CLINICAL USE

Treatment of type 2 diabetes in combination with metformin or a thiazolidinedione

DOSE IN NORMAL RENAL FUNCTION

100 mg once daily

PHARMACOKINETICS

  • Molecular weight                           :523.3 (as phosphate)
  • %Protein binding                           :38
  • %Excreted unchanged in urine     : 79
  • Volume of distribution (L/kg)       :198 litres
  • half-life – normal/ESRD (hrs)      :12.4/Probably increased

    DOSE IN RENAL IMPAIRMENT

    GFR (mL/MIN)

    30–50 50 mg once daily<30 25 mg once daily

    DOSE IN PATIENTS UNDERGOING RENAL REPLACEMENT THERAPIES

  • CAPD                :Not dialysed. Dose as in GFR>30 mL/min
  • HD                     :Not dialysed. Dose as in GFR>30 mL/min
  • HDF/high flux   :Dialysed. Dose as in GFR>30 mL/min
  • CAV/VVHD      :Unknown dialysability. Dose as in GFR>30 mL/min

    IMPORTANT DRUG INTERACTIONS

    Potentially hazardous interactions with other drugs

  • None known

    ADMINISTRATION

    Reconstition

    –

    Route

    Oral

    Rate of Administration

    –

    Comments

    –

    OTHER INFORMATION

    13.5% of dose is removed during a 3–4 hour haemodialysis sessionIn severe renal impairment (GFR<30 mL/min) the AUC was increased 4-fold50 mg and 25 mg tablets are only available in the USA at present.

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