Nordette (Levonorgestrel / Ethinyl Estradiol) - Description and Clinical Pharmacology

Revised NOVEMBER 2004

3109091582501

Patients should be counseled that this product does not protect against HIV infection (AIDS) and other sexually transmitted diseases .

DESCRIPTION

21 light-orange Nordette tablets, each containing 0.15 mg of levonorgestrel, (d (-)-13 beta-ethyl-17-alpha-ethinyl-17-beta-hydroxygon-4-en-3-one), a totally synthetic progestogen, and 0.03 mg of ethinyl estradiol, (19-nor-17α-pregna-1,3,5 (10)-trien-20-yne-3,17-diol), and 7 pink inert tablets. The inactive ingredients present are cellulose, D&C Red 30, FD&C Yellow 6, lactose, magnesium stearate, and polacrilin potassium.

Levonorgestrel

Ethinyl Estradiol

CLINICAL PHARMACOLOGY

Combination oral contraceptives act by suppression of gonadotropins. Although the primary mechanism of this action is inhibition of ovulation, other alterations include changes in the cervical mucus (which increase the difficulty of sperm entry into the uterus) and the endometrium (which reduce the likelihood of implantation).