MEGACE TABLET

Country: Canada

Language: English

Source: Health Canada

Active ingredient:

MEGESTROL ACETATE

Available from:

BRISTOL-MYERS SQUIBB CANADA

ATC code:

L02AB01

INN (International Name):

MEGESTROL

Dosage:

160MG

Pharmaceutical form:

TABLET

Composition:

MEGESTROL ACETATE 160MG

Administration route:

ORAL

Units in package:

30

Prescription type:

Prescription

Therapeutic area:

ANTINEOPLASTIC AGENTS

Product summary:

Active ingredient group (AIG) number: 0111633003; AHFS:

Authorization status:

CANCELLED POST MARKET

Authorization date:

2009-03-09

Summary of Product characteristics

PRODUCT MONOGRAPH
MEGACE*
(megestrol acetate)
Tablets USP, 40 and 160 mg
Progestogen / Antineoplastic / Antianorexic / Anticachectic
MEGACE* OS
(megestrol acetate, USP)
Oral Suspension, 40 mg/mL
Antianorexic / Anticachectic
Date of Preparation:
Bristol-Myers Squibb Canada
October 25, 2005
2365 Côte de Liesse Rd
Montreal, Canada.
Date of Revision:
*
TM of Mead Johnson & Company used under licence by
Bristol-Myers Squibb Canada
Control Number:
101903
1
PRODUCT MONOGRAPH
NAME OF DRUG
MEGACE*
(megestrol acetate)
Tablets USP, 40 and 160 mg
THERAPEUTIC CLASSIFICATION
Progestogen / Antineoplastic / Antianorexic / Anticachectic
MEGACE* OS
(megestrol acetate, USP)
Oral Suspension, 40 mg/mL
THERAPEUTIC CLASSIFICATION
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.
MEGACE (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
2
*
Pharmacokinetic data from one patient excluded due to unusually high
drug levels.
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
ma