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Lanoxin
Formulations

PRESENTATIONS
Lanoxin Tablets 250mcg are white, round, biconvex tablets, bisected and debossed "D025" on the same side and plain on the other side. Each tablet contains 250mcg (0.250mg) of Digoxin BP.

Lanoxin PG Tablets are blue, round, biconvex tablets, debossed "D06" on the one side and plain on the other side.

Each tablet contains 62.5mcg (0.0625mg) of Digoxin BP.

USES
Cardiac Failure
Lanoxin is indicated in the management of chronic cardiac failure where the dominant problem is systolic dysfunction. Its therapeutic benefit is greatest in those patients with ventricular dilatation.

Lanoxin is specifically indicated where cardiac failure is accompanied by atrial fibrillation.

Supraventricular Arrhythmias
Lanoxin is indicated in the management of certain supraventricular arrhythmias, particularly atrial flutter and fibrillation, where a major beneficial effect is reduction of the ventricular rate.

DOSAGE AND ADMINISTRATION
The dose of Lanoxin for each patient has to be tailored individually according to age, lean body weight and renal function. Suggested doses are intended only as an initial guide.

Adults and children over 10 years
Rapid Oral Loading

750 to 1500 μg (0.75 to 1.5 mg) as a single dose.

Where there is less urgency, or greater risk of toxicity e.g. in the elderly, the oral loading dose should be given in divided doses 6 hours apart, with approximately half the total dose given as the first dose.

Clinical response should be assessed before giving each additional dose (see Warnings and Precautions).

Slow Oral Loading
250 to 750 g (0.25 to 0.75 mg) should be given daily for 1 week followed by an appropriate maintenance dose. A clinical response should be seen within one week.

NOTE: The choice between slow and rapid oral loading depends on the clinical state of the patient and the urgency of the condition.

Maintenance
The maintenance dosage should be based upon the percentage of the peak body stores lost each day through elimination. The following formula has had wide clinical use:-

Where:- Peak body stores = loading dose
              daily loss (in percent) = 14 + creatinine clearance (Ccr)/5
Ccr is creatinine clearance corrected to 70 kg bodyweight or 1.73 m2 body surface area.

If only serum creatinine (Scr) concentrations are available, a Ccr (corrected to 70 kg bodyweight) may be estimated in men as


NOTE: Where serum creatinine values are obtained in μmol/L, these may be converted to mg/100 ml (mg%) as follows:-


Where 113.12 is the molecular weight of creatinine. For women, this result should be multiplied by 0.85.
N.B.: These formulae cannot be used for creatinine clearance in children.

In practice, this will mean that most patients will be maintained on 125 to 750 μg (0.125 to 0.75 mg) digoxin daily; however in those who
show increased sensitivity to the adverse effects of digoxin, a dose of 62.5μg (0.0625 mg) daily or less may suffice.

Neonates, infants and children up to 10 years of age (if cardiac glycosides have not been given in the preceding two weeks):-
In the newborn, particularly in the premature infant, renal clearance of digoxin is diminished and suitable dose reductions must be observed, over and above general dosage instructions.

Beyond the immediate newborn period, children generally require proportionally larger doses than adults on the basis of body weight or body surface area, as indicated in the schedule below. Children over 10 years of age require adult dosages in proportion to their body weight.

Oral loading dose; This should be administered in accordance with the following schedule:-
  Preterm neonates < 1.5 kg - 25 μg/kg per 24 hours.
  Preterm neonates 1.5 kg to 2.5 kg - 30 μg/kg per 24 hours.
  Term neonates to 2 years - 45 μg/kg per 24 hours.
  2 to 5 years - 35 μg/kg per 24 hours.
  5 to 10 years - 25 μg/kg per 24 hours.

The loading dose should be administered in divided doses with approximately half the total dose given as the first dose and further fractions of the total dose given at intervals of 4 to 8 hours, assessing clinical response before giving each additional dose.

Maintenance
The maintenance dose should be administered in accordance with the following schedule:-
Preterm neonates:-
  daily dose = 20 % of 24-hour loading dose (oral).
Term neonates and children up to 10 years:-
  daily dose = 25 % of 24-hour loading dose (oral).

These dosage schedules are meant as guidelines and careful clinical observation and monitoring of serum digoxin levels (see Monitoring) should be used as a basis for adjustment of dosage in these paediatric patient groups.

If cardiac glycosides have been given in the two weeks preceding commencement of Lanoxin therapy, it should be anticipated that optimum loading doses of Lanoxin will be less than those recommended above.

The elderly:-
The tendency to impaired renal function and low lean body mass in the elderly influences the pharmacokinetics of Lanoxin such that high serum digoxin levels and associated toxicity can occur quite readily, unless doses of Lanoxin lower than those in non-elderly patients are used. Serum digoxin levels should be checked regularly and hypokalaemia avoided.

Dose Recommendations in Specific Patients Groups
See Warnings and Precautions.

The serum concentration of digoxin can be determined by radioimmunoassay.

Blood should be taken 6 hours or more after the last dose of Lanoxin. There are no rigid guidelines as to the range of serum concentrations that are most efficacious but most patients will benefit, with little risk of toxic symptoms and signs developing, with digoxin concentrations from 0.8 ng/ml (1.02 nmol/L) to 2.0 ng/ml (2.56 nmol/L). Above this range toxic symptoms and signs become more frequent and levels above 3.0 ng/ml (3.84 nmol/L) are quite likely to be toxic. However, in deciding whether a patient's symptoms are due to digoxin, the clinical state together with the serum potassium level and thyroid function are important factors.

Other glycosides, including metabolites of digoxin, can interfere with the assays that are available and one should always be wary of values which do not seem commensurate with the clinical state of the patient.

CONTRA-INDICATIONS
Lanoxin is contra-indicated in intermittent complete heart block or second degree atrioventricular block, especially if there is a history of
Stokes-Adams attacks.

Lanoxin is contra-indicated in arrhythmias caused by cardiac glycoside intoxication.

Lanoxin is contra-indicated in supraventricular arrhythmias associated with an accessory atrioventricular pathway, as in the Wolff-Parkinson-White syndrome, unless the electrophysiological characteristics of the accessory pathway and any possible deleterious effect of digoxin on these characteristics have been evaluated. If an accessory pathway is known or suspected to be present and there is no history of previous supraventricular arrhythmias, Lanoxin is similarly contra-indicated.

Lanoxin is contra-indicated in ventricular tachycardia or ventricular fibrillation.

Lanoxin is contra-indicated in hypertrophic obstructive cardiomyopathy, unless there is concomitant atrial fibrillation and heart failure but even then caution should be exercised if Lanoxin is to be used.

Lanoxin is contra-indicated in patients known to be hypersensitive to digoxin or other digitalis glycosides.

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