Product Overview
[Drug Name]
Generic Name: Levamlodipine Besylate Tablets
Trade Name: Xinta
English Name: Levamlodipine Besylate Tablets
Chinese Pinyin: BenHuangSuanZuoXuanAnLvDiPingPian
[Ingredients]
Levamlodipine besylate.
[Properties]
This product is a white tablet.
[Indications]
1. Hypertension. 2. Angina pectoris.
[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 to be associated with this product.
[Contraindications]
This product is contraindicated in patients with hypersensitivity to dihydropyridine calcium channel blockers.
[Precautions]
1. As with all calcium channel blockers, this product should be used with extreme caution in patients with impaired liver function. 2. For patients with renal failure, the normal dose can be used. 3. This product is not suitable for dialysis. Please read the package insert carefully and use as directed by your doctor.
[Special Use in Special Populations]
Precautions for use in children:
This product is not available for use in children. Precautions for Pregnancy and Lactation:
This product is only recommended when there are no safer alternatives and the disease itself poses a greater risk to the mother and child.
Precautions for the Elderly:
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 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, coadministration of this product with digoxin did not alter digoxin plasma concentrations or renal clearance; coadministration of this product with cimetidine did not alter its pharmacokinetics. 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 warfarin's changes in prothrombin time.
[Pharmacological Actions]
1. This drug is a calcium influx blocker (also known as a calcium channel blocker or calcium ion antagonist), which blocks the entry of extracellular calcium ions into myocardial and vascular smooth muscle cells through calcium ion channels (slow channels) in the cell membrane. 2. This drug directly relaxes vascular smooth muscle and has antihypertensive effects. 3. The mechanism of action of this drug in relieving angina pectoris has not been 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, increasing myocardial oxygen supply in patients with coronary artery spasm (variant angina). 6. This drug undergoes prolonged metabolism in the liver. Like all other calcium antagonists, caution should be exercised when using this drug in patients with impaired liver function.
[Storage] Store in a cool, dark, and airtight place.
[Strength] 2.5mg (calculated as levamlodipine)
[Packaging] 2.5mg x 14s
[Expiry Date] 36 months
[Approval Number] National Medicine Standard H20093088
[Manufacturer] Company Name: Simcere Pharmaceutical Co., Ltd.
