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SEASONALE
Contraception
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Drug Name:

SEASONALE Rx

Generic Name and Formulations:
Levonorgestrel 0.15mg, ethinyl estradiol 30micrograms (84 tabs); inert (7 tabs).

Company:
Teva Pharmaceuticals

Therapeutic Use:

Indications for SEASONALE:

Oral contraception.

Adult:

1 tab daily for 91 days; repeat. Use Sunday start for first cycle.

Children:

Premenarchal: not recommended.

Contraindications:

High risk of arterial or venous thrombotic disease (eg, smokers or migraineurs over age 35, history of DVT or PE, cerebrovascular or coronary artery disease, thrombogenic valvular disease, atrial fibrillation, subacute bacterial endocarditis, hypercoagulopathies, uncontrolled hypertension, diabetes with vascular disease, headaches with focal neurologic symptoms). Undiagnosed abnormal uterine bleeding. Breast or other estrogen- or progestin-sensitive neoplasms. Hepatic disease or tumors. Pregnancy. Concomitant ombitasvir/paritaprevir/ritonavir, with or without dasabuvir.

Warnings/Precautions:

Increased risk of cardiovascular events esp. in cigarette smokers >35yrs of age. 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. Cardio- or cerebrovascular disease. 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). Nursing mothers: not recommended.

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. May be antagonized by CYP3A4 or other enzyme inducers (eg, phenytoin, barbiturates, carbamazepine, bosentan, felbamate, griseofulvin, oxcarbazepine, rifampicin, topiramate, rifabutin, rufinamide, aprepitant, St. John’s wort); 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).

Pharmacological Class:

Progestin + estrogen.

Adverse Reactions:

Headache, menorrhagia, nausea, dysmenorrhea, acne, migraine, breast tenderness, weight increased, depression; pulmonary embolus, cholecystitis, breakthrough bleeding, amenorrhea, oligomenorrhea, chloasma, liver disease.

Generic Availability:

YES

How Supplied:

Dispenser (13-week supply)—3

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