Bisoprolol Fumarate and Amlodipine Besilate Tablets

Haihuining ® Bisoprolol Amlodipine Tablets

Medicare Category B

Long-acting combination for effective blood pressure control

Precise heart rate regulation and target organ protection

[Drug Name]

       Generic name: Bisoprolol Amlodipine Tablets

[Indications]

       As a substitution therapy in hypertension, indicated for patients whose blood pressure is well controlled with the same doses of bisoprolol and amlodipine given separately.

[Usage and Dosage]

       Abrupt discontinuation is prohibited, as this may cause transient worsening of clinical condition, especially in patients with ischemic heart disease.

   Hepatic impairment:

       Amlodipine elimination may be prolonged in patients with impaired hepatic function. No established dose recommendations for mild-to-moderate impairment. No pharmacokinetic data in severe hepatic impairment. Use with caution.

       For severe hepatic impairment: maximum bisoprolol dose should not exceed 10 mg daily.

   Renal impairment:

        No dose adjustment required in mild-to-moderate renal impairment.

        Plasma concentrations of amlodipine are not correlated with renal function; amlodipine is not dialyzable.

        For severe renal impairment (creatinine clearance <20 ml/min): maximum bisoprolol dose should not exceed 10 mg daily.

   Elderly:

        May be given at standard doses, but caution is advised with dose escalation.

   Pediatric population:

       Safety and efficacy in children and adolescents under 18 years not established. No available data.

   Administration:

       Taken in the morning, with or without food. Swallow whole, do not chew.

[Contraindications]

        Contraindicated in patients allergic to bisoprolol, amlodipine, dihydropyridine derivatives, or any excipients.

        Refer to package insert for details.

[Specification]

       Bisoprolol fumarate 5 mg + Amlodipine besylate (equivalent to 5 mg amlodipine)

[Validity Period]

       24 months

[Approval Number]

       National Medical Approval Number: H20249542



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