Mircette

[desogestrel/ ethinyl estradiol and ethinyl estradiol]

Ethinyl estradiol:

Ethinyl estradiol is subject to a significant degree of presystemic conjugation (phase II metabolism). Ethinyl estradiol escaping gut wall conjugation undergoes phase I metabolism and hepatic conjugation (phase II metabolism). Major phase I metabolites are 2-OH-ethinyl estradiol and 2-methoxy-ethinyl estradiol. Sulfate and glu-curonide conjugates of both ethinyl estradiol and phase I metabolites, which are excreted in bile, can undergo enterohepatic circulation.

Excretion

Text Continues Below

---

Etonogestrel and ethinyl estradiol are excreted in urine, bile, and feces. At steady state, on Day 21, the elimination half-life of etonogestrel is 27.8± 7.2 hours and the elimination half-life of ethinyl estradiol for the combination tablet is 23.9± 25.5 hours. For the 0.01 mg ethinyl estradiol tablet [yellow], the elimination half-life at steady state, Day 28, is 18. 9± 8.3 hours.

Special Populations

Race

There is no information to determine the effect of race on the pharmacokinetics of Mircette ® (desogestrel/ ethinyl estradiol and ethinyl estradiol) Tablets.

Hepatic Insufficiency

No formal studies were conducted to evaluate the effect of hepatic disease on the disposi-tion of Mircette ® .

Renal Insufficiency

No formal studies were conducted to evaluate the effect of renal disease on the disposition of Mircette ® .

Drug-Drug Interactions

Interactions between desogestrel/ ethinyl estradiol and other drugs have been reported in the literature. No formal drug-drug interaction studies were conducted (see PRECAUTIONS section).

Page:  << Prev | 1 | 2 | 3