Amlodipine tablets 10 mg. №20

Description

Ingredients

active ingredient: amlodipine;

1 tablet contains:

• amlodipine besylate, in terms of amlodipine – 5 mg;

excipients: lactose, monohydrate, potato starch, povidone, calcium stearate.

Medicinal form

Tablets.

Main physico-chemical properties: tablets of white or almost white color with a flat surface, with a line and a chamfer.

Pharmacotherapeutic group

Selective calcium antagonists with a predominant effect on blood vessels. Dihydropyridine derivatives. ATX code C08S A01.

Pharmacological properties

Pharmacodynamics.

Amlodipine is a calcium antagonist (dihydropyridine derivative) that blocks the influx of calcium ions to the myocardium and smooth muscle cells.

The mechanism of hypotensive action of amlodipine is caused by a direct relaxing effect on vascular smooth muscles. The exact mechanism of the antianginal effect of amlodipine is not well defined, but the following effects play a role.

1. Amlodipine dilates peripheral arterioles and, thus, reduces peripheral resistance (afterload). As the heart rate remains stable, the reduction in cardiac workload leads to a reduction in energy consumption and myocardial oxygen demand.

2. Dilation of the main coronary arteries and coronary arterioles (normal and ischemic) may also play a role in the mechanism of action of amlodipine. Such expansion increases myocardial oxygen saturation in patients with coronary artery spasm (Prinzmetal’s angina or variant angina).

In patients with arterial hypertension, the use of the drug 1 time per day provides a clinically significant decrease in blood pressure within 24 hours in both lying and standing positions. Because of the slow onset of action of amlodipine, acute arterial hypotension is usually not observed.

In patients with angina pectoris, using a single daily dose of the drug increases the total time of physical exertion, the time to the onset of angina pectoris, and the time to reaching 1 mm of ST segment depression on the ECG. The drug reduces the frequency of angina attacks and reduces the need to use nitroglycerin.

Amlodipine is not associated with any adverse metabolic effects or changes in plasma lipids and can be used in patients with asthma, diabetes and gout.

Indications

• Arterial hypertension.
• Chronic stable angina pectoris.
• Vasospastic angina (Prinzmetal’s angina).

Amlodipine contraindications

• Hypersensitivity to dihydropyridines, amlodipine or any other component of the drug is known.
• Severe arterial hypotension.
• Shock (including cardiogenic shock).
• Obstruction of the outflow tract of the left ventricle (for example, severe aortic stenosis).
• Hemodynamically unstable heart failure after acute myocardial infarction.
• Unstable angina.

Directions

Adults

For the treatment of arterial hypertension and angina pectoris, the usual initial dose of Amlodipine is 5 mg once a day. Depending on the patient’s response to therapy, the dose can be increased to a maximum dose of 10 mg once a day.

In patients with angina pectoris, the drug can be used as monotherapy or in combination with other antianginal drugs in case of resistance to nitrates and/or adequate doses of beta-blockers.

There is experience in using the drug in combination with thiazide diuretics, alpha-blockers, beta-blockers or angiotensin-converting enzyme inhibitors in patients with arterial hypertension.

There is no need to adjust the dose of the drug during simultaneous use with thiazide diuretics, beta-blockers and angiotensin-converting enzyme inhibitors.

Children over 6 years of age with arterial hypertension.

The recommended initial dose of Amlodipine for this category of patients is 2.5 mg once a day. If the required level of blood pressure is not achieved within 4 weeks, the dose can be increased to 5 mg per day. The use of the drug in doses higher than 5 mg for this category of patients has not been studied.

Elderly patients.

There is no need to adjust the dose for this category of patients. Increasing the dose should be done with caution.

Patients with impaired renal function.

It is recommended to use the usual doses of the drug, since changes in the concentration of amlodipine in the blood plasma are not related to the degree of severity of renal failure. Amlodipine is not removed by dialysis.

Patients with impaired liver function.

Doses of the drug for use in patients with impaired liver function from a mild to moderate degree have not been established, therefore the selection of the dose should be carried out with caution and the use of the drug should be started with the lowest dose in the dose range. The pharmacokinetics of amlodipine have not been studied in patients with severe hepatic impairment. For patients with severe hepatic impairment, amlodipine should be started at the lowest dose and gradually increased.