Abstract
(PUD) is no longer a rare problem. Despite various claims for efficacy, there are few objective data available to support any treatment regimens for PUD. We are prospectively evaluating the safety, pharmacokinetics and therapeutic efficacy of R(R), a new H2 antagonist in the treatment of PUD. Nine children (C) (3.5-6.5yrs) who presented with complaints of epigastric pain (8), vomiting (8), nausea (7), hematemesis (3) and melena (1) have been studied. Six C had chronic complaints (>3 wks) and 2 C had a hx of recent ASA use. All C (5M:4F) had endoscopically proven ulcers (5 gastric, 2 pyloric, 2 duodenal). Therapy was designed to achieve gastric acid suppression and ulcer healing. After basal acid output (BAO) was determined a R infusion was given to achieve 90% suppression of BAO. Individual pharmacokinetics were determined and an effective serum concentration 22.6 ng/ml (9-65 ng/ml) was required to achieve 90% suppression. Once C were eating and placed on oral R, dosage was adjusted to account for individual differences in bioavailability. Weekly followup revealed no clinical, biochemical, hepatic or renal abnormalities. Eight C were asymptomatic within the first 3 wks of R therapy. One child has shown steady symptomatic improvement but nausea persists. Complete ulcer healing has been endoscopically documented after 6 wks of therapy. An oral dose of 0.5 mg/kg q 12h is effective in healing ulcers healing in C. R appears to be a safe and effective drug for the treatment of PUD.
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Rothstein, F., Reed, M., Kaplan, B. et al. PROSPECTIVE EVALUATION OF RANITIDINE (R) IN PEDIATRIC ULCER DISEASE (PUD). Pediatr Res 18 (Suppl 4), 210 (1984). https://doi.org/10.1203/00006450-198404001-00701
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DOI: https://doi.org/10.1203/00006450-198404001-00701