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Bystolic Tablets

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Bystolic Tablets

Bystolic Tablets

INDICATIONS

Hypertension

BYSTOLIC is indicated for the treatment of hypertension, to lower blood pressure [see Clinical Studies]. BYSTOLIC may be used alone or in combination with other antihypertensive agents [see DRUG INTERACTIONS].

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 BYSTOLIC.

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, such as those of the National High Blood Pressure Education Program's Joint National Committee on Prevention, Detection, Evaluation, and Treatment of High Blood Pressure (JNC).

Numerous antihypertensive drugs, from a variety of pharmacologic classes and with different mechanisms of action, have been shown in randomized controlled trials to reduce cardiovascular morbidity and mortality, and it can be concluded that it is blood pressure reduction, and not some other pharmacologic property of the drugs, that is largely responsible for those benefits. The largest and most consistent cardiovascular outcome benefit has been a reduction in the risk of stroke, but reductions in myocardial infarction and cardiovascular mortality also have been seen regularly.

Elevated systolic or diastolic pressure causes increased cardiovascular risk, and the absolute risk increase per mmHg is greater at higher blood pressures, so that even modest reductions of severe hypertension can provide substantial benefit. Relative risk reduction from blood pressure reduction is similar across populations with varying absolute risk, so the absolute benefit is greater in patients who are at higher risk independent of their hypertension (for example, patients with diabetes or hyperlipidemia), and such patients would be expected to benefit from more aggressive treatment to a lower blood pressure goal.

Some antihypertensive drugs have smaller blood pressure effects (as monotherapy) in black patients, and many antihypertensive drugs have additional approved indications and effects (e.g., on angina, heart failure, or diabetic kidney disease). These considerations may guide selection of therapy.

DOSAGE AND ADMINISTRATION

Hypertension

The dose of BYSTOLIC must be individualized to the needs of the patient. For most patients, the recommended starting dose is 5 mg once daily, with or without food, as monotherapy or in combination with other agents. For patients requiring further reduction in blood pressure, the dose can be increased at 2-week intervals up to 40 mg. A more frequent dosing regimen is unlikely to be beneficial.

Renal Impairment

In patients with severe renal impairment (ClCr less than 30 mL/min) the recommended initial dose is 2.5 mg once daily; titrate up slowly if needed. BYSTOLIC has not been studied in patients receiving dialysis [see CLINICAL PHARMACOLOGY].

Hepatic Impairment

In patients with moderate hepatic impairment, the recommended initial dose is 2.5 mg once daily; titrate up slowly if needed. BYSTOLIC has not been studied in patients with severe hepatic impairment and therefore it is not recommended in that population [see CLINICAL PHARMACOLOGY].

Subpopulations

Geriatric Patients

It is not necessary to adjust the dose in the elderly [see Use in Specific Populations].

CYP2D6 Polymorphism

No dose adjustments are necessary for patients who are CYP2D6 poor metabolizers. The clinical effect and safety profile observed in poor metabolizers were similar to those of extensive metabolizers [see CLINICAL PHARMACOLOGY].

HOW SUPPLIED

Dosage Forms And Strengths

BYSTOLIC is available as tablets for oral administration containing nebivolol hydrochloride equivalent to 2.5, 5, 10, and 20 mg of nebivolol.

BYSTOLIC tablets are triangular-shaped, biconvex, unscored, differentiated by color and are engraved with “FL” on one side and the number of mg (2 ½, 5, 10, or 20) on the other side.

Storage And Handling

BYSTOLIC is available as tablets for oral administration containing nebivolol hydrochloride equivalent to 2.5, 5, 10, and 20 mg of nebivolol.

BYSTOLIC tablets are triangular-shaped, biconvex, unscored, differentiated by color and are engraved with “FL” on one side and the number of mg (2 ½, 5, 10, or 20) on the other side. BYSTOLIC tablets are supplied in the following strengths and package configurations:

BYSTOLIC
Tablet Strength Package Configuration NDC # Tablet Color
2.5 mg Bottle of 30 0456-1402-30 Light Blue
Bottle of 100 0456-1402-01
10 x 10 Unit Dose 0456-1402-63
5 mg Bottle of 30 0456-1405-30 Beige
Bottle of 100 0456-1405-01
10 x 10 Unit Dose 0456-1405-63
10 mg Bottle of 30 0456-1410-30 Pinkish-Purple
Bottle of 100 0456-1410-01
10 x 10 Unit Dose 0456-1410-63
20 mg Bottle of 30 0456-1420-30 Light Blue
Bottle of 100 0456-1420-01
10 x 10 Unit Dose 0456-1420-63

Store at 20° to 25°C (68° to 77°F) [see USP for Controlled Room Temperature].

Dispense in a tight, light-resistant container as defined in the USP using a child-resistant closure.

Rev. June 2011. Distributed by: Forest Pharmaceuticals, Inc. Subsidiary of Forest Laboratories, Inc. St. Louis, MO 63045, USA.

Last reviewed on RxList: 1/4/2012
This monograph has been modified to include the generic and brand name in many instances.

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