NEO ESTRONE TAB 1.25MG TABLET

Land: Kanada

Tungumál: enska

Heimild: Health Canada

Virkt innihaldsefni:

ESTERIFIED ESTROGENS

Fáanlegur frá:

NEOLAB INC

ATC númer:

G03CA

INN (Alþjóðlegt nafn):

NATURAL AND SEMISYNTHETIC ESTROGENS, PLAIN

Skammtar:

1.25MG

Lyfjaform:

TABLET

Samsetning:

ESTERIFIED ESTROGENS 1.25MG

Stjórnsýsluleið:

ORAL

Einingar í pakka:

100/500

Gerð lyfseðils:

Prescription

Lækningarsvæði:

ESTROGENS

Vörulýsing:

Active ingredient group (AIG) number: 0106444001; AHFS:

Leyfisstaða:

CANCELLED POST MARKET

Leyfisdagur:

2008-04-02

Vara einkenni

- 1 -
PRODUCT MONOGRAPH
NEO-ESTRONE
ESTERIFIED ESTROGEN
TABLETS
1.25mg, 0.625mg, 0.3mg
ESTROGEN
NEOLAB INC.
Date of Preparation: January 30, 2004
5476 Upper Lachine Road MG-101-D
Montréal, Québec
Control Number
: 085532
H4A 2A4
- 2 -
PRODUCT MONOGRAPH
NEO-ESTRONE
ESTERIFIED ESTROGEN
TABLETS
1.25mg, 0.625mg, 0.3mg
PHARMACOLOGIC CLASSIFICATION
ESTROGEN
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.
. Estrogens with or without progestins should be prescribed for the
shortest period possible for the
recognized indication.
- 3 -
ACTIONS AND CLINICAL PHARMACOLOGY
NEO-ESTRONE TABLETS contain a sulphate ester form of estrone used in
relieving the menopausal
and post-menopausal symptoms of naturally or surgically induced
estrogen deficiency states.
In general, estrogens are of importance in the development and
maintenance of the female reproductive
system as well as secondary sexual characteristics. After menopause
the ovarian follicle produces less
and less estradiol to convert to estrone. Whereas the ratio of
circulating estradiol to estrone was close to
equal before menopause, after menopause most of the endogenous
circulating hormone is the sulphate ester
form of estrone coming from the conversion of androstendione secreted
by the adrenal cortex. Metabolic
conversion occurring mostly in the liver creates an equilibrium of
various forms of estrogen through
interconversions. Sulfated forms of estrone create a reservoir for
deriv