Amlodipine Besylate Dispersible Tablets

Amlodipine is a calcium channel 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 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.

Amlodipine besylate. Chemical name: 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 can 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. It is recommended that elderly patients and patients with liver dysfunction use lower doses for treatment. 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 adverse events were: Autonomic nervous system: flushing; General: fatigue; Cardiovascular, general: edema; Central and peripheral nervous system: dizziness and headache; Gastrointestinal: abdominal pain and nausea; Heart rate/rhythm: palpitations; Psychological: somnolence; No significant clinical laboratory abnormalities related to this product were found in these clinical trials. Less common adverse events observed after marketing are: Autonomic nervous system: dry mouth, increased sweating; General: weakness, back pain, malaise, pain, weight gain/loss; Cardiovascular, general: hypotension, syncope; Central and peripheral nervous system: high muscle tone, hypoesthesia/paresthesia, peripheral neuropathy, tremor; Endocrine: breast hyperplasia; Gastrointestinal: changes in bowel habits, dyspepsia (including gastritis), gingival hyperplasia, pancreatitis, vomiting; Metabolic/nutritional: hyperglycemia; Musculoskeletal Bone: arthralgia, muscle cramps, myalgia; Platelets/bleeding/coagulation: purpura, thrombocytopenic purpura; Psychological: impotence, insomnia, attitude change; Respiratory: cough, dyspnea; Skin/appendages: hair loss, skin discoloration; Special senses: taste disturbances, tinnitus; Urinary: frequent urination; Vascular (extracardiac): vasculitis; Visual: visual disturbances; Leukocyte/reticuloendothelial system: leukopenia; Allergic reactions are rare and include pruritus, rash, angioedema, and erythema multiforme. Very rare cases of hepatitis, jaundice, and elevated transaminases (usually associated with cholestasis) have been reported. Some serious cases requiring hospitalization have been reported in association with the use of amlodipine. However, in most cases, a causal relationship has not been established. Similar to other calcium channel blockers, 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 bradycardia, ventricular tachycardia and atrial fibrillation) and chest pain.

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. However, animal test results show that 10 mg/kg of this product can cause a decrease in the number of litters in rats, an increase in stillbirths, delayed delivery and dystocia, so 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, and breastfeeding women who take the 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 drug-time curve (AUC) and the extension of the elimination half-life in elderly patients have a downward trend in clearance rate. It has been reported that when receiving similar doses of amlodipine, elderly patients have the same good tolerance as young patients. Therefore, elderly patients can use normal doses. However, it is appropriate to start with a smaller dose and then increase it gradually.

This product is safe when used in combination with the following drugs: thiazide diuretics, а-adrenergic receptor blockers, β-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 using human plasma showed that this product does 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 does not change the pharmacokinetics of amlodipine. Grapefruit juice: 20 healthy volunteers took 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): Taking aluminum/magnesium antacids and a single dose of amlodipine at the same time,

Keep away from light and store in sealed container.

5mg (calculated as amlodipine)

36 months

Guangzhou Yipinhong Pharmaceutical Co., Ltd.

• Founded in:

  2010-07-16

• Address:

  No. 6 Dongbo Road, East District, Guangzhou Economic and Technological Development Zone

• Tax NO.:

  914401015583834183

• Registered Funds:

  50 million yuan

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