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In many cases, pharmaceutical manufacturers do not embark on lenghty licencing procedures for pediatric medications. Therefore, formulations and dosages suitable for children are often not available, and even medications that have been approved for pediatric use sometimes lack the information and tools required for correct usage. Therefore, choosing a suitable medication that allows for individual dosing, taking into account physiological peculiarities, providing appropriate tools and comprehensive information for parents and/or nursing staff is vital to the success of drug treatments in pediatric patients.

Objective: To report adverse effects in a newborn infant whose mother had been treated with doxepin during pregnancy and while breast-feeding., Case Summary: The nine-day-old white boy was admitted because of poor sucking and swallowing, with muscle hypotonia and vomiting. He was drowsy and had lost 150 g. At the time of admission, he was breast-fed by his mother who was being treated with doxepin 35 mg/d. Samples of plasma and breast milk were taken and analyzed by HPLC and fluorescence polarization immunoassay. The amount of doxepin and N-desmethyldoxepin (DDP) ingested via breast-feeding was approximately 10-20 micrograms/kg/d (i.e., only 2.5% of the weight-adjusted dose of the mother). Doxepin was detectable in small amounts in the infant's plasma (approximately 10 micrograms/L); DDP was below the lower limit of detection of 10 micrograms/L. All adverse effects subsided within 48 hours after breast-feeding was stopped., Discussion: Despite the small doses of doxepin and its active metabolite ingested by breast-fed babies, there is a risk of accumulation and resultant adverse effects. In newborns, the metabolic activity is considerably decreased and may be further reduced by hyperbilirubinemia., Conclusions: Available data suggest that women treated with doxepin should breast-feed their infants with great caution, if at all, although much larger databases are needed to confirm this.

Objective: To compare the serum concentrations attained following intravenous and oral administration of phenytoin in premature neonates., Design: A prospective, uncontrolled study was conducted over 6 years. Phenhydan concentrate for infusion (Desitin, Hamburg, Germany) was used for intravenous infusion, and Epanutin suspension (Parke-Davis, Freiburg, Germany) was used for oral therapy. Blood samples were analyzed by using a fluorescence polarization immunoassay analyzer TDx model by Abbott Laboratories., Setting: A university-affiliated district hospital., Participants: Twenty premature neonates who were administered intravenous and/or oral phenytoin between February 1991 and February 1997., Main Outcome Measures: Serum phenytoin concentrations on intravenous and oral phenytoin., Results: Nine patients received intravenous (group A) and 15 patients received oral (group B) therapy. Mean +/- SD postnatal age (41 +/- 8.7 vs. 48 +/- 17 d; p = 0.03) and actual body weight (1.56 +/- 0.38 vs. 1.88 +/- 0.75 kg; p = 0.02) were slightly higher in group B. There were no significant differences between the groups in mean +/- SD gestational age (26.1 +/- 1.37 vs. 26.9 +/- 3.30 wk), 5-minute Apgar score (8.7 +/- 1.11 vs. 7.7 +/- 2.26), daily dosage (8.1 +/- 3.86 vs. 8.1 +/- 4.21 mg/kg/d), and phenytoin serum concentration (8.7 +/- 7.36 vs. 9.6 +/- 5.83 micrograms/mL)., Conclusions: Contrary to data in the current literature, reliable serum concentrations in premature neonates were achieved by oral administration of phenytoin suspension. Oral therapy offers a number of advantages and considerably reduces the cost of therapy. Due to substantial variations in phenytoin pharmacokinetics in neonates, close monitoring of serum concentrations is required. Further investigation is required to confirm these results, especially in neonates younger than 20 days' postnatal age and those receiving products other than Epanutin.