KARVILEKS table. 6.25 mg 30 tablets
KARVILEKS table. 6.25 mg 30 tablets
KARVILEKS WHAT IS AND WHAT IT IS USED
Karvileks belongs to a group of medicines called " beta-blockers " , but has an alpha blocker . Through its beta blocking activity , it reduces blood pressure , heart rate and cardiac output . By blocking the alpha adrenoceptors it causes enlargement and decreased peripheral vascular resistance . Due to these effects, carvedilol reduces the voltage of the myocardium , and affects the symptoms of angina, decreased blood pressure , and in patients with heart failure , improves the pumping function of the heart and increases the ejection fraction of the left kamera.Karvileks used to treat :
• Light , moderate or severe heart failure as an adjunct to standard therapy ( diuretics, digitalis , ACE inhibitors and other vasodilators ) ;
• Hypertension ( high blood pressure) , alone or in combination with other antihypertensive agents ;
• Prophylactic treatment of stable angina pectoris .
2 . WHAT YOU NEED TO KNOW BEFORE YOU START KARVILEKS
Karvileks not apply to :
• Allergy to carvedilol or to any of the excipients ;
• Bronchial asthma and / or obstructive diseases of the respiratory system;
• Decompensated heart failure with marked fluid retention requiring intravenous administration of medicinal products that stimulate the heart muscle ( inotropic therapy) ;
• Severe hypotension ( drop in systolic blood pressure below 85 mmHg)
• Cardiogenic shock;
• Marked bradycardia ( slow heart rate below 50 beats / minute) ;
• On deterioration in cardiac impulse conduction ( syndrome sick sinus or P - nd and III- grade AB block) ;
• Severe hepatic impairment
• Metabolic acidosis (a disorder of the acid condition of the body ) ;
* Pheochromocytoma ( active endocrine tumor of the adrenal glands ) , unless it is adequately controlled by means of drugs to block the alpha activity.
When taking this medicine, you should consider:
Caution should be exercised and medical supervision when conducting therapy Karvileks in the following cases : In patients with chronic heart failure at baseline and at a dose increase is possible due to worsening heart failure or fluid retention . If such symptoms occur , the dose of diuretic should be corrected by the dose of carvedilol should not be increased to stabilize the condition. Sometimes it may be necessary to reduce the dose of carvedilol treatment or temporarily discontinued . Such episodes do not preclude subsequent successful rise dozata.Pri hypertensive patients who have chronic heart failure with digoxin , diuretics and / or ACE inhibitors, carvedilol should be used with caution ( since digoxin and carvedilol may delay an AB conduct ) . Carvedilol should be used with caution in patients with diabetes mellitus , as the early signs and symptoms of hypoglycemia (low blood sugar ) can be obscured or altered . In patients with congestive heart failure and diabetes application of carvedilol can worsen glycemic control . Therefore, in diabetics when starting or adjusting therapy, carvedilol, should be carried out continuous monitoring of blood sugar and need to adjust the dose of glucose-lowering medications. In the treatment of patients with congestive heart failure, and low blood pressure (systolic less than 100 mmHg), ischemic heart disease , vascular disease and / or renal failure accompanying Reversible deterioration of renal function . This requires regular monitoring of indicators of kidney function and if necessary dose reduction or discontinuation of treatment. Wearing contact lenses should be advised of the possibility of reduced salzootdelyane.Lechenieto carvedilol should not be stopped abruptly , particularly in patients with ischemic heart disease. This should be done gradually (1-2 weeks) , the dose is reduced by half in three days. In patients with peripheral vascular disease ( Raynaud's syndrome ) , carvedilol should be used with caution , because it as a beta-blocker can provoke or aggravate symptoms of arterial insufficiency . However, as carvedilol also has alfablokirashti properties , this effect is largely otslaben.Kakto other beta -blockers, carvedilol may mask the symptoms of thyrotoxicosis ( svrahfunktsiya thyroid ) . If treatment with carvedilol cause a decrease in heart rate below 55 beats / min, the dose should be carefully namali.Osobeno should be administered carvedilol in patients with evidence of severe allergic reactions and in those undergoing treatment desenzibilizirashto as beta - blockers may increase the severity of anaphylactic reactions and weaken the response of allergic tests. Patients with evidence of onset of psoriasis associated with treatment with beta -blockers should not take carvedilol only after an assessment of the benefit / risk.Pri patients with pheochromocytoma ( tumor of endocrine active nadbybrechnite glands) should start treatment with alpha- blocker before administration of beta-blockers (including carvedilol ) . products with non-selective beta- blocking activity may provoke chest pain in patients with angina of Prinzmetal type . Therefore, although carvedilol has alpha- blocking activity , it should be used with caution in these patsienti.Poradi risk of aggravation of bronchial obstruction , patients with a tendency to bronchospastic reactions generally should not take carvedilol . The treatment is carried out with a minimal effective dose, in the occurrence of bronchial obstruction , carvedilol treatment immediately cease
Application of Karvileks and intake of food and drink
No evidence of a need for a special diet or restrictions on certain types of food and beverages during treatment with this product. It is recommended Karvileks be taken after meals to slow absorption , and to prevent orthostatic effect ( sudden drop in blood pressure when standing up ) .
Before taking any medicines , consult your doctor or farmatsevt.Poradi hazard to the fetus and newborn , pregnant women are advised not to take this medicine except in exceptional cases where the expected benefit to the mother justifies the risk the fetus.
Before taking any medicines , consult your doctor or farmatsevt.Karvedilol and its metabolites are excreted in human milk . Therefore, during the treatment with carvedilol breastfeeding is not recommended .
Driving and using machines
At the beginning of treatment Karvileks and a change in dosage regimen may experience an excessive reduction of blood pressure and a temporary dizziness and vertigo, which can affect the ability to drive and use mashini.Vazhna information about some of the ingredients of Karvileks : This medicinal product contains lactose as an ingredient , which makes it unsuitable for patients with lactase intolerance .
Taking other medicines :
Please tell your doctor or pharmacist if you are taking or have recently taken any other medicines , even if they have not been prescribed by your lekar.Pri concomitant administration of carvedilol with other medicinal products can be observed the following reactions :
Carvedilol may potentiate the effect of other antihypertensive ( blood pressure lowering ) drugs. Co-administration with drugs that deplete catecholamines (eg, reserpine and MAO inhibitors) may lead to hypotension and / or severe bradycardia.
With concomitant administration of carvedilol with calcium channel blockers such as diltiazem and verapamil may occur conduction abnormalities in the development of extreme bradycardia (strong decrease in heart rate ), and atrioventricular block (impaired conduction of the cardiac impulse ) . When given in combination with calcium antagonists of the dihydropyridine type risk of excessive fall in blood pressure
Concomitant use of antiarrhythmic drugs (class IA and IC), administered intravenously , can cause significant inhibition of myocardial function. Upon oral administration of antiarrhythmic agents caution is required with frequent follow-up and electrocardiographic monitoring .
Carvedilol may potentiate the effects of insulin or oral hypoglycemic agents . Signs of low blood sugar may be obscured or diminished. This requires regular monitoring of blood zahar.Ednovremennata use of carvedilol digoxin may lead to increased serum concentrations of digoksina.Sapatstvashto carvedilol treatment with cardiac glycosides may prolong AV ???????????.?????????????? administration of carvedilol increases the risk of hypotension and bradycardia. When treatment is required, such products should be discontinued first cease taking carvedilol and after a few days and klonidin.Tsimetidin increases the serum concentrations of carvedilol and rifampicin them namalyava.Po during anesthesia should be paying attention to the mutually reinforcing negative effects on heart rate and blood pressure decrease of carvedilol and some anesthetics . Co-administration of carvedilol and cyclosporine can lead to elevated plasma concentrations of cyclosporin , and it is therefore desirable that regular monitoring of plasma levels and where necessary adjusting the dose of cyclosporin .
3 . HOW TO TAKE KARVILEKS
Always Karvileks according to the instructions of the attending lekar.V depending on the complaints, the doctor will determine the appropriate treatment of your illness doza.Tabletkite Karvileks taken orally unchewed with sufficient liquid after hrana.Zastoyna heart failure : Treatment should be initiated only in supervision of a physician and after a careful assessment of the state of patsienta.Dozata should be individually determined at the beginning of treatment and change in dosage regimen . Before starting treatment with carvedilol, rates of application accordingly digitalis , ACE inhibitor or diuretic should be stabilized . It is recommended prior to initiation of therapy with carvedilol to minimize fluid retention .
The recommended starting dose of carvedilol is 3,125 mg, twice daily for two weeks . For patients who tolerated this dose , it can be increased to 6.25 , 12.5 or 25 mg, twice a day at intervals of at least two weeks. The dose should be increased to the highest level tolerated by the patient .. The maximum dose in patients with mild to moderate heart failure is 25 mg twice daily for patients weighing less than 85 kg and 50 mg twice daily for weight over 85 kg. during dose escalation in patients with systolic blood pressure < 100 mmHg may deteriorate renal and / or cardiac function . Therefore, before any increase in dose , these patients should be evaluated by a physician for renal function and symptoms of worsening heart failure or peripheral vascular expansion . Transient worsening heart failure or vasodilation fluid retention should be treated with the correct dose administered diuretics or ACE inhibitors or with dose reduction or even suspension of treatment with carvedilol . Following a dose increase is done after stabilization sastoyanietoAko treatment is interrupted for more than two weeks , it must be renewed again with a dose of 3,125 mg twice daily, rising and must be made as described above nachin.Patsienti Elderly Like adults.
Safety and effectiveness in patients below the age of 18 years have not been established .
Hypertension : It is recommended that application once a day.
The dosage should be individualized . The recommended starting dose of carvedilol was 12,5 mg, taken once in the morning after food. After 7 to 14 days , the dose may be increased to 25 mg in the morning . If there is no sufficient effect , after a period of 14 days, the dose can be increased up to a maximum of 50 mg once daily or divided into two in the advanced priema.Patsienti vazrastPreporachitelnata starting dose is 12,5 mg per day. If inadequate, the dose may be increased to a maximum recommended dose of 50 mg once daily or in two divided doses . Dose escalation should be performed at intervals of at least two weeks.
DetsaBezopasnostta and effectiveness in patients below the age of 18 years is not ustanovena.Lechenie ???????????????????????????????????? starting dose of carvedilol twice daily after meals 12,5 mg for the first two days. Then, the recommended dose is 25 mg once daily .
The dose should not exceed twice the 25 mg daily.
Safety and effectiveness in patients below the age of 18 years is not ustanovena.Patsienti with liver zabolyavaneKarvedilol is contraindicated in patients with impaired hepatic function.
Patients with underlying renal disease
No adjustment of the dose , while systolic blood pressure > 100mmHg.
Duration of treatment
Treatment with carvedilol is generally continuous . It does not have to be interrupted abruptly , and gradually over a few days to a reduction of the administered dose . This is particularly important in patients with concomitant coronary bolest.Ako have the impression that the effect of Karvileks is strong or too weak, talk to your doctor or pharmacist.
If you take more than the prescribed dose Karvileks :
When taking a higher dose than prescribed immediately contact a doctor ! Most common symptoms of overdose include hypotension ( drop in blood pressure with dizziness, vertigo and rarely syncope) and bradycardia ( slow heart rate ) . They can result from heart failure , cardiogenic shock and cardiac arrest ( cardiac arrest ) . Overdose are possible occurrence of dyspnea ( shortness of breath ) , bronchospasm (increased resistance to breathing ) , vomiting, impaired cardiac conduction disturbance of consciousness to coma and generalized seizures.
Treatment is symptomatic :
- In very slow pulse : atropine 0.5 to 2 mg intravenously.
- For maintenance of the cardiovascular activity : intravenous administration of catecholamines ( adrenaline , dopamine , dobutamine, orciprenaline ) .
- When medically unresponsive bradycardia should put a temporary pacemaker .
- If bronchospasm should be applied beta -agonists or aminophylline IV - If seizures : slow intravenous diazepam or ??????????.????????????????? of treatment depends on the degree of intoxication . In severe intoxication with symptoms of shock, supportive treatment should be continued for sufficient as can be expected prolongation of radiation from the body of karvedilol.Pri manifestations of symptoms of overdose , immediately contact a doctor! If you forget to use Karvileks If you miss a dose, take it at the next regular intake without increasing the dose .
4 . POSSIBLE SIDE EFFECTS
Like all medicines , Karvileks can cause adverse reaktsii.Te usually seen in the initial application or when increasing the dose more frequently in patients with chronic heart failure, as a rule are prehodni.Pri chronic heart failure
• Cardiovascular system :
- Common: bradycardia ( slow heart rate ) , orthostatic hypotension ( drop in blood pressure when standing up ) , hypotension ( low blood pressure) , edema ( including generalized , peripheral , stagnation and genital edema , swelling of the legs, fluid overload ) . - No Uncommon: syncope (including presyncope ) , conduct disorder cardiac impulse ( AB- block II and III degree) , progression of heart failure - mainly during dose escalation .
• Metabolic :
- Common: weight gain , increased serum cholesterol , high or low blood sugar , worsening of glucose control in patients with diabetes mellitus.
• Central nervous system:
- Very common: dizziness , headache , fatigue , usually mild , and occur predominantly at the start of treatment.
• Blood :
- Rarely, thrombocytopenia ( low platelet count in the blood) .
- In rare cases, leucopenia ( reduced amount of leukocytes in the blood) .
• Gastrointestinal system :
- Common: nausea , vomiting , and diarrhea.
• Skin and appendages :
- Dermatitis, and increased sweating . • Other:
- Frequent , visual disturbances .
- Rare: acute renal failure, and abnormal renal function in patients with diffuse vascular disease and / or renal funktsiya.Chestotata of adverse reactions is dose dependent , with the exception of dizziness, abnormal vision , and slow pulse .
In hypertension and angina
Observed side effects are similar to those seen in chronic heart failure , although the frequency of events is low.
• Cardiovascular system :
- Common: bradycardia , orthostatic hypotension, hypotension, especially in early treatment.
- Uncommon : syncope , hypotension, peripheral circulatory disorder ( cold extremities , exacerbation of symptoms in patients with intermittent claudication and Raynaud's phenomenon ) , AB block, angina, symptoms of heart failure , and peripheral edema.
• Central nervous system:
- Common: dizziness , headache and fatigue , which are usually mild and occurred mainly at the beginning of treatment.
- Uncommon : sleep disturbances , paresthesia , fatigue , mood swings .
• Metabolic :
- Due to the beta-blocking properties is possible manifestation of latent diabetes mellitus manifested may deteriorate .
• Biochemical changes: - Isolated cases of changes in liver enzymes.
• Blood :
- In rare cases, thrombocytopenia and leukopenia (decreased number of platelets and leukocytes in the blood) .
• Respiratory system :
- Common: asthma, shortness of breath and bronchospasm in susceptible patients .
- Rare: nasal congestion , wheezing , flu-like symptoms.
• Gastrointestinal system :
- Common: decreased appetite , nausea, abdominal pain, diarrhea , increased flatulence .
- Uncommon : constipation, vomiting.
• Skin and appendages :
- Uncommon : skin reaction (eg allergic rash , dermatitis, rash , pruritus , lichen planus like reactions , increased sweating ) . Possible appearance of psoriatic skin manifestations or exacerbation of existing ones.
- Common: pain in extremity, reduced lacrimation .
- Uncommon : decreased libido , impaired vision.
- Rare: dry mouth, difficulty in urinating , eye irritation .
- Single cases of allergic reactions.
If you notice any side effects not listed is this leaflet, please tell your doctor or pharmacist.
5 . STORAGE CONDITIONS
Keep out of reach of children ! At temperatures below 25 ° C. Do not use after the expiry date stated on the package ! Shelf life : two (2 ) years from date of manufacture.