Country: South Africa
Language: English
Source: South African Health Products Regulatory Authority (SAHPRA)
Schering
CLIMARA-50 CLIMARA-75 CLIMARA-100 SCHEDULING STATUS: S4 PROPRIETARY NAME (and dosage form): CLIMARA-50 CLIMARA-75 CLIMARA-100 Estradiol transdermal systems COMPOSITION Climara-50: 12,5 cm² patch containing 3,9 mg of estradiol hemihydrate (corresponding to estradiol 3,8 mg). Climara-75: 18,75 cm² patch containing 5,9 mg of estradiol hemihydrate (corresponding to estradiol 5,7 mg). Climara-100: 25,0 cm² patch containing 7,8 mg of estradiol hemihydrate (corresponding to estradiol 7,6 mg). PHARMACOLOGICAL CLASSIFICATION A. 21.8.1 Estrogens. PHARMACOLOGICAL ACTION Estrogens are largely responsible for development and maintenance of the female reproductive and secondary sexual characteristics. Estradiol is the principal intracellular human estrogen and is substantially more potent than its metabolites estrone and estriol at receptor level. Circulating estrogens modulate the pituitary secretion of gonadotrophins, luteinising hormone (LH) and follicle stimulating hormone (FSH) through a negative feedback mechanism. After dermal application of Climara, estradiol is absorbed through the skin. Nominal average estradiol absorption rates of 50, 75 and 100 micrograms/day were calculated for Climara-50, Climara-75 and Climara-100, respectively. During a once-a-week application regimen of Climara patches, smooth and consistent estradiol and estrone serum level profiles within the desired range are achieved. The estradiol serum level profile is directly proportional to the area of the patch. Mean steady state estradiol serum levels are approximately 35 pg/mL (12,5 cm² patch), 53 pg/mL (18,75 cm² patch) and 70 pg/mL (25 cm² patch). INDICATIONS Estrogen replacement therapy for patients with symptoms due to natural menopause or surgically induced menopause (only if due to noncarcinomatous diseases) eg vasomotor sympt Read the complete document