Low-dose sultamicillin oral suspension in the treatment of mild to moderate paediatric infections in Turkey.
A total of 101 children (47 males, 54 females; age range, 3 months-16 years) with mild to moderate upper or lower respiratory tract infections, or skin and soft tissue infections entered a clinical study conducted at two centres in Izmir, Turkey. The children received a mean daily dose of 25 mg/kg sultamicillin oral suspension administered as two equal doses approximately 12 h apart. In total, 100 children met all requirements for evaluability and were included in the clinical efficacy assessment, and 49 children were evaluated for bacteriological efficacy. Clinical cure was reported by the investigators in 93 patients, improvement in six and failure in only one. The bacteriological eradication rate of isolated pathogens was 100%. Of the 101 patients evaluated for drug safety, four experienced adverse drug-related or possibly drug-related reactions. All side-effects were gastro-intestinal and diarrhoea was reported in three patients. No discontinuation of therapy was reported, nor were any significant laboratory abnormalities recorded.
Raillard
P
P
Medical Operations, Pfizer International, New York.
Kose
G
G
Ozkan
H
H
Hasanoglu
A
A
Firat
S
S
Feiner
C
C
D000284:Administration, Oral; D000293:Adolescent; D000667:Ampicillin / Q000008:administration & dosage* / Q000009:adverse effects; D001424:Bacterial Infections / Q000188:drug therapy*; D002648:Child; D002675:Child, Preschool; D003240:Connective Tissue Diseases / Q000188:drug therapy; D004334:Drug Administration Schedule; D004359:Drug Therapy, Combination / Q000008:administration & dosage / Q000009:adverse effects; D005260:Female; D006801:Humans; D007223:Infant; D008297:Male; D012141:Respiratory Tract Infections / Q000188:drug therapy; D017192:Skin Diseases, Bacterial / Q000188:drug therapy; D013407:Sulbactam / Q000008:administration & dosage* / Q000009:adverse effects; D013535:Suspensions
D013535:Suspensions; C035444:sultamicillin; D000667:Ampicillin; D013407:Sulbactam