NEBIVOLOL tablet

Land: Vereinigte Staaten

Sprache: Englisch

Quelle: NLM (National Library of Medicine)

Wirkstoff:

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

Verfügbar ab:

Ajanta Pharma USA Inc.

Verabreichungsweg:

ORAL

Verschreibungstyp:

PRESCRIPTION DRUG

Anwendungsgebiete:

Nebivolol tablets are indicated for the treatment of hypertension, to lower blood pressure [see Clinical Studies (14.1)]. Nebivolol tablets 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 nebivolol tablets. 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 guidelin

Produktbesonderheiten:

Nebivolol is available as tablets for oral administration containing nebivolol hydrochloride equivalent to 2.5 mg, 5 mg, 10 mg, and 20 mg of nebivolol. Nebivolol tablets 2.5 mg: Beige colored, mottled, triangular shaped, biconvex, unscored, uncoated tablets debossed with ‘NE1’ on one side and plain on other side, are supplied in the following package size: Bottle of 30 (NDC 27241-179- 30) Nebivolol tablets 5 mg: Beige colored, mottled, triangular shaped, biconvex, unscored, uncoated tablets debossed with ‘NE2’ on one side and plain on other side, are supplied in the following package sizes: Bottle of 30 (NDC 27241-180- 30) Bottle of 90 (NDC 27241-180 -90) Nebivolol tablets 10 mg: Pinkish-purple colored, mottled, triangular shaped, biconvex, unscored, uncoated tablets debossed with ‘NE3’ on one side and plain on other side, are supplied in the following package sizes: Bottle of 30 (NDC 27241-181- 30) Bottle of 90 (NDC 27241-181 -90) Nebivolol tablets 20 mg: Light blue colored, mottled, triangular shaped, biconvex, unscored, uncoated tablets debossed with ‘NE4’ on one side and plain on other side, are supplied in the following package sizes: Bottle of 30 (NDC 27241-182 -30) Bottle of 90 (NDC 27241-182 -90) Store at 20ºC to 25ºC (68ºF to 77ºF); excursions permitted to 15°C to 30°C (59°F to 86°F) [see USP Controlled Room Temperature]. Dispense in a tight, light-resistant container as defined in the USP using a child-resistant closure.

Berechtigungsstatus:

Abbreviated New Drug Application

Fachinformation

NEBIVOLOL - NEBIVOLOL TABLET
AJANTA PHARMA USA INC.
----------
HIGHLIGHTS OF PRESCRIBING INFORMATION
THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE
NEBIVOLOL TABLETS
SAFELY AND EFFECTIVELY. SEE FULL PRESCRIBING INFORMATION FOR NEBIVOLOL
TABLETS.
NEBIVOLOL TABLETS, FOR ORAL USE
INITIAL U.S. APPROVAL: 2007
RECENT MAJOR CHANGES
Warnings and Precautions, Hypoglycemia (_5.5_) 6/2023
INDICATIONS AND USAGE
Nebivolol tablets are 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 mg, 5 mg, 10 mg, 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: May mask symptoms of hypoglycemia and alter glucose levels;
monitor (_5.5_)
ADVERSE REACTIONS
MOST COMMON ADVERSE REACTIONS (_6.1_):
Headache, fatigue
TO REPORT SUSPECTED ADVERSE REACTIONS, CONTACT AJANTA PHARMA USA INC.
AT 855-664-
7744 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 dec