MEGESTROL ACETATE tablet

Negara: Amerika Serikat

Bahasa: Inggris

Sumber: NLM (National Library of Medicine)

Bahan aktif:

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

Tersedia dari:

State of Florida DOH Central Pharmacy

INN (Nama Internasional):

MEGESTROL ACETATE

Komposisi:

MEGESTROL ACETATE 40 mg

Rute administrasi :

ORAL

Jenis Resep:

PRESCRIPTION DRUG

Indikasi Terapi:

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.

Ringkasan produk:

Megestrol Acetate Tablets, USP 20 mg white, round, scored tablets (Identified 54 763) 40 mg white, round, scored tablets (Identified 54 352) They are supplied by State of Florida DOH Central Pharmacy as follows: Dispense in a well-closed container as defined in the USP/NF.

Status otorisasi:

Abbreviated New Drug Application

Karakteristik produk

MEGESTROL ACETATE - MEGESTROL ACETATE TABLET
STATE OF FLORIDA DOH CENTRAL PHARMACY
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MEGESTROL ACETATE TABLETS USP, 20 MG AND 40 MG
RX ONLY.
DES CRIPTION
Megestrol acetate, is a synthetic, antineoplastic and progestational
drug. Megestrol acetate is a white,
crystalline solid chemically designated as
pregna-4,6-diene-3,20-dione, 17-(acetyloxy)-6-methyl-.
Solubility at 37°C in water is 2 mcg per mL, solubility in plasma is
24 mcg per mL. Its molecular weight
is 384.51. The empirical formula is C
H O and the structural formula is represented as follows:
MEG ESTEROL ACETATE, USP
Megestrol acetate tablets are supplied for oral administration
containing 20 mg or 40 mg megestrol
acetate and the following inactive ingredients: acacia, colloidal
silicon dioxide, dibasic calcium
phosphate, lactose monohydrate, magnesium stearate, and starch (corn).
CLINICAL PHARMACOLOGY
While the precise mechanism by which megestrol 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 sti