Product Overview
[Drug Name]
Generic Name: Amlodipine Besylate Dispersible Tablets
Trade Name: XiluoNing Amlodipine Besylate Dispersible Tablets 5mg*14 Tablets
Pinyin Full Code: XiLuoNing BenHuangSuanAnLvDiPingFenSanPian 5mg*14Pian
[Main Ingredients]
Chemical Name: 3-Ethyl-5-methyl-2-(2-aminoethoxymethyl)-4-(2-chlorophenyl)-1,4-dihydro-6-methyl-3,5-pyridinedicarboxylate benzenesulfonate. Molecular Formula: C20H25N2O5·C6H6O3S Molecular Weight: 567.1
[Properties]
This product is white or off-white tablets.
[Indications/Main Functions]
(1) Hypertension. This product can be used alone or in combination with other antihypertensive drugs. (2) Chronic stable angina pectoris and variant angina pectoris. This product can be used alone or in combination with other anti-anginal medications.
[Specifications]
5mg*14 tablets
[Dosage and Administration]
1. Oral. The initial dose for the treatment of hypertension is 5 mg once daily, with a maximum dose of 10 mg once daily. For frail or elderly patients, or those with hepatic insufficiency, the initial dose is 2.5 mg once daily; this dose may also be the dose used in addition to other antihypertensive medications. Dose adjustments should be made based on individual patient response. Generally, dose adjustments should be initiated after 7-14 days. If clinically necessary, dose adjustments may be initiated sooner, with close patient monitoring. 2. Oral. The initial dose for the treatment of 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/day.
[Adverse Reactions]
See package insert for details.
[Contraindications]
This product is contraindicated in patients with hypersensitivity to dihydropyridines or any of the ingredients in this product.
[Precautions]
1. Warning: A very small number of patients, particularly those with severe coronary artery obstructive disease, may experience increased frequency, prolonged duration, and/or worsening of angina pectoris, or acute myocardial infarction, when initiating calcium antagonist therapy or increasing the dose. The mechanism of action is currently unknown. 2. Because the vasodilatory effect of this drug is gradual, rare cases of acute hypotension have been reported after taking this drug. However, caution should be exercised when using this drug in combination with other peripheral vasodilators in patients with severe aortic stenosis. 3. Use in Patients with Heart Failure: Calcium antagonists should be used with caution in patients with congestive heart failure. In a long-term, placebo-controlled study (PRAISE-2) in patients with non-ischemic heart failure (NYHA class IV), although the incidence of exacerbations of heart failure was not significantly different from placebo, there was an increase in reports of amlodipine-related pulmonary edema. 4. Use in Patients with Impaired Hepatic Function: As with all other calcium antagonists, the half-life of this drug is prolonged in patients with impaired hepatic function, but a recommended dose for this drug in such patients has not yet been established. Therefore, this product should be used with caution. 5. Use in patients with renal failure: Changes in amlodipine blood concentrations are not correlated with the degree of renal impairment; therefore, a normal dose can be used. This product cannot be dialyzed.
