Country: South Africa
Language: English
Source: South African Health Products Regulatory Authority (SAHPRA)
Schering
YASMIN SCHEDULING STATUS: S3 PROPRIETARY NAME (and dosage form): YASMIN Tablets COMPOSITION The 28-day pack (Every-Day pack) contains 21 hormonal tablets each with drospirenone (6beta,7beta,15beta,16beta- dimethylene-3-oxo-17alpha-pregn-4-ene-21,17-carbolactone) 3 mg and ethinylestradiol (17alpha-ethinyl-1,3,5(10)- estratriene-3,17beta-diol) 0,03 mg, plus 7 inactive tablets. PHARMACOLOGICAL CLASSIFICATION A. 18.8 Ovulation controlling agents. PHARMACOLOGICAL ACTION Pharmacodynamic properties The contraceptive effect of Yasmin is based on the interaction of various factors, the most important of which are seen as the inhibition of ovulation and the changes in the endometrium. Yasmin is a combined oral contraceptive with ethinylestradiol and the progestogen drospirenone. In a therapeutic dosage, drospirenone also possesses antiandrogenic and mild antimineralocorticoid properties. It has no estrogenic, glucocorticoid and antiglucocorticoid activity. There are indications from clinical studies that the mild antimineralocorticoid properties of Yasmin result in a mild antimineralocorticoid effect. With the use of the higher dosed combined oral contraceptives (50 micrograms ethinylestradiol) the risk of endometrial and ovarian cancer is reduced. Whether this also applies to lower dosed combined oral contraceptives remains to be confirmed. Pharmacokinetic properties • Drospirenone (3 mg) Absorption The absolute bioavailability of drospirenone is between 76 and 85%. Concomitant ingestion of food has no influence on bioavailability. Distribution After oral administration, serum drospirenone levels decrease in two phases which are characterised by half-lives of 1,6 +0,7 hours and 27,0 +7,5 hours, respectively. Drospirenone is bound to serum albumin and does not bind to sex hormone binding globulin (SHBG) Read the complete document