Amlodipine Maleate Dispersible Tablets

Amlodipine is a calcium ion blocker (also known as a slow channel blocker or calcium ion antagonist) that can block extracellular calcium ions from entering myocardial and smooth muscle cells through cell membrane calcium ion channels. The mechanism of this product's antihypertensive effect is to directly relax vascular smooth muscle. The exact mechanism of relieving angina pectoris has not been fully confirmed, but it can relieve angina pectoris by dilating peripheral arterioles and coronary arteries, reducing total peripheral vascular resistance, relieving coronary artery spasm, reducing cardiac afterload, and reducing cardiac energy consumption and oxygen demand. A two-year study was conducted in rats and mice, where amlodipine was given by food at doses of 0.5 mg/kg/day, 1.25 mg/kg/day, and 2.5 mg/kg/day, and no evidence of carcinogenicity was found. Mutagenicity studies showed no drug-related effects at the gene or chromosome level. Amlodipine 10 mg/kg/day (calculated as mg/m2, 8 times the maximum recommended human dose of 10 mg) had no effect on the reproductive capacity of rats.

The main ingredient of this product is amlodipine maleate. Chemical name: 3-ethyl-5-methyl-2-(2-aminoethoxymethyl)-4-(2-chlorophenyl)-1,4-dihydro-6-methyl-3,5-pyridinedicarboxylic acid diester maleate. Chemical structure: Molecular formula: C20H25ClN2O5·C4H4O4 Molecular weight: 542.95

This product is white or off-white tablets.

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 antianginal drugs.

1. Treatment of hypertension: The initial dose is 1 tablet (5 mg), once a day, and the maximum dose is 2 tablets (10 mg), once a day. The initial dose for weak or elderly patients and patients with liver dysfunction is half a tablet (2.5 mg), once a day. This dose can also be the dose of this product that needs to be added to the original treatment with other antihypertensive drugs. The dose should be adjusted according to the individual response of the patient: general dose adjustment should be started after 7-14 days. If clinically necessary, the dose adjustment can be started in a shorter time under close monitoring of the patient. 2. Treatment of angina pectoris: The initial dose is 1-2 tablets (5-10 mg), once a day. Lower doses are recommended for elderly and liver dysfunction patients. The effective dose for most people is 2 tablets (10 mg)/day.

Patients tolerate this product well at a dose of 10 mg/day. In placebo-controlled clinical trials for the treatment of hypertension or angina pectoris, the most common side effects are headache, edema, fatigue, drowsiness, nausea, abdominal pain, hot flushes, palpitations and dizziness. No abnormal clinical test indicators related to this product were found in these clinical trials. Less common side effects observed after marketing include: alopecia, changes in bowel habits, joint pain, weakness, back pain, indigestion, dyspnea, gingival hyperplasia, gynecomastia in men, hyperglycemia, impotence, frequent urination, leukopenia, general discomfort, mood changes, dry mouth, muscle cramps, myalgia, peripheral neuropathy, pancreatitis, increased sweating, syncope, thrombocytopenia, vasculitis and visual impairment. In most cases, the above changes are causally related to this product.

Patients who are allergic to dihydropyridines or any of the ingredients in this product are contraindicated.

Precautions for children: There is no data on the use of this product in children. Precautions for pregnancy and lactation: The safety of this product for use during pregnancy or lactation has not been determined. In animal experiments, at a dose of 50 times the maximum recommended human dose, this product did not show any reproductive toxicity except for delayed delivery and dystocia in rats. Therefore, this product is only recommended when there are no other safer alternative drugs and the disease itself poses a greater risk to mother and child. Precautions for the elderly: The peak time of the blood concentration of this product is similar in elderly and young patients. The increase in the area under the drug-time curve (AUC) and the extension of the elimination half-life in elderly patients have led to a downward trend in clearance. It has been reported that elderly patients have the same good tolerance as young patients when receiving similar doses of amlodipine. Therefore, normal doses can be used for elderly patients. However, it is appropriate to start with a smaller dose and then gradually increase the dose.

This product is safe to be used in combination with the following drugs: thiazide diuretics, beta-adrenergic receptor blockers, angiotensin converting enzyme inhibitors, long-acting nitrates, sublingual nitroglycerin, nonsteroidal anti-inflammatory drugs, antibiotics and oral hypoglycemic drugs. Studies on healthy volunteers have shown that the combination of this product with digoxin does not change the serum digoxin concentration and the renal clearance of digoxin, and the combination with cimetidine does not change the pharmacokinetics of this product. In vitro study data using human plasma showed that this product does not affect the plasma protein binding rate of digoxin, phenytoin sodium, warfarin or indomethacin. In a study of male healthy volunteers, the combination of this product with warfarin did not significantly change the effect of warfarin on the prothrombin time. Pharmacokinetic studies have shown that this product does not significantly change the pharmacokinetics of cyclosporine.

Keep away from light and store in sealed container.

5mg (calculated as amlodipine)

24 months

Jiangsu Wangao Pharmaceutical Co., Ltd.

• Founded in:

  2003-11-28

• Address:

  No. 688 Dinghai Road, Haimen Economic and Technological Development Zone, Jiangsu Province

• Tax NO.:

  913206847558853886

• Registered Funds:

  62.6 million yuan

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