Amlodipine BesilateTablets Reference Listed Drug

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Name	Amlodipine BesilateTablets
Trade name	Norvasc
Specifications	5mg as amlodipine (C20H25ClN2O5)
Dosage form	tablet
Licensee	Pfizer Inc
Remarks	American Orange Book

The indications of this product are: 1. Hypertension This product is suitable for the treatment of hypertension. This product can be used alone or in combination with other antihypertensive drugs. The control of hypertension is part of the comprehensive management of cardiovascular risk. Comprehensive management measures may need to include: lipid control, diabetes management, antithrombotic therapy, smoking cessation, physical exercise and restriction of sodium intake. The increase in systolic or diastolic blood pressure increases the cardiovascular risk. At higher basal blood pressure levels, the absolute risk increase brought by the increase in blood pressure per millimeter of mercury will be higher. The relative degree of risk reduction obtained by lowering blood pressure is similar among people with different absolute cardiovascular risks. In patients with severe hypertension, a slight reduction in blood pressure can bring greater clinical benefits. For adults with hypertension, generally speaking, lowering blood pressure can reduce the risk of cardiovascular events, mainly stroke and myocardial infarction. 2. Coronary Heart Disease (CAD) Chronic stable angina This product is suitable for the symptomatic treatment of chronic stable angina pectoris. It can be used alone or in combination with other anti-angina drugs. Vasospasm angina (Prinzmetal's or variant angina) This product is suitable for the treatment of confirmed or suspected vasospasm angina pectoris. It can be used alone or in combination with other anti-angina drugs. In patients with coronary heart disease confirmed by angiography, but with an ejection fraction ≥ 40% and no heart failure, this product can reduce the risk of hospitalization for angina and the risk of coronary artery reconstruction.

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