Trade Name:
Diacerein
30 hard gelatin capsules
Composition:
Diacerein 50 mg
Properties:
Diacerein has a novel mode of action that differentiate it from other non-steroidal anti-inflammatory drugs and conventional therapies. Dacerein inhibits the stimulation of interleukin-t beta production and production of nitrous oxide. It also significantly reduces severity of pathological changes of osteoarthritis, increases the expression of transforming growth factor (TGF)-beta and TGF-beta 2 with potential cartilage repair properties. Diacerein does not alter renal or platelet cyclo-oxygenase activity and may therefore be tolerated by patients with prostaglandin-dependent renal function. Diacerein has moderate anti-inflammatory activity without an irritating effect on the stomach. Its action appears on the 30th day of treatment and is significant on the 45th day. The effect is advice in association with NSAIDs.
Indications.
Diacerein is indicated tor the treatment of knee and hip osteoarthritis.
Dosage and administration:
Diacerein 50 mg is to be administered orally 1 capsule in the middle of a meal with a glass of water twice daily for 2 to 4 weeks (tor adults over 15 years old).It is recommended to continue treatment for 6 months. The clinical studies have demonstrated that the drug can be used for 2 years without serious adverse effects.
Contraindications:
Hypersensitivity to diacerein or any of the product’s ingredients.
Side effects:
Generally diacerein is well tolerated. The most common adverse reaction was diarrhea. Few cases of abdominal pain have been reported. These adverse effects may be caused by dose adjustment. Other adverse effects are urine discoloration, rash and eczema.
Warnings and precautions:
- General antacid use may decrease diacerein absorption so t is advised to take antacids within an interval of two hours.
- Diacerein daily dose should be reduced by doctor in patients with severe renal insufficiency.
- Close clinical monitoring is advised for patients with hepatic insufficiency.
- •Patients with rare hereditary problems of galactose intolerance, the Lapp lactase deficiency or glucose-galactose malabsorption should inform their doctors about that before taking diacerein to avoid serious adverse reactions.
Pregnancy and lactation:
Pregnancy: It is rot recommended for use Diacerein in pregnancy.
Lactation: Pharmacokinetics of
Diacerein has not been studied in lactating women and its administration is not recommended.
Pediatric Use: Pharmacokinetics of Diaceren has not been studied in pediatric population and its administration is not recommended for children under 15 years.
Elderly:
Among the elderly. given the good tolerance of the product, it is not necessary to modify the dose, despite slower elimination.
Storage:s.
Keep in a cool dry place, at a temperature not exceeding 30°C.
Package.
Carton box holds 3 strips each of 10 hard gelatin capsules and paper instruction