Open AccessOverview of the safety profile of clarithromycin suspension in pediatric patients
Author(s) -
J Carl Craft,
Nancy Siepman
Publication year - 1993
Publication title -
the pediatric infectious disease journal/the pediatric infectious disease journal
Language(s) - English
Resource type - Journals
SCImago Journal Rank - 1.028
H-Index - 140
eISSN - 1532-0987
pISSN - 0891-3668
DOI - 10.1097/00006454-199312003-00009
Subject(s) - clarithromycin , medicine , adverse effect , amoxicillin , cefaclor , diarrhea , vomiting , population , nausea , gastroenterology , antibiotics , cephalosporin , helicobacter pylori , microbiology and biotechnology , environmental health , biology
Results of preclinical studies conducted to characterize the safety of clarithromycin oral suspension in juvenile mice, rats and dogs as compared with that in adult animals indicate that there is no enhanced risk in younger animals. Adverse events in these preclinical studies mainly involved decreased body and increased liver and kidney weights. The safety profile of clarithromycin suspension also has been evaluated in Phase II (pharmacokinetic) and III (clinical) United States and international clinical trials conducted in pediatric patients. The most frequently reported adverse events occurring among the 1676 patients studied who received clarithromycin suspension in Phase III trials included diarrhea (7%), vomiting (6%), abdominal pain (2%), headache (2%) and nausea (1%). Adverse events were not serious and were usually rapidly reversible. Adverse event rates did not vary with sex or race. Overall adverse event rates were generally similar to those of comparator beta-lactam suspensions (i.e. amoxicillin, amoxicillin/clavulanate, penicillin VK, cefaclor, cefadroxil). With regard to specific gastrointestinal events, however, clarithromycin was better tolerated than amoxicillin/clavulanate whereas penicillin VK showed a lower incidence of gastrointestinal events. Overall clarithromycin oral suspension appears to be safe and well-tolerated, making it suitable for use in the pediatric population.