Vedicardol, tablets 6.25 mg, 30 pcs.

Alpha- and beta-adrenoblocker. Carvedilol has a combined non-selective effect caused by blockade of 1-, 2- and 1-adrenoreceptors. The drug has no sympathomimetic activity of its own and has membrane stabilizing properties. Due to blockade of the -adrenoreceptors of the heart, BP, cardiac output and HR decreases.

Carvedilol suppresses the renin-angiotensin-aldosterone system through blockade of -adrenoreceptors in the kidneys, causing a decrease in plasma renin activity. By blocking adrenoreceptors, the drug may cause dilation of peripheral blood vessels, thereby reducing RPS.

A combination of adrenoreceptor blockade and vasodilatation has the following effects: in arterial hypertension – decrease of BP; in CHD – antianginal action; in patients with left ventricular dysfunction and circulatory insufficiency it has favorable effect on hemodynamic parameters, increases left ventricular ejection fraction and helps to reduce its size.

Indications

– arterial hypertension (as monotherapy and in combination with diuretics);

– coronary heart disease: stable angina;

– chronic heart failure (as part of combination therapy).

Pharmacological effect

Alpha and beta blocker. Carvedilol has a combined non-selective effect due to the blockade of 1-, 2- and 1-adrenergic receptors. The drug does not have its own sympathomimetic activity, but has membrane-stabilizing properties. Thanks to the blockade of β-adrenergic receptors of the heart, blood pressure and cardiac output decrease and heart rate decreases.

Carvedilol suppresses the renin-angiotensin-aldosterone system by blocking renal adrenergic receptors, causing a decrease in plasma renin activity. By blocking adrenergic receptors, the drug can cause expansion of peripheral vessels, thereby reducing peripheral vascular resistance.

The combination of blockade of adrenergic receptors and vasodilation has the following effects: for arterial hypertension – a decrease in blood pressure; for ischemic heart disease – antianginal effect; in patients with left ventricular dysfunction and circulatory failure, it has a beneficial effect on hemodynamic parameters, increases the ejection fraction of the left ventricle and helps reduce its size.

Special instructions

Therapy should be carried out for a long time and not be stopped abruptly, especially in patients with coronary artery disease, because this can lead to worsening of the underlying disease. If necessary, the dose reduction should be gradual over 1-2 weeks.

At the beginning of Vedicardol therapy or when the dose of the drug is increased in patients, especially elderly patients, an excessive decrease in blood pressure may be observed, mainly when standing up. A dose adjustment of the drug is necessary. In patients with chronic heart failure, when selecting a dose, an increase in symptoms of heart failure and the appearance of edema is possible. In this case, the dose of Vedicardol should not be increased; it is recommended to prescribe large doses of diuretics until the patient’s condition is stabilized.

Continuous monitoring of ECG and blood pressure is recommended while prescribing Vedicardol and slow calcium channel blockers, phenylalkylamine derivatives (verapamil), benzodiazepine derivatives (diltiazem), as well as with class I antiarrhythmic drugs.

It is recommended to monitor renal function in patients with chronic renal failure, arterial hypotension and chronic heart failure.

In case of surgery using general anesthesia, the anesthesiologist should be warned about previous therapy with Vedicardol.

Vedicardol does not affect the concentration of glucose in the blood and does not cause changes in the glucose tolerance test in patients with non-insulin-dependent diabetes mellitus.

Patients with pheochromocytoma should be prescribed alpha-blockers before starting therapy.

When prescribing to patients who use contact lenses, it should be taken into account that the drug may cause a decrease in tear production.

Avoid drinking ethanol during treatment.

Impact on the ability to drive vehicles and operate machinery

It is not recommended to drive a car at the beginning of therapy and when increasing the dose of Vedicardol. You should refrain from other activities that require high concentration of attention and rapid psychomotor reactions.

Active ingredient

Carvedilol

Composition

Active substance:

carvedilol 6.25 mg.

Excipients:

microcrystalline cellulose,

calcium stearate,

crospovidone,

talc,

lactose monohydrate.

Contraindications

– acute heart failure;

— chronic heart failure (in the stage of decompensation);

– severe liver failure;

— AV blockade II-III degree;

— severe bradycardia (less than 50 beats/min);

— SSSU;

— arterial hypotension (systolic blood pressure less than 85 mm Hg);

– cardiogenic shock;

— chronic obstructive pulmonary disease;

– age under 18 years (efficacy and safety have not been established);

– hypersensitivity to the components of the drug.

Use with caution in Prinzmetal’s angina, thyrotoxicosis, occlusive diseases of peripheral vessels, pheochromocytoma, psoriasis, renal failure, AV block of the first degree, with extensive surgical interventions and general anesthesia, with diabetes, hypoglycemia, depression, myasthenia gravis.

Side Effects

From the central nervous system and peripheral nervous system: dizziness, headache (usually mild at the beginning of treatment), loss of consciousness, myasthenia gravis (usually at the beginning of treatment), fatigue, depression, sleep disturbances, paresthesia.

From the cardiovascular system: bradycardia, orthostatic hypotension, AV blockade of II-III degree; rarely – impaired peripheral circulation, progression of heart failure (during the period of increasing dose), edema of the lower extremities, angina pectoris, marked decrease in blood pressure, intermittent claudication.

From the digestive tract: dry mouth, nausea, diarrhea or constipation, vomiting, abdominal pain, loss of appetite, increased activity of liver transaminases.

From the hematopoietic system: rarely – thrombocytopenia, leukopenia.

Metabolism: weight gain, carbohydrate metabolism disorders.

From the respiratory system: shortness of breath and bronchospasm (in predisposed patients).

From the organ of vision: blurred vision, decreased tear production.

From the musculoskeletal system: myalgia, arthralgia, pain in the extremities.

From the urinary system: rarely – impaired urination, impaired renal function.

Allergic reactions: skin manifestations, nasal congestion.

Dermatological reactions: exacerbation of psoriasis.

Other: flu-like syndrome, sneezing.

Interaction

Carvedilol may potentiate the effect of other concomitantly taken antihypertensive drugs or drugs that have a hypotensive effect (nitrates).

When carvedilol and diltiazem are used together, cardiac conduction disturbances and hemodynamic disturbances may develop.

When carvedilol and digoxin are taken simultaneously, the concentration of the latter increases and the AV conduction time may increase.

Carvedilol may potentiate the effect of insulin and oral hypoglycemic agents, and the symptoms of hypoglycemia (especially tachycardia) may be masked; therefore, regular monitoring of blood sugar levels is recommended in patients with diabetes mellitus.

Inhibitors of microsomal oxidation (cimetidine) enhance, and inducers (phenobarbital, rifampicin) weaken the hypotensive effect of carvedilol.

Drugs that reduce the content of catecholamines (reserpine, MAO inhibitors) increase the risk of developing arterial hypotension and severe bradycardia.

With simultaneous use of cyclosporine, the concentration of the latter increases (adjustment of the daily dose of cyclosporine is recommended).

Concomitant administration of clonidine may potentiate the antihypertensive and heart rate-lowering effects of carvedilol.

General anesthetics enhance the negative inotropic and hypotensive effect of carvedilol.

Overdose

Symptoms: decreased blood pressure (accompanied by dizziness or fainting), bradycardia. Shortness of breath may occur due to bronchospasm and vomiting. In severe cases, cardiogenic shock, respiratory failure, confusion, and conduction disturbances are possible.

Treatment: monitoring and correction of vital signs is necessary, if necessary in the ICU. Symptomatic therapy is carried out. It is advisable to administer intravenously m-anticholinergic agents (atropine), adrenergic agonists (epinephrine, norepinephrine).

Storage conditions

The drug should be stored out of the reach of children, in a dry, dark place at a temperature not exceeding 25°C.

Shelf life

2 years

Manufacturer

Sintez, Russia