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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: Essential hypertension Chronic stable angina pectoris Adjunctive treatment of moderate to severe stable chronic heart failure.
Verbatim from this product's MHRA label. Tap a section to expand.
Oral use. Posology Essential 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, however the recommended maximum single dose is 25 mg and the recommended maximum daily dose is 50 mg.
5 mg once a day for the first two days. Thereafter the treatment is continued at the dose 25 mg/day. If necessary, the dose may be further increased gradually at intervals of two weeks or more rarely. 5 mg once a day which may also be sufficient for continued treatment.
However, if the therapeutic response is inadequate at this dose, the dose may be further increased gradually at intervals of two weeks or more rarely.
Chronic stable angina pectoris:
A twice-daily regimen is recommended. 5 mg twice a day for the first two days. Thereafter, the treatment is continued at the dose 25 mg twice a day. If necessary, the dose may be further increased gradually at intervals of two weeks or more rarely to the recommended maximum dose of 100 mg a day divided into two doses (twice daily).
5 mg twice daily for two days. Thereafter, the treatment is continued at the dose 25 mg twice daily, which is the recommended maximum daily dose..
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.
(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:. Very common (≥1/10) Common (≥1/100 to < 1/10) Uncommon (≥1/1000 to <1/100) Rare (≥1/10000 to <1/1000) Very rare (< 1/10,000) Infections and infestations Common: Bronchitis, pneumonia, upper respiratory tract infection, urinary tract infection Blood and lymphatic system disorders Common: Anaemia Rare: Thrombocytopenia.
Very rare:
Leucopenia.
Immune system disorders Very rare:
Hypersensitivity (allergic reaction) Metabolism and nutrition disorders Common: Weight increases, hypercholesterolaemia, impaired blood glucose control (hyperglycaemia, hypoglycaemia) in patients with pre-existing diabetes Psychiatric disorders Common: Depression, depressed mood Uncommon: Sleep disorders, confusion Nervous system disorders Very common: Dizziness, headache Uncommon: Presyncope, syncope, paraesthesia Eye disorders Common: Visual impairment, lacrimation decreased (dry eye), eye irritation Cardiac disorders Very common: Cardiac failure Common: Bradycardia, oedema, hypervolaemia, fluid overload.
g. g. Erythema multiforme, Stevens-Johnson syndrome, Toxic epidermal necrolysis) Musculoskeletal and connective tissue disorders Common: Pain in extremities Renal and urinary disorders Common: Renal failure and renal function abnormalities in patients with diffuse vascular disease and/or underlying renal insufficiency, micturition disorders Very rare: Urinary incontinence in women Reproductive system and breast disorders Uncommon: Erectile dysfunction General disorders and administration site conditions Very common: Asthenia (fatigue) Common: Pain (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.
Warnings to be considered particularly in heart failure patients In chronic heart failure patients carvedilol should be administered principally in addition to diuretics, ACE inhibitors, digitalis and/or vasodilators. Initiation of therapy should be under the supervision of a hospital physician.
Therapy should only be initiated, if the patient is stabilized on conventional basic therapy for at least 4 weeks. Patients with severe heart failure, salt and volume depletion, elderly or patients with low basic blood pressure should be monitored for approximately 2 hours after the first dose or after dose increase as hypotension may occur.
Hypotension due to excessive vasodilatation is initially treated by reducing the dose of the diuretic. If symptoms still persist, the dose of any ACE inhibitor may be reduced. At the start of therapy or during up-titration of Carvedilol worsening of heart failure or fluid retention may occur.
In these cases, the dose of diuretic should be increased. However, sometimes it will be necessary to reduce or withdraw carvedilol medication. The carvedilol dose should not be increased before symptoms due to the worsening of heart failure or hypotension due to vasodilatation are under control.
Since, to date, there are few data in patients with congestive heart failure class IV of the NYHA, if it is necessary to treat this group of patients with carvedilol, it should be done with special precaution. It is recommended to follow the instructions indicated in this section.
Reversible deterioration of renal function has been observed during carvedilol therapy in heart failure patients with low blood pressure (systolic BP < 100 mm Hg), ischaemic heart disease and generalized atherosclerosis, and/or underlying renal insufficiency.
In heart failure patients with these risk factors, renal function should be monitored during dose titration of carvedilol. If significant worsening of renal function occurs, the carvedilol dose must be reduced or therapy must be discontinued.
1. • Heart failure belonging to NYHA Class IV of the heart failure classification with marked fluid retention or overload requiring intravenous inotropic treatment. 4). • Clinically significant hepatic dysfunction. • Bronchial asthma. • AV block, degree II or III (unless a permanent pacemaker is in place).
• Severe bradycardia (<50 bpm). • Sick sinus syndrome (incl. sino-atrial block). • Cardiogenic shock. • Severe hypotension (systolic blood pressure below 85 mmHg). • Prinzmetal's angina. • Untreated phaeochromocytoma. • Metabolic acidosis.
• Severe peripheral arterial circulatory disturbances. 5).
Not medical advice. Always read the patient information leaflet and follow your prescriber or pharmacist.
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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).
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. Renal insufficiency Dosage must be determined for each patient individually, but according to pharmacokinetic parameters there is no evidence that dose adjustment of carvedilol in patients with renal impairment is necessary.
Moderate hepatic dysfunction Dose adjustment may be required. Paediatric population (< 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).
Method of administration:
The tablets should be taken with an 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.
SUMMARY OF PRODUCT CHARACTERISTICS 4 CLINICAL PARTICULARS
4% respectively, in patients with left ventricular dysfunction following acute myocardial infarction). 4). As a class, beta-adrenergic receptor blockers may cause latent diabetes to become manifest, manifest diabetes to be aggravated, and blood glucose counter-regulation to be inhibited.
Carvedilol may cause urinary incontinence in women which resolves upon discontinuation of the medication. Reporting of suspected adverse reactions Reporting suspected adverse reactions after authorisation of the medicinal product is important.
It allows continued monitoring of the benefit/risk balance of the medicinal product. uk/yellowcard or search for MHRA Yellow Card in the Google Paly or Apple App Store.
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 past 48 hours, and the dose of the ACE inhibitor should have been stable for at least the past 24 hours.
5). Other warnings as regards carvedilol and beta-blockers in general 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. Patients with a chronic obstructive pulmonary disease with a tendency towards bronchospasms who are not treated with oral or inhalation medicine should only be given carvedilol if the expected improvement outweighs the possible risk.
Patients should be monitored closely in the initial phase, and titration of carvedilol and carvedilol dose should be reduced in case of bronchospasms. Carvedilol may mask symptoms and signs of acute hypoglycaemia. Impaired blood glucose control may occasionally occur in patients with diabetes mellitus and heart failure in connection with the use of carvedilol.
5). Blood glucose levels should also be closely monitored after a longer period of fasting. Carvedilol may mask features (symptoms and signs) of thyrotoxicosis. Carvedilol may cause bradycardia. If there is a decrease in pulse rate to less than 55 beats per minute, and symptoms associated with bradycardia occur, the carvedilol dose should be reduced.
When carvedilol is used concomitantly with calcium channel blocking agents such as verapamil and diltiazem or with other antiarrhythmics, specifically amiodarone, the patient's blood pressure and ECG have to be monitored. 5). 5). Persons wearing contact lenses should be advised of a possible reduction of the secretion of lacrimal fluid.
Care should be taken in administrating 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.
Cautions should be exercised when prescribing beta-blockers to patients with psoriasis since skin reactions may be aggravated. 8). Carvedilol should be permanently discontinued in patients who experience severe cutaneous adverse reactions possibly attributable to Eucardic.
Carvedilol should be used with caution in patients with peripheral vascular diseases, as beta-blockers may aggravate symptoms of the disease. The same also applies to those with Raynaud's syndrome, as there may be exacerbation or aggravation of symptoms.
2). Since there is limited clinical experience, carvedilol should not be administered in patients with labile or secondary […]