Amlodipine Maleate Tablets

This product is a calcium blocker (also known as a slow channel blocker or calcium ion antagonist). It blocks calcium ions from entering the myocardium and vascular smooth muscle across the membrane. The mechanism of this product's antihypertensive effect is to directly relax vascular smooth muscle. The exact mechanism of action for relieving angina pectoris has not been fully determined, but it can relieve angina pectoris by dilating peripheral arterioles and coronary arteries, reducing total peripheral vascular resistance, relieving coronary artery spasm, reducing the afterload of the heart, and reducing the heart's energy consumption and oxygen demand.

The main ingredient of this product is amlodipine maleate, and its chemical name is racemic-2-[(2-aminoethoxy)methyl]-4-(2-chlorophenyl)-1,4-dihydro-6-methyl-3,5-pyridinedicarboxylic acid 3-ethyl 5-methyl ester maleate.

This product is 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.

The usual starting oral dose is 5 mg, once a day, and the maximum dose is no more than 10 mg, once a day. Thin people, weak people, elderly patients or those with impaired liver function start taking the drug from 2.5 mg, once a day; those who take other antihypertensive drugs in combination also start taking the drug from this dose. The dosage is adjusted according to individual needs, and the adjustment period should be no less than 7-14 days so that the doctor can fully evaluate the patient's response to the dose. However, under the premise of clinical guarantee, the adjustment speed can be accelerated. The recommended dose for the treatment of angina pectoris is 5-10 mg, and the elderly patients or those with impaired liver function need to reduce the dose.

Patients can 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, flushing, palpitations and dizziness. No abnormal clinical test indicators related to this product were found in these clinical trials. Less side effects observed after listing include alopecia, changes in bowel habits, joint pain, weakness, back pain, dyspepsia, dyspnea, gingival hyperplasia, male breast feminization, hyperglycemia, impotence, frequent urination, leukopenia, general discomfort, mood changes, dry mouth, muscle spasms, myalgia, peripheral neuropathy, pancreatitis, increased sweating, syncope, thrombocytopenia, vasculitis and visual impairment. In most cases, the causal relationship between the above changes and this product has not been determined. Allergic reactions are rare, including pruritus, rash, angioedema and erythema multiforme. There have been extremely rare reports of hepatitis, jaundice, and elevated liver enzymes (usually consistent with hepatic stasis). Some cases of hospitalization for serious illness have been reported to be associated with the use of amlodipine. In many cases, the causal relationship cannot be determined. Similar to other calcium antagonists, the following adverse events have also been reported in a small number of cases, but the events are difficult to distinguish from the natural course of the underlying disease, such as myocardial infarction, arrhythmias (including ventricular tachycardia and atrial fibrillation), and chest pain.

It is contraindicated for people who are allergic to any ingredient in this drug.

Precautions for children: Safety and effectiveness have not yet been determined. Precautions for pregnancy and lactation: There is a lack of research data on the use of this drug in pregnant women, but according to the results of animal tests, this product can only be used in pregnant women when it is absolutely necessary. It is not yet known whether this product can be secreted through breast milk. Lactating women who take this drug should stop breastfeeding. Precautions for the elderly: Clinical studies have not confirmed that the elderly react to this drug differently from young people, but considering that the elderly often have decreased liver, kidney and heart function, and are accompanied by other diseases and corresponding drug treatments, the lower limit of the dosage range is generally used for initial medication. The clearance rate of this product is reduced in the elderly, and the drug-time curve (AUC) increases by about 40%-60%, so a lower starting dose is also required.

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. In vitro study data on healthy volunteers showed that the combination of this product with digoxin did not change the serum digoxin concentration and the renal elimination rate of digoxin, and the combination with cimetidine did not change the pharmacokinetics of this product. In vitro study data using human plasma showed that this product did not affect the plasma protein binding rate of digoxin, phenytoin, 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 show changes in the pharmacokinetics of cyclosporine.

Keep in a light-proof and airtight container.

5mg (based on amlodipine free base)

24 months

Hainan Simcere Pharmaceutical Co., Ltd.

• Founded in:

  1993-04-28

• Address:

  No. 2, Yaogu 3rd Road, Xiuying District, Haikou City, Hainan Province

• Tax NO.:

  91460000201357380E

• Registered Funds:

  221.1109 million yuan

• Website:

  Log in to view

• Email:

  Log in to view