Acne vulgaris (Moderate), Contraception

Contraceptive; Estrogen and Progestin Combination

Distribution: Drospirenone: ~4 L/kg; Ethinyl estradiol: ~4 to 5 L/kg Metabolism: Drospirenone: To inactive metabolites, minor metabolism hepatically via CYP3A4; Ethinyl estradiol: Hepatic via CYP3A4; forms metabolites; undergoes first-pass metabolism and enterohepatic circulation Bioavailability: Drospirenone: ~76%; Ethinyl estradiol: ~40% Half-life elimination: Terminal: Drospirenone: ~30 hours; Ethinyl estradiol: ~24 hours Excretion: Drospirenone, ethinyl estradiol: Urine and feces

Adrenal insufficiency Breast cancer or other estrogen or progestin-sensitive cancer, current or past history Cerebrovascular disease Concomitant use with hepatitis C drug combinations containing ombitasvir, paritaprevir/ritonavir, with or without dasabuvir Coronary artery disease Deep vein thrombosis or pulmonary embolism, current or past history Diabetes mellitus with vascular disease Headaches with focal neurological symptoms or migraine headaches with or without aura if over age 35 years Hepatic dysfunction Hepatic tumors, benign or malignant Hypercoagulopathies, inherited or acquired Hypertension, uncontrolled Pregnancy Renal insufficiency Smoking and over age 35 years Thrombogenic valvular or thrombogenic rhythm diseases of the heart (eg, subacute bacterial endocarditis with valvular disease or atrial fibrillation) Uterine bleeding, undiagnosed, abnormal

Drospirenone: X(FDA) Ethinyl Estradiol: X(FDA)

Infant risk has been demonstrated.

Cardiovascular: Arterial thromboembolism, cerebral thrombosis, hypertension, local thrombophlebitis, mesenteric thrombosis, myocardial infarction, pulmonary embolism, retinal thrombosis Central nervous system: Cerebral hemorrhage Gastrointestinal: Gallbladder disease Hepatic: Hepatic adenoma, hepatic neoplasm (benign)

1 active tablet orally every day for 24 consecutive days followed by 1 inert (white) tablet daily for 4 days per menstrual cycle; repeat cycle.