Artrodar Special Precautions



TRB Chemedica




TRB Chemedica
Full Prescribing Info
Special Precautions
Severe renal insufficiency modifies the pharmacokinetics of diacerein and therefore a dose reduction is recommended in such cases (creatinine clearance <30 ml/min). In patients with moderate renal insufficiency (creatinine clearance 30-49 ml/min), no change in the usual recommended dose is necessary. When diacerein is taken with food, there is an increase (about 24%) in its absorption; on the other hand, severe nutritional deficiencies decrease the bioavailability of diacerein.
Intake of ARTRODAR may lead to loose stool and/or diarrhea at the start of treatment, however, these symptoms would disappear spontaneously with continuing treatment. Taking ARTRODAR with meals and starting treatment with 1 capsule/day can decrease these symptoms. However, if the patient still has unusually frequent liquid or watery stools, which could lead to dehydration and hypokalemia, treatment should be stopped and the patient should consult his/her physician. During the first 2-4 weeks of treatment, caution should be exercised in patients receiving diuretics, because dehydration and hypokalemia may occur. Particular caution should also be exercised in case of hypokalemia in patients treated with cardiac glycosides (digitoxin, digoxin).
Laxatives should not be taken concomitantly with ARTRODAR especially during the first 2-4 weeks of treatment.
Before treatment with ARTRODAR is initiated, the patient should be questioned about possible comorbid conditions and past or concurrent liver disease and screened for major causes of active hepatic disease. A diagnosis of severe liver disease is a contraindication to diacerein use. Signs of hepatic injury should be monitored and caution should be exercised when diacerein is used concomitantly with other medicinal products associated with hepatic injury.
Patients should be advised to limit their alcohol intake while on treatment with ARTRODAR. Treatment should be discontinued if symptoms suggestive of liver damage arise (abdominal pain, jaundice, pruritus, and increases in liver enzyme).
Use with caution in patients aged 65 years and above, or in patients with liver disease or history of liver disease.
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