Absorption of salicylate and bismuth from a bismuthsubsalicylate-containing compound (Pepto-Bismol)

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MANY OVER-THE COUNTER ANTIDIARRHEAL COMPOUNDS are commonly given to children with diarrhea in an attempt to alleviate symptoms. Bismuth subsalicylate has been an active ingredient in some products used for this purpose. It was thought that bismuth subsalicylate was not absorbed from the gastrointestinal tract; however, a study in adults 1 indicates that after hydrolysis of bismuth subsalicylate in the gastrointestinal tract, measurable concentrations of salicylate in serum are achieved. The purpose of this study was to evaluate the absorption of salicylate and bismuth following single and multiple oral doses of a bismuth subsalicylate-containing compound (Pepto-Bismol, NorwichEaton Pharmaceuticals) in children and adults. MATERIALS AND METHODS Patient selection. Two groups of volunteers were studied. Seven healthy male children (ages 6 to 7 years) received single or multiple doses of Pepto-Bismol according to label instructions; these children collected urine specimens and did not have blood drawn. Four healthy male adult volunteers (ages 32 to 37 years) ingested multiple does of PB and subsequently had blood specimens collected. The adults were used for the blood studies because of constraints on human experimentation in children. The studies were approved by the Committees for the Protection of Human Subjects at The University of Texas Medical School and the University of Houston. Children were enrolled after obtaining their assent and parental permission; adults gave their informed consent. All subjects had a history negative for aspirin sensitivity or bleeding disorders, were receiving no medications, and had received no~ aspirin or salicylate-containing compounds for at least seven days prior to study. Immediately before administration of PB, all children had urine tested for salicylate concentration.