Perindopril Arginine and Amlodipine Besylate Tablets
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Product Description
Approval Number:
H20253635
Indications:
Used for adult patients with hypertension whose blood pressure is inadequately controlled by monotherapy.
Serves as an alternative therapy for patients with essential hypertension controlled by the combined use of perindopril and amlodipine at the same dose level.
Administration：
Oral. Take 1 tablet once daily, preferably before breakfast.
Add-On Therapy:
For patients whose blood pressure is not effectively controlled by monotherapy with perindopril or amlodipine.
The 10 mg/5 mg combination can be used for patients inadequately controlled by perindopril 10 mg or amlodipine 5 mg alone.
Dose adjustment should be based on individual patient response and blood pressure targets. For patients with insufficient response, the dose may be gradually increased at 1–2-week intervals.
Maximum Daily Dose: 1 tablet of perindopril arginine/amlodipine 10/10 mg once daily.
Alternative Therapy:
Dose titration for perindopril and amlodipine can be performed separately before switching to the fixed-dose combination.
This fixed-dose combination is suitable as an alternative to the combined use of the two monocomponents at corresponding doses.
This product is NOT indicated for initial treatment of hypertension.
Special Populations
Renal Impairment and Elderly Patients
In elderly patients and those with renal failure, the clearance of perindoprilat decreases. Regular medical follow-up, including frequent monitoring of creatinine and potassium levels, is required.
Suitable for patients with creatinine clearance (Clcr) ≥ 60 mL/min. Not recommended for patients with Clcr < 60 mL/min; monocomponent therapy with individualized dose adjustment is advised.
Amlodipine is well-tolerated at similar doses in both elderly and young patients. Normal dosing is recommended for the elderly, but caution is advised when increasing the dose.
Amlodipine plasma concentration is unrelated to the degree of renal impairment, and it is not removed by dialysis.
Hepatic Impairment
Recommended doses have not been established for patients with mild to moderate hepatic impairment. Therefore, dose selection should be cautious, starting with low doses.
Individualized dose adjustment using free combinations of amlodipine and perindopril monocomponents is recommended to determine the optimal starting and maintenance doses for patients with hepatic impairment.
Pharmacokinetic studies of amlodipine in severe hepatic impairment have not been conducted. Patients with severe hepatic impairment should start with the lowest dose of amlodipine and adjust slowly.
Specifications:
Each tablet contains 10 mg of perindopril arginine and 5 mg of amlodipine besylate (calculated as C₂₀H₂₅ClN₂O₅).
The company has production licenses for tablets, capsules, granules, suppositories, powders, injections, oral solutions, dry suspensions, and eye drops.
The main products cover cardiovascular diseases, diabetic complications, anti-tumor, calcium supplementation, digestive system, respiratory system, and orthopedics.
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