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XULANE
Contraception
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Drug Name:

XULANE Rx

Generic Name and Formulations:
Norelgestromin 150mcg/day, ethinyl estradiol 35mcg/day; transdermal patch.

Company:
Mylan Inc.

Therapeutic Use:

Indications for XULANE:

Transdermal contraception.

Limitations Of use:

May be less effective in patients ≥90kg (198lbs).

Adult:

Apply to abdomen, buttock, upper outer arm, or back; with each new patch, rotate application site (may use same anatomic area). Apply 1 patch once weekly for 3 weeks, then 1 patch-free week; repeat.

Children:

Premenarchal: not applicable.

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.

Warnings/Precautions:

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. Higher estrogen exposure than oral contraceptives (may increase side effect risk). Gallbladder disease. Uncontrolled dyslipidemia. Hypertriglyceridemia; increased risk of pancreatitis. Diabetes. Obesity. Depression. Hereditary angioedema. Cholasma gravidarum. Evaluate significant changes in headaches, irregular uterine bleeding, amenorrhea. Monitor blood pressure. Do regular complete physical exams. Use barrier contraception with Sunday starts or postpartum starts (see full labeling). Nursing mothers: not recommended.

Interactions:

Antagonized by hepatic enzyme inducing drugs (eg, rifampin, griseofulvin, St. John's Wort, barbiturates, bosentan, carbamazepine, felbamate, oxcarbazepine, phenytoin, topiramate), possibly others. May antagonize lamotrigine; consider dosage adjustment. May be affected by HIV protease inhibitors, NNRTIs. May be potentiated by acetaminophen, ascorbic acid, atorvastatin, rosuvastatin, and CYP3A4 inhibitors (eg, itraconazole, ketoconazole, voriconazole, fluconazole, grapefruit juice). May potentiate cyclosporine, prednisolone, theophylline, tizanidine, voriconazole. May antagonize acetaminophen, clofibric acid, morphine, salicyclic acid, temazepam. May affect measurement of clotting factors, thyroid binding globulin, sex hormone binding globulin, lipds, glucose, other serum binding proteins.

Pharmacological Class:

Progestin + estrogen.

Adverse Reactions:

Breast symptoms, nausea, vomiting, headache, application site disorder, abdominal pain, dysmenorrhea, vaginal bleeding, menstrual disorders, mood, affect, and anxiety disorders; hypertension, amenorrhea, oligomenorrhea, transient delay of ovulation after discontinuation, edema, intolerance to contact lens, possible venous thromboembolism; others (see full labeling).

Metabolism:

Hepatic. >97% protein bound.

Elimination:

Fecal, renal.

How Supplied:

Patches—3

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