País: Canadà
Idioma: anglès
Font: Health Canada
ESTERIFIED ESTROGENS
NEOLAB INC
G03CA
NATURAL AND SEMISYNTHETIC ESTROGENS, PLAIN
1.25MG
TABLET
ESTERIFIED ESTROGENS 1.25MG
ORAL
100/500
Prescription
ESTROGENS
Active ingredient group (AIG) number: 0106444001; AHFS:
CANCELLED POST MARKET
2008-04-02
- 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 Llegiu el document complet