BYSTOLIC nebivolol hydrochloride tablet

Maa: Yhdysvallat

Kieli: englanti

Lähde: NLM (National Library of Medicine)

Aktiivinen ainesosa:

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

Saatavilla:

Avera McKennan Hospital

INN (Kansainvälinen yleisnimi):

nebivolol hydrochloride

Koostumus:

nebivolol 5 mg

Prescription tyyppi:

PRESCRIPTION DRUG

Valtuutuksen tilan:

New Drug Application

Valmisteyhteenveto

BYSTOLIC- NEBIVOLOL HYDROCHLORIDE TABLET
AVERA MCKENNAN HOSPITAL
----------
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 FOREST LABORATORIES,
INC. 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