小児におけるジゴキシン散の分包紙付着による血中濃度低下とその対応策

概要

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We investigated the degree of adhesion of a 0.01% digoxin powder (prepared by mixing a 0.1% digoxin powder with a lactose vehicle) to drug package paper, the effect of such adhesion on blood digoxin levels in children and measures to prevent it. The mean blood digoxin level after the administration of the 0.01 % powder was 41% of that after the administration of a digoxin elixir. This decrease was particularly notable in neonates and infants aged less than 1 year, so it was realized that the blood digoxin levels hoped for could not be obtained through administration of the 0.01% powder. The recovery rates of digoxin on removal of the 0.01% powder from the package were 36.4%±2.0% (0.2 g/package) and 56.8±3.5% (0.5g/package), but this increased to 76.2±2.3% for the 0.2g/package and 88.1±4.0% for the 0.5 g/package when a vitamin preparation was added to the 0.01% powder (DG-PVi). Following administration of DG-PV_1, the blood digoxin level obtained was better, achieving 68% of that for the elixir, and in this case, there was no particularly marked decrease in blood digoxin level for neonates or infants. These results suggest that preventing the adhesion of digoxin powder to drug package paper by the addition of a vitamin preparation is effeclive in obtaining stable blood digoxin levels.
日本医療薬学会の論文
2004-02-10