Abstract
S-6437 (Sustained release cephalexin granule for pediatric use) was studied with the following results:
1) Following the single oral administration of 25mg/kg of S-6437 in 6 children of 4-6 years old, the following blood levels (average) of cephalexin were obtained: 3.1μg/ml in one hour after the administration, 8.6 Eg/ml in 2 hours, 8.7 in 4. hours, 7.2 in 6 hours, 4.0 in 8 hours and 1.2 in 12 hours.
Effective blood levels of cephalexin by S-6437 were maintained for longer period of time than those by regular cephalexine dry syrup.
In 4 of 6 children receiving S-6437, cephalexin was scarcely detected in their blood in 12 hours after the administration. From this, it is not considered that S-6437 is accumulated in body.
2) S-6437 was administered to 38 patients including: 7 with pneumonia, 7 with acute bronchitis, 1 with suppurative lymphadenitis, 4 with acute pharyngitis, 15 with acute tonsillitis and 4 with acute urinary tract infections. Out of the 35 cases, 31 (88.6%) responded to S-6437, and 3 cases could not be evaluated.
3) Transient diarrhea in 2 patients, rash in 1 and elevation of serum GOT, GPT and LDH in 1 were observed. However, these side effects were improved by discontinuation of S-6437.
