Country: Сједињене Америчке Државе
Језик: Енглески
Извор: NLM (National Library of Medicine)
nebivolol hydrochloride (UNII: JGS34J7L9I) (nebivolol - UNII:030Y90569U)
Allergan, Inc.
nebivolol hydrochloride
nebivolol 5 mg
ORAL
PRESCRIPTION DRUG
BYVALSON is indicated for the treatment of hypertension, to lower blood pressure. Lowering blood pressure reduces the risk of fatal and nonfatal cardiovascular events, primarily strokes and myocardial infarctions. These benefits have been seen in controlled trials of antihypertensive drugs from a wide variety of pharmacologic classes, including the β-blocker class to which nebivolol principally belongs and the ARB class to which valsartan principally belongs. There are no controlled trials demonstrating risk reduction with BYVALSON. Control of high blood pressure should be part of comprehensive cardiovascular risk management, including, as appropriate, lipid control, diabetes management, antithrombotic therapy, smoking cessation, exercise, and limited sodium intake. Many patients will require more than one drug to achieve blood pressure goals. For specific advice on goals and management, see published guidelines, such as those of the National High Blood Pressure Education Program's Joint National Committee on
BYVALSON tablets are supplied in the following strengths and package configurations: Store at 20° to 25°C (68° to 77°F) [see USP for Controlled Room Temperature]. Dispense in a tightly closed container.
New Drug Application
BYVALSON- NEBIVOLOL HYDROCHLORIDE AND VALSARTAN TABLET, FILM COATED ALLERGAN, INC. ---------- HIGHLIGHTS OF PRESCRIBING INFORMATION THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE BYVALSON SAFELY AND EFFECTIVELY. SEE FULL PRESCRIBING INFORMATION FOR BYVALSON. BYVALSON (NEBIVOLOL AND VALSARTAN) TABLETS, FOR ORAL USE INITIAL U.S. APPROVAL: 2016 WARNING: FETAL TOXICITY _SEE FULL PRESCRIBING INFORMATION FOR COMPLETE BOXED WARNING._ WHEN PREGNANCY IS DETECTED, DISCONTINUE BYVALSON AS SOON AS POSSIBLE (5.1, 8.1) DRUGS, INCLUDING BYVALSON, THAT ACT DIRECTLY ON THE RENIN-ANGIOTENSIN SYSTEM CAN CAUSE INJURY AND DEATH TO THE DEVELOPING FETUS. (5.1, 8.1) INDICATIONS AND USAGE BYVALSON is a beta adrenergic blocker and an angiotensin II receptor blocker (ARB) indicated for the treatment of hypertension, to lower blood pressure. Lowering blood pressure reduces the risk of fatal and nonfatal cardiovascular events, primarily strokes and myocardial infarctions. (1) DOSAGE AND ADMINISTRATION As initial therapy and in patients not adequately controlled on valsartan 80 mg or nebivolol up to and including 10 mg, the recommended dose is 5 mg/ 80 mg taken orally once daily. (2) Maximum antihypertensive effects are attained within 2 to 4 weeks. (2) BYVALSON may be substituted for its components in patients already receiving 5 mg nebivolol and 80 mg valsartan. (2) DOSAGE FORMS AND STRENGTHS Tablets: 5 mg/ 80 mg (3) CONTRAINDICATIONS Severe bradycardia (4) Heart block greater than first degree (4) Patients with cardiogenic shock (4) Decompensated cardiac failure (4) Sick sinus syndrome (unless a permanent pacemaker is in place) (4) Patients with severe hepatic impairment (Child-Pugh >B) (4) Hypersensitivity to any component of this product (4) Do not co-administer aliskiren with BYVALSON in patients with diabetes. (4) WARNINGS AND PRECAUTIONS Acute exacerbation of coronary artery disease upon cessation of therapy: Do not abruptly discontinue. (5.3) Diabetes: Monitor glucose as β-blockers may mask symptoms of hypoglycemi Прочитајте комплетан документ