Therapeutic efficacy and equivalence of tablet and syrup formulations of procaterol hydrochloride in childhood asthma.
It has been reported that albuterol syrup produces more improvement in pulmonary function and greater increases in heart rate than an equal dose of albuterol tablets in asthmatic children. Consequently, tablet and syrup formulations of a new beta 2-adrenergic drug, procaterol hydrochloride, were tested for efficacy and equivalence. The two formulations were compared after the first dose and after 1 week of double-blind treatment in 11 children. Statistical analyses indicated that there were few significant differences in the bronchodilating efficacy of the tablet and syrup formulations. Improvement in pulmonary function began within one-half hour postdose and continued until four to six hours postdose. Increases in heart rate were small. Adverse effects were similar for the two formulations. Five patients showed minimal electrocardiogram changes. Tremor, reported by four patients, was the only other adverse effect. In conclusion, the tablet and syrup formulations of procaterol hydrochloride were equivalent in bronchodilating efficacy and safety in childhood asthma.
Kemp
J P
JP
Welch
M J
MJ
Meltzer
E O
EO
Orgel
H A
HA
D000318:Adrenergic beta-Agonists / Q000008:administration & dosage* / Q000009:adverse effects / Q000627:therapeutic use; D001249:Asthma / Q000188:drug therapy* / Q000503:physiopathology; D001993:Bronchodilator Agents / Q000008:administration & dosage* / Q000009:adverse effects / Q000627:therapeutic use; D002648:Child; D004311:Double-Blind Method; D004334:Drug Administration Schedule; D004562:Electrocardiography; D004983:Ethanolamines / Q000008:administration & dosage* / Q000009:adverse effects / Q000627:therapeutic use; D005260:Female; D006801:Humans; D008297:Male; D017265:Procaterol; D012123:Pulmonary Ventilation; D012996:Solutions; D013607:Tablets; D013610:Tachycardia / Q000139:chemically induced; D014797:Vital Capacity
D000318:Adrenergic beta-Agonists; D001993:Bronchodilator Agents; D004983:Ethanolamines; D012996:Solutions; D013607:Tablets; D017265:Procaterol