Product Overview
[Drug Name]
Generic Name: Amlodipine Besylate Tablets
Trade Name: Aizoxin
English Name: Amlodipine Besylate Tablets
Chinese Pinyin: Amlodipine Besylate Tablets
[Ingredients]
The main ingredient of this product is amlodipine.
[Properties]
This product is white tablets.
[Indications]
1. Hypertension (used alone or in combination with other medications). 2. Angina pectoris: especially spontaneous angina (used alone or in combination with other medications).
[Dosage and Administration]
The usual starting oral dose is 5 mg once daily, with a maximum of 10 mg once daily. Patients of small stature, frail constitution, elderly patients, or those with impaired liver function should start with 2.5 mg once daily. Patients taking other antihypertensive medications should also start with this dose. The dosage should be adjusted based on individual needs, and the adjustment period should be at least 7-14 days to allow the physician to fully assess the patient's response to the dose. However, faster adjustment may be used if clinically warranted. The recommended dose for the treatment of angina pectoris is 5-10 mg. A reduced dose is required for elderly patients or those with impaired liver function.
[Adverse Reactions]
The most common adverse reactions are headache and edema.
[Contraindications]
Allergy to dihydropyridine calcium channel blockers.
[Precautions]
1. Warning: A very small number of patients, especially those with severe coronary artery obstructive disease, may experience increased frequency, prolonged duration, and/or severity of angina pectoris, or acute myocardial infarction, when starting calcium channel blocker therapy or increasing the dose. The mechanism of action is currently unknown. 2. Because the drug's vasodilatory effect develops gradually, rare cases of acute hypotension have been reported after taking the drug. However, caution should be exercised when using the drug in combination with other peripheral vasodilators in patients with severe aortic stenosis. 3. Use in Patients with Heart Failure: Calcium channel blockers should be used with caution in patients with congestive heart failure. In the PRAISE-2, a placebo-controlled study of amlodipine besylate tablets in patients with non-ischemic heart failure (NYHA class III-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 calcium channel blockers, the half-life of this drug is prolonged in patients with impaired hepatic function. However, a recommended dose has not yet been established, so caution should be exercised when using this drug. 5. Use in Patients with Renal Failure: Amlodipine plasma concentrations do not correlate with the degree of renal impairment. Therefore, a normal dose can be used. Amlodipine is not dialyzable. Please read the package insert carefully and use as directed by your healthcare provider.
[Use in Special Populations]
Precautions for Pediatric Use:
Safety and efficacy in children have not been established.
Precautions for Pregnancy and Lactation:
There is a lack of research data on the use of this drug in pregnant women. However, based on animal studies, this drug should only be used in pregnant women when absolutely necessary. It is unknown whether this drug is excreted in breast milk. Breastfeeding women taking this drug should discontinue breastfeeding.
Precautions for Elderly Patients:
Clinical studies have not demonstrated that elderly individuals respond differently to this drug than younger individuals. However, given that elderly individuals often have impaired liver, kidney, and heart function, as well as other medical conditions and medications, the lower end of the initial dose range is generally used. Elderly individuals experience decreased clearance of this drug, with the area under the curve (AUC) increasing by approximately 40% to 60%, necessitating a lower initial dose.
[Drug Interactions]
Cimetidine, grapefruit juice, and acidogens: Coadministration does not alter the pharmacokinetics of this drug. Atorvastatin, digoxin, and ethanol: This drug does not affect the pharmacokinetics of these agents. Sildenafil: Single-dose administration of sildenafil (Viagra) has no effect on the pharmacokinetics of this drug in patients with essential hypertension. The two drugs produce independent antihypertensive effects when taken together. Warfarin: This drug does not alter the prothrombin action time of warfarin. Digoxin, phenytoin, and warfarin: Concomitant use with this drug has no effect on plasma protein binding. Anesthetics: Inhaled hydrocarbons may cause hypotension when used with this drug. Nonsteroidal anti-inflammatory drugs: Indomethacin, in particular, may attenuate the antihypertensive effect of this drug. Beta-blockers: Concomitant use with this drug is well tolerated but may cause excessive hypotension and, rarely, worsen heart failure. Estrogens: Concomitant use may cause fluid retention and increase blood pressure. Sulfinpyrazone: Concomitant use may increase protein binding of this drug, resulting in changes in plasma concentrations. Lithium: Concomitant use may cause neurotoxicity, resulting in nausea, vomiting, diarrhea, ataxia, tremor, and/or numbness; caution is advised. Sympathomimetic amines: May attenuate the antihypertensive effect of this drug. Sublingual nitroglycerin and long-acting nitrate preparations: Concomitant use with this drug may enhance the antianginal effect. Although rebound effects have not been reported, discontinuation of this drug should be followed by a gradual dose reduction under the guidance of a physician. Thiazide diuretics, ACE inhibitors, digoxin, warfarin, antibiotics, and oral hypoglycemic agents can be safely used with this product.
[Pharmacological Actions]
Pharmacological Actions: Amlodipine besylate is a dihydropyridine calcium antagonist (calcium ion antagonist or slow-channel blocker). Cardiac and smooth muscle contraction depends on the entry of extracellular calcium ions into cells through specific ion channels. This product selectively inhibits the transmembrane entry of calcium ions into smooth muscle cells and cardiomyocytes, with a greater effect on smooth muscle than on myocardium. Its interaction with calcium channels is determined by the progressive rate of binding and dissociation between receptor sites, resulting in a gradual onset of pharmacological action. This product is a peripheral arterial dilator, acting directly on vascular smooth muscle, reducing peripheral vascular resistance and thereby lowering blood pressure. Negative inotropic effects have been observed in vitro at therapeutic doses, but not in whole animal studies. This product does not affect plasma calcium concentrations.
[Storage] Store in a dark, airtight container. [Strength] 5mg
[Packaging] 5mg x 14s/box
[Expiry Date] 24 months
[Approval Number] National Medicine Standard H20093187
[Manufacturer] Company Name: Hubei Hengan Fulin Pharmaceutical Co., Ltd.
