Vacodil Special Precautions



Aurobindo Pharma


Full Prescribing Info
Special Precautions
Chronic heart failure: In chronic heart failure patients, worsening cardiac failure or fluid retention may occur during up-titration of Vacodil. If such symptoms occur, diuretics should be increased and the Vacodil dose should not be advanced until clinical stability resumes. Occassionally, it may be necessary to lower the Vacodil dose or, in rare cases, temporarily discontinue it. Such episodes do not preclude subsequent successfully titration of Vacodil, Vacodil should be used with caution in combination with digitalis glycosides, as both drugs slow AV conduction.
Renal function in chronic heart failure: Reversible deterioration of renal has been observed with Vacodil therapy in chronic heart failure patients with low blood pressure (systolic BP <100 mmHg, ischemic heart disease and diffuse vascular disease, and/or underlying renal insufficiency).
Chronic obstructive pulmonary disease: Vacodil 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 Vacodil and the dose of Vacodil should be reduced if any evidence of bronchospasm is observed during treatment.
Diabetes: Care should be taken in the administration of Vacodil to patients with diabetes mellitus, as the early signs and symptoms of acute hypoglycemia may be masked or attenuated. In chronic heart failure patients with diabetes, the use of Vacodil may be associated with worsening control of blood glucose.
Peripheral vascular disease: Vacodil 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: Vacodil 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: Vacodil, like other agents with beta-blocking properties, 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 Vacodil and anesthetic drugs.
Bradycardia: Vacodil may induce bradycardia. If the patient's pulse rate decreases to less than 55 beats per minute, the dosage of Vacodil should be reduced.
Hypersensitivity: Care should be taken in administering Vacodil to patients with a history of serious hypersensitivity reactions, and in those undergoing desensitization therapies, 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 take Vacodil 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.
Pheochromocytoma: In patients with pheochromocytoma, an alpha-blocking agent should be initiated prior to the use of any beta-blocking agent. Although Vacodil has both alpha- and beta-blocking pharmacological activities, there is no experience with its use in this condition. Caution should therefore be taken in the administration of Vacodil of patients suspected of having pheochromocytoma.
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 Vacodil in these patients although the alpha-blocking activity of Vacodil may prevent such symptoms. Caution should: however, be taken in the administration of Vacodil to patients suspected of having Prinzmetal's variant angina.
Contact lenses: Wearers of contact lenses should bear in mind the possibility of reduced lacrimation.
Withdrawal syndrome: Vacodil treatment should not be discontinued abruptly, particularly in patients suffering from ischemic heart disease. The withdrawal of Vacodil should be gradual (over a period of two weeks).
Effects on ability to drive and use machines: No studies have been performed on the effects of Vacodil on patient's fitness to drive or operate machinery.
Because of individually variable reactions (e.g. dizziness, tiredness), the ability to drive, operate machinery, or work without firm support may be impaired. This applies particularly at the start of treatment, after dose increases, on changing products, and in combination with alcohol.
Use in Children: safety and efficacy have not yet been established.
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