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Reclipsen Generic Name & Formulations
Legal Class
Rx
General Description
Desogestrel 0.15mg, ethinyl estradiol 30micrograms (21 tabs); inert (7 tabs).
Pharmacological Class
Progestin + estrogen.
How Supplied
Packs—6
Manufacturer
Reclipsen Indications
Indications
Oral contraception.
Reclipsen Dosage and Administration
Adult
1 tab daily for 28 days; repeat.
Children
Not applicable.
Reclipsen Contraindications
Contraindications
Thrombophlebitis or thromboembolic disorders. Cerebral vascular or coronary artery disease. Valvular heart disease with thrombogenic complications. Severe hypertension. Diabetes with vascular involvement. Headaches with focal neurologic symptoms. Major surgery with prolonged immobilization. Breast or other estrogen-dependent neoplasms. Undiagnosed abnormal genital bleeding. Cholestatic jaundice of pregnancy or jaundice with prior OC use. Hepatic disease or tumors. Pregnancy (Cat.X). Concomitant ombitasvir/paritaprevir/ritonavir, with or without dasabuvir.
Reclipsen Boxed Warnings
Boxed Warning
Cigarette smoking increases risk of serious cardiovascular events.
Reclipsen Warnings/Precautions
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. Depression. Fluid rentention. 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.
Reclipsen Pharmacokinetics
See Literature
Reclipsen Interactions
Interactions
See Contraindications. ALT elevations with HCV regimen ombitasvir/paritaprevir/ritonavir, with or without dasabuvir; discontinue Reclipsen 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).
Reclipsen Adverse Reactions
Adverse Reactions
Nausea, vomiting, breakthrough bleeding, amenorrhea, transient delay of ovulation after discontinuation, edema, chloasma, headache, weight changes, intolerance to contact lenses; serious thromboembolic events, liver disease, hypertension.
Reclipsen Clinical Trials
See Literature
Reclipsen Note
Not Applicable
Reclipsen Patient Counseling
See Literature
