Country: South Africa
Language: English
Source: South African Health Products Regulatory Authority (SAHPRA)
Schering
TRIODENE ED SCHEDULING STATUS: S3 PROPRIETARY NAME (and dosage form): TRIODENE ED Tablets COMPOSITION The 28-day pack (Every-Day pack) contains 21 hormonal tablets, 6 tablets each with gestodene (17alpha-ethinyl-13- ethyl-17beta-hydroxy-4,15-gonadiene-3-one) 0,05 mg and ethinylestradiol (17alpha-ethinyl-estra-1,3,5(10)-triene- 3,17beta-diol) 0,03 mg, plus 5 tablets each with gestodene 0,07 mg and ethinylestradiol 0,04 mg, plus 10 tablets each with gestodene 0,10 mg and ethinylestradiol 0,03 mg, plus 7 non-hormonal tablets. PHARMACOLOGICAL CLASSIFICATION A. 21.8.2 Progesterones with estrogens. PHARMACOLOGICAL ACTION Triodene ED is a low dose triphasic oral contraceptive which is well balanced in terms of estrogenic and progestogenic peripheral effects. Triodene ED contains the progestogen gestodene, the biochemical profile of which is very similar to that of progesterone, in respect of binding sites for steroid hormones. With gestodene there is a virtual absence of estrogenic activity. The mode of action of gestodene in combination with ethinylestradiol includes the inhibition of ovulation by suppression of the mid-cycle surge of luteinising hormone, suppression of endometrial development thus rendering the endometrium unreceptive to implantation and the thickening of cervical mucus so as to constitute a barrier to sperm. Pharmacokinetics Ethinylestradiol and gestodene are rapidly and completely absorbed from the gastrointestinal tract. Peak plasma levels of each substance are reached within 1 to 2 hours. Post maximum concentration curves show two phases with half-lives of 1 and 15 hours in the case of gestodene, and 1 to 3 and approximately 24 hours in the case of ethinylestradiol. After oral administration, gestodene unlike ethinylestradiol is not subject to first-pass metabolism. Foll Read the complete document