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DESOGEN
Contraception
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Drug Name:

DESOGEN Rx

Generic Name and Formulations:
Desogestrel 0.15mg, ethinyl estradiol 30micrograms (21 tabs); inert (7 tabs).

Company:
Merck & Co., Inc.

Therapeutic Use:

Indications for DESOGEN:

Oral contraception.

Adult:

1 tab daily for 28 days; repeat.

Children:

Pre-menarche: not applicable.

Contraindications:

Thrombophlebitis or thromboembolic disorders. Cerebral vascular or coronary artery disease. Valvular heart disease with thrombogenic complications. Inherited or acquired hypercoagulopathies. Severe hypertension. Diabetes with vascular involvement. Headaches with focal neurologic symptoms. Major surgery with prolonged immobilization. Breast, endometrium, or other estrogen-dependent neoplasms. Undiagnosed abnormal genital bleeding. Cholestatic jaundice of pregnancy or jaundice with prior OC use. Hepatic disease or tumors. Smokers >35yrs. Pregnancy. Concomitant ombitasvir/paritaprevir/ritonavir, with or without dasabuvir.

Boxed Warning:

Cigarette smoking increases risk of serious cardiovascular events.

Warnings/Precautions:

Increased risk of cardiovascular events (eg, stroke, MI) esp. in cigarette smokers >35yrs of age. 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. Gallbladder disease. Diabetes. Prediabetes. Uncontrolled dyslipidemias. Hypertriglyceridemia. History of depression. Conditions aggravated by fluid retention. Monitor blood pressure. Hepatic or renal impairment. Do regular complete physical exams. May need barrier contraception with Sunday starts or postpartum use (see full labeling). Nursing mothers: not recommended.

Pharmacological Class:

Progestin + estrogen.

Interactions:

See Contraindications. ALT elevations with HCV regimen ombitasvir/paritaprevir/ritonavir, with or without dasabuvir; discontinue Desogen prior to starting HCV regimen and restart 2wks after completion. May be antagonized by barbiturates, rifampin, phenylbutazone, phenytoin, carbamazepine, felbamate, oxcarbazepine, topiramate, griseofulvin, St. John's wort. May be potentiated by atorvastatin, ascorbic acid, acetaminophen, itraconazole, ketoconazole. May be affected by protease inhibitors. May potentiate cyclosporine, prednisolone, theophylline. May antagonize acetaminophen, temazepam, salicylic acid, morphine, clofibric acid. May affect laboratory tests (eg, coagulation factors, lipids, glucose tolerance, binding proteins).

Adverse Reactions:

Depression, headache, nausea, vomiting, abdominal pain, breast tenderness/pain, weight increased, fluid retention, libido decreased, migraine, diarrhea, rash, urticaria, breast enlargement; breakthrough bleeding/spotting, contact lens intolerance, serious thromboembolic events, liver disease, hypertension.

How Supplied:

Packs—1

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