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LOSEASONIQUE
Contraception
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Drug Name:

LOSEASONIQUE Rx

Generic Name and Formulations:
Levonorgestrel 0.1mg + ethinyl estradiol 20micrograms (84 orange tabs); ethinyl estradiol 10micrograms (7 yellow tabs).

Company:
Teva Pharmaceuticals

Therapeutic Use:

Indications for LOSEASONIQUE:

Oral contraception.

Adult:

1 tab daily for 91 days; repeat. Take at the same time daily. Use Sunday start for 1st cycle; use backup method until orange tabs are taken for 7 consecutive days. Allow at least 4 weeks postpartum, if not breastfeeding, to begin cycle. Use backup method if 2 consecutive orange tabs are missed (see full labeling).

Children:

Pre-menarchal: not recommended.

Contraindications:

High risk of arterial or venous thrombotic disease (eg, smokers or migraineurs over age 35, history of DVT or thromboembolism, 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). 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, or jaundice occurs, and at least 4 weeks before through 2 weeks after surgery associated with increased risk of thromboembolism. Gallbladder disease. Diabetes. Prediabetes. Uncontrolled dyslipidemias. Hypertriglyceridemia. Pregnancy-related cholestasis. Depression. Evaluate significant changes in headaches, irregular uterine bleeding, amenorrhea. Monitor blood pressure. Do regular complete physical exams. Nursing mothers: not recommended.

Interactions:

See Contraindications. ALT elevations with HCV regimen ombitasvir/paritaprevir/ritonavir, with or without dasabuvir; discontinue Loseasonique prior to starting HCV regimen and restart 2wks after completion. May be antagonized by CPY3A4 or other enzyme inducers (eg, barbiturates, bosentan, carbamazepine, felbamate, griseofulvin, oxcarbazepine, phenytoin, rifampin, St. John's wort, topiramate); use backup contraception. May be affected by protease inhibitors. May antagonize lamotrigine. May affect lab tests (eg, coagulation factors, lipids, glucose tolerance, binding proteins). May need dose adjustment of thyroid hormones.

Pharmacological Class:

Progestin + estrogen.

Adverse Reactions:

Irregular uterine bleeding, nausea, breast tenderness, headache, dysmenorrhea, vomiting, back pain, acne, weight gain; thromboembolic events, liver disease.

How Supplied:

Dispensers—2 (2 X 91 day cycles)

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