NEBIVOLOL- nebivolol tablet

País: Estados Unidos

Idioma: inglés

Fuente: NLM (National Library of Medicine)

Ingredientes activos:

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

Disponible desde:

Amerigen Pharmaceuticals Inc.

Designación común internacional (DCI):

NEBIVOLOL HYDROCHLORIDE

Composición:

NEBIVOLOL 2.5 mg

Vía de administración:

ORAL

tipo de receta:

PRESCRIPTION DRUG

indicaciones terapéuticas:

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 non fatal 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. 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, su

Resumen del producto:

Nebivolol Tablets are available for oral administration containing nebivolol hydrochloride equivalent to 2.5, 5, 10, and 20 mg of nebivolol. 2.5 mg tablets:  white to off-white, round, unscored tablets debossed with “A4” on one side with the other side blank, are supplied in the following package sizes: Bottles of 30 (NDC 43975-248-03) Bottles of 100 (NDC 43975-248-10) 5 mg tablets:  white to off-white, round, unscored tablets debossed with “A49” on one side with the other side blank, are supplied in the following package sizes: Bottles of 30 (NDC 43975-249-03) Bottles of 100 (NDC 43975-249-10) 10 mg tablets:  white to off-white, round, unscored tablets debossed with “A50” on one side with the other side blank, are supplied in the following package sizes: Bottles of 30 (NDC 43975-250-03) Bottles of 100 (NDC 43975-250-10) 20mg tablets:  white to off-white, round, unscored tablets debossed with “A51” on one side with the other side blank, are supplied in the following package sizes:. Bottles of 30 (NDC 43975-251-03) Bottles of 100 (NDC 43975-251-10) Store at  20° to 25°C (68° to 77°F) excursions permitted to 15°-30°C (59-86°F) . [See USP Controlled Room Temperature.] Dispense in a tight, light-resistant container as defined in the USP using a child-resistant closure. KEEP THIS AND ALL MEDICATIONS OUT OF THE REACH OF CHILDREN.

Estado de Autorización:

Abbreviated New Drug Application

Ficha técnica

NEBIVOLOL- NEBIVOLOL TABLET
AMERIGEN PHARMACEUTICALS INC.
----------
HIGHLIGHTS OF PRESCRIBING INFORMATION
THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE
NEBIVOLOL SAFELY AND EFFECTIVELY. SEE FULL
PRESCRIBING INFORMATION FOR NEBIVOLOL.
NEBIVOLOL (NEBIVOLOL) TABLET FOR ORAL USE.
INITIAL U.S. APPROVAL: 2007
THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE
NEBIVOLOL SAFELY AND EFFECTIVELY.SEE FULL
PRESCRIBING INFORMATION FOR NEBIVOLOL
NEBIVOLOL (NEBIVOLOL) TABLET FOR ORAL USE.
INITIAL U.S. APPROVAL:2007
INDICATIONS AND USAGE
Indications and Usage (1.1) 12/2011 (1)
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 non
fatal cardiovascular events, primarily strokes and
myocardial infarctions. (1.1) (1)
DOSAGE AND ADMINISTRATION
Can be taken with and without food. Individualize to the needs of the
patient and monitor during up-titration. (2) (2)
• Hypertension: Most patients start at 5 mg once daily. Dose can be
increased at 2-week intervals up to 40 mg. (2.1) (2)
DOSAGE FORMS AND STRENGTHS
Tablets: 2.5, 5, 10, 20 mg (3) (3)
CONTRAINDICATIONS
• Severe bradycardia (4) (4)
• Heart block greater than first degree (4) (4)
• Patients with cardiogenic shock (4) (4)
• Decompensated cardiac failure (4) (4)
• Sick sinus syndrome (unless a permanent pacemaker is in place) (4)
(4)
• Patients with severe hepatic impairment (Child-Pugh >B) (4) (4)
• Hypersensitive to any component of this product (4) (4)
WARNINGS AND PRECAUTIONS
• Acute exacerbation of coronary artery disease upon cessation of
therapy: Do not abruptly discontinue (5.1) (5)
• Diabetes: Monitor glucose as ß-blockers may mask symptoms of
hypoglycemia (5.5) (5)
ADVERSE REACTIONS
Most common adverse reactions (6.1): (6)
• Headache, fatigue
TO REPORT SUSPECTED ADVERSE REACTIONS, CONTACT AMERIGEN
PHARMACEUTICALS LTD AT 877-220-3784 AND
WWW.AMERIGENPHARMA.COM OR FDA AT 1-800-FDA-1088 OR T