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Renal Impairment: In patients with mild-to-severe renal impairment, there was a significant increase in the area-under-the-curve and a decrease in the total apparent clearance compared to the healthy adults. Severe renal failure (creatinine clearance 10 to 27 milliliters/minute) showed a significantly decreased renal clearance of rhein, therefore, a 50% reduction in the dose of Diacerein should be made in patients with severe renal insufficiency.
Hepatic Impairment: No significant difference in pharmacokinetic parameters of rhein between patients with liver impairment and healthy volunteers was observed either in plasma or in urine assessments. However, since cirrhosis may influence drug accumulation after multiple doses, close clinical monitoring is advised for patients with hepatic insufficiency.
Use in Pregnancy: Use of Diacerein is not recommended in women attempting to conceive. No clinical data on exposed pregnancies are available for Diacerein. The potential for human risk in pregnancy is unknown.
Use in Lactation: Pharmacokinetics of Diacerein has not been studied in lactating women and its administration is not recommended.
Use in Children: Pharmacokinetics of Diacerein has not been studied in pediatric population and its administration is not recommended in pediatric population.
Use in the Elderly: Daily doses exceeding 100 milligrams may warrant close clinical monitoring in geriatric patients.
