Land: Verenigde Staten
Taal: Engels
Bron: NLM (National Library of Medicine)
NEBIVOLOL HYDROCHLORIDE (UNII: JGS34J7L9I) (NEBIVOLOL - UNII:030Y90569U)
Amerigen Pharmaceuticals Inc.
NEBIVOLOL HYDROCHLORIDE
NEBIVOLOL 2.5 mg
ORAL
PRESCRIPTION DRUG
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
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.
Abbreviated New Drug Application
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 Lees het volledige document