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METOCLOPRAMIDE PHARMACODYNAMICS IN INFANTS

A pilot study of metoclopramide (M) pharmacodynamics (PD) was conducted in 6 infants (0.9-5.4 mo.; 3.2-5.4 kg) with gastroesophageal reflux (GER). M was administered P.O. at a dose of 0.15 mg/kg q6 hr. Esophageal pH was continuously recorded for 24 hr prior to M administration and for 6 hr. following the first (D1) and tenth (D10) dose. Serum M was quantitated by HPLC from repeated blood samples obtained over 24 and 6 hr following D1 and D10, respectively. A significant reduction in the number of GER episodes >5 min. duration was found between the pre-dose (3.33 ± 1.33) and D10 (0.0) evaluations. Similarly, the longest GER epidose with pH <4 was significantly reduced following D10 (1.88 ± 0.71 min) as compared to the pre-dose (18.33 ± 7.82 min.) evaluation. These findings were associated with a Cmax of 56.8 ± 10.5 ng/ml following D10 but were not correlated with the M serum concentration vs. time profile. Significant changes in the time that esophageal pH was <4 and acid clearance were not found when examined as a function of feeding time. Four of six infants showed marked clinical improvement (ie., reduction in choking spells and emesis volume) at the D10 evaluation. No adverse drug effects were noted in any of the infants. M in a dose of 0.15 mg/kg q6 hr appears to be effective in reducing the incidence and severity of GER in infants. This dose deserves further PD and pharmacokinetic evaluation.