Product: LoSeasonique

Company: Duramed

Pharmacologic class: Combination extended- cycle oral contraceptive (progestin + estrogen)

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Active ingredient: Levonorgestrel 0.1 mg + ethinyl estradiol 20 mg (84 orange tabs); ethinyl estradiol 10 mg (seven yellow tabs)

Indication: Oral contraception

Pharmacology: Combination oral contraceptives work by suppressing ovulation and possibly by causing cervical and endometrial changes that reduce the likelihood of implantation. Extended-cycle oral contraceptives offer users the convenience of only four planned menses, each lasting about two to three days, per year. However, unscheduled bleeding and/or spotting may occur, particularly in the first few cycles. This tends to diminish over time.

Clinical trials: A 12-month, open-label trial was conducted to assess the safety and efficacy of LoSeasonique in the prevention of pregnancy. There was no exclusion for BMI or weight, and the weight range for the 2,185 subjects was 87-381 lb. The pregnancy rate in women age 18-35 years was 2.74 pregnancies per 100 women-years, including women who did not take the drug correctly.

Adults: One tab daily for 91 days; repeat. Take at the same time daily. Use Sunday start for first cycle; use backup method until orange tabs are taken for seven consecutive days. Allow at least four weeks postpartum, if not breastfeeding, to begin cycle. Use backup method if two consecutive orange tabs are missed (see literature).

Children: Premenarchal: not recommended.

Contraindications: High risk of arterial or venous thrombotic disease (e.g., smokers or migraineurs over age 35 years, history of deep venous thrombosis or thromboembolism, cerebrovascular or coronary artery disease, thrombogenic valvular disease, atrial fibrillation, subacute bacterial endocarditis, hypercoagulopathies, uncontrolled hypertension, hypertension or diabetes with vascular disease, headaches with focal neurologic symptoms). Breast or other estrogen- or progestin-sensitive neoplasms. Hepatic disease or tumors. Pregnancy (Cat. X).

Precautions: Discontinue if thrombotic event, unexplained visual changes, or jaundice occurs, and at least four weeks before through two weeks after surgery associated with increased risk of thromboembolism. Diabetes. Prediabetes. Uncontrolled dyslipidemias. Pregnancy-related cholestasis. Evaluate significant changes in headaches, irregular uterine bleeding, amenorrhea. Monitor BP. Nursing mothers: not recommended.

Interactions: May be antagonized by CYP3A4 or other enzyme inducers (e.g., 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 (e.g., coagulation factors, lipids, glucose tolerance, binding proteins). May require dose adjustment of thyroid hormones.

Adverse reactions: Irregular uterine bleeding, nausea, mastodynia, headache, acne, decreased libido, fluid retention, melasma, hyperglycemia, hypertriglyceridemia, depression, weight changes; others (see literature). Increased risk of gallbladder disease, thromboembolic disorders.

How supplied: Dispensers—2 (91-day cycles)

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