Amlodipine and Atorvastatin Calcium Tablets

Amlodipine and atorvastatin calcium tablets are a compound preparation of amlodipine and atorvastatin. Amlodipine is a dihydropyridine calcium (ion) antagonist (calcium ion antagonist or slow channel blocker). Atorvastatin is a 3-hydroxy-3-methylglutaryl coenzyme A (HMG-CoA) reductase inhibitor. Amlodipine can inhibit the inward movement of calcium ions across the membrane into vascular smooth muscle and myocardium, while atorvastatin is a selective and competitive inhibitor of HMG-CoA reductase (statin). The function of HMG-CoA reductase is to convert hydroxymethylglutaryl coenzyme A into mevalonic acid, which is a sterol precursor including cholesterol. See the instructions for details.

This product is a compound preparation, the main ingredients of which are amlodipine besylate and atorvastatin calcium. Excipients: calcium carbonate, cross-linked carboxymethyl cellulose sodium, microcrystalline cellulose, pregelatinized starch, polysorbate 80 (II), hydroxypropyl cellulose, colloidal silicon dioxide, magnesium stearate, film coating premix (gastric soluble).

This product is a white film-coated tablet, which appears white or off-white after removing the coating.

This product (amlodipine and atorvastatin) is suitable for patients who need combined treatment with amlodipine and atorvastatin. Please refer to the instructions for details.

When using this product to treat hypertension or angina pectoris with hyperlipidemia, the individualized treatment dose must be considered, and the doses of amlodipine and atorvastatin should be adjusted accordingly according to the patient's therapeutic effect and tolerance of each component. This product has the same effect as its two components used alone and can be replaced with each other. Patients can be given drugs equivalent to the single doses of the two components, or amlodipine or atorvastatin or both can be increased on the basis of the single dose to increase the anti-anginal, antihypertensive or lipid-lowering effects. This product can be used for patients who have already used one of the drugs, atorvastatin or amlodipine, and need to add the other drug for treatment. This product can be used for the initial treatment of patients with hypertension or angina pectoris accompanied by hyperlipidemia. The recommended starting dose should be appropriately combined according to the recommended dose of each single drug component. See the instructions for details.

The safety of this product was evaluated in a double-blind, placebo-controlled study of 1,092 patients with hypertension and hyperlipidemia. This product is well tolerated during treatment. For most patients, adverse reactions are mild to moderate. In clinical studies of this product, no special adverse reactions related to this combination preparation were found. The nature, severity and frequency of adverse reactions are similar to those reported for amlodipine and atorvastatin (please see the corresponding adverse event table below). In controlled clinical trials, only 5.1% of patients receiving amlodipine and atorvastatin needed to stop taking the drug due to clinical adverse events or abnormal laboratory tests, while the proportion of patients receiving placebo was 4.0%. See the instructions for details.

The research data of drug interaction between amlodipine 10mg and atorvastatin 80mg in healthy subjects showed that the pharmacokinetics of amlodipine did not change when the two were used together, and the pharmacokinetics of amlodipine on atorvastatin showed no effect on the maximum plasma concentration (Cmax): 91% (90% confidence interval: 80-103%), but when used together with amlodipine, the area under the curve AUC of atorvastatin increased by 18% (90% confidence interval: 109-127%), which has no clinical significance. See the instructions for details.

Keep away from light and store in a sealed container.

7 pieces/plate x 2 plates/box

Jilin Deshang Pharmaceutical Co., Ltd.

• Founded in:

  2012-06-12

• Address:

  North 1st Street, Economic Development Zone, Huinan County, Jilin Province

• Tax NO.:

  912205235944926971

• Registered Funds:

  118.7619 million yuan

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