Country: South Africa
Language: English
Source: South African Health Products Regulatory Authority (SAHPRA)
Schering
ANDROCUR 10 mg TABLETS SCHEDULING STATUS: S4 PROPRIETARY NAME (and dosage form): ANDROCUR 10 mg TABLETS Oral antiandrogen COMPOSITION 1 Androcur 10 mg tablet contains cyproterone acetate (6-chloro-17-hydroxy-1alpha,2alpha-methylene-pregna-4,6- diene-3,20-dione-acetate) 10 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 Moderately severe signs of androgenisation in women, eg: • moderately severe forms of hirsutism. • moderately severe androgen-dependent loss of scalp hair (moderately severe androgenetic alopecia). • severe and moderately severe forms of acne and seborrhoea. CONTRA-INDICATIONS Pregnancy; lactation; liver diseases; 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; wasting diseases; depression; previous or existing thromboembolic processes; diabetes with vascular changes; sickle-cell anaemia. DOSAGE AND DIRECTIONS FOR USE Before starting Androcur therapy a thorough general medical and gynaecological examination (including the breasts Read the complete document