Zuellig Pharma
Concise Prescribing Info
Management of chronic cardiac failure where systolic dysfunction is dominant: Patients w/ ventricular dilatation; cardiac failure w/ atrial fibrillation. Management of certain supraventricular arrhythmias particularly chronic atrial flutter & fibrillation.
Dosage/Direction for Use
Adult & childn >10 yr Rapid oral loading: 750-1,500 mcg as single dose. Where there is less urgency or greater risk of toxicity eg, elderly: Approx ½ the total dose is given as 1st dose & further doses at 6-hr intervals. Slow oral loading: 250-750 mcg daily for 1 wk. If cardiac glycosides have not been given the preceeding 2 wk Parenteral loading dose: 500-1,000 mcg daily given as IV infusion over 10-20 min. Maintenance: 125-250 mcg daily. Where there is increased sensitivity to adverse effect of digoxin: ≤62.5 mcg daily. Neonate, infant & childn up to 10 yr (if cardiac glycosides have not been given the preceeding 2 wk) Oral loading dose: 5-10 yr 25 mcg/kg, 2-5 yr 35 mcg/kg, term neonate to 2 yr 45 mcg/kg, preterm neonate 1.5-2.5 kg 30 mcg/kg, <1.5 kg 25 mcg/kg. All doses given over 24 hr in divided doses w/ approx ½ the total dose as 1st dose & further fractions at 4-8 hr intervals. Maintenance daily dose: Term neonate & childn up to 10 yr 25% of 24-hr oral loading dose; preterm neonate 20% of 24-hr oral loading dose.
May be taken with or without food.
Hypersensitivity to digoxin & other digitalis glycosides. Intermittent complete heart block or 2nd-degree AV block especially w/ history of Stokes-Adams attacks; arrhythmias caused by cardiac glycoside intoxication; supraventricular arrhythmias associated w/ accessory AV pathway (Wolff-Parkinson-White syndrome); known or suspected accessory pathway even w/o history of previous supraventricular arrhythmias; ventricular tachycardia or fibrillation; hypertrophic obstructive cardiomyopathy.
Special Precautions
Not be used in constrictive pericarditis unless to control ventricular rate in atrial fibrillation or improve systolic dysfunction. Avoid use in heart failure patients associated w/ cardiac amyloidosis; myocarditis. Precipitated arrhythmias due to digoxin toxicity; incomplete AV block; exacerbated sinus bradycardia or cause SA block; post MI; PR interval prolongation & ST segment depression on ECG; severe resp disease; hypokalaemia; hypoxia, hypomagnesaemia, marked hypercalcaemia; hypothyroidism; malabsorption syndrome, GI reconstructions. Withhold for 24 hr prior to performing cardioversion. Periodically assess serum electrolytes & renal function. Regularly check & monitor serum digoxin levels. Concomitantly treat thiamine deficiency in patients w/ beriberi heart disease. May affect ability to drive & use machines. Pregnancy & lactation. Elderly.
Adverse Reactions
CNS disturbances, dizziness; visual disturbances (blurred/yellow vision); arrhythmia, conduction disturbances, bigeminy, trigeminy, PR prolongation, sinus bradycardia; nausea, vomiting, diarrhoea; urticarial or scarlatiniform skin rashes, may be accompanied by pronounced eosinophilia.
Drug Interactions
Increased AV conduction time w/ β-adrenoceptor blockers. Increased sensitivity w/ agents causing hypokalaemia or intracellular K deficiency eg, lithium salts, corticosteroids, carbenoxolone, some diuretics. Moderate increased risk of toxicity in heart failure patients w/ sennosides. Increased susceptibility to effects of suxamethonium-exacerbated hyperkalaemia. Serious arrhythmias in digitalized patients w/ IV Ca. Increased serum levels w/ amiodarone, flecainide, prazosin, propafenone, quinidine, spironolactone, macrolides (eg, erythromycin, clarithromycin), tetracyclines, gentamicin, itraconazole, quinine, trimethoprim, alprazolam, indomethacin, propantheline, nefazodone, atorvastatin, cyclosporine, epoprostenol (transient), tolvaptan, carvedilol, verapamil, felodipine, tiapamil. Reduced serum levels w/ antacids, some bulk laxatives, kaolin-pectin, acarbose, neomycin, penicillamine, rifampicin, some cytostatics, metoclopramide, sulfasalazine, adrenaline, salbutamol, cholestyramine, phenytoin, St. John's wort. Increased blood conc, enhanced absorption & reduced renal clearance w/ P-glycoprotein inhibitors.
MIMS Class
ATC Classification
C01AA05 - digoxin ; Belongs to the class of digitalis glycosides. Used in the treatment of heart failure.
Lanoxin inj (amp) 500 mcg/2 mL
5 × 1's
Lanoxin PG elixir 50 mcg/mL
(lime flavour) 60 mL x 1's
Lanoxin tab 250 mcg
Lanoxin PG tab 62.5 mcg
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