Contraception:
Indications for: SEASONIQUE
Oral contraception.
Adult Dosage:
1 tab daily for 91 days; repeat. Use Sunday-start regimen. Take pills in order (84 levonorgestrel + ethinyl estradiol tabs, then 7 ethinyl estradiol tabs).
Children Dosage:
Premenarchal: not recommended.
SEASONIQUE Contraindications:
High risk of arterial or venous thrombotic disease (eg, smokers or migraineurs over age 35, DVT or PE, cerebrovascular or coronary artery disease, thrombogenic valvular disease, atrial fibrillation, subacute bacterial endocarditis, hypercoagulopathies, uncontrolled hypertension, hypertension with vascular disease, diabetes over age 35, diabetes with hypertension or vascular disease or other end-organ damage, diabetes of >20yrs duration, headaches with focal neurologic symptoms). Breast or other estrogen or progestin-sensitive neoplasms. Hepatic tumors, acute viral hepatitis, or severe (decompensated) cirrhosis. Undiagnosed abnormal uterine bleeding. Concomitant ombitasvir/paritaprevir/ritonavir, with or without dasabuvir.
Boxed Warning:
Cigarette smoking increases risk of serious cardiovascular events.
SEASONIQUE Warnings/Precautions:
Increased risk of cardiovascular and cerebrovascular events (eg, stroke, MI) esp. women over age 35, smokers, and females with hypertension, dyslipidemia, diabetes, or obesity. Evaluate any medical or family history of thrombotic or thromboembolic disorders prior to initiation. Discontinue if thrombotic event, unexplained visual changes, or jaundice occurs, and at least 4 weeks before through 2 weeks after surgery associated with increased risk of thromboembolism. Gallbladder disease. Pregnancy-related cholestasis. Diabetes. Prediabetes. Uncontrolled dyslipidemia. Hypertriglyceridemia. Depression. Hereditary angioedema. Evaluate significant changes in headaches, irregular uterine bleeding, amenorrhea. Cholasma gravidarum. Monitor blood pressure; discontinue if significant hypertension occurs. Do regular complete physical exams. Hepatic impairment: not studied. Pregnancy: discontinue if occurs. Nursing mothers: use other methods of contraception until breastfeeding is discontinued.
SEASONIQUE Classification:
Progestin + estrogen.
SEASONIQUE Interactions:
See Contraindications. ALT elevations with HCV regimen ombitasvir/paritaprevir/ritonavir, with or without dasabuvir; discontinue Seasonique prior to starting HCV regimen and restart 2wks after completion. Concomitant glecaprevir/pibrentasvir: not recommended. May be antagonized by CYP3A4 or other enzyme inducers (eg, aprepitant, barbiturates, bosentan, carbamazepine, efavirenz, felbamate, griseofulvin, oxcarbazepine, phenytoin, rifampin, rifabutin, rufinamide, St. John’s wort, topiramate, certain protease inhibitors); use backup contraception. May be affected by protease inhibitors, NNRTIs, atorvastatin, acetaminophen, ascorbic acid, itraconazole, ketoconazole. May antagonize lamotrigine. May affect laboratory tests (eg, coagulation factors, lipids, glucose tolerance, binding proteins). May need dose adjustment of thyroid hormones.
Adverse Reactions:
Irregular/heavy uterine bleeding, weight gain, acne, nausea, breast tenderness, headache; pulmonary embolus, cholecystitis, breakthrough bleeding, amenorrhea, oligomenorrhea, chloasma, liver disease.
Drug Elimination:
Levonorgestrel: renal (~45%), fecal (~32%). Ethinyl estradiol: renal, fecal. Half-life: ~34 hours (levonorgestrel); ~18 hours (ethinyl estradiol).
Generic Drug Availability:
YES
How Supplied:
Dispenser (13-week supply)—2
