Source: Medicines & Healthcare Products Regulatory Agency (GB) Revision Year: 2014 Publisher: Generics [UK] Limited t/a Mylan, Station Close, Potters Bar, Hertfordshire, EN6 1TL
Sulindac is a fluorinated indene with a structural resemblance to indometacin. It has analgesic, anti-inflammatory and antipyretic actions.
Sulindac is incompletely absorbed from the gastro-intestinal tract. It is metabolised by reversible reduction to the sulphide metabolite, which appears to be the biologically active form, and by irreversible oxidation to the sulphone metabolite. Peak plasma concentrations of the sulphide metabolite are achieved in about 2 to 4 hours. The mean half-life of sulindac is about 7 to 8 hours and of the sulphide metabolite about 16 to 18 hours. About 50% is excreted in the urine mainly as a sulphone metabolite and its glucuronide conjugate. Sulindac and its metabolites are also excreted in bile and undergo extensive enterohepatic circulation.
There are no preclinical safety data of relevance to the prescriber which are additional to that already included in other sections of the SmPC.
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