- Distribution System
Active ingredients: Diacerein
Producer: Trima Israel Pharmaceutical Products, Maabarot Ltd.
Capsule, Oral, Diacerein 50mg
Diacerein directly inhibits IL-1 synthesis and release in vitro and down modulate IL-1 induced activities and have been shown to posses disease modifying effect in experimental models of osteoarthritis and in human subjects with finger joint and knee osteoarthritis. IL-1 plays a fundamental role in osteoarthritis pathophysiology and cartilage destruction. IL-1 also promotes expression of inducible nitric oxide synthase, increase release of prostaglandin E2, IL-6,IL-8 in human osteoarthritis chondrocytes, which promote joint degradation. Hence, by inhibiting IL-1 diacerein retards all pathological prepossess initiated in OA. Diacerein also inhibits IL-1 induced expression of cartilage degrading enzymes. It also enhances expression of TGF BETA-1 and TGF BETA 2 thus favoring matrix synthesis and turnover in articular chondrocytes, thereby accounting for disease modifying property of diacerein.It also inhibits superoxide production, chemotaxis and phagocytic activity of neutrophils in addition to effect on macrophage migration and phagocytosis. In contrast to NSAIDS, diacerein does not inhibit synthesis of prostaglandins; hence no gastrointestinal toxicity has been observed with diacerein. It is also demonstrated to be involved in prevention of loss of hydroxyprolin and proteoglycans in the joint cartilage, an effect not observed with conventional NSAIDS or COX-2 inhibitors.
Symptomatic treatment of functional symptoms of osteoarthritis
As some patients may experience loose stools or diarrhea, the recommended starting dose is 50 mg once daily with evening meal for the first 2 to 4 weeks of treatment, after which the recommended daily dose is 50mg twice daily .
The treatment should be taken with food, one capsule with breakfast and the other capsule
with evening meal. The capsules must be swallowed intact, without opening them, together with a glass of water.
In patients older than 65 years, caution should be exercised during use of this medicine; close supervision and monitoring of adverse reactions should be performed.
In the elderly, and in moderate renal impairment, there is no need to change the dosage.
In severe renal insufficiency (creatinine clearance below 30 ml/min), the daily dosage are to be halved.
Inflammatory organic bowel disease (ulcerative colitis, Crohn’s disease).
• Intestinal obstruction or partial obstruction.
• Abdominal pain syndromes of indeterminate etiology.
• Known allergy to rhein (substance in the anthraquinone group) and substances with
• Known hypersensitivity to any excipient.
• Current and/or history of liver disease
Taking Diatrim can often cause to diarrhea and consequently increase the risk of hypokalemia and dehydration.
To reduce the risk of developing severe diarrhea:
- It is recommended to start treatment with a lower dosage of 50mg per day for the first 2-4 weeks of treatment with the medicine. After this period and when instructed by the doctor, the treatment dosage can be increased to 50mg twice a day (morning and evening)
- If you develop diarrhea, stop treatment with the medicine and refer to a doctor as soon as possible.
- If you are 65 years of age or older, be sure to more closely monitor side effects that may develop.
Osteoarthritis Adult: the recommended dose is 50 mg to be taken twice daily
The preparation is not intended for patients with liver disease or with a history of liver disease.