Amlodipine-TEVA tablets 10 mg. №30

Description

Amlodipine-TEVA tablets Ingredients

active ingredient: amlodipine;

• 1 tablet contains  6.944 mg of amlodipine besylate, which is equivalent to 5 mg of amlodipine, or  13.888 mg of amlodipine besylate, which is equivalent to 10 mg of amlodipine;

excipients: microcrystalline cellulose, calcium hydrogen phosphate anhydrous, sodium starch glycolate (type A), magnesium stearate.

Medicinal form

Tablets.

The main physical and chemical properties:

• 5 mg tablets: round white tablets, 8 mm in diameter, slightly curved, with a break line and embossed “A5” on one side and slightly convex, smooth on the other side;
• 10 mg tablets: round white tablets, 11 mm in diameter, slightly curved, with a break line and debossed “A10” on one side and slightly convex, smooth on the other side.

Pharmacotherapeutic group

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

Amlodipine-TEVA 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.

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.

Expansion of the main coronary arteries and coronary arterioles (normal and ischemic) 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 one daily dose of the drug increases the total time of physical exertion, the time to the onset of angina pectoris and the time to reach 1 mm of ST segment depression. 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-TEVA contraindications

• Known hypersensitivity to dihydropyridines, amlodipine or any other component of the drug;
• 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.

Directions

For oral administration. Amlodipine-TEVA tablets should be taken with a glass of liquid (for example, water), during or without meals.

The break line is intended to better break the tablet for easier swallowing, not to divide it into two doses.

Adults

For the treatment of arterial hypertension and angina pectoris, the usual starting 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. Increase the dose should be done with caution.

Patients with impaired renal function.

It is recommended to use the usual doses of Amlodipine-TEVA tablets, since the concentration of amlodipine in the blood plasma is 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, so the selection of the dose should be carried out with caution and the use of the drug should be started with the lowest dose. The pharmacokinetics of amlodipine have not been studied in patients with severe hepatic impairment. In patients with severe hepatic impairment, amlodipine should be started at the lowest dose and gradually increased.

Children.

Amlodipine-TEVA tablets can be used by children aged 6 years and older.

It is not known how amlodipine affects blood pressure in patients under 6 years of age.

Overdose

The experience of intentional drug overdose is limited.

Symptoms: Available information suggests that a significant overdose of amlodipine will result in excessive peripheral vasodilatation and possibly reflex tachycardia. Significant and possibly prolonged systemic hypotension, including fatal shock, has been reported.

Treatment: clinically significant arterial hypotension caused by an overdose of amlodipine requires active support of the cardiovascular system, in particular, frequent monitoring of heart and respiratory functions, providing the patient with a horizontal position, raising the lower extremities, monitoring the volume of circulating fluid and urination.

Vasoconstrictor drugs can be used to restore blood vessel tone and blood pressure, making sure there are no contraindications to their use. Intravenous administration of calcium gluconate may be useful in reversing the effects of calcium channel blockade.

In some cases, gastric lavage may be helpful. The use of activated charcoal in healthy volunteers within 2 hours after administration of 10 mg of amlodipine significantly reduced its absorption.

Since amlodipine is largely bound to blood proteins, the effect of dialysis is insignificant.