Product Overview
[Drug Name]
Generic Name: Amlodipine Besylate Tablets (For Near-Expiration Date)
Trade Name: Dahongying Pharmaceutical Amlodipine Besylate Tablets (For Near-Expiration Date) 5mg*28 Tablets
Pinyin Code: DaHongYingYaoYe BenHuangSuanAnLvDiPingPian (JinXiaoQiZhuanYong) 5mg*28 Tablets
[Main Ingredient]
The main ingredient of this product is amlodipine besylate. Chemical name: (±)-2-[(2-aminoethoxy)methyl]-4-(2-chlorophenyl)-1,4-dihydro-6-methyl-3,5-pyridinedicarboxylic acid-5-methyl ester, 3-ethyl ester benzenesulfonate. Molecular formula: C20H25CIN2O5·C6H6O3S Molecular weight: 567.05
[Properties]
This product is white or off-white tablets.
[Indications/Main Functions]
1. Hypertension: This product is indicated for the treatment of hypertension. It can be used alone or in combination with other antihypertensive drugs. Hypertension control is part of comprehensive cardiovascular risk management, which may include lipid control, diabetes management, antithrombotic therapy, smoking cessation, physical exercise, and sodium restriction. Increases in either systolic or diastolic blood pressure increase cardiovascular risk. The absolute risk increase per mmHg increase is greater at higher baseline blood pressure levels. The relative magnitude of risk reduction achieved by lowering blood pressure is similar among populations with varying absolute cardiovascular risk. In patients with severe hypertension, even a small reduction in blood pressure can provide significant clinical benefit. In adults with hypertension, lowering blood pressure generally reduces the risk of cardiovascular events, primarily stroke and myocardial infarction. 2. Coronary Artery Disease (CAD) and Chronic Stable Angina: This product is indicated for the symptomatic treatment of chronic stable angina. It can be used alone or in combination with other antianginal drugs. This drug is indicated for the treatment of confirmed or suspected vasospastic angina (Prinzmetal's or variant angina). It can be used alone or in combination with other anti-anginal drugs. In patients with angiographically confirmed coronary artery disease (CAD), an ejection fraction ≥40%, and no heart failure, this drug can reduce the risk of hospitalization for angina and the need for coronary revascularization.
[Specifications]
5mg x 28 tablets
[Dosage and Administration]
The typical starting dose for hypertension in adults is 5mg once daily, with a maximum dose of 10mg once daily. For patients who are small, frail, elderly, or have hepatic insufficiency, the starting dose is 2.5mg once daily; this dose can also be used in combination with other antihypertensive drugs. Dose adjustments should be made based on individual patient response and target blood pressure. Generally, a 7-14 day waiting period is recommended before any adjustment is made. Rapid dose adjustments can be made if clinically necessary and under close patient monitoring. The recommended dose for the treatment of chronic stable or vasospastic angina is 5-10 mg once daily. Lower doses are recommended for elderly patients and those with hepatic impairment. The effective dose for most patients is 10 mg once daily. The recommended dose for the treatment of coronary artery disease is 5-10 mg once daily. In clinical studies, most patients required a dose of 10 mg/day.
[Adverse Reactions]
See the package insert for details.
[Contraindications]
This product is contraindicated in patients with hypersensitivity to amlodipine or any of its ingredients.
[Precautions]
1. Hypotension: Symptomatic hypotension may occur, particularly in patients with severe aortic stenosis. Because the vasodilatory effect of this product is gradual, rare cases of acute hypotension have been reported after taking this product. 2. Exacerbation of angina or myocardial infarction: In a very small number of patients, particularly those with severe coronary artery obstructive disease, worsening of angina or acute myocardial infarction may occur when initiating amlodipine besylate treatment or increasing the dose. 3. Use in patients with impaired liver function: Because this product is extensively metabolized by the liver, and the plasma elimination half-life (t1/2) in patients with impaired liver function is 56 hours, this product should be slowly increased in doses when used in patients with severe impaired liver function.
