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CARVEDILOL is a brand name for Carvedilol. The medicine, its uses, side effects and dosage are the same regardless of brand.
Used for: Chronic heart failure Carvedilol is adjunctive therapy for the treatment of moderate to severe stable chronic heart failure. Hypertension Carvedilol is indicated for the treatment of hypertension. Angina Carvedilol is indicated for the prophylactic treatment of stable angina
Verbatim from this product's MHRA label. Tap a section to expand.
The tablets should be taken with fluid. Hypertension Carvedilol may be used for the treatment of hypertension alone or in combination with other antihypertensives, especially thiazide diuretics. Once daily dosing is recommended. 5 mg once a day for the first two days.
Thereafter the recommended dosage is 25 mg once a day. Although this is an adequate dose in most patients, if necessary the dose may be titrated up to a recommended daily maximum dose of 50 mg given once a day or in divided doses. Dose titration should occur at intervals of at least two weeks.
5 mg daily is recommended. This has provided satisfactory control in some cases. If the response is inadequate the dose may be titrated up to the recommended daily maximum dose of 50 mg given once a day or in divided doses. Paediatric population Safety and efficacy in children (under 18 years) has not been established.
Angina A twice-daily regimen is recommended. 5 mg twice a day for the first two days. Thereafter, the recommended dosage is 25 mg twice a day. Elderly The recommended maximum daily dose is 50 mg given in divided doses. Paediatric population Safety and efficacy in children (under 18 years) has not been established.
Heart Failure Carvedilol is given in moderate to severe heart failure in addition to conventional basic therapy with diuretics, ACE inhibitors, digitalis, and/or vasodilators. The patient should be clinically stable (no change in NYHA-class, no hospitalisation due to heart failure) and the basic therapy must be stabilized for at least 4 weeks prior to treatment.
3). 125 mg twice a day for two weeks. 5 mg twice a day and finally up to 25 mg twice a day. The dosage should be increased to the highest tolerable level. The recommended maximum dosage is 25 mg twice a day for patients with a body weight of less than 85 kg, and 50 mg twice a day for patients with a body weight above 85 kg, provided that the heart failure is not severe.
A dose increase to 50 mg twice daily should be performed carefully under close medical supervision of the patient. Transient worsening of symptoms of heart failure may occur at the beginning of treatment or due to a dose increase, especially in patients with severe heart failure and/or under high dose diuretic treatment.
This does usually not call for discontinuation of treatment, but dose should not be increased. The patient should be monitored by a physician/cardiologist for two hours after starting treatment or increasing the dose. g. renal function, body weight, blood pressure, heart rate and rhythm).
(a) Summary of the safety profile The frequency of adverse reactions is not dose-dependent, with the exception of dizziness, abnormal vision and bradycardia. (b) Tabulated list of adverse reactions The risk of most adverse reactions associated with carvedilol is similar across all indications.
Exceptions are described in subsection (c). Frequency categories are as follows:Adverse drug reactions are listed below by system organ class and frequency. 4) Cardiac disorders Atrioventricular-block, angina pectoris Skin and subcutaneous tissue disorder Dermatitis, increased sweating, alopecia Uncommon (>1/1000, <1/100) Nervous system disorders Presyncope, syncope Rare (>1/10000, <1/1000) Blood and lymphatic system disorders Thrombocytopenia Blood and lymphatic system disorders Leucopenia Immune system disorder Hypersensitivity (Allergic reaction) Hepatobiliary disorder Alanine aminotransferase (ALT), aspartate aminotransferase (AST) and gammaglutamyltransferase (GGT) increased Renal and urinary disorders Urinary incontinence in women Very rare (incl.
g. 5) In patients with hypertension and angina The profile is similar to that observed in chronic heart failure although the incidence of events is generally lower in patients with hypertension or angina treated with carvedilol. Frequency System organ class Adverse events Frequency System organ class Adverse events Very common (> 1/10) Cardiac disorders Vascular disorders Cardiac failure Hypotension Infections and infestations Bronchitis, pneumonia, upper respiratory tract infection, urinary tract infection Blood and lymphatic system disorders Anaemia Psychiatric disorder Depression and depressed mood Nervous system disorders Dizziness, fatigue, headache: usually mild, occur particularly at the start of treatment Eye disorders Lacrimation decreased (dry eye), visual impairment, eye irritation Cardiac disorders Vascular disorders Bradycardia, postural hypotension, especially at the beginning of treatment.
Chronic Heart Failure In chronic heart failure patients, worsening cardiac failure or fluid retention may occur during up-titration of carvedilol. If such symptoms occur, the dose of diuretic should be increased and the carvedilol dose should not be advanced until clinical stability resumes.
Occasionally it may be necessary to lower the carvedilol dose or in rare cases, temporarily discontinue it. Such episodes do not preclude subsequent successful titration of carvedilol. 5). In hypertensive patients who have chronic heart failure controlled with digoxin, diuretics and/or an ACE inhibitor, carvedilol should be used with caution since both digoxin and carvedilol may slow A-V conduction.
Renal function in Chronic Heart Failure Reversible deterioration of renal function has been observed with carvedilol therapy in chronic heart failure patients with low blood pressure (systolic BP < 100 mmHg), ischaemic heart disease and diffuse vascular disease, and/or underlying renal insufficiency.
In patients with these risk factors, renal function should be monitored during up-titration of Carvedilol and the drug discontinued or dosage reduced if worsening of renal failure occurs. Left ventricular dysfunction following acute myocardial infarction Before treatment with carvedilol is initiated the patient must be clinically stable and should have received an ACE inhibitor for at least the preceding 48 hours, and the dose of the ACE inhibitor should have been stable for at least the preceding 24 hours.
Chronic obstructive pulmonary disease Carvedilol should be used with caution, in patients with chronic obstructive pulmonary disease (COPD) with a bronchospastic component who are not receiving oral or inhaled medication, and only if the potential benefit outweighs the potential risk.
In patients with a tendency to bronchospasm, respiratory distress can occur as a result of a possible increase in airway resistance. Patients should be closely monitored during initiation and up-titration of carvedilol and the dose of carvedilol should be reduced if any evidence of bronchospasm is observed during treatment.
1. • Carvedilol is contra-indicated in patients with marked fluid retention or overload requiring intravenous inotropic support. • Patients with obstructive airways disease, unstable/decompensated heart failure, clinically manifested liver dysfunction.
• As with other beta-blocking agents: History of bronchospasm or asthma, 2nd and 3rd degree A-V heart block (unless a permanent pacemaker is in place), severe bradycardia (< 50 bpm), cardiogenic shock, sick sinus syndrome (including sino-atrial block), severe hypotension (systolic blood pressure < 85 mmHg), metabolic acidosis and phaeochromocytoma (unless adequately controlled by alpha blockade).
• Prinzmetal's angina. • Severe peripheral arterial circulatory disturbances. 5). • Unsuitable for patients with lactase insufficiency, galactosaemia or glucose/galactose malabsorption syndrome.
Not medical advice. Always read the patient information leaflet and follow your prescriber or pharmacist.
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Worsening of heart failure or fluid retention is treated by increasing the dose of diuretic, and the dose of carvedilol should not be increased until the patient is stabilized. If bradycardia appears or in case of lengthening of AV conduction, the level of digoxin should first be monitored.
Occasionally it may be necessary to reduce the carvedilol dose or temporarily discontinue treatment altogether. Even in these cases, carvedilol dose titration can often be successfully continued. Renal function, thrombocytes and glucose (in case of NIDDM and/or IDDM) should be monitored regularly during dose titration.
However, after dose titration the frequency of monitoring can be reduced. 125 mg twice a day and increased gradually according to the above recommendations. 2). 2). Children and adolescents (< 18 years) Carvedilol is not recommended for the use in children below 18 years of age due to insufficient data on the efficacy and safety of carvedilol.
Elderly Elderly patients may be more susceptible to the effects of carvedilol and should be monitored more carefully. 4). Methods of administration The tablets should be taken with the adequate supply of fluid. It is recommended that heart failure patients take their carvedilol medication with food to allow the absorption to be slower and the risk of orthostatic hypotension to be reduced.
Orthostatic hypotension, disturbances of peripheral circulation (cold extremities, peripheral vascular disease, exacerbation of intermittent claudication and Raynaud’s phenomenon) Respiratory, thoracic and mediastinal disorders Dyspnea, pulmonary oedema and asthma in predisposed patients Common (>1/100, <1/10) Gastro-intestinal disorders Gastro-intestinal upset (with symptoms such as abdominal pain, dyspepsia, diarrhoea, nausea) Musculoskeletal and connective tissue disorder Pain in the extremities Renal and urinary disorders Micturition disorder General disorder Pain Nervous system disorders Asthenia, syncope, paraesthesia Psychiatric disorder Sleep disorder Eye disorders Disturbed vision Cardiovascular system Angina pectoris (including chest pain), AV-block, symptoms of heart failure and peripheral oedema.
Gastro-intestinal disorders Constipation, vomiting Uncommon (>1/1000, <1/100) Skin and subcutaneous tissue disorder Skin reactions (eg allergic exanthema, dermatitis, increased sweating, lichen planus-like skin lesions, pruritus, urticaria).
Psoriatic skin lesions may occur Frequency System organ class Adverse events or existing lesions exacerbated. Alopecia Reproductive system Sexual impotence, erectile dysfunction Rare (>1/10000, <1/1000) Respiratory, thoracic and mediastinal disorders Flu-like symptoms, nasal congestion, wheezing Gastro-intestinal disorders Dryness of the mouth Blood and lymphatic system disorders Changes in serum transaminases, leucopenia, thrombocytopenia Immune system disorder Hypersensitivity (Allergic reaction) Hepatobiliary disorder Alanine aminotransferase (ALT), aspartate aminotransferase (AST) and gammaglutamyltransferase (GGT) increased Renal and urinary disorders Urinary incontinence in women Very rare (incl.
g. Erythema mulitforme, Stevens-Johnson syndrome, Toxic epidermal necrolysis) (c) Description of selected adverse reactions Dizziness, syncope, headache and asthenia are usually mild and are more likely to occur at the beginning of treatment.
4). Cardiac failure is a commonly reported […]
Alternatives to beta-blocking agents are generally preferred in insulin- dependent patients. In chronic heart failure patients with diabetes, the use of carvedilol may be associated with worsening control of blood glucose. Therefore, regular monitoring of blood glucose is required in diabetics when carvedilol is initiated or up-titrated and hypoglycaemic therapy adjusted accordingly.
Peripheral vascular disease Carvedilol should be used with caution in patients with peripheral vascular disease as beta-blockers can precipitate or aggravate symptoms of arterial insufficiency. However as carvedilol also has alpha-blocking properties this effect is largely counterbalanced.
Raynaud's phenomenon Carvedilol should be used with caution in patients suffering from peripheral circulatory disorders (eg Raynaud's phenomenon) as there may be exacerbation of symptoms. 2). Thyrotoxicosis Carvedilol may obscure the symptoms of thyrotoxicosis.
Anesthesia and major surgery Caution should be exercised in patients undergoing general surgery, because of the synergistic negative inotropic effects of carvedilol and anaesthetic drugs. Bradycardia Carvedilol may induce bradycardia.
If the patient's pulse rate decreases to less than 55 beats per minute, the dosage of carvedilol should be reduced. Hypersensitivity Care should be taken in administering carvedilol to patients with a history of serious hypersensitivity reactions and in those undergoing desensitisation therapy as beta- blockers may increase both the sensitivity towards allergens and the seriousness of anaphylactic reactions.
Psoriasis Patients with a history of psoriasis associated with beta-blocker therapy should be given carvedilol only after consideration of the risk-benefit ratio. Concomitant use of calcium channel blockers Careful monitoring of ECG and blood pressure is necessary in patients receiving concomitant therapy with calcium channel blockers of the verapamil or diltiazem type or other antiarrhythmic drugs.
Phaeochromocytoma In patients with phaeochromocytoma, an alpha-blocking agent should be initiated prior to the use of any beta-blocking agent. Although carvedilol has both alpha and beta- blocking pharmacological activities, there is no experience of the use of carvedilol in this condition.
Therefore, caution should be taken in the administration of carvedilol to patients suspected of having phaeochromocytoma. Prinzmetal's variant angina Agents with non-selective beta-blocking activity may provoke chest pain in patients with Prinzmetal's variant angina.
There is no clinical experience with carvedilol in these patients, although the alpha-blocking activity of carvedilol may prevent such symptoms. However, caution should be taken in the administration of carvedilol to patients suspected of having Prinzmetal's variant angina.
Contact lenses Wearers of contact lenses should be advised of the possibility of reduced lacrimation. Withdrawal syndrome Although angina has not been reported on stopping treatment, carvedilol treatment should not be discontinued abruptly, particularly in patients suffering from ischaemic heart disease.
The withdrawal of carvedilol should be gradual (over a period of two weeks). Lactose Carvedilol contains lactose. Patients with rare hereditary problems of galactose intolerance, Lapp lactase deficiency or glucose-galactose malabsorption should not take this medicine.
In patients with a tendency […]