Eravacycline

US prescribing information §2.1 (XERAVA for injection). No UK SPC was captured in this bundle, so this is US labelling and must be verified against the UK SPC. DURATION: 4 to 14 days for complicated intra-abdominal infection, guided by the severity and location of infection and the patient's clinical response. The dose is calculated on ACTUAL body weight (1 mg/kg actual body weight). SEVERE HEPATIC IMPAIRMENT (Child-Pugh C): 1 mg/kg every 12 hours on Day 1, then 1 mg/kg every 24 hours starting on Day 2, for a total duration of 4 to 14 days; no adjustment is warranted in mild to moderate hepatic impairment (Child-Pugh A and B). CONCOMITANT STRONG CYP3A INDUCER: 1.5 mg/kg every 12 hours for a total duration of 4 to 14 days; no adjustment is warranted with weak or moderate CYP3A inducers. ADMINISTRATION: for intravenous infusion only; each vial is single-dose; reconstituted vial content must be diluted within 1 hour or discarded; diluted solutions must be infused within 12 hours at room temperature or within 8 days if refrigerated at 2 to 8 degrees C; do not freeze. May be given through a dedicated line or a Y-site; if the same line is used for sequential infusions, flush before and after with 0.9% sodium chloride. XERAVA is compatible with 0.9% sodium chloride only and should not be mixed with other drugs or added to solutions containing other drugs. PAEDIATRIC: safety and effectiveness in paediatric patients have not been established, and because of tetracycline-class effects on tooth development and bone growth, use in paediatric patients less than 8 years of age is not recommended - verify any paediatric use against a children's formulary. ELDERLY: no overall differences in safety or efficacy were observed in patients 65 years and over, and no clinically relevant pharmacokinetic differences with respect to age.