Table 4.
Measured pharmacokinetic parameters for pseudoephedrine in milk, and simulated average milk concentrations and infant doses
Volunteer | Cmax*(µg l–1) | tmax*(h) | t1/2*(h) | AUC(0,∞)*(µg l−1 h) | M : P*† | Cav(µg l−1)‡ | Absolute infant dose (µg kg−1 day−1) | Relative infant dose (%)‡ |
---|---|---|---|---|---|---|---|---|
1 | 679 | 1.3 | 3.9 | 3240 | 3.1 | 540 | 81 | 3.8 |
2 | 593 | 1.5 | 4.8 | 3639 | 1.5 | 607 | 91 | 3.2 |
3 | 496 | 2.0 | 4.5 | 3531 | 2.8 | 589 | 88 | 2.2 |
4 | 614 | 1.0 | 4.4 | 4518 | 2.5 | 753 | 113 | 4.3 |
5 | 750 | 1.0 | 7.2 | 6443 | 3.4 | 1074 | 161 | 4.8 |
6 | 682 | 3.1 | 5.8 | 5673 | 3.8 | 945 | 142 | 4.3 |
7 | 1003 | 1.4 | 6.9 | 7365 | 4.1 | 1227 | 184 | 6.7 |
8 | 767 | 2.5 | 4.5 | 5365 | 5.6 | 894 | 134 | 5.0 |
Mean (95% CI) | 698 (572, 824) | 1.7 (1.1, 2.3) | 5.3 (4.3, 6.3) | 4972 (3544, 6040) | 3.4 (2.4, 4.4) | 829 (621, 1038) | 124 (93, 155) | 4.3 (3.3, 5.4) |
Measured or calculated from the 60 mg single dose of pseudoephedrine HCl;
estimated from single paired milk and plasma samples 1 h after dose;
calculated at steady-state for a 60 mg dose of pseudoephedrine HCl given four times daily.