Country: South Africa
Language: English
Source: South African Health Products Regulatory Authority (SAHPRA)
Schering
ANDROCUR 50 mg TABLETS SCHEDULING STATUS: S4 PROPRIETARY NAME (and dosage form): ANDROCUR 50 mg TABLETS Oral antiandrogen COMPOSITION 1 Androcur 50 mg tablet contains cyproterone acetate (6-chloro-17-hydroxy-1alpha,2alpha-methylene-pregna-4,6- diene-3,20-dione-acetate) 50 mg. PHARMACOLOGICAL CLASSIFICATION A. 21.12 Hormone inhibitors. PHARMACOLOGICAL ACTION Androcur is an antiandrogenic hormone preparation. The active substance, cyproterone acetate, has three partial effects: an antiandrogenic effect, a progestational effect and an antigonadotropic effect. Cyproterone acetate blocks the effect of endogenously produced and exogenously administered androgens at the target organs by means of competitive inhibition. The stimulating effect of male sex hormones on androgen dependent structures and functions is weakened or abolished by cyproterone acetate. The inherent progestational activity exerts a negative feedback on the hypothalamic receptors so leading to a reduction in gonadotropin release, and hence to diminished production of androgens. INDICATIONS • In men Reduction of drive in sexual deviations, antiandrogen treatment in inoperable carcinoma of the prostate. • In women Severe signs of androgenisation, eg very severe hirsutism, androgen-dependent severe loss of scalp hair eventually resulting in baldness (severe androgenic alopecia), often attended by severe forms of acne and/or seborrhoea. CONTRA-INDICATIONS Pregnancy; lactation; liver disease; a history of jaundice or persistent itching during a previous pregnancy; a history of herpes of pregnancy; Dubin-Johnson syndrome; Rotor syndrome; previous or existing liver tumours (in carcinoma of the prostate only if these are not due to metastases); wasting diseases (with the exception of carcinoma of the prostate); depression; Read the complete document