DOM-MEDROXYPROGESTERONE TABLET

Страна: Канада

Язык: английский

Источник: Health Canada

Активный ингредиент:

MEDROXYPROGESTERONE ACETATE

Доступна с:

DOMINION PHARMACAL

код АТС:

G03DA02

ИНН (Международная Имя):

MEDROXYPROGESTERONE

дозировка:

10MG

Фармацевтическая форма:

TABLET

состав:

MEDROXYPROGESTERONE ACETATE 10MG

Администрация маршрут:

ORAL

Штук в упаковке:

100/500

Тип рецепта:

Prescription

Терапевтические области:

PROGESTINS

Обзор продуктов:

Active ingredient group (AIG) number: 0106339006; AHFS:

Статус Авторизация:

CANCELLED POST MARKET

Дата Авторизация:

2016-10-25

Характеристики продукта

PRODUCT MONOGRAPH
PR
DOM-MEDROXYPROGESTERONE
(Medroxyprogesterone acetate Tablets USP)
2.5mg, 5 mg and 10 mg
PROGESTIN
DOMINION PHARMACAL
Date of Preparation:
6111 Royalmount Avenue, Suite 100
May 05, 2003
Montreal, Quebec
H4P 2T4
Date of Revision:
May 10, 2004
CONTROL #:
084985
2
PRODUCT MONOGRAPH
PR
DOM-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
Dom-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),
Dom-
MEDROXYPROGESTERONE
transforms
a
proliferative
endometrium
into
a
secretory
endometrium. Furthermore, the anti-cancer activity of
Dom-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
which
in
t