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Ashlyna Generic Name & Formulations
Legal Class
Rx
General Description
Levonorgestrel 0.15mg, ethinyl estradiol 30mcg (84 tabs); ethinyl estradiol 10mcg (7 tabs).
Pharmacological Class
Progestin + estrogen.
How Supplied
Tabs—91
Manufacturer
Ashlyna Indications
Indications
Oral contraception.
Ashlyna Dosage and Administration
Adult
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
Premenarchal: not recommended.
Ashlyna Contraindications
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. Undiagnosed abnormal uterine bleeding. Pregnancy.
Ashlyna Boxed Warnings
Not Applicable
Ashlyna Warnings/Precautions
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. 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.
Ashlyna Pharmacokinetics
See Literature
Ashlyna Interactions
Interactions
May be antagonized by CYP3A4 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, 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.
Ashlyna Adverse Reactions
Adverse Reactions
Bleeding irregularities, weight gain, acne, headache, nausea, vomiting, breast tenderness, dysmenorrhea, abdominal pain, depression; angioedema, chloasma, others (see full labeling).
Ashlyna Clinical Trials
See Literature
Ashlyna Note
Not Applicable
Ashlyna Patient Counseling
See Literature
