GENERESS Fe

Generess Fe Generic Name & Formulations

Legal Class

General Description

Norethindrone 0.8mg, ethinyl estradiol 25mcg (24 tabs), inert+ (4 tabs); +contains ferrous fumarate 75mg; chewable tabs; spearmint flavor.

Pharmacological Class

Progestin + estrogen.

How Supplied

Packs—3

Manufacturer

AbbVie

Generic Availability

YES

Generess Fe Indications

Indications

Oral contraception.

Generess Fe Dosage and Administration

Adult

Chew 1 tab daily without water 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.

Generess Fe 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 (Cat.X).

Generess Fe Boxed Warnings

Boxed Warning

Cigarette smoking increases risk of serious cardiovascular events.

Generess Fe Warnings/Precautions

Warnings/Precautions

Increased risk of cardiovascular events esp. in cigarette smokers >35yrs of age; not recommended. Discontinue if thrombotic event, unexplained visual changes, jaundice, migraine or other severe headaches occur, and at least 4 weeks before through 2 weeks after surgery associated with increased risk of thromboembolism. Uncontrolled hypertension. 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. Women with a BMI >35kg/m²: not evaluated. Nursing mothers: not recommended.

Generess Fe Pharmacokinetics

Metabolism

Hepatic. >95% serum protein bound.

Elimination

Renal, fecal. Half-life: 10.8 hours (norethindrone); 17.1 hours (ethinyl estradiol).

Generess Fe 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.

Generess Fe Adverse Reactions

Adverse Reactions

Nausea/vomiting, headaches/migraine, depression/mood complaints, dysmenorrhea, acne, anxiety symptoms, breast pain/tenderness, increased weight, others.

Generess Fe Clinical Trials

See Literature

Generess Fe Note

Not Applicable

Generess Fe Patient Counseling