NEBIVOLOL HYDROCHLORIDE tablet

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

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

Available from:

Unichem Pharmaceuticals (USA), Inc.

Administration route:

ORAL

Prescription type:

PRESCRIPTION DRUG

Therapeutic indications:

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

Product summary:

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 are supplied in the following strengths and package configurations: 2.5 mg tablets:  orange, mottled, triangular, flat, unscored, uncoated tablets debossed with "U" on one side and "375" on the other side.  Bottles of 30   NDC 29300-375-13 Bottles of 90   NDC 29300-375-19 Bottles of 500 NDC 29300-375-05 5 mg tablets:  orange, mottled, triangular, flat, unscored, uncoated tablets debossed with "U" on one side and "376" on the other side. Bottles of 30   NDC 29300-376-13 Bottles of 90   NDC 29300-376-19 Bottles of 500 NDC 29300-376-05 10 mg tablets:  light blue, mottled, triangular, flat, unscored, uncoated tablets debossed with "U" on one side and "377" on the other side. Bottles of 30   NDC 29300-377-13 Bottles of 90   NDC 29300-377-19 Bottles of 500 NDC 29300-377-05 20 mg tablets:  white to off-white, triangular, flat, unscored, uncoated tablets debossed with "U" on one side and "378" on the other side. Bottles of 30   NDC 29300-378-13 Bottles of 90   NDC 29300-378-19 Bottles of 500 NDC 29300-378-05 Store at 20° to 25°C (68° to 77°F); excursions permitted between 15° to 30°C (59° 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.

Authorization status:

Abbreviated New Drug Application

Summary of Product characteristics

NEBIVOLOL HYDROCHLORIDE - NEBIVOLOL HYDROCHLORIDE TABLET
UNICHEM PHARMACEUTICALS (USA), INC.
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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 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)
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, 5, 10, 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 UNICHEM PHARMACEUTICALS
(USA) INC. AT
1-866-562-4616 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