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Vienva Generic Name & Formulations
Legal Class
Rx
General Description
Levonorgestrel 0.1mg, ethinyl estradiol 20mcg (21 tabs); inert (7 tabs).
Pharmacological Class
Progestin + estrogen.
How Supplied
Blister packs—3
Manufacturer
Vienva Indications
Indications
Oral contraception.
Vienva Dosage and Administration
Adult
1 tab daily for 28 days; repeat. Take pills in order (21 levonorgestrel + ethinyl estradiol tabs, then 7 inert tabs).
Children
Premenarchal: not recommended.
Vienva Contraindications
Contraindications
Thrombophlebitis or thromboembolic disorders. History of DVT or thromboembolism, cerebrovascular or coronary artery disease. Thrombogenic valvular disease or rhythm disorders. Hereditary or acquired thrombophilias. Major surgery with prolonged immobilization. Diabetes with vascular involvement. Headaches with focal neurological symptoms. Uncontrolled hypertension. Known or suspected breast carcinoma, endometrial carcinoma or other estrogen-dependent neoplasia. Undiagnosed abnormal genital bleeding. Cholestatic jaundice of pregnancy or jaundice with prior pill use. Hepatic disease or tumors. Pregnancy (Cat.X). Concomitant HCV drugs containing ombitasvir/paritaprevir/ritonavir, with or without dasabuvir.
Vienva Boxed Warnings
Boxed Warning
Cigarette smoking increases risk of serious cardiovascular events.
Vienva Warnings/Precautions
Warnings/Precautions
Increased risk of cardiovascular events (eg, MI, stroke, DVT, VTE) esp. smokers >35 years of age. Discontinue if thrombotic event, unexplained visual changes, persistently elevated BP, migraine or other severe headaches, 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. Cardio- or cerebrovascular diseases. Increased risk of breast or cervical cancer and hepatic neoplasia. Gallbladder disease. Obesity. Diabetes. Prediabetes. Uncontrolled dyslipidemias. Hypertriglyceridemia. Hypertension. Evaluate significant changes in headaches, abnormal vaginal bleeding, amenorrhea. Ectopic pregnancy. Depression. Conditions aggravated by fluid retention; monitor. Do regular complete physical exams (eg, Pap smear, mammogram, BP). Nursing mothers: not recommended.
Vienva Pharmacokinetics
See Literature
Vienva Interactions
Interactions
See Contraindications. Risk of ALT elevations with concomitant HCV therapy containing ombitasvir/paritaprevir/ritonavir, with or without dasabuvir. May be antagonized by antibiotics, anticonvulsants or other enzyme inducers (eg, rifampin, rifabutin, barbiturates, primidone, phenylbutazone, phenytoin, dexamethasone, carbamazepine, felbamate, oxcarbazepine, topiramate, griseofulvin, modafinil, St. John’s wort); use back-up contraception. May be affected by HIV protease inhibitors. May be potentiated by atorvastatin, ascorbic acid, acetaminophen, or CYP3A4 inhibitors (eg, indinavir, itraconazole, ketoconazole, fluconazole, troleandomycin). May potentiate cyclosporine, theophylline, prednisolone, or other corticosteroids. May antagonize acetaminophen, temazepam, salicylic acid, morphine, or clofibric acid. May affect lab tests (eg, coagulation factors, binding proteins, lipids, glucose tolerance, serum folate).
Vienva Adverse Reactions
Adverse Reactions
Nausea, vomiting, breakthrough bleeding, weight changes, breast tenderness/pain/enlargement, amenorrhea, edema, melasma, headache, GI symptoms, intolerance to contact lenses; oligomenorrhea, cholasma, liver disease.
Vienva Clinical Trials
See Literature
Vienva Note
Not Applicable
Vienva Patient Counseling
See Literature
