Amlodipine Besylate Capsules

Amlodipine is a calcium blocker (also known as a slow channel blocker or calcium ion antagonist) that blocks calcium ions from entering myocardial and vascular smooth muscle cells across the membrane. The mechanism of amlodipine'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 dilate peripheral arterioles and coronary arteries, reduce total peripheral vascular resistance, relieve coronary artery spasm, reduce the afterload of the heart, and reduce the heart's energy consumption and oxygen demand, thereby relieving angina pectoris.

Amlodipine besylate.

This product is a hard capsule, and the contents are white or off-white granules or powder.

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. The initial dose for the treatment of hypertension is 5 mg (1 tablet), once a day, and the maximum dose is 10 mg (2 tablets), once a day. The initial dose for weak or elderly patients and patients with liver dysfunction is 2.5 mg (0.5 tablets), once a day; this dose can also be the dose that requires the addition of this product to other antihypertensive drugs. Dose adjustment should be based on the individual response of the patient. General dose adjustment should be started after 7 to 14 days. If clinically necessary, dose adjustment can be started more quickly after close observation of the patient. 2. The initial dose for the treatment of angina pectoris is 5 to 10 mg (1 to 2 tablets), once a day. It is recommended to use a lower dose for the elderly and patients with liver dysfunction. The effective dose for most people is 10 mg (2 tablets) per day.

Amlodipine is well tolerated. In placebo-controlled clinical trials for the treatment of hypertension or angina, the most common side effects were: Autonomic nervous system: flushing Systemic: fatigue Cardiovascular, general: edema Central and peripheral nervous system: dizziness, headache Gastrointestinal: abdominal pain, nausea Heart rate/rhythm: palpitations Psychological: drowsiness No significant clinical laboratory abnormalities related to this product were found in these clinical trials. Less common side effects observed after marketing are: Autonomic nervous system: dry mouth, increased sweating Systemic: weakness, back pain, malaise, pain, weight gain/loss Cardiovascular.

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: There is a lack of relevant research data on the use of this product in pregnant women, but according to the results of animal tests, this product can only be used in pregnant women when it is very 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: The peak time of amlodipine blood concentration is similar in elderly and young patients. The increase in the area under the curve (AUC) and the extension of the elimination half-life in elderly patients have a downward trend in the elimination rate. It has been reported that when receiving similar doses of amlodipine, elderly patients have the same good tolerance as young patients. Therefore, normal doses can be used for elderly patients. However, it is appropriate to start with a smaller dose and then increase the dose gradually.

This product is safe to be used in combination with the following drugs: thiazide diuretics, alpha;-adrenergic receptor blockers, beta;-adrenergic receptor blockers, angiotensin converting enzyme inhibitors, long-acting nitrates, sublingual nitroglycerin, nonsteroidal anti-inflammatory drugs, antibiotics and oral hypoglycemic drugs. In vitro data from studies using human plasma showed that this product did not affect the plasma protein binding rate of digoxin, phenytoin sodium, warfarin or indomethacin. Effects of other drugs on amlodipine: Cimetidine: Co-administration with cimetidine did not change the pharmacokinetics of amlodipine. Grapefruit juice: 20 healthy volunteers took 240ml grapefruit juice and 10mg amlodipine at the same time, and no significant effect on the pharmacokinetics of amlodipine was observed. Aluminum/magnesium (antacids): Taking aluminum/magnesium antacids and a single dose of amlodipine at the same time did not have a significant effect on the pharmacokinetics of amlodipine. Sildenafil (Viagra) (SILDENAFIL): A single dose of 100 mg of sildenafil does not affect the pharmacokinetics of amlodipine in patients with essential hypertension. When the two drugs are used together, each drug exerts its antihypertensive effect independently. Effects of amlodipine on other drugs: Atorvastatin (ATORVASTATIN): The steady-state pharmacokinetic parameters of atorvastatin were not significantly changed when 10 mg of amlodipine and 80 mg of atorvastatin were used simultaneously. Digoxin: When amlodipine and digoxin were used together, there was no change in the plasma digoxin concentration or renal clearance rate of normal volunteers. Ethanol (alcohol): Single or multiple administrations of 10 mg of amlodipine had no effect on the pharmacokinetics of ethanol. Warfarin: The combination of amlodipine and warfarin does not change the prothrombin reaction time of warfarin. Cyclosporine: Pharmacokinetic studies have shown that amlodipine does not significantly change the pharmacokinetics of cyclosporine.

Keep in a light-proof and airtight container.

5mg (calculated as amlodipine)

24 months

Nantong Huashan Pharmaceutical Co., Ltd.

• Founded in:

  1993-12-24

• Address:

  No. 78 Tongsheng Avenue, Economic and Technological Development Zone, Nantong City, Jiangsu Province (Production and operation address: No. 78 Tongsheng Avenue, Economic and Technological Development Zone, Nantong City, Jiangsu Province, 5th Floor, Building No. 3, Economic and Technological Development Zone, Nantong City, Jiangsu Province)

• Tax NO.:

  913206916083078799

• Registered Funds:

  14.4101 million yuan

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