DEPO-PROVERA- medroxyprogesterone acetate injection, suspension

Land: USA

Språk: engelska

Källa: NLM (National Library of Medicine)

Aktiva substanser:

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

Tillgänglig från:

Physicians Total Care, Inc.

INN (International namn):

MEDROXYPROGESTERONE ACETATE

Sammansättning:

MEDROXYPROGESTERONE 400 mg in 1 mL

Administreringssätt:

INTRAMUSCULAR

Receptbelagda typ:

PRESCRIPTION DRUG

Terapeutiska indikationer:

Adjunctive therapy and palliative treatment of inoperable, recurrent, and metastatic endometrial or renal carcinoma. - Known or suspected pregnancy or as a diagnostic test for pregnancy - Undiagnosed vaginal bleeding - Known or suspected malignancy of breast - Active thrombophlebitis, or current or past history of thromboembolic disorders, or cerebral vascular disease - Liver dysfunction or disease - Known sensitivity to DEPO-PROVERA (medroxyprogesterone acetate or any of its other ingredients).

Produktsammanfattning:

DEPO-PROVERA Sterile Aqueous Suspension is available as 400 mg/mL in 2.5 mL vials   NDC 54868-3348-1.

Bemyndigande status:

New Drug Application

Produktens egenskaper

DEPO-PROVERA - MEDROXYPROGESTERONE ACETATE INJECTION, SUSPENSION
PHYSICIANS TOTAL CARE, INC.
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DEPO-PROVERA
MEDROXYPROGES TERONE
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:
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
car