Land: Canada
Taal: Engels
Bron: Health Canada
DANAZOL
SANOFI-AVENTIS CANADA INC
G03XA01
DANAZOL
50MG
CAPSULE
DANAZOL 50MG
ORAL
100
Prescription
ANDROGENS
Active ingredient group (AIG) number: 0110952003; AHFS:
APPROVED
2006-04-05
PRODUCT MONOGRAPH Pr CYCLOMEN ® (danazol capsules, USP) _ _ 50mg, 100mg, 200mg Capsules Pituitary Gonadotropin Inhibitor sanofi-aventis Canada Inc. 2905 Place Louis-R.-Renaud Laval, Quebec H7V 0A3 Date of Revision: May 18, 2017 Submission Control No. : 204093 s-a Version dated May 18, 2017 2 PRODUCT MONOGRAPH Pr Cyclomen ® (danazol capsules, USP) THERAPEUTIC CLASSIFICATION Pituitary gonadotropin inhibitor ACTIONS AND CLINICAL PHARMACOLOGY In women of reproductive age, the primary mode of action of Cyclomen (danazol) is believed to be by suppression of the pituitary-ovarian axis, and inhibition of the output of gonadotropins from the pituitary gland. Other mechanisms of action currently postulated to explain its effects are: 1) inhibition of midcycle FSH and LH surges; 2) inhibition of enzymes required for gonadal hormone synthesis; and 3) competitive binding of danazol to steroid receptors at target organs. Danazol may also inhibit cyclic AMP accumulation in granulosa and luteal cells in response to gonadotrophic hormones. A wide range of actions on plasma proteins including increasing prothrombin, plasminogen, antithrombin III, alpha-2-macroglobulin, C1 esterase inhibitor, erythropoietin and reducing fibrinogen, thyroid binding and sex hormone binding globulins has been observed. Danazol increases the proportion and concentration of testosterone carried unbound in the plasma. In postmenopausal women, danazol suppresses FSH and LH levels. It has a weak dose-related androgenic activity. Danazol is a weak androgen but anti-androgenic, progestogenic, anti-progestogenic, estrogenic and anti-estrogenic actions have also been observed. Following oral administration in healthy adult females, danazol displays dose dependent absorption, which approaches linearity over the dosage range 100 to 400 mg twice daily in multiple dosing. Absorption is affected by prandial state, being approximately doubled if danazol is taken just after, compared with two hours before, a meal. The principal metabolites of danazol appear to be e Lees het volledige document