LO LOESTRIN FE

Last Updated: May 18, 2011

Indication(s):

Oral contraception.

Pharmacology:

Combination oral contraceptives reduce the risk of becoming pregnant primarily by the suppression of ovulation. Changes in the endometrium and cervical mucus may play a role as well in reducing the likelihood of implantation.

Clinical Trials:

A one-year, multicenter, open-label trial was conducted to assess the efficacy of this product in the prevention of pregnancy. The study included 1,270 women 18–35 years of age, completing the equivalent of 12,482 evaluable cycles of exposure. Patients with a body mass index (BMI) over 35kg/m² were excluded. The pregnancy rate (Pearl Index) was 2.92 pregnancies per 100 women-years of use, which included data from those women who did not take the drug correctly.

Legal Classification:

Rx

Adults:

1 tab daily for 28 days; repeat. Take at the same time daily, in the correct order. Start Day 1 of menstrual cycle. Allow at least 4 weeks postpartum, if not breastfeeding, to begin cycle; use backup method for first 7 days.

Children:

Premenarchal: not applicable.

Contraindication(s):

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 (Cat.X).

Warnings/Precautions:

Not for use in women with BMI >35kg/m². 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.

Interaction(s):

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.

Adverse Reaction(s):

Headache, nausea, vomiting, bleeding irregularities, dysmenorrhea, weight change, mastodynia, acne, abdominal pain, anxiety, depression; angioedema, chloasma, others (see literature).

How Supplied:

Packs—5

Last Updated:

6/16/2011