NEBIVOLOL- nebivolol hydrochloride tablet

Nchi: Marekani

Lugha: Kiingereza

Chanzo: NLM (National Library of Medicine)

Viambatanisho vya kazi:

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

Inapatikana kutoka:

Glenmark Pharmaceuticals Inc., USA

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 guidelin

Bidhaa muhtasari:

Nebivolol is available as tablets for oral administration containing nebivolol hydrochloride equivalent to 2.5, 5, 10, and 20 mg of nebivolol. Nebivolol Tablets are round, flat beveled, differentiated by color and debossed with “G” on one side and with the number “15” (2.5 mg), “616” (5 mg), “617” (10 mg) or “618” (20 mg) on the other side. Nebivolol Tablets are supplied in the following strengths and package configurations: Nebivolol Tablets Tablet Strength Package Configuration NDC # Tablet Color 2.5 mg Bottle of 30 with child-resistant closure 68462-615-30 Light Blue Bottle of 100 with child-resistant closure 68462-615-01 10 x 10 Unit Dose 68462-615-11 5 mg Bottle of 30 with child-resistant closure 68462-616-30 Beige to Light Brown Bottle of 100 with child-resistant closure 68462-616-01 10 x 10 Unit Dose 68462-616-11 10 mg Bottle of 30 with child-resistant closure 68462-617-30 Pinkish-Purple Bottle of 100 with child-resistant closure 68462-617-01 10 x 10 Unit Dose 68462-617-11 20 mg Bottle of 30 with child-resistant closure 68462-618-30 Light Blue Bottle of 100 with child-resistant closure 68462-618-01 10 x 10 Unit Dose 68462-618-11 Store at 20°C to 25°C (68°F to 77°F) [see USP 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 HYDROCHLORIDE TABLET
GLENMARK PHARMACEUTICALS INC., USA
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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
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)
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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 GLENMARK
PHARMACEUTICALS INC., USA AT
1 [phone] 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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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: May mask symptoms of hypoglycemia and alter glucose levels;
monitor. (5.5)
Headache, fatigue
CYP2D6 enzyme inhibitors may increase nebivolol levels. (7.1)
Reserpine or clonidine may produce excessive reduction of sympathetic
activity.