NORELGESTROMIN AND ETHINLY ESTRADIOL

12.1 Mechanism of Action NGMN is the active progestin largely responsible for the progestational activity that occurs in women following application of norelgestromin and ethinyl estradiol transdermal system. NGMN is also the primary active metabolite produced following oral administration of NGM, the progestin component of some oral contraceptive products. Combination hormonal 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).

Contraindications

• • if over age 35 [see Boxed Warning
• • and Warnings and Precautions (5.1) ] Have deep vein thrombosis or pulmonary embolism
• • subacute bacterial endocarditis with valvular disease
• • benign or malignant
• • or liver disease [see Warnings and Precautions (5.3)