MEGESTROL ACETATE- megestrol acetate tablet

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

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

Available from:

West-Ward Pharmaceuticals Corp.

INN (International Name):

MEGESTROL ACETATE

Composition:

MEGESTROL ACETATE 20 mg

Administration route:

ORAL

Prescription type:

PRESCRIPTION DRUG

Therapeutic indications:

Megestrol acetate is 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.

Product summary:

Megestrol Acetate Tablets USP 20 mg tablets are supplied as a white, flat faced, round tablet; scored on one side and product identification “54 763” debossed on the other side. NDC 0054-8603-25: 10x10 Unit-Dose Tablets NDC 0054-4603-25: Bottle of 100 Tablets 40 mg tablets are supplied as a white, flat faced, round tablet; scored on one side and product identification “54 352” debossed on the other side. NDC 0054-8604-25: 10x10 Unit-Dose Tablets NDC 0054-4604-25: Bottle of 100 Tablets Dispense in a tight, child-resistant container as defined in the USP/NF.

Authorization status:

Abbreviated New Drug Application

Summary of Product characteristics

MEGESTROL ACETATE- MEGESTROL ACETATE TABLET
WEST-WARD PHARMACEUTICALS CORP.
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MEGESTROL ACETATE TABLETS USP
RX ONLY
DES CRIPTION
Megestrol acetate, is a synthetic, antineoplastic and progestational
drug. Megestrol acetate USP is a
white to creamy white, crystalline powder 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:
Megestrol Acetate Tablets USP are supplied for oral administration
containing 20 mg or 40 mg
megestrol acetate USP. Each tablet contains 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 stimul