Amlodipine Maleate Tablets

Amlodipine is a calcium blocker (also known as calcium channel inhibitor or calcium ion antagonist), which 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 cardiac afterload, reduce cardiac energy consumption and oxygen demand, thereby relieving angina pectoris. Carcinogenic, mutagenic and teratogenic. Rats and mice were fed amlodipine for two years at a daily dose of 0.5, 1.25 and 2.5 mg/KG, and no carcinogenicity was confirmed. The highest dose has reached the maximum tolerance of mice, but rats have not yet reached it (calculated based on the clinical maximum recommended dose of 10 mg mg/㎡). Both the gene and chromosome levels did not reveal drug-related mutagenicity. Male rats were given amlodipine 64 days before mating and female rats were given amlodipine 14 days before mating, with a daily dose of 10 mg/kg (8 times the maximum recommended human dose), which did not affect 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 amlodipine at a dose of 10 mg/kg starting 14 days before mating and throughout the mating and gestational periods, which led to a significant decrease in litter size (about 50%), a significant increase in the number of intrauterine deaths (about 5 times), and a prolonged gestational time and delivery process. Toxicity: Mice and rats were given amlodipine at a single dose of up to 40 mg/kg and 100 mg/kg, respectively, which can cause death. Dogs taking a single dose of 4 mg/kg or higher will cause significant peripheral vasodilation and hypotension.

The main ingredient of this product is amlodipine maleate.

This product is off-white tablets.

1. Hypertension (used alone or in combination with other drugs); 2. Angina pectoris: especially spontaneous angina pectoris (used alone or in combination with other 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 therapeutic dose of this product that is required for 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 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 5-10 mg, 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/day.

Amlodipine has good tolerance. In placebo-controlled clinical trials for the treatment of hypertension or angina pectoris, the most common side effects are: Autonomic nervous system: flushing. Whole body: fatigue. Cardiovascular,; General: edema. Central nervous system: dizziness, headache. Gastrointestinal: abdominal pain, nausea. Heart rate/heart rhythm: palpitations. Psychological: drowsiness. No clinical laboratory abnormalities related to this product were found in these clinical trials. Less common side effects observed after marketing are: Autonomic system: dry mouth, increased sweating. Whole body: weakness, back pain, general malaise, pain, weight gain/loss, cardiovascular,; General: hypotension, syncope. Central and peripheral nervous systems: high muscle tension, hypoesthesia/paresthesia, peripheral neuropathy, tremor. Endocrine: breast hyperplasia. Gastrointestinal: changes in bowel habits, dyspepsia (including gastritis), gingival hyperplasia, pancreatitis, vomiting. Metabolic/nutritional: hyperglycemia. Musculoskeletal: Arthralgia, muscle cramps, myalgia. Platelets/Hemorrhage/Coagulation: Purpura, thrombocytopenic purpura. Psychological: Impotence, insomnia, attitude change. Respiratory: Cough, dyspnea. Skin/Appendages: Alopecia, discoloration of extremities. Special Senses: Taste disturbances, tinnitus. Urinary: Frequent urination. Vascular (Extracardiac): Vasculitis. Visual: Visual disturbances. Leukocytes/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 severe 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.

1. It is contraindicated for patients who are allergic to dihydropyridine calcium antagonists; 2. It is contraindicated for patients with severe hypotension or aortic valve stenosis.

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%-60%, so a lower initial dose is also required.

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: Combination 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): However, a 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. Effect of amlodipine on other drugs: Atorvastatin: When 10 mg of amlodipine and 80 mg of atorvastatin were used at the same time, there was no significant change in the steady-state pharmacokinetic parameters of atorvastatin. Digoxin: When amlodipine and digoxin were used together, there was no significant 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. Cyclosporin: Pharmacokinetic studies have shown that amlodipine does not significantly change the pharmacokinetics of cyclosporin. Drug/physical laboratory test interaction: Unknown.

Keep in a light-proof and airtight container.

5mg (calculated as amlodipine)

24 months

Suzhou First Pharmacertical Co., Ltd.

• Founded in:

  2005-12-23

• Address:

  No. 1 Hualing Street, Suzhou Industrial Park

• Tax NO.:

  91320594783360722P

• Registered Funds:

  181.625 million yuan

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