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The half-life of metabolite excretion is about 1.8 days. Its metabolites are excreted at a urinary to biliary ratio of about 1:2. Cyproterone acetate is partly excreted in unchanged form. The clearance rate from serum is about 3.6 mL/min/kg.Įlimination: Cyproterone acetate serum levels decrease in two phases which are characterized by half-lives of about 0.8 h and about 2.3 - 3.3 days. The main metabolite in plasma was identified as 15β-OH-CPA which is formed via the cytochrome P450 enzyme CYP3A4. Metabolism: Cyproterone acetate is almost completely metabolized. The apparent volume of distribution of cyproterone acetate is about 986±437 L. The ethinylestradiol-induced increase in SHBG does not influence the serum protein binding of cyproterone acetate.
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Only 3.5 - 4.0 % of the total serum drug concentrations are present as free steroid. Bioavailability is about 88 %.ĭistribution: Cyproterone acetate is almost exclusively bound to serum albumin. Peak serum concentrations of 15 ng/mL are reached at about 1.6 hours after single ingestion. Pharmacokinetics: Cyproterone acetate: Absorption: Orally administered cyproterone acetate is rapidly and completely absorbed. The latter may result in a decrease in the occurrence of iron deficiency. In addition to protection against pregnancy, estrogen/progestogen combinations have - besides adverse properties (see Warnings under Precautions, Adverse Reactions) - positive properties: The cycle is more regular and the menstruation is often less painful and bleeding is lighter. The contraceptive effect of Cyproterone acetate + Ethinylestradiol (Diane-35) is based on the interaction of various factors, the most important of which are seen as the inhibition of ovulation and the changes in the cervical secretion. In women experiencing mild forms of hirsutism and, in particular, slightly increased facial hair, results do not, however, become apparent until after several months of use.
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The excessive greasiness of the hair and skin generally disappears earlier. Treatment with Cyproterone acetate + Ethinylestradiol (Diane-35) leads - usually after 3 to 4 months of therapy - to the healing of existing acne efflorescences. The most recent data suggest that the frequency of VTE diagnosis is approximately 4 per 10,000 woman years in non-pregnant non-COC users, and ranges between 20 to 30 per 10,000 pregnant women or postpartum. Post Authorization Safety Studies (PASS) have shown that the frequency of VTE diagnosis ranges between 7-10 per 10,000 woman years in low estrogen dose (< 50 μg ethinylestradiol) COC users. It thereby reduces free, biologically available androgen in the circulation. This antigonadotropic effect is amplified by ethinylestradiol which up-regulates as well the synthesis of Sexual-Hormone-Binding-Globulin (SHBG) in plasma.
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Both substances contained in Cyproterone acetate + Ethinylestradiol (Diane-35) influence beneficially the hyperandrogenic state: Cyproterone acetate is a competitive antagonist on the androgen receptor, has inhibitory effects on the androgen-synthesis in target cells and produces a decrease of the androgen blood concentration through an antigonadotropic effect. Acne, seborrhea, hirsutism and androgenetic alopecia are clinical conditions resulting from aberrations of this target organ which may be caused by increased sensitivity or higher plasma levels of androgen.
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Pharmacology: Pharmacodynamics: The pilosebaceous unit - consisting of the sebaceous gland and the hair follicle - is an androgen-sensitive skin component.