Amlodipine Besylate Dispersible Tablets

This product is a calcium blocker (also known as a slow channel blocker or calcium ion antagonist) that blocks calcium ions from crossing the membrane into myocardial and vascular smooth muscle cells.

3-Ethyl-5-methyl-2-(2-aminoethoxymethyl)-4-(2-chlorophenyl)-1,4-dihydro-6-methyl-3,5-pyridinedicarboxylate benzenesulfonate

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 The initial dose for the treatment of hypertension is 5 mg, once a day, and the maximum dose is 10 mg, once a day. The initial dose for weak or elderly patients and patients with liver dysfunction is 2.5 mg, once a day; this dose may also be the dose that requires the addition of this product to the original treatment with other antihypertensive drugs. Dose adjustment should be based on the individual response of the patient. General dose adjustment should be started after 7-14 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 5-10 mg, once a day. Lower doses are recommended for elderly and liver dysfunction patients. The effective dose for most people is 10 mg/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: somnolence No significant clinical laboratory abnormalities related to amlodipine were found in these clinical trials. Less common side effects observed post-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 the blood concentration of this product 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 it 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 of digoxin, phenytoin sodium, warfarin or indomethacin. In the following studies, when amlodipine was used simultaneously with other drugs, there was no significant change in the pharmacokinetics of amlodipine or other drugs. Effects of other drugs on amlodipine: Cimetidine: Combination with cimetidine did not change the pharmacokinetics of amlodipine. Grapefruit juice: 20 healthy volunteers took 240 ml of grapefruit juice and 10 mg of amlodipine at the same time, and no significant effect on the pharmacokinetics of amlodipine was observed. Aluminum/magnesium (antacids): The simultaneous administration of aluminum/magnesium antacids and a single dose of amlodipine did not significantly affect the pharmacokinetics of amlodipine. Sildenafil (Viagra): A single dose of 100 mg of sildenafil did 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): Multiple doses of 10 mg of amlodipine combined with 80 mg of atorvastatin did not significantly change the steady-state pharmacokinetic parameters of atorvastatin. Digoxin: The combination of amlodipine and digoxin did not change the plasma digoxin concentration or renal clearance of normal volunteers. Ethanol (alcohol): Single or multiple doses of 10 mg of amlodipine had no effect on the pharmacokinetics of ethanol. Warfarin: The combination of amlodipine and warfarin did not change the prothrombin reaction time of warfarin. Cyclosporine: Pharmacokinetic studies have shown that amlodipine does not significantly alter the pharmacokinetics of cyclosporine. Drug/Laboratory Test Interactions: None known.

Keep in a sealed container and away from light. The shelf life is tentatively 18 months.

5mg (calculated as amlodipine)

24 months

Nantong Jiuhe Pharmaceutical Co., Ltd.

• Founded in:

  2002-07-29

• Address:

  No. 118, Jianghai West Road, Chengao Industrial Park, Rudong, Jiangsu Province

• Tax NO.:

  91320623741329559W

• Registered Funds:

  10.18 million yuan

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