Mode of administration: ELORES (Ceftriaxone/Sulbactam 1.5 g/Vial Powder for Solution for Injection/Infusion) is to be administered intravenously after reconstitution, over a period of 30 minutes. The PK-PD simulation study done for ELORES on 30, 60 and 90 min infusions recommends 90 minutes infusion regimen for better clinical response in case of clinical isolate exhibiting intermediate sensitivity.
Diluents containing calcium (e.g. Ringer's solution or Hartmann's solution) must not be used to reconstitute ELORES 1.5 g/vial powder for infusion or to further dilute a reconstituted vial for IV administration because precipitates can form at higher calcium concentration. Therefore, ELORES and calcium-containing solutions must not be mixed or administered simultaneously.
Dosage and rate of administration should be determined by the severity of the infection, susceptibility of the causative organism and the patient's condition.
Adults (18 years and above): The usual adult daily dose is 1.5 g to 3 g every 24 hours or in two divided doses, which could be increased as per severity of infection (in severe septicemic cases) to a maximum dosage of 6 g per day in divided doses.
The duration of therapy varies according to the course of the disease. As with antibiotic therapy in general, administration of ELORES should be continued for a minimum of 48 to 72 hours after the patient has become afebrile or evidence of bacterial eradication has been obtained.
Elderly: These dosages do not require modification in elderly patients provided that renal and hepatic functions are satisfactory (see below).
Renal and hepatic impairment: In patients with impaired renal function, there is no need to reduce the dosage of ELORES. Only in cases of pre-terminal renal failure (creatinine clearance <10 ml per minute) should the daily dosage be limited to 3 g or less.
In patients with liver damage there is no need for the dosage to be reduced provided renal function is intact.
In severe renal impairment accompanied by hepatic insufficiency, the plasma concentration of ELORES should be determined at regular intervals and dosage adjusted.
In patients undergoing dialysis, no additional supplementary dosing is required following the dialysis. Serum concentrations should be monitored, however, to determine whether dosage adjustments are necessary, since the elimination rate in these patients may be reduced.
Duration of Therapy: The usual duration of ELORES treatment is from 5 to 14 days. In all conditions, the duration of therapy should be guided by the severity of the infection and the patient's clinical and bacteriological progress.