NEBIVOLOL tablet

Nchi: Marekani

Lugha: Kiingereza

Chanzo: NLM (National Library of Medicine)

Viambatanisho vya kazi:

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

Inapatikana kutoka:

Major Pharmaceuticals

Njia ya uendeshaji:

ORAL

Dawa ya aina:

PRESCRIPTION DRUG

Matibabu dalili:

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 guide

Bidhaa muhtasari:

Nebivolol tablets are available as tablets for oral administration containing nebivolol hydrochloride equivalent to 2.5, 5, 10, and 20 mg of nebivolol. Nebivolol tablets have a mosaic appearance, are round, biconvex, uncoated, unscored, differentiated by color and are plain on one side and debossed with the number 53, 1354, 1355 or 1356 on the other side for the 2.5, 5, 10 and 20 mg tablets, respectively. Nebivolol tablets are supplied in the following strengths and package configurations: 2.5 mg tablets are light blue colored with mosaic appearance, round, biconvex uncoated tablets, debossed with "53" on one side and plain on other side. 5 mg tablets are beige colored with mosaic appearance, round, biconvex uncoated tablets, debossed with "1354" on one side and plain on other side. Cartons of 30 tablets (10 tablets per blister card x 3), NDC 0904-7189-04 10 mg tablets are pinkish purple colored with mosaic appearance, round, biconvex uncoated tablets, debossed with "1355" on one side and plain on other side. Cartons of 30 tablets (10 tablets per blister card x 3), NDC 0904-7190-04 20 mg tablets are light blue colored with mosaic appearance, round, biconvex uncoated tablets, debossed with "1356" on one side and plain on other side.                                                  Store at 20° to 25°C (68° to 77°F), excursions permitted to 15° to 30°C (59° to 86°F) [see USP for Controlled Room Temperature.] Dispense in a tight, light-resistant container as defined in the USP using a child-resistant closure.

Idhini hali ya:

Abbreviated New Drug Application

Tabia za bidhaa

NEBIVOLOL- NEBIVOLOL TABLET
MAJOR PHARMACEUTICALS
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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
INDICATIONS AND USAGE
Nebivolol 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)
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DOSAGE FORMS AND STRENGTHS
Tablets: 2.5, 5, 10, 20 mg (3)
CONTRAINDICATIONS
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WARNINGS AND PRECAUTIONS
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ADVERSE REACTIONS
Most common adverse reactions (6.1):
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TO REPORT SUSPECTED ADVERSE REACTIONS, CONTACT TORRENT PHARMA INC. AT
1-800-912-9561
OR FDA AT 1-800-FDA-1088 OR WWW.FDA.GOV/MEDWATCH.
DRUG INTERACTIONS
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USE IN SPECIFIC POPULATIONS
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SEE 17 FOR PATIENT COUNSELING INFORMATION.
REVISED: 3/2023
Hypertension: Most patients start at 5 mg once daily. Dose can be
increased at 2-week intervals up to
40 mg. (2.1)
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)
Acute exacerbation of coronary artery disease upon cessation of
therapy: Do not abruptly
discontinue. (5.1)
Diabetes: Monitor glucose as -blockers may mask symptoms of
hypoglycemia. (5.5)
Headache, fatigue
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