CYCLOMEN CAPSULE

Land: Canada

Sprog: engelsk

Kilde: Health Canada

Aktiv bestanddel:

DANAZOL

Tilgængelig fra:

SANOFI-AVENTIS CANADA INC

ATC-kode:

G03XA01

INN (International Name):

DANAZOL

Dosering:

100MG

Lægemiddelform:

CAPSULE

Sammensætning:

DANAZOL 100MG

Indgivelsesvej:

ORAL

Enheder i pakken:

100

Recept type:

Prescription

Terapeutisk område:

ANDROGENS

Produkt oversigt:

Active ingredient group (AIG) number: 0110952002; AHFS:

Autorisation status:

APPROVED

Autorisation dato:

2006-04-05

Produktets egenskaber

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