PMS-MEDROXYPROGESTERONE TABLET

Country: Canada

Language: English

Source: Health Canada

Active ingredient:

MEDROXYPROGESTERONE ACETATE

Available from:

PHARMASCIENCE INC

ATC code:

G03DA02

INN (International Name):

MEDROXYPROGESTERONE

Dosage:

2.5MG

Pharmaceutical form:

TABLET

Composition:

MEDROXYPROGESTERONE ACETATE 2.5MG

Administration route:

ORAL

Units in package:

100/500

Prescription type:

Prescription

Therapeutic area:

PROGESTINS

Product summary:

Active ingredient group (AIG) number: 0106339004; AHFS:

Authorization status:

CANCELLED POST MARKET

Authorization date:

2016-10-28

Summary of Product characteristics

PRODUCT MONOGRAPH
PR
PMS-MEDROXYPROGESTERONE
(Medroxyprogesterone acetate Tablets USP)
2.5mg, 5 mg and 10 mg
PROGESTIN
PHARMASCIENCE INC..
Date of Preparation:
6111 Royalmount Avenue, Suite 100
September 27, 2002
Montreal, Quebec
H4P 2T4
Date of Revision:
May 10, 2004
CONTROL NO.
085000
2
PRODUCT MONOGRAPH
PR
PMS-MEDROXYPROGESTERONE
(Medroxyprogesterone acetate Tablets USP)
2.5mg, 5 mg and 10 mg
PHARMACOLOGICAL CLASSIFICATION
Progestin
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:
·
Estrogens with or without progestins
SHOULD NOT
be prescribed for primary or secondary
prevention of cardiovascular diseases.
·
Estrogens with or without progestins should be prescribed at
THE LOWEST EFFECTIVE DOSE
for the
approved indication.
·
Estrogen with or without progestins should be prescribed for
THE SHORTEST PERIOD
possible for
the recognized indication.
3
ACTION AND CLINICAL PHARMACOLOGY
pms-MEDROXYPROGESTERONE
(medroxyprogesterone
acetate)
is
an
orally
active
progestational steroid (progestin) derived from a natural source
(soybeans). When administered
to
women
with
adequate
levels
of
estrogen
(endogenous
or
exogenous),
pms-
MEDROXYPROGESTERONE
transforms
a
proliferative
endometrium
into
a
secretory
endometrium. Furthermore, the anti-cancer activity of
pms-MEDROXYPROGESTERONE at
pharmacologic doses, may be dependent on its effect on the
hypothalamic/ pituitary/ gonadal
axis, estrogen receptors and metabolism of steroids at the tissue
level.
CLINICAL PHARMACOLOGY
Medroxyprogesterone acetate is a progestational agent devoid of
androgenic and estrogenic
activity.
Endocrine:
In
appropriate
doses,
medroxyprogesterone
acetate
suppresses
the
secretion
of
pituitary
gonadotropins wh