Carvedilol Tablets UPS 6.25 mg

Chronic congestive heart failure: Carvedilol should be administered principally in addition to diuretics, ACE inhibitors, digitalis and/or vasodilators. Therapy should only be initiated if the patient is stabilised on conventional basic therapy for at least 4 weeks. Decompensated patients have to be re-compensated. Patients with severe heart failure, salt and volume depletion, elderly patients 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.
Renal function in congestive 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 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.
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.
First degree AV block: Because of its negative dromotropic action, carvedilol should be administered with caution to patients with first degree heart block.
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.
Diabetes: Care should be taken in the administration of carvedilol to patients with diabetes mellitus, as the early signs and symptoms of acute hypoglycaemia may be masked or attenuated. In chronic heart failure patients with diabetes, the use of carvedilol may be associated with worsening control of blood glucose.
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.
Raynaud’s phenomenon: Carvedilol should be used with caution in patients suffering from peripheral circulatory disorders (e.g. Raynaud’s phenomenon) as there may be exacerbation of symptoms.
Thyrotoxicosis: Carvedilol may obscure the symptoms of thyrotoxicosis.
Anaesthesia 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.
Severe skin reactions: Very rare cases of severe skin reactions, such as toxic epidermal necrolysis (TEN) and Stevens-Johnson syndrome (SJS) have been reported during treatment with carvedilol.
Psoriasis: Patients with a history of psoriasis associated with beta-blocker therapy should take carvedilol only after consideration of the risk-benefit ratio.
Metabolic acidosis: Carvedilol should be used with caution in patients with metabolic acidosis.
Withdrawal syndrome: Carvedilol treatment should not be discontinued abruptly, particularly in patients suffering from ischaemic heart disease. The withdrawal of carvedilol should be gradual.