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 litreshalf-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/minHDF/high flux   :Unlikely to be dialysed. Dose as in GFR <10 mL/minCAV/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
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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