BYSTOLIC- nebivolol hydrochloride tablet

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

NEBIVOLOL HYDROCHLORIDE (UNII: JGS34J7L9I) (NEBIVOLOL - UNII:030Y90569U)

Available from:

A-S Medication Solutions

Administration route:

ORAL

Prescription type:

PRESCRIPTION DRUG

Therapeutic indications:

BYSTOLIC is indicated for the treatment of hypertension, to lower blood pressure [see Clinical Studies ( 14.1)]. BYSTOLIC may be used alone or in combination with other antihypertensive agents [see Drug   Interactions ( 7)].   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 class to which this drug principally belongs. There are no controlled trials demonstrating risk reduction with BYSTOLIC. 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 t

Product summary:

Product: 50090-3326 NDC: 50090-3326-0 30 TABLET in a BOTTLE

Authorization status:

New Drug Application

Summary of Product characteristics

BYSTOLIC- NEBIVOLOL HYDROCHLORIDE TABLET
A-S MEDICATION SOLUTIONS
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HIGHLIGHTS OF PRESCRIBING INFORMATION
THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE
BYSTOLIC SAFELY AND
EFFECTIVELY. SEE FULL PRESCRIBING INFORMATION FOR BYSTOLIC.
BYSTOLIC (NEBIVOLOL) TABLETS, FOR ORAL USE
INITIAL U.S. APPROVAL: 2007
INDICATIONS AND USAGE
BYSTOLIC is a beta-adrenergic blocking agent 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. (1.1)
DOSAGE AND ADMINISTRATION
Can be taken with and without food. Individualize to the needs of the
patient and monitor during up-
titration. (2)
Hypertension: Most patients start at 5 mg once daily. Dose can be
increased at 2-week intervals up to
40 mg. (2.1)
DOSAGE FORMS AND STRENGTHS
Tablets: 2.5, 5, 10, 20 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)
Hypersensitive to any component of this product (4)
WARNINGS AND PRECAUTIONS
Acute exacerbation of coronary artery disease upon cessation of
therapy: Do not abruptly discontinue.
(5.1)
Diabetes: Monitor glucose as β-blockers may mask symptoms of
hypoglycemia. (5.5)
ADVERSE REACTIONS
MOST COMMON ADVERSE REACTIONS (6.1):
Headache, fatigue
TO REPORT SUSPECTED ADVERSE REACTIONS, CONTACT ALLERGAN AT
1-800-678-1605 OR FDA AT
1-800-FDA-1088 OR WWW.FDA.GOV/MEDWATCH.
DRUG INTERACTIONS
CYP2D6 enzyme inhibitors may increase nebivolol levels. (7.1)
Reserpine or clonidine may produce excessive reduction of sympathetic
activity. (7.2)
Both digitalis glycosides and β-blockers slow atrioventricular
conduction and decrease heart rate.
Concomitant use can increase the risk of bradycardia. (7.3)
Verapamil- or diltiazem-type calcium channel blockers ma