Indications for use
- arterial hypertension. Essential arterial hypertension (in the form of monotherapy or combination therapy with other antihypertensive drugs, for example, blockers of “slow” calcium channels or diuretics).
- coronary heart disease (including in patients with unstable angina and silent myocardial ischemia).
- chronic heart failure. Treatment of mild, moderate and severe chronic heart failure of ischemic or non-ischemic origin (to reduce the number of complications - hospitalization for cardiovascular reasons, and mortality, as well as improve well-being and slow the progression of the disease), when used in combination with ACE inhibitors , diuretics and, sometimes, digitalis preparations (standard therapy).
Dilatrend can be prescribed both in addition to standard therapy and in patients who are not receiving digitalis drugs, vasodilators, or nitrates.
Dilatrend®
Chronic heart failure
In patients with chronic heart failure, during the period of dose selection of Dilatrend®, an increase in symptoms of chronic heart failure or fluid retention may be observed. If such symptoms occur, it is necessary to increase the dose of diuretics and not increase the dose of Dilatrend® until hemodynamic parameters stabilize. Sometimes it is necessary to reduce the dose of Dilatrend® or, in rare cases, temporarily discontinue the drug. Such episodes do not prevent further correct selection of the dose of Dilatrend®.
Dilatrend® is used with caution in combination with cardiac glycosides (excessive slowing of AV conduction is possible).
Kidney function in chronic heart failure
When prescribing Dilatrend® to patients with chronic heart failure and low blood pressure (systolic blood pressure less than 100 mm Hg), coronary heart disease and diffuse vascular changes and/or renal failure, a reversible deterioration in renal function was observed. The dose of the drug is selected depending on the functional state of the night.
COPD
For patients with COPD (including bronchospastic syndrome) who are not receiving oral or inhaled antiasthmatic drugs, Dilatrend® is prescribed only if the possible benefits of its use outweigh the potential risks. If there is an initial predisposition to bronchospastic syndrome, shortness of breath may develop when taking Dilatrend® as a result of increased airway resistance. At the beginning of treatment and when increasing the dose of Dilatrend®, these patients should be carefully monitored, reducing the dose of the drug when initial signs of bronchospasm appear.
Diabetes
The drug is prescribed with caution to patients with diabetes mellitus, since beta-blockers may increase insulin resistance and mask the symptoms of hypoglycemia (especially tachycardia). In patients with chronic heart failure and diabetes mellitus, the use of Dilatrend® may be accompanied by disturbances in glycemic control. However, numerous studies have shown that beta blockers with vasodilating properties (such as carvedilol) have a more beneficial effect on glucose concentrations and lipid profiles. Carvedilol has a modest positive effect on insulin sensitivity and may also improve some symptoms of metabolic syndrome.
Peripheral vascular diseases
Caution is required when prescribing Dilatrend® to patients with peripheral vascular diseases (including Raynaud's syndrome), since beta-blockers may increase the symptoms of arterial insufficiency.
Thyrotoxicosis
Like other beta-blockers, Dilatrend® can reduce the severity of symptoms of thyrotoxicosis.
General anesthesia and major surgery
Caution is required in patients undergoing surgery under general anesthesia due to the possibility of additive negative effects of Dilatrend® and general anesthesia agents.
Bradycardia
Dilatrend® can cause bradycardia; if the heart rate decreases to less than 55 beats/min, the dose of Dilatrend® should be reduced.
Increased sensitivity
Caution should be exercised when prescribing Dilatrend® to patients with a history of severe hypersensitivity reactions or undergoing desensitization, since beta-blockers may increase sensitivity to allergens and the severity of hypersensitivity reactions.
Severe skin reactions
In rare cases, carvedilol can cause the development of serious skin reactions such as toxic epidermal necrolysis and Stevens-Johnson syndrome (see section "Side effects", subsection "Post-marketing observations"). If severe skin reactions develop while using Dilatrend®, the drug should be completely stopped.
Psoriasis
Patients with anamnestic indications of the emergence or exacerbation of psoriasis when using beta-blockers Dilatrend® can be prescribed only after a thorough analysis of the possible benefits and risks.
Interaction with other drugs
There are a number of important pharmacokinetic and pharmacodynamic interactions with other drugs (including digoxin, cyclosporine, rifampicin, antiarrhythmic drugs and drugs for general anesthesia) (see section "Interaction with other drugs", subsection "Pharmacodynamic interactions").
Concomitant use of slow calcium channel blockers (SCBCs)
In patients simultaneously taking BMCCs such as verapamil or diltiazem, as well as other antiarrhythmic drugs, it is necessary to regularly monitor ECG and blood pressure.
As with other drugs with beta-blocking properties, the administration of carvedilol together with non-dihydropyridine slow calcium channel blockers (NSCBs) such as verapamil or diltiazem, amiodarone or other antiarrhythmic drugs is recommended under ECG and blood pressure monitoring.
Pheochromocytoma
Patients with pheochromocytoma should be given an alpha blocker before starting any beta blocker. Although Dilatrend® has both beta- and alpha-blocking properties, there is no experience with its use in such patients, so cm should be prescribed with caution to patients with suspected pheochromocytoma.
Prinzmetal's angina
Non-selective beta-blockers may cause pain in patients with Prinzmetal's angina. There is no experience in prescribing Dilatrend® to these patients. Although its alpha-blocking properties may prevent such symptoms, Dilatrend® should be prescribed with caution in such cases.
Contact lenses
Patients who wear contact lenses should be aware of the possibility of reducing the amount of tear fluid.
Withdrawal syndrome
Treatment with Dilatrend® is long-term. As with treatment with other beta-blockers, therapy with Dilatrend® should not be stopped abruptly; the dose of the drug should be gradually reduced at weekly intervals. This is especially important in patients with coronary heart disease.
If it is necessary to perform surgery using general anesthesia, you must notify the anesthesiologist about previous therapy with Dilatrend®.
During the treatment period, alcohol consumption is excluded.
Handling unused and expired medicines
The release of medicinal products into the environment should be minimized. Disposal of Dilatrend® through wastewater or household waste is not permitted. Where possible, special systems should be used to dispose of medications.
Directions for use and doses
Inside, with a sufficient amount of liquid.
- Essential hypertension. The recommended initial dose is 12.5 mg 1 time per day for the first 2 days, then 25 mg 1 time per day. If necessary, the dose can be further increased at intervals of at least 2 weeks, reaching the highest recommended dose of 50 mg once a day (or divided into two doses).
- Cardiac ischemia. The recommended initial dose is 12.5 mg 2 times a day in the first 2 days, after that - 25 mg 2 times a day. If necessary, the dose can subsequently be increased at intervals of at least 2 weeks, reaching the highest daily dose of 100 mg, divided into 2 doses.
- Chronic heart failure. The dose is selected individually; careful medical supervision is necessary. In patients receiving digitalis preparations, diuretics and ACE inhibitors, their doses should be stabilized before starting treatment with Dilatrend.
Dilatrend
Special conditions
Dilatrend should be prescribed with caution to patients with Prinzmetal's angina, because the drug (like other beta-blockers with a similar mechanism of action) can provoke pain. There is no experience with the use of Dilatrend in such cases, although the alpha-blocking properties of carvedilol may prevent the occurrence of such symptoms. Dilatrend is prescribed with caution to patients with labile and secondary arterial hypertension due to insufficient experience in using the drug in such patients. Dilatrend should be prescribed with caution to patients with circulatory insufficiency who are receiving digitalis preparations, diuretics and/or ACE inhibitors, since carvedilol slows myocardial conduction (the same as digitalis preparations). Dilatrend is prescribed with caution to patients with peripheral vascular diseases, since the course of the disease may worsen (beta-blockers may increase the symptoms of arterial insufficiency and Raynaud's syndrome). When heart rate decreases to 55 beats per minute, Dilatrend should be discontinued. When prescribing Dilatrend to patients with chronic heart failure and low blood pressure (systolic blood pressure below 100 mm Hg), coronary artery disease, diffuse vascular changes and/or severe renal impairment, laboratory indicators of renal function should be carefully monitored and, if they worsen, reduce the dose or discontinue a drug. When selecting the dose of Dilatrend in patients with circulatory insufficiency, an increase in symptoms and an increase in fluid retention in the body is possible. At the same time, the dose of diuretics is increased, but the dose of Dilatrend is not increased until the patient’s condition is stabilized (in some cases, a dose reduction or temporary discontinuation of the drug is required). In the future, it is possible to select an adequate dose of carvedilol. Before each dose increase, patients with heart failure should undergo a medical examination. When using Dilatrend simultaneously with calcium channel blockers (such as verapamil or diltiazem), as well as with class I antiarrhythmics, blood pressure and ECG should be carefully monitored. During therapy with Dilatrend, these drugs cannot be prescribed intravenously. Dilatrend may mask the symptoms of thyrotoxicosis. Dilatrend should be prescribed with caution to patients with diabetes mellitus, since the drug may mask early symptoms of hypoglycemia. In this regard, regular monitoring of blood glucose levels and, if necessary, adjustment of glucose-lowering therapy is recommended. The drug should be prescribed with caution to patients with psoriasis that has previously worsened after taking beta-blockers; patients wearing contact lenses (due to a possible decrease in tear production). Caution should be exercised when prescribing Dilatrend to patients with a history of severe hypersensitivity reactions and to persons receiving desensitization therapy, since beta-blockers may increase sensitivity to allergens and aggravate the severity of anaphylactic reactions. Prescribe Dilatrend with caution to patients with pheochromia
Contraindications
- hypersensitivity to carvedilol or any component of the drug;
- acute and decompensated chronic heart failure, requiring intravenous administration of inotropic agents;
- clinically significant liver dysfunction;
- age under 18 years (the effectiveness and safety of Dilatrend have not been established);
- pregnancy;
- AV blockade of the II and III degrees (except for patients with an artificial pacemaker), severe bradycardia (less than 50 beats/min);
- sick sinus syndrome;
- severe arterial hypotension (systolic blood pressure less than 85 mm Hg);
- cardiogenic shock;
- anamnestic indications of bronchospasm and bronchial asthma.
Dilatrend®
Chronic heart failure.
In patients with chronic heart failure, during the period of dose selection of Dilatrend, an increase in symptoms of heart failure or fluid retention may be observed. If such symptoms occur, it is necessary to increase the dose of diuretics and not increase the dose of Dilatrend until the patient’s condition has stabilized. Sometimes it may be necessary to reduce the dose of Dilatrend or, in rare cases, temporarily discontinue the drug. Such episodes do not prevent further correct selection of the dose of Dilatrend. Dilatrend is used with caution in combination with cardiac glycosides (excessive slowing of AV conduction is possible).
Kidney function in chronic heart failure.
When Dilatrend was prescribed to patients with chronic heart failure and low blood pressure (systolic blood pressure less than 100 mm Hg), coronary heart disease and diffuse vascular changes and/or renal failure, a reversible deterioration in renal function was observed. The dose of the drug is adjusted depending on the functional state of the kidneys.
Chronic obstructive pulmonary disease (COPD)
. For patients with chronic obstructive pulmonary diseases (including bronchospastic syndrome) who are not receiving oral or inhaled antiasthmatic drugs, Dilatrend is prescribed only if the possible benefits of its use outweigh the potential risks. If there is an initial tendency to bronchospastic syndrome when taking Dilatrend, respiratory distress syndrome may develop as a result of increased airway resistance. At the beginning of treatment and when increasing the dose of Dilatrend, these patients should be carefully monitored, reducing the dose of the drug when initial signs of bronchospasm appear.
Diabetes
. The drug is prescribed with caution to patients with diabetes mellitus, since it can mask or weaken the symptoms of hypoglycemia (especially tachycardia). In patients with heart failure and diabetes mellitus, the use of Dilatrend may be accompanied by decompensation of carbohydrate metabolism.
Peripheral vascular diseases
. Caution is required when prescribing Dilatrend to patients with peripheral vascular diseases (including Raynaud's syndrome), since beta-blockers may enhance the symptoms of arterial insufficiency.
Thyrotoxicosis
. Like other beta blockers, Dilatrend can reduce the severity of symptoms of thyrotoxicosis.
General anesthesia and major surgery
. Caution is required in patients undergoing surgery under general anesthesia, due to the possibility of additive negative effects of Dilatrend and anesthetics.
Bradycardia.
Dilatrend can cause bradycardia; if the heart rate decreases below 55 beats per minute, the dose of Dilatrend should be reduced.
Increased sensitivity
. Caution should be exercised when prescribing Dilatrend to persons with a history of severe hypersensitivity reactions or undergoing a desensitization course, since beta-blockers may increase sensitivity to allergens and the severity of anaphylactic reactions.
Psoriasis
. In patients with anamnestic indications of the occurrence or exacerbation of psoriasis when using beta-blockers, Dilatrend can be prescribed only after a thorough analysis of the possible benefits and risks.
Concomitant use of slow calcium channel blockers
. In patients simultaneously taking slow calcium channel blockers such as verapamil or diltiazem, as well as other antiarrhythmic drugs, it is necessary to regularly monitor ECG and blood pressure.
Pheochromocytoma.
Patients with pheochromocytoma should be prescribed an alpha blocker before starting any beta-blocker. Although Dilatrend has both beta- and alpha-blocking properties, there is no experience with its use in such patients, so it should be prescribed with caution to patients with suspected pheochromocytoma.
Prinzmetal's angina.
Non-selective beta-blockers can provoke pain in patients with Prinzmetal's angina. There is no experience in prescribing Dilatrend to these patients. Although its alpha-blocking properties may prevent such symptoms, carvedilol should be used with caution in such cases.
Contact lenses.
Contact lens wearers should be aware of the possibility of reducing the amount of tear fluid.
Withdrawal syndrome.
Treatment with Dilatrend is long-term. It should not be stopped abruptly, but the dose of the drug should be gradually reduced at weekly intervals. This is especially important in patients with coronary heart disease.
When stored in light, the color of the tablets may change.
If it is necessary to perform surgery using general anesthesia, it is necessary to warn the anesthesiologist about previous therapy with Dilatrend.
During the treatment period, the use of ethanol is excluded.
Influence on the ability to drive vehicles and work with machines and mechanisms.
Studies on the effect of Dilatrend on the ability to drive vehicles or work with machines and mechanisms have not been conducted. Due to individual reactions to the drug (for example, dizziness, general weakness), it may be disrupted (especially at the beginning of treatment, when changing the dosage, and also in the case of simultaneous intake of alcohol). It should be prescribed with caution to patients whose work requires a rapid psychomotor reaction.
