Drug interactions: No impairment of renal function has so far been observed after concurrent administration of large doses of Elores and potent diuretics (e.g. Furosemide).
No interference with the action or increase in nephrotoxicity of aminoglycosides has been observed during simultaneous administration with Ceftriaxone/disodium edetate/ sulbactam powder for infusion. Probenecid decreases the renal tubular secretion of sulbactam. Concurrent use of probenecid with ELORES may result in increased and prolonged blood levels of sulbactam.
In an in-vitro study antagonistic effects have been observed with the combination of chloramphenicol and ceftriaxone. The clinical relevance of this finding is unknown, but caution is advised if concurrent administration of ceftriaxone with chloramphenicol is proposed.
In patients treated with Ceftriaxone/Sulbactam 1.5 g/Vial Powder for Solution for Injection/Infusion, the Coombs' test may rarely become false-positive. Ceftriaxone/Sulbactam 1.5 g/Vial Powder for Solution for Injection/Infusion, like other antibiotics, may result in false-positive tests for galactosaemia. Likewise, non-enzymatic methods for glucose determination in urine may give false-positive results. For this reason, urine-glucose determination during therapy with Elores should be done enzymatically.
Ceftriaxone may adversely affect the efficacy of oral hormonal contraceptives. Consequently, it is advisable to use supplementary (non-hormonal) contraceptive measures during treatment and in the month following treatment.
Effects on ability to drive and use machines: Since ceftriaxone sometimes induces dizziness the ability to drive and use machines can be impaired with Elores.
Carcinogenesis, mutagenesis, Impairment of fertility: Long-term studies in animals have not been performed to evaluate carcinogenic or mutagenic potential. Ceftriaxone produced no impairment in fertility when given intravenously to rats at daily doses up to 586 mg/kg/day, approximately 20 times the recommended dose of 3 g/day of Elores.
Use in Pregnancy: Pregnancy Category B. For Ceftriaxone/Sulbactam 1.5 g/Vial Powder for Solution for Injection/Infusion, limited clinical data on Elores exposed pregnancies are available. Ceftriaxone crosses the placental barrier. Reproductive studies in animals have shown no evidence of embryotoxicity, foetotoxicity, teratogenicity or adverse effects on male or female fertility, birth or perinatal and postnatal development. In primates, no embryotoxicity or teratogenicity has been observed. Since safety in human pregnancy is not established, Elores should be used with caution.
Use in Lactation: Low concentrations of ceftriaxone and sulbactam are excreted in the milk; therefore, caution should be exercised when ELORES is administered to a nursing woman.
Use in Elderly: The pharmacokinetics of Elores were only minimally altered in geriatric patients compared to healthy adult subjects and dosage adjustments are not necessary for geriatric patients with Elores dosages up to 3 g/day.