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LOMEDIA 24 Fe
Contraception
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Drug Name:

LOMEDIA 24 Fe Rx

Generic Name and Formulations:
Norethindrone acetate 1mg, ethinyl estradiol 20mcg (24 white tabs); inert+ (4 tabs); +contains ferrous fumarate 75mg.

Company:
Amneal Pharmaceuticals

Therapeutic Use:

Indications for LOMEDIA 24 Fe:

Oral contraception.

Adult:

1 tab daily for 28 days; repeat.

Children:

Premenarchal: not recommended.

Contraindications:

Thrombophlebitis or thromboembolic disease. History of DVT, cerebrovascular or coronary artery disease. Thrombogenic valvular disease. Severe hypertension. Diabetes with vascular disease. Headaches with focal neurologic symptoms. Major surgery with prolonged immobilization. Known or suspected breast carcinoma, endometrial or other estrogen-dependent neoplasia. Undiagnosed abnormal genital bleeding. Pregnancy-related cholestasis. Hepatic disease or tumors. Pregnancy (Cat. X).

Warnings/Precautions:

Increased risk for arterial or venous thrombotic disease in smokers or women >35yrs. Discontinue if thrombotic event, unexplained visual changes, jaundice, or headache/migraine occurs, and at least 4 weeks before through 2 weeks after surgery associated with increased risk of thromboembolism, and during and after prolonged immobilization. Cardio- or cerebrovascular diseases. Gallbladder disease. Obesity. Diabetes. Prediabetes. Hypertriglyceridemia. Depression. Conditions aggravated by fluid retention; monitor. Evaluate significant changes in headaches, irregular uterine bleeding, amenorrhea, retinal vein thrombosis. Monitor BP. Do regular complete physical exams. Nursing mothers: not recommended.

Interactions:

May be antagonized by anti-infectives and anticonvulsants (eg, phenytoin, phenylbutazone, barbiturates, carbamazepine, felbamate, griseofulvin, oxcarbazepine, rifampin, topiramate), St. John’s wort; use backup contraception. May be potentiated by atorvastatin, acetaminophen, ascorbic acid, or CYP3A4 inhibitors (eg, itraconazole, ketoconazole). May be affected by HIV protease inhibitors. May antagonize acetaminophen, temazepam, salicylic acid, morphine, clofibric acid. May potentiate cyclosporine, prednisolone, theophylline. May affect laboratory tests (eg, coagulation factors, lipids, glucose tolerance, binding proteins, serum folate).

Pharmacological Class:

Progestin + estrogen.

Adverse Reactions:

Headache, vaginal candidiasis, upper respiratory tract infection, nausea, menstrual cramps, breast tenderness, sinusitis, bacterial vaginitis, abnormal cervical smear, acne, UTI, mood swings, weight gain, vomiting, metrorrhagia; serious cardiovascular events and stroke, vascular events, hypertension, irregular uterine bleeding, liver disease.

How Supplied:

Blister cards—3

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