GEN-MEDROXY TABLET 10MG

País: Canadá

Idioma: inglés

Fuente: Health Canada

Ingredientes activos:

MEDROXYPROGESTERONE ACETATE

Disponible desde:

GENPHARM ULC

Código ATC:

G03DA02

Designación común internacional (DCI):

MEDROXYPROGESTERONE

Dosis:

10MG

formulario farmacéutico:

TABLET

Composición:

MEDROXYPROGESTERONE ACETATE 10MG

Vía de administración:

ORAL

Unidades en paquete:

100/500

tipo de receta:

Prescription

Área terapéutica:

PROGESTINS

Resumen del producto:

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

Estado de Autorización:

CANCELLED POST MARKET

Fecha de autorización:

2010-08-04

Ficha técnica

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