Drug Information for Bystolic (Physicians Total Care, Inc.): DOSAGE AND ADMINISTRATION

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  • 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.

  • Drug Information Provided by National Library of Medicine (NLM).
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