Suspension is available as 400 mg/mL in 2.5 mL vials. NDC 0009-0626-01   2.5ml vial

Autorisasjon status:

New Drug Application

Preparatomtale

DEPO-PROVERA- MEDROXYPROGESTERONE ACETATE INJECTION, SUSPENSION
PHARMACIA AND UPJOHN COMPANY LLC
----------
DEPO-PROVERA
MEDROXYPROGESTERONE
ACETATE INJECTABLE
SUSPENSION, USP
DESCRIPTION
DEPO-PROVERA Sterile Aqueous Suspension contains medroxyprogesterone
acetate, which is a
derivative of progesterone and is active by the parenteral and oral
routes of administration. It is a white
to off-white, odorless crystalline powder, stable in air, melting
between 200° and 210° C. It is freely
soluble in chloroform, soluble in acetone and in dioxane, sparingly
soluble in alcohol and methanol,
slightly soluble in ether and insoluble in water.
The chemical name for medroxyprogesterone acetate is Pregn-4-ene-3,
20-dione, 17-(acetyloxy)-6-
methyl-, (6_α_)-. The structural formula is:
MEDROXYPROG ESTERONE ACETATE
DEPO-PROVERA for intramuscular injection is available as 400 mg/mL
medroxyprogesterone acetate.
Each mL of the 400 mg/mL suspension contains:
Medroxyprogesterone acetate
400 mg
Polyethylene glycol 3350
20.3 mg
Sodium sulfate anhydrous
11 mg
with
Myristyl-gamma-picolinium
chloride
1.69 mg
added as preservative
When necessary, pH was adjusted with sodium hydroxide and/or
hydrochloric acid.
ACTIONS
Medroxyprogesterone acetate, administered parenterally in the
recommended doses to women with
®
adequate endogenous estrogen, transforms proliferative endometrium
into secretory endometrium.
Medroxyprogesterone acetate inhibits (in the usual dose range) the
secretion of pituitary gonadotropin
which, in turn, prevents follicular maturation and ovulation.
Because of its prolonged action and the resulting difficulty in
predicting the time of withdrawal
bleeding following injection, medroxyprogesterone acetate is not
recommended in secondary
amenorrhea or dysfunctional uterine bleeding. In these conditions oral
therapy is recommended.
INDICATIONS AND USES
Adjunctive therapy and palliative treatment of inoperable, recurrent,
and metastatic endometrial or renal
carcinoma.
CONTRAINDICATIONS
1. Active thrombophlebitis, or current o