BYSTOLIC is indicated for the treatment of hypertension. BYSTOLIC may be used alone or in combination with other antihypertensive agents.

The dose of BYSTOLIC should 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; upward titration should be performed cautiously if needed. BYSTOLIC has not been studied in patients receiving dialysis (see CLINICAL PHARMACOLOGY, Special Populations).

Hepatic Impairment

In patients with moderate hepatic impairment, the recommended initial dose is 2.5 mg once daily; upward titration should be performed cautiously if needed. BYSTOLIC has not been studied in patients with severe hepatic impairment and therefore it is not recommended in that population (see PRECAUTIONS and CLINICAL PHARMACOLOGY, Special Populations).

Geriatric Patients

It is not necessary to adjust the dose in the elderly (see above and PRECAUTIONS, Geriatric Use).

CYP2D6 Polymorphism (see CLINICAL PHARMACOLOGY,Pharmacokinetics)

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.

BYSTOLIC is available as tablets for oral administration containing nebivolol hydrochloride equivalent to 2.5, 5, and 10 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 1/4 , 5, or 10) on the other side. BYSTOLIC tablets are supplied in the following strengths and package configurations:

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.

Forest Pharmaceuticals Inc. Subsidiary of Forest Laboratories, St. Louis, MO 63045, USA. Licensed from Mylan Laboratories, Inc.Under License from Janssen, Pharmaceutica N.V., Beerse, Belgium, Actidose-Aqua® is a registered trademark of Paddock Laboratories, Inc. Rev. 12/07. FDA rev date: 12/17/2007

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