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 &nbsp &nbsp &nbsp &nbsp &nbsp &nbsp &nbsp &nbsp &nbsp &nbsp &nbsp &nbsp &nbsp :437.3

%Protein binding &nbsp &nbsp &nbsp &nbsp &nbsp &nbsp &nbsp &nbsp &nbsp &nbsp &nbsp &nbsp &nbsp :40 (similar to mesalazine), (NASA – 80%)

%Excreted unchanged in urine &nbsp &nbsp : 25 (as metabolites)

Volume of distribution (L/kg) &nbsp &nbsp &nbsp :No data

half-life – normal/ESRD (hrs)&nbsp &nbsp &nbsp :No data (T½ NASA = 6–9)

DOSE IN RENAL IMPAIRMENT

GFR (mL/MIN)

20 to 50 &nbsp &nbsp : Dose as in normal renal function

10 to 20 &nbsp &nbsp : Use with caution and only if necessary

<10 &nbsp &nbsp &nbsp &nbsp &nbsp : Start with low doses and monitor closely

DOSE IN PATIENTS UNDERGOING RENAL REPLACEMENT THERAPIES

CAPD &nbsp &nbsp &nbsp &nbsp &nbsp &nbsp &nbsp &nbsp:Unlikely to be dialysed. Dose as in GFR <10 mL/min

HD &nbsp &nbsp &nbsp &nbsp &nbsp &nbsp &nbsp &nbsp &nbsp &nbsp :Unlikely to be dialysed. Dose as in GFR <10 mL/min

HDF/high flux &nbsp :Unlikely to be dialysed. Dose as in GFR <10 mL/min

CAV/VVHD &nbsp &nbsp &nbsp:Unknown dialysability. Dose as in GFR 10 to 20 mL/min

IMPORTANT DRUG INTERACTIONS

Potentially hazardous interactions with other drugsNone known

ADMINISTRATION

Reconstition

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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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