Contraception:

Indications for: LO LOESTRIN Fe

Oral contraception.

Adult Dosage:

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 Dosage:

Premenarchal: not applicable.

LO LOESTRIN Fe 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. Concomitant ombitasvir/paritaprevir/ritonavir, with or without dasabuvir.

Boxed Warning:

Cigarette smoking and serious cardiovascular events.

LO LOESTRIN Fe 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, and during and after prolonged immobilization. Diabetes. Prediabetes. Uncontrolled dyslipidemias. Hypertriglyceridemia. Gallbladder disease. Pregnancy-related cholestasis. Depression. Evaluate significant changes in headaches, irregular uterine bleeding, amenorrhea. Do regular complete physical exams. Monitor BP; discontinue if significant rise occurs. May need barrier contraception with Sunday starts or postpartum use (see full labeling). BMI >35kg/m2: not evaluated. Pregnancy: do not use. Postmenopausal women, nursing mothers: not recommended.

LO LOESTRIN Fe Classification:

Progestin + estrogen.

LO LOESTRIN Fe Interactions:

See Contraindications. ALT elevations with HCV regimen ombitasvir/paritaprevir/ritonavir, with or without dasabuvir; discontinue Lo Loestrin Fe prior to starting HCV regimen and restart 2wks after completion. 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 potentiated by atorvastatin, acetaminophen, ascorbic acid, or CYP3A4 inhibitors (eg, itraconazole, ketoconazole). May be affected by protease inhibitors, NNRTIs. May antagonize lamotrigine. May affect laboratory tests (eg, coagulation factors, lipids, glucose tolerance, binding proteins). May need dose adjustment of thyroid hormones.

Adverse Reactions:

Nausea, vomiting, headache, bleeding irregularities, dysmenorrhea, weight change, breast tenderness, acne, abdominal pain, anxiety, depression; DVT, ovarian vein thrombosis, cholecystitis, chloasma, liver disease.

Metabolism:

Hepatic.

Drug Elimination:

Renal, fecal. Half-life: ~10 hours (norethindrone); ~16 hours (ethinyl estradiol).

How Supplied:

Dispensers—5, 30 (blister cards)