Country: South Africa
Language: English
Source: South African Health Products Regulatory Authority (SAHPRA)
Schering
ANDROCUR 100 mg TABLETS SCHEDULING STATUS: S4 PROPRIETARY NAME (and dosage form): ANDROCUR 100 mg TABLETS Oral antiandrogen COMPOSITION 1 Androcur 100 mg tablet contains cyproterone acetate (6-chloro-17-hydroxy-1alpha,2alpha-methylene-pregna-4,6- diene-3,20-dione-acetate) 100 mg. PHARMACOLOGICAL CLASSIFICATION A. 21.12 Hormone inhibitors. PHARMACOLOGICAL ACTION Cyproterone acetate has an antiandrogenic, progestational and antigonadotropic effect. Cyproterone acetate inhibits competitively the effect of androgens at their target organs. The following associated effects, among others, have been described in men: inhibition of sexual drive, reduction of sebaceous gland activity, influence on hair growth, prevention of androgenic growth impulses to the prostatic tissue. Cyproterone acetate has a central inhibiting effect. The antigonadotropic effect leads to a reduction of testosterone synthesis in the testes and, hence, to a reduction of the serum concentration of testosterone. The antigonadotropic effect of cyproterone acetate is also exerted when the substance is combined with LH-RH agonists. The initial increase of testosterone provoked by this substance group is decreased by cyproterone acetate. Prolactin levels may increase with higher doses of cyproterone acetate. INDICATIONS Inoperable carcinoma of the prostate. CONTRA-INDICATIONS Liver diseases, Dubin-Johnson syndrome, Rotor syndrome, previous or existing liver tumours (if these are not due to metastases), wasting diseases (with the exception of inoperable carcinoma of the prostate), severe chronic depression, existing thromboembolic processes. In patients with a history of thromboembolic processes or suffering from sickle-cell anaemia or from severe diabetes with vascular changes, the risk:benefit ratio must be considered carefully in each individual Read the complete document