Country: Canada
Language: English
Source: Health Canada
CYPROTERONE ACETATE; ETHINYL ESTRADIOL
ALTIUS HEALTHCARE INC
G03HB01
CYPROTERONE AND ESTROGEN
2MG; 0.035MG
TABLET
CYPROTERONE ACETATE 2MG; ETHINYL ESTRADIOL 0.035MG
ORAL
21
Prescription
OTHER MISCELLANEOUS THERAPEUTIC AGENTS
Active ingredient group (AIG) number: 0232337001; AHFS:
APPROVED
2017-03-20
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 Read the complete document