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Tambocor injection may be given as a bolus injection in an emergency or for rapid effect, or as a slow intravenous infusion when prolonged administration .is required a).
Bolus injection: Administer 2 mg/kg over not less than ten minutes, or in divided doses. Alternatively .dilute with 5% glucose and give as a mini-infusion Continuous ECG monitoring is recommended. Stop .the injection when the arrhythmia is controlled For sustained ventricular tachycardia, or people with a history of cardiac failure (who may become decompensated during administration) give the initial dose over 30 minutes and monitor the ECG .carefully .The maximum recommended bolus dose is 150 mg b).
Intravenous infusion: The recommended procedure is to start with a slow injection of 2 mg/kg over 30 minutes, then continue intravenous infusion :at the following rates .
First hour: 1.5 mg/kg per hour .
Second and later hours: 0.1 – 0.25 mg/kg per hour The maximum recommended infusion duration is 24 hours; if exceeded, and in patients receiving high .doses, monitor plasma levels The maximum cumulative dose over the first 24 .hours should not exceed 600 mg In severe renal impairment (creatinine clearance 35 ml/min/1.73 sq.m.) reduce the above dosage > .recommendations by half Oral maintenance dosing should be started as soon .as possible after stopping the.
Children .Not recommended in children under 12 years.
Elderly Patients: The rate of elimination of flecainide may be .reduced, so dose adjustment may be necessary.
Serious ventricular arrhythmia that have not responded to other drugs, paroxysmal atrial fibrillation; atrial flutter.
– Cardiac failure.
– History of myocardial infarction with either asymptomatic ventricular ectopics, or asymptomatic non-sustained ventricular tachycardia.
– Long-standing atrial fibrillation where there has been no attempt to convert to sinus rhythm.
– Haemodynamically significant valvular heart .diseaseUnless pacing rescue is available, do not give
– to patients with sinus node dysfunction, atrial conduction effects, second degree or greater atrio-ventricular block, bundle branch block or distal block.
– Correct any electrolyte disturbances before using Tambocor injection.
– Plasma elimination of flecainide may be markedly slower in patients with significant hepatic impairment. Do not use, unless the .potential benefits clearly outweigh the risks Careful plasma monitoring is recommended.
– Decreased endocardial pacing sensitivity may occur; this effect is reversible and more marked on the acute pacing threshold than on the chronic.
– Use with caution in all patients with permanent .pacemakers or temporary pacing electrodes Do not administer to patients with existing poor ,thresholds, or non-programmable pacemakers unless suitable pacing rescue is available.
– Flecainide’s minor negative inotropic effect may become important in patients predisposed to cardiac failure. Difficulty in defibrillating some patients has been reported. The majority of these cases had pre-existing heart disease with cardiac enlargement, a history of myocardial infarction, arteriosclerotic heart disease and cardiac failure.
– Use cautiously in patients with acute onset .atrial fibrillation following cardiac surgery.
– Cardiovascular: Pro-arrhythmic effects – most likely in patients with structural heart disease .and/or significant left ventricular impairment 1:1 AV conduction following initial atrial slowing with resultant ventricular acceleration may occur most commonly seen following use of the) .(injection for acute conversion This effect is usually short lived and abates quickly once therapy is stopped. Other reported effects: AV block-second-degree and third degree, bradycardia, cardiac failure/congestive ,cardiac failure, chest pain, hypotension myocardial infarction, palpitation, sinus pause or ,arrest and tachycardia (AT or VT).
– Skin and appendages: Allergic skin reactions rashes, urticaria, photosensitivity.
– Immune system: Increased anti-nuclear antibodies with and without systemic inflammatory involvement.
– Haematological: Reductions in red and white ,blood cells and platelets reported occasionally.
– Psychiatric: Hallucinations, depression confusion, amnesia, anxiety, insomnia.
– Gastrointestinal: Nausea, vomiting, abdominal ,pain, anorexia, constipation, diarrhoea dyspepsia, flatulence.
– Liver and biliary system: Elevated liver enzymes, jaundice which is reversible on stopping treatment, hepatic dysfunction.
– Neurological: Giddiness, dizziness, lightheadedness, dyskinesia, convulsions. During long ,term therapy peripheral neuropathy, paraesthesia ataxia, flushing, headache, hypoaesthesia, increased ,sweating, somnolence, syncope, tinnitus, tremor vertigo.
– Ophthalmological: Double vision, blurred .vision, corneal deposits.
– Respiratory: Dyspnoea, pneumonitis
Flecainide is a class I antiarrhythmic. Possible interactions include :
– Additive effects with other antiarrhythmic drugs or with drugs affecting the metabolism of flecainide.
– Cardiac glycosides: flecainide can cause plasma Digoxin to rise by about 15%. Digoxin plasma level in digitalised patients should be measured, not less than six hours after any Digoxin dosebefore or after administration of flecainide.
– Class II antiarrhythmics: additive negativeinotropic effects of beta-blockers and other
cardiac depressants with flecainide should berecognised.
– Class III antiarrhythmics: reduce the dose of flecainide by 50% in the presence of Amiodarone to avoid additive effects. Monitor patients for adverse events and plasma level monitoring isstrongly recommended.
– Class IV antiarrhythmics: use of flecainide with other sodium channel blockers is not recommended.
– Antidepressants: flecainide increases plasma flecainide concentration. Tricyclics increase the risk of arrhythmias. Reboxetine manufacturer advises caution.
– Antiepileptics: Known enzyme inducers (Phenytoin, Phenobarbital, Carbamazepine) increase the rate of flecainide elimination by approximately 30%.
– Antipsychotics: Clozapine increases the risk of arrhythmias.
– Antihistamines: Mizolastine and Terfenadine increase the risk of ventricular arrhythmias.
– Antimalarials: Quinine increases plasma flecainide concentration.
– Antivirals: plasma flecainide concentrations are increased by Ritonavir, Lopinavir and Indinavir to increase risk of ventricular arrhythmias. Avoid concomitant use.
– Diuretics: Hypokalaemia may cause cardiac toxicity.
– Cimetidine: Increases plasma flecainide by approximately 30%.
– Anti-smoking aids: Bupropion may increase flecainide plasma concentration by inhibitory effects on CYP2D6, the isoenzyme responsible for flecainide metabolism.
– Tambocor injection is compatible with oral .anticoagulants.
Pregnancy and Lactation
Flecainide crosses the placenta; however, the safety of Tambocor injection in pregnancy has not been .established Flecainide is excreted in human milk and appears in .concentrations which reflect those in maternal blood The risk of adverse effects to the nursing infant is very small.
No specific antidote or rapid method of removing flecainide from the system is known. Forced acid diuresis may be helpful (theoretically), but dialysis and haemoperfusion are not. Injections of .anticholinergics are not recommended Treatment of flecainide overdose may include ,use of an inotropic agent, intravenous calcium, (circulatory assistance (e.g. balloon pumping mechanically assisting respiration, or temporarily inserting a transvenous pacemaker if there are severe conduction disturbances or the patient’s left .ventricular function is otherwise compromised.