Amlodipine Maleate Tablets

Amlodipine is a calcium blocker (also known as a slow channel blocker or calcium ion antagonist) that blocks calcium ions from entering the myocardial and vascular smooth muscle cells across the membrane. The mechanism of its 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 cardiac afterload, reduce cardiac energy consumption and oxygen demand, thereby relieving angina pectoris. Carcinogenicity, mutagenicity and teratogenicity Rats and mice were fed amlodipine for two years at doses of 0.5, 1.25 and 2.5 mg/kg per day, and no carcinogenicity was confirmed. The highest dose has reached the maximum tolerated dose in mice, but not in rats (calculated based on the clinical maximum recommended dose of 10 mg mg/m2). No drug-related mutagenicity was revealed at the gene and chromosome levels. Male rats were given amlodipine 64 days before mating and female rats were given amlodipine 14 days before mating, at a daily dose of 10 mg/kg (8 times the maximum recommended human dose), without affecting reproductive capacity. Pregnant rats and rabbits were given amlodipine 10 mg/kg (8 times and 23 times the maximum recommended human dose) during the period of major organ formation, and no teratogenicity or other embryotoxicity was found. However, rats were given 10 mg/kg of amlodipine starting 14 days before mating and throughout the mating and gestational periods, resulting in a significant decrease in the number of pups in the litter (about 50%), a significant increase in the number of intrauterine deaths (about 5 times), and a prolonged gestational time and delivery course. Toxicity: Single doses of amlodipine up to 40 mg/kg and 100 mg/kg, respectively, can cause death in mice and rats. A single dose of 4 mg/kg or higher in dogs will cause significant peripheral vasodilation and hypotension.

The main ingredient of this product is amlodipine maleate.

This product is a film-coated tablet, which appears white or off-white after removing the coating.

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 antihypertensive drugs.

1. The usual initial dose for the treatment of hypertension is 5 mg, once a day, and the maximum dose is no more than 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 is also the initial dose for the treatment of 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, the dose adjustment can be started faster when the patient is closely monitored. 2. The recommended dose for the treatment of angina pectoris is 5 to 10 mg, once a day. Low-dose treatment is recommended for the elderly and patients with liver dysfunction. The effective dose for most people is 10 mg/day.

Amlodipine has good tolerance. In placebo-controlled clinical trials for the treatment of hypertension or angina pectoris, the most common side effects are: Common adverse reactions: 1. Autonomic nervous system: flushing. 2. Whole body: fatigue. 3. Cardiovascular, general: edema. 4. Central and peripheral nervous systems: dizziness, headache. 5. Gastrointestinal: abdominal pain, nausea. 6. Heart rate/heart rhythm: palpitations. 7. Psychological: drowsiness. No clinical laboratory abnormalities related to this product were found in clinical trials. Less common adverse reactions observed after marketing are: 1. Autonomic nervous system: dry mouth, increased sweating. 2. Whole body: weakness, back pain, general discomfort, pain, weight gain/loss. 3. Cardiovascular, general: hypotension, syncope. 4. Central and peripheral nervous systems: high muscle tension, hypoesthesia/paresthesia, peripheral neuropathy, tremor. 5. Endocrine: breast hyperplasia. 6. Gastrointestinal: changes in bowel habits, dyspepsia (including gastritis), gingival hyperplasia, pancreatitis, vomiting. 7. Metabolic/Nutritional: hyperglycemia. 8. Musculoskeletal: arthralgia, muscle cramping pain, myalgia. 9. Platelets/Hemorrhage/Coagulation: purpura, thrombocytopenic purpura. 10. Psychological: impotence, insomnia, attitude changes. 11. Respiratory: cough, dyspnea. 12. Skin/Appendages: hair loss, skin discoloration. 13. Special senses: taste disturbances, tinnitus. 14. Urinary: frequent urination. 15. Vascular (extracardiac): vasculitis. 16. Visual: visual impairment. 17. 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 consistent with cholestasis) have been reported. Some serious cases requiring hospitalization have been reported in association with the use of amlodipine. However, in most cases, causality has not been established. Similar to other calcium antagonists, the following adverse reactions 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.

It is contraindicated in patients who have overdosed on dihydropyridines or any of the ingredients in this product.

Precautions for children: There is no data on the use of this product for 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) in elderly patients has a tendency to decrease the elimination rate due to the extension of the elimination half-life. 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 gradually increase the dose.

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 study data using human plasma showed that amlodipine did not affect the plasma protein binding rate of digoxin, phenytoin sodium, warfarin or indomethacin. Effects of other drugs on amlodipine; cimetidine: Combination with cimetidine does 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 (antacid): 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): A single dose of 100 mg sildenafil does not affect the pharmacokinetics of amlodipine in patients with essential hypertension. When the two are used together, each drug exerts its antihypertensive effect independently. Effects of amlodipine on other drugs: Atorvastatin: When 10 mg amlodipine and 80 mg atorvastatin are used simultaneously, there is no significant change in the steady-state pharmacokinetic parameters of atorvastatin. Digoxin: When amlodipine and digoxin are used together, there is no change in the plasma digoxin concentration or renal clearance rate of normal volunteers. Ethanol (alcohol): Single or multiple administrations of 10 mg amlodipine have 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. Drug/laboratory test interactions: Unknown.

Keep in a light-proof and airtight container.

5mg*12 tablets/box

24 months

Jiangsu Lianhuan Pharmaceutical Co., Ltd.

• Founded in:

  2000-02-22

• Address:

  No. 9, Jiankang 1st Road, Yangzhou Bio-Health Industrial Park, Yangzhou City, Jiangsu Province

• Tax NO.:

  91321000714094280W

• Registered Funds:

  285.45627 million yuan

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