País: República de Sud-àfrica
Idioma: anglès
Font: South African Health Products Regulatory Authority (SAHPRA)
Schering
CLIMEN TABLETS SCHEDULING STATUS: S4 PROPRIETARY NAME (and dosage form): CLIMEN TABLETS COMPOSITION 11 white tablets each containing estradiol-17-valerate (estra-1,3,5(10)-triene-3,17beta-diol-17-valerate) 2 mg, plus 10 pink tablets each containing estradiol -17-valerate 2 mg and cyproterone acetate (6-chloro-17-hydroxy- 1alpha,2alpha-methylene-pregna-4,6-diene-3,20-dione-acetate) 1 mg, plus 7 non-hormonal tablets. PHARMACOLOGICAL CLASSIFICATION A. 21.8.2 Progesterones with estrogens. PHARMACOLOGICAL ACTION Estradiol valerate and cyproterone acetate are completely absorbed after oral administration. During the absorption process and the first liver passage, estradiol valerate but not cyproterone acetate is extensively metabolised. Despite complete absorption and ester hydrolysis of estradiol valerate only 3% of the dose is bioavailable as estradiol after oral administration. Cyproterone acetate is completely bioavailable after oral administration. During the absorption process and the first liver passage estradiol valerate is rapidly hydrolysed to 17beta-estradiol and valeric acid. Cyproterone acetate is mainly metabolised to 15beta-OH cyproterone acetate, a pharmacologically active metabolite with similar high antiandrogenic but much lower progestogenic activity as compared to the parent drug. INDICATIONS Climen is indicated in patients (with intact uteri) suffering from climacteric symptomatology. Climen therapy may be used as an adjunct in preventing osteoporosis in postmenopausal women. CONTRA-INDICATIONS Pregnancy, lactation, severe disturbances of liver function, jaundice or persistent itching during a previous pregnancy, previous or existing tumours of the liver, uterus, ovaries or breast or a suspicion of such tumours, endometriosis, existing or previous thromboembolic processes, severe diabetes mellitus wi Llegiu el document complet