GEN-MEDROXY TABLET 5MG

Country: Canada

Language: English

Source: Health Canada

Active ingredient:

MEDROXYPROGESTERONE ACETATE

Available from:

GENPHARM ULC

ATC code:

G03DA02

INN (International Name):

MEDROXYPROGESTERONE

Dosage:

5MG

Pharmaceutical form:

TABLET

Composition:

MEDROXYPROGESTERONE ACETATE 5MG

Administration route:

ORAL

Units in package:

100/500

Prescription type:

Prescription

Therapeutic area:

PROGESTINS

Product summary:

Active ingredient group (AIG) number: 0106339005; AHFS:

Authorization status:

CANCELLED POST MARKET

Authorization date:

2010-08-04

Summary of Product characteristics

PRODUCT MONOGRAPH
PR GEN-MEDROXY
MEDROXYPROGESTERONE ACETATE TABLETS USP
2.5 MG, 5 MG AND 10 MG
PROGESTAGEN-PROGESTATIONAL STEROID
GENPHARM INC. DATE OF PREPARATION: NOVEMBER 08, 2003
37 ADVANCE ROAD DATE OF REVISION: APRIL 19, 2004
ETOBICOKE, ONTARIO
M8Z 2S6 CONTROL NUMBER: 084817
1
WARNING
As the Women’s Health Initiative (WHI) study results indicated
increased risk of myocardial
infarction (MI), stroke, invasive breast cancer, pulmonary emboli and
deep venous thrombosis
in postmenopausal women receiving treatment with combined conjugated
equine estrogens and
medroxyprogesterone acetate compared to those receiving placebo
tablets, the following
should be highly considered:
C
Estrogen with or without progestins
SHOULD NOT
be prescribed for primary or secondary
prevention of cardiovascular diseases.
C
Estrogens with or without progestins should be prescribed at
THE LOWEST EFFECTIVE DOSE
for the approved indication.
C
Estrogen with or without progestins should be prescribed for
THE SHORTEST PERIOD
possible for the recognized indication
.
PRODUCT MONOGRAPH
PR GEN-MEDROXY
(MEDROXYPROGESTERONE ACETATE TABLETS, USP) 2.5 MG, 5 MG AND 10 MG
PHARMACOLOGIC CLASSIFICATION
PROGESTAGEN-PROGESTATIONAL STEROID
2
ACTION AND CLINICAL PHARMACOLOGY
GEN-MEDROXY
(medroxyprogesterone acetate), an orally-active progestational
steroid, when
administered to women with adequate endogenous estrogen, transforms a
proliferative endometrium
into a secretory endometrium.
GEN-MEDROXY
inhibits the secretion of pituitary gonadotropin
which, in turn, prevents follicular maturation and ovulation.
It has been well established that endometrial hyperplasia experienced
by a large number of post-
menopausal women receiving estrogen only therapy is caused primarily
by the action of estrogen
on the uterus in the absence of progesterone. This unchecked growth of
the endometrium
significantly increases the risk among those women with an intact
uterus of developing endometrial
cancer.
Therefore, for women with intact uteri, progestin therapy is added to
e