Clinical studies on Ceftriaxone in the field of oral surgery

Abstract

1) Following 1-h i.v. drip infusion with Ceftriaxone (CTRX) at 33 mg/kg into NZW rabbits, the serum level remained high for a long period of time : The C_max was 67.761 mcg/ml and the T_1/2 4.189 h. The proportion of oral tissue level to serum level was 41 to 95% at the peak and 42 to 119% 10 h post-dose.
2) With administration of CTRX at 1 or 2 g once daily into 96 patients with osteitis or cellulitis of the jaw, both acute suppurative infections in the oral surgery field, the clinical efficacy rate was 86.8% (91/96) by judging the numerical rating on the 3rd day and 84.4% according to the evaluation by the doctor in charge.
3) Adverse reactions were observed in 3 patients (3%) . Drug administration was discontinued in 1 of the 3 due to nausea and fever which appeared immediately after the i.v. injection. In the other 2, natural remission was observed during the course of continued administration.
4) In clinical laboratory tests, abnormal parameter values were detected in 16% (12 patients) ; liver dysfunction suggested by an increase in transaminase, etc. in 10, an increase in BUN in 1 and an increase in eosinophils in 1.
5) CTRX is characterized by a broad antibacterial spectrum, long half-life, favourable tissue transfer and enough clinical efficacy with once-a-day dosing to enable outpatient treatment. When treating with the drug, however, patients should be carefully observed for liver function.