olsalazine sodium

CLINICAL USE

Induction and maintenance of remission in ulcerative colitis

DOSE IN NORMAL RENAL FUNCTION

1–3 g dailyMaintenance: 500 mg twice daily

PHARMACOKINETICS

Molecular weight :346.2

%Protein binding :>99

%Excreted unchanged in urine : 1–2

Volume of distribution (L/kg) :6 litres

half-life – normal/ESRD (hrs) :1/Unchanged

DOSE IN RENAL IMPAIRMENT

GFR (mL/MIN)

20 to 50 : Caution – use only if necessary; start with low dose and increase according to response

10 to 20 : Caution – use only if necessary; start with low dose and increase according to response

<10 : Caution – use only if necessary; start with low dose and increase according to response

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 drugs

None known

ADMINISTRATION

Reconstition

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Route

Oral

Rate of Administration

–

Comments

–

OTHER INFORMATION

Potential to be nephrotoxic due to 5–aminosalicylic acid (5-ASA) component. Both 5-ASA and its acetylated metabolite are rapidly excreted in the urineHalf-life of metabolite is 7 days Less than 3% of an oral dose is absorbed before the drug reaches the colonUnlikely that renal dysfunction will have any important effect on the kinetics of the drugManufacturers recommend that the use of olsalazine in patients with significant renal impairment is contraindicated due to lack of experience of its use in this patient population.

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