Product Overview
[Drug Name]
Generic Name: Amlodipine Besylate Tablets
Trade Name: Shulekang Amlodipine Besylate Tablets, 5mg x 28 tablets
Pinyin Code: SheangBeangaDiingPian8an
[Main Ingredients]
Benzenesulfonic acid, amlodipine. [Appearance] This product is a white tablet.
[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 systolic or diastolic blood pressure increase cardiovascular risk. At higher baseline blood pressure levels, the absolute risk increase per mmHg increase is greater. The relative degree 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) 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. Vasospastic angina (Prinzmetazoline) This product is indicated for the treatment of confirmed or suspected vasospastic angina. It can be used alone or in combination with other anti-anginal drugs. For patients with angiographically confirmed coronary artery disease (CAD), an ejection fraction ≥ 40%, and no heart failure, this product can reduce the risk of hospitalization for angina and the need for coronary revascularization.
[Specifications]
5mg x 28 tablets
[Dosage and Administration]
The usual starting dose is 5mg orally once daily, with a maximum of 10mg once daily.
[Adverse Reactions]
The most common adverse reactions are headache and edema.
[Contraindications]
This product is contraindicated in patients with hypersensitivity to dihydropyridine calcium channel blockers or any of the ingredients in this product.
[Drug Interactions]
1. Cimetidine, grapefruit juice, and acidogens: Coadministration does not alter the pharmacokinetics of this product.
2. Atorvastatin , digoxin, and ethanol: This product does not affect their pharmacokinetics. 3. Sildenafil: A single dose of sildenafil has no effect on the pharmacokinetics of this product in patients with primary hypertension. The two drugs produce an independent antihypertensive effect when used together. 4. Warfarin: This product does not alter the prothrombin action time of warfarin. 5. Digoxin, phenytoin, and warfarin: Concomitant use with this product has no effect on plasma protein binding. 6. Anesthetics: Concomitant use of inhaled hydrocarbons with this product may cause hypotension. 7. Nonsteroidal anti-inflammatory drugs: Indomethacin, in particular, may reduce the antihypertensive effect of this product. 8. Anti-blockers: Concomitant use with this product is well tolerated but may cause excessive hypotension and rarely worsen heart failure. 9. Estrogens Hormones: Concomitant use may cause fluid retention and increase blood pressure. 10.Sulfinpyrazone: Concomitant use may increase the protein binding rate of this drug, resulting in changes in blood drug concentrations. 11. Lithium: Concomitant use may cause neurotoxicity, resulting in nausea, vomiting, diarrhea, ataxia, tremors, and/or numbness; caution is advised. 12. Sympathomimetic amines: May weaken the antihypertensive effect of this drug. 13. 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 reduction in dosage under a physician's guidance. 14. Thiazide diuretics, ACE1, digoxin, warfarin, antibiotics, and oral hypoglycemic agents: These can be safely used with this drug.
[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 worsening 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 vasodilatory effect of amiloride is gradual, rare reports of acute hypotension have been reported following amiloride use. However, caution should be exercised when using amiloride with other peripheral vasodilators in patients with severe aortic stenosis. 3. Use in Patients with Congestive Heart Failure: Calcium channel blockers should be used with caution in patients with congestive heart failure. In patients with non-ischemic heart failure (NYHA) In a long-term, placebo-controlled study (PRASE-2) conducted in a Phase 2 trial (Level V), although the incidence of worsening heart disease was not significantly different from placebo, there was an increase in reports of pulmonary edema associated with alimentazide. 4. Use in Patients with Impaired Hepatic Function: As with all calcitonin inhibitors, the half-life of alimentazide is prolonged in patients with impaired hepatic function, but a recommended dose has not yet been established. Therefore, caution should be exercised when using this drug. 5. Use in Patients with Renal Failure: Changes in alimentazide plasma concentrations are not correlated with the degree of renal impairment; therefore, a normal dose can be used. This drug cannot be dialyzed. Please read the package insert carefully and use as directed by your healthcare provider.
[Pediatric Use]
Safety and efficacy in children have not been established.
[Elderly Use]
Clinical studies have not demonstrated that elderly patients respond differently to this drug than younger patients. However, given that elderly patients 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. The drug's clearance is decreased, and the area under the curve (AUC) increases by approximately 40%-60%, requiring a lower initial dose.
[Overdose]
Overdose can lead to excessive peripheral vasodilation, causing hypotension and possibly reflex tachycardia. Blood pressure monitoring is essential after an overdose, along with cardiac and respiratory monitoring. If hypotension occurs, supportive care should be implemented, including limb elevation and volume expansion as needed. If these measures are ineffective, pressors (such as phenylephrine) may be considered, provided circulating blood volume and urine output permit. Intravenous calcium gluconate can help reverse the calcium antagonist effect. Because this drug is highly bound to plasma proteins, dialysis is ineffective.
[Pharmacology and Toxicology]
1. Pharmacological Action: Amifedipine besylate is a dihydropyridine calcium antagonist (calcium antagonist or slow-channel blocker). Cardiac and smooth muscle contraction depends on the entry of extracellular calcium ions into cells through specific ion channels. 2. Toxic Effects: Carcinogenic, mutagenic, and teratogenic.
