Why the study?
Does 1 mg digoxin in paediatric elixir increase peak plasma concentrations and absorption compared to 4 x 0.25 mg tablets in volunteers?
Does 1 mg digoxin in paediatric elixir increase peak plasma concentrations and absorption compared to 4 x 0.25 mg tablets in volunteers?
Digoxin absorption varies significantly between formulations and individuals, indicating that direct plasma concentration measurement is necessary to accurately assess digitalization rather than relying on dosage algorithms.
Formulation differences may alter digoxin exposure, warranting caution; leaves open whether plasma monitoring should replace dosage algorithms.
In a group of 8 volunteers, peak plasma digoxin concentrations and areas under 80-hour plasma concentration curves were significantly greater after 1 mg digoxin in paediatric elixir than after 4 0,25 mg tablets. Mean cumulative urinary excretion of digoxin over 12 days was 46.4 per cent after tablets, 53.6 per cent after elixir, and 70.8 per cent after intravenous injection. Mean percentage absorption was estimated to be 63 per cent from tablets and 75 per cent from elixir, but considerable between-subject variation was noted. Individual estimates of percentage absorption were significantly correlated with plasma concentrations in the steady state. Computer programmes to relate steady state plasma concentration to oral digoxin dosage take no account of absorptive capacity, are limited to gross approximations, and cannot replace determination of plasma concentration to assess the degree of digitalization.
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Johnson et al. (1975) studied this question.
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