Balsalazide sodium

CLINICAL USE

Treatment, and maintenance of remission, in mild to moderate ulcerative colitis

DOSE IN NORMAL RENAL FUNCTION

Acute treatment: 2.25 g, 3 times a dayMaintenance: 1.5 g twice daily, maximum 6 g/day

PHARMACOKINETICS

  • Molecular weight                           :437.3
  • %Protein binding                           :40 (similar to mesalazine), (NASA – 80%)
  • %Excreted unchanged in urine     : 25 (as metabolites)
  • Volume of distribution (L/kg)       :No data
  • half-life – normal/ESRD (hrs)      :No data (T½ NASA = 6–9)

    DOSE IN RENAL IMPAIRMENT

    GFR (mL/MIN)

  • 20 to 50     : Dose as in normal renal function
  • 10 to 20     : Use with caution and only if necessary
  • <10           : Start with low doses and monitor closely

    DOSE IN PATIENTS UNDERGOING RENAL REPLACEMENT THERAPIES

  • CAPD                :Unlikely to be dialysed. Dose as in GFR <10 mL/min
  • HD                     :Unlikely to be dialysed. Dose as in GFR <10 mL/min
  • HDF/high flux   :Unlikely to be dialysed. Dose as in GFR <10 mL/min
  • CAV/VVHD      :Unknown dialysability. Dose as in GFR 10 to 20 mL/min

    IMPORTANT DRUG INTERACTIONS

    Potentially hazardous interactions with other drugsNone known

    ADMINISTRATION

    Reconstition

    Route

    Oral

    Rate of Administration

    Comments

    OTHER INFORMATION

  • Balsalazide is a prodrug of mesalazine (5-amino-salicylic acid)
  • Mesalazine is best avoided in patients with established renal impairment, but if necessary should be used with caution and the patient carefully monitored
  • Serious blood dyscrasias have been reported with mesalazine – monitor full blood count closely
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