Safety and Effectiveness of Onon Dry Syrup 10% (Pranlukast hydrate) in Children Aged Less Than 1 year with Bronchial Asthma

—Prospective Study—

Abstract

A Post-marketing surveillance study was carried out to investigate the safety and effectiveness of Onon Dry Syrup 10% (Pranlukast hydrate) in actual clinical settings in pediatric patients with bronchial asthma aged less than 1 year.
For the investigation, a prospective, central registry system was employed, and as a result, a total of 192 cases were collected from 93 medical institutions all over Japan. Among 184 patients included in the safety analysis population, no occurrence of adverse drug reaction was observed. Among 173 patients included in the efficacy analysis population, 159 showed improvement (improvement rate of 91.9%). The result of the analysis by patient background factors showed no special concern with the effectiveness of drug.
In conclusion, it was confirmed that Onon Dry Syrup is a highly safe and effective medication for bronchial asthma in infants aged less than 1 year.