Amlodipine Besylate Tablets

Amlodipine 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 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 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, once a day. Lower doses are recommended for elderly patients and patients with liver dysfunction. 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: 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% to 60%, so a lower initial dose is also required.

Cimetidine, grapefruit juice, acidogens: The pharmacokinetics of this product are not changed when used together. Atorvastatin, digoxin, ethanol: This product does not affect their pharmacokinetics. Sildenafil: A single dose of sildenafil (Viagra) in patients with essential hypertension has no effect on the pharmacokinetics of this product. The two drugs produce an independent antihypertensive effect when used together. Warfarin: This product does not change the prothrombin action time of warfarin. Digoxin, phenytoin and warfarin: The combination with this product has no effect on the plasma protein binding rate. Anesthetics: Inhaled hydrocarbons combined with this product can cause hypotension. Nonsteroidal anti-inflammatory drugs: Indomethacin in particular can weaken the antihypertensive effect of this product. -Blockers: The combination with this product is well tolerated, but it can cause excessive hypotension and rarely aggravate heart failure. Estrogen: The combination can cause fluid retention and increase blood pressure. Sulfinpyrazone: The combination can increase the protein binding rate of this product and produce changes in blood drug concentration. Lithium: Co-administration may cause neurotoxicity, nausea, vomiting, diarrhea, ataxia, tremor and/or numbness, so be cautious. Sympathomimetic amines: May weaken the antihypertensive effect of this product. Sublingual nitroglycerin and long-acting nitrate preparations: Co-administration with this product may enhance the anti-anginal effect. Although rebound effects have not been reported, the dosage should be gradually reduced under the guidance of a doctor when the drug is discontinued. Thiazide diuretics, ACEI, digoxin, warfarin, antibiotics and oral hypoglycemic drugs: Can be safely used with this product.

Keep in a dark, sealed, cool place (no higher than 20℃). The validity period is tentatively 24 months.

5mg

24 months.

Lepu Pharmaceutical (Beijing) Co., Ltd.

• Founded in:

  1998-11-08

• Address:

  Room 2032, Block B, No. 9 Chaoqian Road, Science and Technology Park, Changping District, Beijing

• Tax NO.:

  91110114634394670K

• Registered Funds:

  38.26666667 million yuan

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