CLÉO -35 TABLET

Pays: Canada

Langue: anglais

Source: Health Canada

Ingrédients actifs:

CYPROTERONE ACETATE; ETHINYL ESTRADIOL

Disponible depuis:

ALTIUS HEALTHCARE INC

Code ATC:

G03HB01

DCI (Dénomination commune internationale):

CYPROTERONE AND ESTROGEN

Dosage:

2MG; 0.035MG

forme pharmaceutique:

TABLET

Composition:

CYPROTERONE ACETATE 2MG; ETHINYL ESTRADIOL 0.035MG

Mode d'administration:

ORAL

Unités en paquet:

21

Type d'ordonnance:

Prescription

Domaine thérapeutique:

OTHER MISCELLANEOUS THERAPEUTIC AGENTS

Descriptif du produit:

Active ingredient group (AIG) number: 0232337001; AHFS:

Statut de autorisation:

APPROVED

Date de l'autorisation:

2017-03-20

Résumé des caractéristiques du produit

PRODUCT MONOGRAPH
PR
CLÉO -35
2 mg cyproterone acetate and 0.035 mg ethinyl estradiol tablets
THERAPEUTIC CLASSIFICATION
Acne Therapy
Altius Healthcare Inc.
Date of Preparation:
31B - 665 Millway Avenue,
March 16, 2017
Concord, Ontario
L4K 3T8
Submission Control No.: 202061
2
PRODUCT MONOGRAPH
PR CLÉO -35
cyproterone acetate and ethinyl estradiol tablets
THERAPEUTIC CLASSIFICATION
Acne Therapy
ACTION AND CLINICAL PHARMACOLOGY
Cyproterone acetate and ethinyl estradiol is a combination
antiandrogen-estrogen for use in
the treatment of androgen-dependent dermatological conditions in
females.
Cyproterone acetate is a steroid compound with potent antiandrogenic,
progestogenic and
antigonadotrophic activity. It exerts its antiandrogenic effect by
blocking androgen receptors. It
also reduces androgen synthesis by a negative feedback effect on the
hypothalamo-pituitary-
ovarian systems. The estrogen component (ethinyl estradiol) of
cyproterone acetate and ethinyl
estradiol increases levels of sex hormone binding globulin (SHBG) and
thus reduces the free
circulating plasma levels of androgens. Cyproterone acetate has no
tendency to reduce SHBG
levels.
If used alone in women, cyproterone acetate leads to menstrual cycle
disturbances which are
avoided when combined with ethinyl estradiol. When cyproterone acetate
and ethinyl
estradiol tablets are administered in a cyclic manner it has the added
effect of preventing
ovulation and possible conception.
The components of cyproterone acetate and ethinyl estradiol tablets
are rapidly absorbed after
oral administration. Due to the long terminal half-life of cyproterone
acetate, a 4-fold increase in
plasma levels occurs after 6 to 12 days of daily dosing. Long-term
therapy (36 months) with
cyproterone acetate and ethinyl estradiol tablets did not have a
significant influence on lipid
metabolism. A trend to increased plasma cholesterol and triglyceride
levels was observed. There
was a slight decrease in low density lipoprotein (LDL) with a
simultaneous increase in high
density lip