Product Overview
[Drug Name]
Generic Name: Levamlodipine Besylate Tablets
Trade Name: Anmeiping
English Name: Levamlodipine Besylate Tablets
Chinese Pinyin: Levamlodipine Besylate Tablets
[Ingredients]
Levamlodipine Besylate.
[Properties]
This product is a white tablet.
[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]
1. The initial dose for the treatment of hypertension and angina pectoris is 2.5 mg once daily. The dose may be increased based on the patient's clinical response, up to a maximum of 5 mg once daily.
2. No dose adjustment is required when this product is used in combination with thiazide diuretics, beta-blockers, and angiotensin-converting enzyme inhibitors.
[Adverse Reactions]
This product is well tolerated by patients. 1. Less common side effects include headache, edema, fatigue, insomnia, nausea, abdominal pain, flushing, palpitations, and dizziness. 2. Extremely rare side effects include itching, rash, dyspnea, weakness, muscle cramps, and indigestion. 3. Similar to other calcium channel blockers, there have been rare reports of adverse reactions such as myocardial infarction and chest pain, and these reactions cannot be clearly distinguished from the patient's underlying medical conditions. 4. No abnormal laboratory parameters have been found related to this product.
[Contraindications]
1. Contraindicated in patients allergic to dihydropyridine calcium channel blockers. 2. Use in pregnant women only when absolutely necessary. It is unknown whether this product is excreted in breast milk; breastfeeding women taking this drug should discontinue breastfeeding.
[Precautions]
1. Angina pectoris and/or myocardial infarction: Rare. Patients with severe obstructive coronary artery disease may experience an increase in the frequency, duration and/or severity of angina attacks, or develop acute myocardial infarction, when they start treatment with calcium channel antagonists or increase the dosage. The mechanism is unknown; 2. Hypotension: Since this product gradually produces a vasodilatory effect, acute hypotension rarely occurs after oral administration. However, caution should still be exercised when this product is used in combination with other peripheral vasodilators, especially for patients with severe aortic valve stenosis; 3. Patients with heart failure: Calcium channel blockers should be used with caution in patients with heart failure; 4. Patients with hepatic insufficiency: This product should be used with caution in patients with severe hepatic insufficiency; 5. Patients with renal failure: The starting dose for patients with renal failure can remain unchanged; 6. Discontinuation of (-blockers: This product has no protective effect against rebound symptoms caused by sudden discontinuation of (-blockers. Therefore, discontinuation of (-blockers still requires a gradual reduction in dosage; 7. This product can be used safely in patients with obstructive pulmonary disease, well-compensated heart failure, peripheral vascular disease, diabetes, and lipid disorders.
[Use in Special Populations]
Precautions for Pediatric Use: No data are available for the use of this product in children.
Precautions for Pregnancy and Lactation: This product is recommended only when there are no safer alternatives and the disease itself poses a greater risk to the mother and child.
Precautions for Elderly Patients: Elderly patients can use the normal dose. However, it is advisable to start with a lower dose and then gradually increase it.
[Drug Interactions]
1. This product is safe to use in combination with the following drugs: thiazide diuretics, beta-blockers, angiotensin-converting enzyme inhibitors, long-acting nitrates, sublingual nitroglycerin, nonsteroidal anti-inflammatory drugs, antibiotics, and oral hypoglycemic agents. 2. In healthy volunteers, the combination of this product with digoxin did not alter digoxin plasma concentrations or renal clearance; the pharmacokinetics of this product were not altered when it was used in combination with cimetidine. 3. In vitro data indicate that this product has no effect on the plasma protein binding of digoxin, phenytoin, warfarin, or indomethacin. 4. In healthy male volunteers, coadministration of this product with warfarin did not affect the changes in prothrombin time induced by warfarin.
[Pharmacological Actions]
1. This product is a calcium influx blocker (also known as a calcium channel blocker or calcium ion antagonist), blocking the entry of extracellular calcium ions into myocardial and vascular smooth muscle cells through calcium channels (slow channels) in the cell membrane. 2. This product directly relaxes vascular smooth muscle and has antihypertensive effects. 3. The mechanism of action of this product in relieving angina pectoris is not fully determined, but it alleviates myocardial ischemia through the following actions: 4. Dilation of peripheral arterioles, reducing peripheral resistance (afterload), thereby reducing myocardial energy consumption and oxygen demand; 5. Dilation of coronary arteries and coronary arterioles in normal and ischemic areas, thereby increasing myocardial oxygen supply in patients with coronary artery spasm (variant angina). 6. This product undergoes prolonged liver metabolism, similar to all other calcium antagonists. Caution should be exercised when using this product in patients with impaired liver function.
[Storage] Store in a dark, airtight, cool place.
[Strength] 2.5 mg (as C₂O₂H₂SCl₂N₂O₂)
[Expiry Date] 24 months.
[Approval Number] National Medicine Standard H20103814
[Manufacturer] Company Name: Suzhou Dawnray Pharmaceutical Co., Ltd.
