BYVALSON- nebivolol hydrochloride and valsartan tablet, film coated

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

nebivolol hydrochloride (UNII: JGS34J7L9I) (nebivolol - UNII:030Y90569U)

Available from:

Allergan, Inc.

INN (International Name):

nebivolol hydrochloride

Composition:

nebivolol 5 mg

Administration route:

ORAL

Prescription type:

PRESCRIPTION DRUG

Therapeutic indications:

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

Product summary:

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.

Authorization status:

New Drug Application

Summary of Product characteristics

BYVALSON- NEBIVOLOL HYDROCHLORIDE AND VALSARTAN TABLET, FILM COATED
ALLERGAN, INC.
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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