Haihuining ® Bisoprolol Amlodipine Tablets
Category B under National Medical Insurance
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.
[Dosage and Administration]
• 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)
[Shelf Life]
24 months
[Approval Number]
National Medical Products Administration Approval Number: H20249542
Hotline: 0591-83512959
Fujian Haixi New Pharmaceutical Creation Co., Ltd. Fujian ICP Record No. 12015727 Internet Drug Information Service Qualification Certificate No.: (Min) - Non-operating-2023-0063
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