Friday, November 20, 2015

Renal Dose Adjustment of Oral Unasyn

Availability:
  • Sultamicillin (Ampicillin and Sulbactam Prodrug) 375 mg
  • Unasyn syrup (250mg/5ml)
Adjustment:
  • Based on patient information leaflet, the dose of sultamicillin in sere impairment patients (<30ml/min) should be administered less frequently in accordance with usual practice for ampicilin
  • However no dose adjustment was given for product
Evidences:
  • Patients with renal failure who were administered parenteral doses of sulbactam plus ampicillin had increased plasma concentrations and delayed excretion of both drugs.
  • Single oral doses of sultamicillin (750mg) administered to 4 groups of 5 patients with varying degress of renal impairment produced similar results
  • Additionally, in a clinical trial of oral sultamicillin in 30 patients (mean age 62 years) with acute exacerbations of chronic bronchitis, increases in mean AUCs and prolonged half-lives for both sulbactam and ampicillin were seen
  • However, in these studies a dose of 750mg OD was used.
Recommendations
  • Patients with renal dysfunction should receive reduced dosages of sultamicillin in accordance with the usual practice for ampicillin
  • Based on these information, it is recommended to either reduce the dose or the interval of Unasyn for patients.
  • For patients undergoing haemodialysis, it is recommended for doses to be given after the haemodialysis
References:
  1. Drug Information leaflet
  2. https://www.medicines.org.uk/emc/medicine/26423
  3. Sultamicilin Drug Review

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