Amlodipine Besylate Tablets

This product is a calcium influx blocker (also known as a calcium channel blocker or calcium ion antagonist), which blocks extracellular calcium ions from entering myocardial and vascular smooth muscle cells through the calcium ion channels (slow channels) of the cell membrane. This product directly relaxes vascular smooth muscle, dilates peripheral arterioles, reduces peripheral resistance (afterload), and dilates coronary arteries, which can relieve coronary artery spasm, and has the effects of anti-hypertension and relieving angina pectoris.

The chemical name of this product is: 3-ethyl-5-methyl-2-(2-aminoethoxymethyl)-4-(2-chlorophenyl)-1,4-dihydro-6-methyl-3,5-pyridinedicarboxylate benzenesulfonate. Molecular formula: C20H25ClN2O5·C6H6O3S, molecular weight: 567.1.

This product is white tablets.

Hypertension and angina pectoris.

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, those with weak constitutions, elderly patients, or those with impaired liver function should start taking the drug from 2.5 mg, once a day; those who take other antihypertensive drugs in combination should 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 tolerate this product well. The most common side effects are headache, edema, fatigue, insomnia, nausea, abdominal pain, flushing, palpitations and dizziness. Less common side effects are itching, rash, dyspnea, weakness, muscle cramps and indigestion. Similar to other calcium antagonists, there are very few reports of adverse reactions such as myocardial infarction and chest pain, and these adverse reactions cannot be clearly distinguished from the patient's underlying diseases. No abnormal laboratory test parameters related to this product have been found.

It is contraindicated in patients who are allergic to dihydropyridine calcium antagonists.

Precautions for children: The safety and effectiveness for children have not 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% to 60%, so a lower initial dose is also required.

This product is safe to be used 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 drugs. In healthy volunteers, the combination of this product with digoxin did not change the blood concentration or renal clearance of digoxin, and the pharmacokinetics of this product did not change when combined with cimetidine. In vitro research data show that this product has no effect on the plasma protein binding rate of digoxin, phenytoin, warfarin or indomethacin. In healthy male volunteers, the use of this product with warfarin did not affect the changes in warfarin on prothrombin time.

Keep in a light-proof and airtight container.

5mg per tablet (calculated as amlodipine)

24 months.

Competent Investments Limited

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