Pharmacological action – antianginal, antihypertensive.
Compound
Active substance:
amlodipine 5 mg;
Excipients:
MCC – 124.056 mg;
calcium hydrophosphate – 63 mg;
sodium carboxymethyl starch – 4 mg;
magnesium stearate – 2 mg;
Pharmacodynamics
A derivative of dihydropyridine – BPC of the III generation, has a hypotensive and antianginal effect. It blocks slow calcium channels, reduces the transmembrane transition of calcium ions into the cell (to a greater extent – into vascular smooth muscle cells than into cardiomyocytes).
Antianginal action is due to the expansion of the coronary and peripheral arteries and arterioles:
– with angina reduces the severity of myocardial ischemia; expanding peripheral arterioles, reduces peripheral vascular resistance, reduces afterload on the heart, reduces myocardial oxygen demand;
– expanding the coronary arteries and arterioles in unchanged and ischemic areas of the myocardium, increases the supply of oxygen to the myocardium (especially with vasospastic angina); prevents spasm of the coronary arteries (including those caused by smoking).
In patients with stable angina pectoris, a single daily dose increases exercise tolerance, slows down the development of angina attacks and ischemic ST segment depression, reduces the frequency of angina attacks and the consumption of nitroglycerin and other nitrates.
It has a long-term dose-dependent hypotensive effect. The hypotensive effect is due to a direct vasodilating effect on vascular smooth muscle. With arterial hypertension, a single dose provides a clinically significant decrease in blood pressure for 24 hours (with the patient lying and standing).
Orthostatic hypotension with the use of amlodipine is quite rare. Amlodipine does not cause a decrease in exercise tolerance, left ventricular ejection fraction. Reduces the degree of hypertrophy of the myocardium of the left ventricle. It does not affect myocardial contractility and conduction, does not cause a reflex increase in heart rate, inhibits platelet aggregation, increases glomerular filtration rate, and has a weak natriuretic effect.
In diabetic nephropathy does not increase the severity of microalbuminuria. It does not have any adverse effect on metabolism and plasma lipid concentration and can be used in the treatment of patients with bronchial asthma, diabetes mellitus and gout. A significant decrease in blood pressure is observed after 6-10 hours, the duration of the effect is 24 hours.
In patients with cardiovascular disease (including coronary atherosclerosis with damage to one vessel and up to stenosis of 3 or more arteries, atherosclerosis of the carotid arteries), who have had myocardial infarction, percutaneous transluminal coronary angioplasty (PTCA) or in patients with angina pectoris, the use of amlodipine prevents the development of thickening of the intima-media carotid arteries, reduces mortality from myocardial infarction, stroke, PTCA, coronary artery bypass grafting; leads to a decrease in the number of hospitalizations for unstable angina and progression of CHF; reduces the frequency of interventions aimed at restoring coronary blood flow.
Does not increase the risk of death or the development of complications and deaths in patients with CHF (III-IV functional class according to the NYHA classification) during therapy with digoxin, diuretics and ACE inhibitors. In patients with CHF (III-IV functional class according to the NYHA classification) of non-ischemic etiology, when using amlodipine, there is a possibility of pulmonary edema.
Indications
Arterial hypertension (both in monotherapy and in combination with other antihypertensive drugs); stable angina and vasospastic angina (Prinzmetal’s angina or variant angina) both in monotherapy and in combination with other antianginal drugs.
Use during pregnancy and lactation
There are no data indicating the excretion of amlodipine in breast milk.
However, other slow calcium channel blockers (dihydropyridine derivatives) are known to be excreted in breast milk.
In this regard, if it is necessary to use Norvasc during lactation, the issue of stopping breastfeeding should be resolved.
The safety of Norvasc during pregnancy has not been established, therefore, use during pregnancy is possible only if the expected benefit to the mother outweighs the potential risk to the fetus.
Contraindications
hypersensitivity to amlodipine and other derivatives of dihydropyridine, as well as excipients that make up the drug;
severe arterial hypotension (SBP less than 90 mm Hg);
left ventricular outflow tract obstruction (including severe aortic stenosis);
hemodynamically unstable heart failure after myocardial infarction;
age up to 18 years (efficacy and safety have not been established).
With caution: liver failure; chronic heart failure of non-ischemic etiology III-IV functional class according to the NYHA classification; unstable angina; aortic stenosis; mitral stenosis; hypertrophic obstructive cardiomyopathy; acute myocardial infarction (and the period within 1 month after it); sinus node weakness syndrome (severe tachycardia, bradycardia); arterial hypotension; simultaneous use with inhibitors or inducers of the CYP3A4 isoenzyme.
How to take, course of administration and dosage
Inside, 1 time per day, washed down with the required volume of water (100 ml).
With arterial hypertension and angina pectoris, the usual initial dose is 5 mg, depending on the individual patient’s response, it can be increased to a maximum of 10 mg.
Use in the elderly. It is recommended to use in usual doses, no change in the dose of the drug is required.
Use in patients with impaired liver function. Despite the fact that T1 / 2 of amlodipine, like all CCBs, increases in patients with this pathology, dose adjustment is usually not required (see “Special Instructions”).
Use in patients with impaired renal function. It is recommended to use Norvasc® in usual doses, however, a possible slight increase in T1 / 2 must be taken into account.
Dose adjustment is not required when used simultaneously with thiazide diuretics, β-blockers and ACE inhibitors.
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