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