Contraception:
Indications for: SEASONALE
Oral contraception.
Adult Dosage:
1 tab daily for 91 days; repeat. Use Sunday start for first cycle.
Children Dosage:
Premenarchal: not recommended.
SEASONALE 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). Undiagnosed abnormal uterine bleeding. Breast or other estrogen- or progestin-sensitive neoplasms. Hepatic tumors, acute viral hepatitis, or severe (decompensated) cirrhosis. Concomitant ombitasvir/paritaprevir/ritonavir, with or without dasabuvir.
Boxed Warning:
Cigarette smoking increases risk of serious cardiovascular events.
SEASONALE 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, jaundice occurs, or at least 4 weeks before through 2 weeks after surgery associated with increased risk of thromboembolism and during and after prolonged immobilization. Gallbladder disease. Pregnancy-related cholestasis. Diabetes. Prediabetes. Uncontrolled dyslipidemia. Hypertriglyceridemia. Depression. Hereditary angioedema. Evaluate significant changes in headaches, irregular uterine bleeding, amenorrhea, retinal vein thrombosis. Cholasma gravidarum. Monitor blood pressure; discontinue if significant hypertension occurs. Do regular complete physical exams. May need barrier contraception with Sunday starts or postpartum use (see full labeling). Hepatic impairment: not studied. Pregnancy: discontinue if occurs. Nursing mothers: use other methods of contraception until breastfeeding is discontinued.
SEASONALE Classification:
Progestin + estrogen.
SEASONALE Interactions:
See Contraindications. ALT elevations with HCV regimen ombitasvir/paritaprevir/ritonavir, with or without dasabuvir; discontinue Seasonale 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 potentiated by atorvastatin, rosuvastatin, acetaminophen, ascorbic acid, or CYP3A4 inhibitors (eg, itraconazole, ketoconazole, voriconazole, fluconazole, grapefruit juice). May be affected by HIV/HCV protease inhibitors or NNRTIs. Concomitant colesevelam; give 4hrs apart. May antagonize acetaminophen, temazepam, salicylic acid, morphine, clofibric acid, lamotrigine. May potentiate cyclosporine, prednisolone, theophylline, tizanidine, voriconazole. May need dose adjustment of thyroid or cortisol hormones. May affect lab tests (eg, coagulation factors, lipids, glucose tolerance, binding proteins, sex hormone binding globulins).
Adverse Reactions:
Headache, menorrhagia, nausea, dysmenorrhea, acne, migraine, breast tenderness, weight increased, depression; pulmonary embolus, cholecystitis, breakthrough bleeding, amenorrhea, oligomenorrhea, chloasma, liver disease.
Drug Elimination:
Levonorgestrel: renal (~45%), fecal (~32%). Ethinyl estradiol: renal, fecal. Half-life: ~30 hours (levonorgestrel); ~15 hours (ethinyl estradiol).
Generic Drug Availability:
YES
How Supplied:
Dispenser (13-week supply)—3
