MEGESTROL ACETATE tablet

Pays: États-Unis

Langue: anglais

Source: NLM (National Library of Medicine)

Ingrédients actifs:

MEGESTROL ACETATE (UNII: TJ2M0FR8ES) (MEGESTROL - UNII:EA6LD1M70M)

Disponible depuis:

Mylan Institutional Inc.

DCI (Dénomination commune internationale):

MEGESTROL ACETATE

Composition:

MEGESTROL ACETATE 20 mg

Mode d'administration:

ORAL

Type d'ordonnance:

PRESCRIPTION DRUG

indications thérapeutiques:

Megestrol Acetate Tablets are indicated for the palliative treatment of advanced carcinoma of the breast or endometrium (i.e., recurrent, inoperable, or metastatic disease). It should not be used in lieu of currently accepted procedures such as surgery, radiation, or chemotherapy. History of hypersensitivity to megestrol acetate or any component of the formulation.

Descriptif du produit:

Megestrol Acetate Tablets USP are available as: 20 mg: White, round, flat-faced, beveled-edge, scored tablet. Debossed with 555/606 on one side and stylized b on the other side. NDC 51079-434-20 – Unit dose blister packages of 100 (10 cards of 10 tablets each). Store at 20° to 25°C (68° to 77°F). [See USP Controlled Room Temperature.]

Statut de autorisation:

Abbreviated New Drug Application

Résumé des caractéristiques du produit

MEGESTROL ACETATE- MEGESTROL ACETATE TABLET
MYLAN INSTITUTIONAL INC.
----------
MEGESTROL ACETATE TABLETS USP
RX ONLY
DESCRIPTION
Megestrol Acetate Tablets USP are a synthetic, antineoplastic and
progestational drug. Megestrol
acetate is a white, crystalline solid chemically designated as
17α-acetyloxy-6-methylpregna-4,6-diene-
3,20-dione. Solubility at 37°C in water is 2 mcg per mL, solubility
in plasma is 24 mcg per mL. The
structural formula is represented as follows:
C
H
O M.W. 384.51
24
32
4
Megestrol Acetate Tablets USP are supplied as tablets for oral
administration containing 20 mg or 40
mg megestrol acetate.
INACTIVE INGREDIENTS: Anhydrous lactose, dibasic calcium phosphate
dihydrate, magnesium stearate,
microcrystalline cellulose, and sodium starch glycolate.
CLINICAL PHARMACOLOGY
While the precise mechanism by which megestrol acetate produces its
antineoplastic effects against
endometrial carcinoma is unknown at the present time, inhibition of
pituitary gonadotrophin production
and resultant decrease in estrogen secretion may be factors. There is
evidence to suggest a local effect
as a result of the marked changes brought about by the direct
instillation of progestational agents into
the endometrial cavity. The antineoplastic action of megestrol acetate
on carcinoma of the breast is
effected by modifying the action of other steroid hormones and by
exerting a direct cytotoxic effect on
tumor cells. In metastatic cancer, hormone receptors may be present in
some tissues but not others. The
receptor mechanism is a cyclic process whereby estrogen produced by
the ovaries enters the target
cell, forms a complex with cytoplasmic receptor and is transported
into the cell nucleus. There it
induces gene transcription and leads to the alteration of normal cell
functions. Pharmacologic doses of
megestrol acetate not only decrease the number of hormone-dependent
human breast cancer cells but
also are capable of modifying and abolishing the stimulatory effects
of estrogen on these cells. It has
been suggested that