MEGESTROL TABLET

Country: Canada

Language: English

Source: Health Canada

Active ingredient:

MEGESTROL ACETATE

Available from:

APOTEX INC

ATC code:

L02AB01

INN (International Name):

MEGESTROL

Dosage:

40MG

Pharmaceutical form:

TABLET

Composition:

MEGESTROL ACETATE 40MG

Administration route:

ORAL

Units in package:

100

Prescription type:

Prescription

Therapeutic area:

ANTINEOPLASTIC AGENTS

Product summary:

Active ingredient group (AIG) number: 0111633001

Authorization status:

APPROVED

Authorization date:

2020-12-16

Summary of Product characteristics

Page 1 of 14
PRODUCT MONOGRAPH
MEGESTROL
MEGESTROL ACETATE TABLETS USP
40 MG AND 160 MG
PROGESTOGEN / ANTINEOPLASTIC / ANTIANOREXIC / ANTICACHECTIC
APOTEX INC.
150 SIGNET DRIVE
TORONTO, ONTARIO
M9L 1T9
DATE OF PREPARATION
:
DECEMBER 10, 2020
CONTROL NO.:
233991
Page 2 of 14
PRODUCT MONOGRAPH
MEGESTROL
Megestrol Acetate Tablets USP 40 mg and 160 mg
THERAPEUTIC CLASSIFICATION
Progestogen / Antineoplastic / Antianorexic / Anticachectic
ACTION AND CLINICAL PHARMACOLOGY
The precise mechanism of action by which megestrol acetate produces
its antineoplastic effects
is unknown at present. Pharmacologic doses of megestrol acetate
exerted a direct cytotoxic effect
on human breast cancer cells _in vitro _and proved capable of
modifying and abolishing the
stimulatory effects of estrogen on breast cancer cell lines.
Megestrol acetate interacts with progesterone receptors to stimulate
cell maturation through a
progestin–inducing mechanism. It has also been shown to have certain
androgenic properties and
may also modify glucocorticoid action by binding to the glucocorticoid
receptor.
In previously untreated breast cancer patients with ER
+
PR
+
receptor status, endocrine therapy has
been shown to produce responses in up to 81% of patients.
Inhibition of persistent endometrial hyperplasia and of persistent
endometrial adenocarcinoma
was observed upon administration of megestrol acetate in doses of 160
mg/day. Megestrol
acetate partially inhibited expression of estrogen dependent secretory
proteins and certain
constituent proteins in the rat uterine epithelium.
Metastatic carcinoma of the prostate responds to a variety of hormone
manipulations that
decrease the level of androgens in androgen–sensitive tissue. The
primary mechanism of action
of megestrol acetate and DES is the suppression of luteinizing hormone
from the pituitary gland,
which leads to suppression of serum androgens arising from the
testicle.
Megestrol acetate may have other mechanisms of action as well,
including an antiandrogen
activity, suppression of adrena