Product Overview
[Drug Name]
Generic Name: Amlodipine Besylate Tablets
Trade Name: Xinhaining Amlodipine Besylate Tablets 5mg*21 Tablets
Pinyin Code: XinHaiNing BenHuangSuanAnLvDiPingPian 5mg*21 Tablets
[Main Ingredients]
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: 567.1
[Properties]
This product is white or off-white tablets.
[Indications/Main Functions]
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 individuals 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) - 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 medications. Vasospastic Angina (Prinzmetal's or variant angina): This product is indicated for the treatment of confirmed or suspected vasospastic angina. It can be used alone or in combination with other antianginal medications. For patients with angiographically confirmed coronary artery disease (CAD) but an ejection fraction ≥40% and no heart failure, this medication can reduce the risk of hospitalization for angina and the need for coronary revascularization.
[Specifications]
5mg*21 tablets
[Dosage and Administration]
The typical starting dose for hypertension in adults is 5 mg once daily, with a maximum dose of 10 mg once daily. For patients who are small, frail, elderly, or have hepatic insufficiency, the starting dose is 2.5 mg once daily; this dose can also be used in combination with other antihypertensive medications. Dose adjustments should be made based on individual patient response and target blood pressure. Generally, a 7-14 day wait is recommended before any adjustment. Rapid dose adjustments can be made under close patient monitoring, if clinically necessary. 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 insufficiency. 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 allergies to amlodipine or any of its components.
[Precautions]
1. Hypotension: Symptomatic hypotension may occur, especially 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: A very small number of patients, especially those with severe coronary artery obstructive disease, may experience worsening angina or acute myocardial infarction when initiating or increasing the dose of amlodipine besylate. 3. Use in Patients with Impaired Hepatic Function: Because this product is extensively metabolized by the liver and has a plasma elimination half-life (t½) of 56 hours in patients with hepatic impairment, the dosage of this product should be increased slowly in patients with severe hepatic impairment.
