Gliclazide

CLINICAL USE

Non-insulin dependent diabetes mellitus

DOSE IN NORMAL RENAL FUNCTION

Initially: 40–80 mg daily, with breakfast, adjusted according to response up to 160 mg as a single dose; higher doses should be divided; maximum 320 mg daily

PHARMACOKINETICS

Molecular weight :323.4

%Protein binding :Approx 95

%Excreted unchanged in urine : <5

Volume of distribution (L/kg) :0.24

half-life – normal/ESRD (hrs) :10–12 (MR: 12–20)/Prolonged

DOSE IN RENAL IMPAIRMENT

GFR (mL/MIN)

20 to 50 : Initially 20–40 mg daily. Use with caution and monitor

10 to 20 : Initially 20–40 mg daily. Use with caution and monitor

<10 : Initially 20–40 mg daily. Use with caution 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 :Unlikely to be dialysed. Dose as in GFR 10 to 20 mL/min

IMPORTANT DRUG INTERACTIONS

Potentially hazardous interactions with other drugs

Analgesics: effects enhanced by NSAIDs

Antibacterials: effects enhanced by chloramphenicol, sulphonamides, and trimethoprim; effect reduced by rifamycins

Anticoagulants: effect possibly enhanced by coumarins; also possibly changes to INR

Antifungals: concentration increased by fluconazole and miconazole and possibly voriconazole – avoid with miconazoleSulfinpyrazone: enhanced effect of sulphonylureas

ADMINISTRATION

Reconstition

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Route

Oral

Rate of Administration

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Comments

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OTHER INFORMATION

Care should be exercised in patients with hepatic and/or renal impairment, and a small starting dose should be used with careful patient monitoringCompany contraindicates prescribing of Diamicron in severe renal impairment, which they define as creatinine clearance below 40 mL/min.

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