Vedicardol tabs 12.5mg #30

Vedicardol instruction

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The drug Vedicardol is a drug for the treatment of cardiovascular diseases.
Carvedilol has a combined non-selective beta-1-, beta-2- and alpha-1- blocking action. The drug does not have its own sympathomimetic activity, has membrane stabilizing properties. Due to the blockade of beta-adrenoreceptors of the heart, blood pressure, cardiac output and heart rate can decrease. Carvedilol inhibits the renin-angiotensin-aldosterone system by blocking the beta-adrenergic receptors of the kidneys, causing a decrease in plasma renin activity. By blocking alpha-adrenoreceptors, the drug can cause expansion of peripheral vessels, thereby reducing systemic vascular resistance. The combination of blockade of beta-adrenergic receptors and vasodilation has the following effects: in patients with arterial hypertension - lowering blood pressure; in patients with ischemic heart disease, anti-ischemic and antianginal effects; in patients with left ventricular dysfunction and circulatory failure - a positive effect on hemodynamic parameters, increases the ejection fraction of the left ventricle and reduces its size.

Pharmacokinetics

Carvedilol is rapidly absorbed from the gastrointestinal tract. It has high lipophilicity. The maximum concentration in the blood is reached in 1-1.5 hours. The half-life is 6-10 hours. Associated with plasma proteins at 95-99%. Bioavailability of the drug is 24-28%. Food intake does not affect bioavailability. Metabolized in the liver with the formation of a number of active metabolites - 60-75% of the adsorbed drug is metabolized during the first "passage" through the liver. Metabolites have a pronounced antioxidant and adrenergic blocking effect. Removal of the drug from the body occurs through the gastrointestinal tract. In case of impaired renal function, the pharmacokinetic parameters of carvedilol do not change significantly. In patients with impaired liver function, the systemic bioavailability of carvedilol is increased by reducing metabolism during the first “passage” through the liver.
With serious violations of the liver, carvedilol is contraindicated. Carvedilol penetrates the placental barrier, is excreted in breast milk.

Indications for use

Indications for use of the drug Vedicardol are:
- Arterial hypertension (in monotherapy and combination with diuretics);
- Chronic heart failure (as part of combination therapy);
- Ischemic heart disease: stable angina.

Mode of application

Tablets Vedicardol taken orally, regardless of the meal, squeezed enough liquid.
In case of arterial hypertension, the initial dose is 12.5 mg 1 time per day in the first 2 days of treatment, then 25 mg 1 time per day, with a possible gradual increase in dose with an interval of at least 2 weeks.
With insufficient severity of the antihypertensive effect after 2 weeks of therapy, the dose may be increased. The maximum recommended daily dose of the drug is 50 mg 1 time per day (possibly divided into 2 doses).
Coronary heart disease: prevention of attacks of stable angina
The initial dose is 12.5 mg 2 times a day for the first 2 days of therapy, then 25 mg 2 times a day. With insufficient expression of the antianginal effect after 2 weeks of therapy, the dose may be increased. The maximum recommended daily dose of the drug is 100 mg per day, divided into 2 doses.
In chronic heart failure, the dose is selected individually (against the background of selected therapy with cardiac glycosides, diuretics, and angiotensin-converting enzyme (ACE) inhibitors), under the careful supervision of a physician. It is necessary to monitor the patient's condition within 2-3 hours after the first dose or after the first increased dose. The recommended initial dose is 3.125 mg (carvedilol may be used at a different dosage of ½ tablets of 6.25 mg with a risk) 2 times a day for 2 weeks.
With good tolerance, the dose is increased at intervals of at least 2 weeks to 6.25 mg 2 times a day, then to 12.5 mg 2 times a day, then to 25 mg 2 times a day. The dose should be increased to the maximum, which is well tolerated. With a body weight less than 85 kg - the maximum dose is 25 mg 2 times a day, with a weight of more than 85 kg - 50 mg 2 times a day. The maximum dose of the drug in patients with severe chronic heart failure is 25 mg 2 times a day, regardless of their body weight.
Before each increase in dose, the physician should examine the patient to identify an increase in symptoms of chronic heart failure or vasodilation. When a transient increase in symptoms of chronic heart failure or fluid retention in the body should increase the dose of diuretics or temporarily cancel Vedicardol. Symptoms of vasodilation can be eliminated by reducing the dose of diuretics. If the symptoms of chronic heart failure persist, you can reduce the dose of an ACE inhibitor (if the patient is taking it), and then, if necessary, a dose of the drug Vedicardol. Do not increase the dose of the drug Vedicardol until the symptoms of chronic heart failure or hypotension stabilize.
Patients with chronic heart failure to prevent orthostatic hypotension are advised to take the drug with meals.
When skipping a dose, the drug should be taken as soon as possible, however, if the time of the next dose is coming, then take it only, without doubling. The abolition of the drug must be made gradually over 1-2 weeks.
If treatment is interrupted for more than 2 weeks, then its renewal begins with a dose of 3.125 mg (carvedilol may be used in a different dosage of ½ tablets of 6.25 mg with a risk) 2 times a day, with a subsequent increase in dose.
In patients with moderate renal failure, dose adjustment of the drug Vedicardol is not required.
Elderly patients dose adjustment of the drug Vedicardol is not required.

Side effects

Classification of the incidence of side effects: very often> 1/10; often> 1/100, <1/10; infrequently> 1/1000, <1/100; rarely> 1/10000, <1/1000; very rarely <1/10000, including individual messages.
The frequency of adverse events does not depend on the dose, with the exception of dizziness, visual disturbances and bradycardia.
In patients with chronic heart failure
From the side of the central nervous system: very often - dizziness, headache (especially at the beginning of treatment or when changing doses), asthenia (including increased fatigue), depression.
Since the cardiovascular system: often - bradycardia, postural hypotension, marked reduction in blood pressure, peripheral edema (including generalized, edema of the perineum, lower extremities, fluid retention); infrequently - exacerbation of the course of chronic heart failure (during the period of increasing doses), syncopal states (including presinkopalnye), AV blockade II-III degree.
On the part of the digestive system: often - nausea, diarrhea, vomiting.
On the part of the metabolism: often - an increase in body weight, a violation of glycemic control.
From the side of blood-forming organs: rarely - thrombocytopenia; very rarely - leukopenia.
On the part of the urinary system: rarely - renal failure and impaired renal function in patients with diffuse vasculitis and / or impaired renal function, severe impairment of renal function.
Laboratory indicators: often - hypercholesterolemia, hyper- or hypoglycemia in patients with diabetes mellitus.
Other: often - visual impairment.
In patients with arterial hypertension and coronary heart disease
The nature of the side effects of the cardiovascular system in the treatment of hypertension and coronary heart disease is similar to that in chronic heart failure, but their frequency is less.
On the part of the central nervous system: often - dizziness, headache, general weakness (especially at the beginning of treatment or when changing doses); infrequently - mood lability, sleep disturbances, paresthesias.
Since the cardiovascular system: often - postural hypotension, bradycardia; infrequently - development or exacerbation of chronic heart failure, peripheral edema, angina (chest pain), AV block II-III degree, syncopal conditions (especially at the beginning of therapy), peripheral circulatory disorders (cooling of limbs, exacerbation of the syndrome of "intermittent" claudication and Raynaud's syndrome).
On the part of the digestive system: often - dyspeptic disorders (including nausea, abdominal pain, diarrhea); infrequently - constipation, vomiting.
On the part of the respiratory system: often - shortness of breath and bronchospasm (in predisposed patients); rarely nasal congestion.
On the part of the skin: rarely - itching, rash, dermatitis and urticaria.
On the part of metabolism: often - a manifestation of latent diabetes mellitus, decompensation of an existing diabetes mellitus or depression of the contrainsular system.
From the side of blood-forming organs: very rarely - thrombocytopenia, leukopenia.
On the part of the urinary system: rarely - a violation of urination, very rarely - urinary incontinence in women, reversible after discontinuation of the drug.
From the genitourinary system: infrequently - reduced potency.
Laboratory indicators: very rarely - increased activity of liver transaminases.
Other: often - pain in the limbs, reduction of tearing and eye irritation; infrequently - visual impairment; rarely, dryness of the oral mucosa; very rarely - flu-like syndrome, sneezing, exacerbation of the course of psoriasis, alopecia.

Contraindications

Contraindications to the use of the drug Vedicardol are: hypersensitivity to carvedilol or other components of the drug, acute and chronic heart failure (at the stage of decompensation), severe hepatic insufficiency, atrioventricular block II II-III, severe bradycardia (less than 50 beats / min), syndrome weakness of the sinus node, arterial hypotension (systolic blood pressure less than 85 mm Hg), cardiogenic shock, chronic obstructive pulmonary disease, age up to 18 years (efficacy and bout their dangers are not installed).
AV I blockade, diabetes mellitus, hypoglycemia, thyrotoxicosis, occlusive peripheral vascular diseases, Prinzmetal angina pectoris, pheochromocytoma (with simultaneous use of alpha-adrenergic blockers), depression, myasthenia, psoriasis, chronic obstructive pulmonary lung disease, bronchospasitis, myasthenia, psoriasis, chronic obstructive pulmonary disease, bronchospasitis, myasthenia monoamine oxidase inhibitors (MAO), renal failure, extensive surgical interventions and general anesthesia, burdened with allergic history (increases sensitivity s to allergens and severity of anaphylactic reactions, decreased response to the administration of epinephrine (adrenaline)), pregnancy.

Pregnancy

Controlled studies of the use of Vedicardol in pregnant women have not been conducted, therefore, prescribing this category of patients is possible only in cases where the benefit to the mother outweighs the potential risk to the fetus. Breastfeeding during carvedilol treatment is not recommended.

Interaction with other drugs

Since carvedilol is both a substrate and an inhibitor of glycoprotein P, its simultaneous use with preparations transported by glycoprotein P may increase its bioavailability.
In addition, the bioavailability of carvedilol may be altered by the action of inducers or inhibitors of glycoprotein R.
Inhibitors and inducers of CYP2D6 and CYP2C9 isoenzymes can stereoselectively alter the systemic and / or systemic metabolism of carvedilol, leading to an increase or decrease in the plasma R (+) and S (-) concentrations of plasma carvedilol.
Carvedilol can potentiate the action of other, simultaneously taken antihypertensive drugs or drugs that have an antihypertensive effect (including nitrates).
With simultaneous use of carvedilol and digoxin, the concentration of the latter increases, and the AV time can increase.
Carvedilol can potentiate the effect of insulin and hypoglycemic agents for oral administration, including sulfonylurea derivatives, and the symptoms of hypoglycemia (especially tachycardia) can be masked, therefore, patients with diabetes mellitus are recommended to regularly monitor plasma glucose concentrations.
Inhibitors of microsomal oxidation (cimetidine) increase, and inductors (phenobarbital, rifampicin) weaken the antihypertensive effect of carvedilol.
Drugs that reduce the content of catecholamines (reserpine, monoamine oxidase inhibitors) increase the risk of arterial hypotension and severe bradycardia.
With the simultaneous use of cyclosporine with carvedilol, the concentration of cyclosporine increases, therefore, correction of the daily dose of cyclosporine is recommended.
The simultaneous use of clonidine can potentiate the antihypertensive effect and the negative chronotropic effect of carvedilol. If you plan to stop the combination therapy with beta-adreno-blocking properties and clonidine, first you should cancel the beta-blocker, and after a few days you can cancel clonidine, gradually reducing its dose.
General anesthetics enhance the negative inotropic effect and the antihypertensive effect of carvedilol.
Blockers of “slow” calcium channels (verapamil, diltiazem) and antiarrhythmic drugs (especially class I) while taking carvedilol may increase the risk of atrioventricular conduction disturbances, provoke pronounced arterial hypotension and heart failure.
Intravenous administration of verapamil and diltiazem simultaneously with taking carvedilol is contraindicated.
In patients with heart failure, amiodarone decreases the clearance of the S (-) carvedilol stereoisomer, suppressing the CYP2C9 isoenzyme. The mean R (+) concentration of the carvedilol stereoisomer does not change. Consequently, due to an increase in the S (-) concentration of carvedilol stereoisomer, there is a risk of an increase in beta-adrenergic blocking action.
With simultaneous use of carvedilol with ergotamine, it is necessary to take into account the vasoconstrictor effect of ergotamine.
Non-steroidal anti-inflammatory drugs reduce the antihypertensive effect of carvedilol due to reduced prostaglandin production.
Fluoxetine inhibits the CYP2D6 isoenzyme, which leads to inhibition of carvedilol metabolism and its accumulation. This may enhance the cardiodepressive effect (including bradycardia). Fluoxetine and, mainly, its metabolites are characterized by prolonged T1 / 2, so the likelihood of drug interaction persists even several days after discontinuing fluoxetine.
Since beta-blockers interfere with the bronchodilator effect of bronchodilators (beta-adrenoreceptor agonists), it is necessary to monitor patients receiving these drugs.

Overdose

Symptoms of an overdose of the drug Vedicardol: pronounced decrease in blood pressure (accompanied by dizziness or fainting), severe bradycardia (less than 50 beats / min), due to bronchospasm, dyspnea and vomiting may occur. In severe cases, respiratory failure, confusion, generalized convulsions, heart failure, conduction disturbances, cardiogenic shock, cardiac arrest are possible.
Treatment: symptomatic, gastric lavage and the appointment of absorbing agents, monitoring and maintaining the vital functions of the body, if necessary, in the intensive care unit.
In severe bradycardia, intravenous administration of m-anticholinergic blocking agents (atropine 0.5-2 mg) is advisable.
If a pronounced decrease in blood pressure prevails in the clinical picture of overdose - to give the patient a “lying down” position with elevated lower limbs, sympathomimetics (norepinephrine (norepinephrine), epinephrine (adrenaline), dobutamine) are administered in different doses, depending on body weight and response to therapy, in conditions of continuous monitoring of blood circulation parameters.
In case of treatment-resistant bradycardia, the use of an artificial pacemaker is indicated. In case of bronchospasm, beta-adrenomimetics are administered in the form of an aerosol (with intravenous inefficiency) or aminophylline intravenously.
For convulsions, diazepam is slowly injected intravenously.
Since severe overdose with symptomatic shock may prolong the half-life of carvedilol and remove the drug from the depot, it is necessary to continue maintenance therapy for a sufficiently long time.

Storage conditions

List B. In a dry, the dark place, at a temperature not higher than 25 ° C. Keep out of the reach of children.

Release form

Vedicardol - tablets 6.25 mg, 12.5 mg, 25 mg.
On 10 tablets in a blister strip packaging from a film of polyvinyl chloride and aluminum foil, printed, lacquered.
1, 2, 3 blisters with instructions for use are placed in a pack of cardboard.

Composition

1 tablet Vedicardol contains the active substance - carvedilol: 6.25 mg, 12.5 mg, 25.0 mg.
Excipients: milk sugar (lactose), potato starch, low molecular weight polyvinylpyrrolidone (povidone), microcrystalline cellulose, calcium stearate (calcium stearate), talc.

Additionally

Therapy should be carried out for a long time and should not stop abruptly, especially in patients with coronary heart disease, as this can lead to a worsening of the course of the underlying disease. If necessary, reducing the dose of the drug Vedicardol should be gradual, within 1-2 weeks.
In patients with chronic heart failure, when selecting a dose, the symptoms of chronic heart failure may increase, and peripheral edema may appear. It should not further increase the dose of the drug Vedicardol, and increase the dose of diuretics until the hemodynamic parameters stabilize. Sometimes there is a need to reduce the dose of the drug Vedicardol or, in rare cases, temporarily cancel it, which does not prevent further correct selection of the dose.
Vedicardol is used with caution in combination with cardiac glycosides (excessive AV conduction may be slowed down).
Vedicardol may cause bradycardia, with a decrease in heart rate less than 60 beats / min, the dose must be reduced or canceled.
Vedicardol is prescribed with caution to patients with thyrotoxicosis, since carvedilol can reduce the severity of thyrotoxicosis symptoms and mask the symptoms of hypoglycemia, especially tachycardia (which should be prevented in patients with diabetes mellitus).
Regular monitoring of the electrocardiogram and blood pressure is recommended while administering the drug Vedicardol and blockers of “slow” calcium channels, derivatives of phenylalkylamine (verapamil) and benzodiazepine (dildiazem), as well as with class I antiarrhythmic drugs.
At the beginning of drug therapy with Vedicardol or with an increase in dose, especially in elderly patients, there may be an excessive decrease in blood pressure, mainly when moving from a "lying" position to a "standing" position, which requires a dose adjustment of the drug.
When prescribing Vedicardol, patients with chronic heart failure and arterial hypotension (systolic blood pressure less than 100 mm Hg), coronary heart disease and diffuse peripheral vascular diseases and / or renal failure showed a reversible deterioration of renal function.
The dose of the drug Vedicardol is selected depending on the functional state of the kidneys.
Patients with chronic obstructive pulmonary disease, not receiving inside or inhalation beta2-adrenomimetiki, Vedicardol is prescribed only if the benefits of its use exceed the potential risk. If there is a predisposition to the bronchospastic syndrome when taking the drug Vedicardol as a result of increasing the resistance of the respiratory tract can develop shortness of breath. At the beginning of therapy and with an increase in the dose of these patients, it is necessary to carefully observe, reducing the dose of the drug at the onset of initial signs of bronchospasm.
Caution is necessary when administering Vedicardol to patients with peripheral vascular disease (including Raynaud's syndrome), since beta-blockers may increase the symptoms of arterial insufficiency.
Care must be taken when prescribing Vedicardol to patients with anamnestic indications of severe hypersensitivity reactions or undergoing desensitization, since beta-blockers may increase sensitivity to allergens and the severity of anaphylactic reactions.
Patients with anamnestic indications of the possibility of the occurrence and exacerbation of psoriasis when using beta-blockers, Vedicardol can be appointed only after a careful analysis of the possible benefits and risks.
In the case of surgery using general anesthesia, the surgeon-anesthesiologist should be warned about prior therapy with Vedicardol.
Patients with pheochromocytoma should be given alpha-blockers before therapy.
Non-selective beta-blockers can provoke pain in patients with Prinzmetal angina pectoris. There is no experience in prescribing Vedicardol in such patients. Although the alpha-adrenergic blocking properties of the drug can prevent such symptoms, Vedicardol should be prescribed in such cases with caution.
Patients wearing contact lenses should be aware that the drug may cause a decrease in the secretion of lacrimal fluid.
Alcohol should be avoided during treatment.

Terms of sell

You can buy Vedicardol without a prescription.