Diaflex capsules 50mg №10×3

Name:
Diaflex caps.50mg in bl. in pack No. 10×3
Description:
Hard gelatin capsules No. 1 of yellow color. The main active ingredient Diacerein Release form capsules Dosage 50 mg Special instructions If necessary, the simultaneous use of antibiotics, due to which the intestinal microflora may be disturbed, consideration should be given to temporarily stopping therapy. The risk/benefit ratio of treatment should be considered in patients with a history of enterocolitis (especially in patients with irritable bowel syndrome). The simultaneous use of food at the same time increases the bioavailability of diacerein (about 24%), while a significant deficiency in the diet reduces the bioavailability. Reception of diacerein in some cases leads to the development of diarrhea, which can cause dehydration and hypokalemia. If diarrhea develops, you should stop taking diacerein and contact your doctor immediately to discuss alternative treatment. Caution must be exercised if the patient is simultaneously receiving diuretics, as dehydration and hypokalemia may develop. Particular care should be taken with hypokalemia in patients receiving cardiac glycosides (digitoxin, digoxin). The simultaneous use of laxatives should be avoided. Attention should be given to patients with renal insufficiency. Safety and efficacy in pediatric practice have not been established. Use in children and adolescents is not recommended due to lack of data. The drug contains lactose, patients with rare hereditary problems of galactose intolerance, Lapp lactose deficiency or glucose-galactose malabsorption should not take this drug. In the course of post-registration monitoring, there were cases of increased activity of liver enzymes in the blood serum and symptomatic acute liver damage. Before starting treatment, the patient should be asked about concomitant, current and history of liver diseases, conduct an examination to identify violations of the functional state of the liver. Liver diseases are a contraindication to the use of diacerein. It is necessary to monitor laboratory and clinical manifestations of liver damage, take precautions when used simultaneously with other drugs with a characteristic risk of developing hepatotoxic reactions. Patients should be advised to limit their alcohol intake while taking diacerein. Treatment with diacerein should be discontinued if an increase in liver enzymes is detected or the development of symptoms of liver damage is suspected. The patient should be informed about the signs and symptoms of hepatotoxicity and advised to seek immediate medical attention if symptoms of liver disease are suspected. Pharmacological action Anti-inflammatory and antirheumatic drugs. Other non-steroidal anti-inflammatory drugs. ATX drug code M01AX21. Pharmacodynamics Diacerein is an anthraquinone derivative with anti-inflammatory activity. The use of diacerein in high doses as an anti-inflammatory agent does not have a toxic effect on the gastrointestinal tract. The action of diacerein is manifested by the 30th day of therapy, and by the 45th day the maximum effect is achieved. Diacerein may be used in combination with NSAIDs. In vitro studies, diacerein demonstrates the following properties: inhibition of phagocytosis and macrophage migration, inhibition of interleukin 1 synthesis, decrease in collagenolytic activity. Interleukin-1 beta (IL-1?) plays an important role in inflammation and destruction of articular cartilage as a trigger for the synthesis of many factors including cytokines, cyclooxygenase, prostaglandins, nitrous oxide, and metalloproteinases responsible for cartilage degradation, synovial inflammation, and subchondral bone remodeling. Diacerein has also been shown in in vitro models to stimulate the synthesis of proteoglycans, glycosaminoglycans, and hyaluronic acid. Studies in osteoarthritic animal models have shown that diacerein slows down the destruction of cartilage compared to controls. The effect of diacerein on joint space narrowing was studied in a three-year, multicenter, randomized, double-blind study (ECHODIAH) in 507 patients with osteoarthritis. The groups of patients who took 50 mg of diacerein in the morning and evening (n = 255) and those who took placebo (n = 252) were compared. The effectiveness of diacerein was evaluated according to the following criteria: the number of patients examined radiologically using MRI, in which joint space contraction was more than 0.5 mm, and the annual dynamics of joint space narrowing (narrowing mm / year) 269 patients completed the study, the following results of therapy were obtained in within 3 years: the progression of joint space narrowing of more than 0.5 mm per year in the diacerein group is significantly lower than in the placebo group; annual narrowing (0.39 mm/year) did not differ significantly in both groups. The clinical significance of these results in terms of prognosis is not known. Indications for use Symptomatic treatment of osteoarthritis of the hip and knee joints in the absence of the need to achieve a quick effect. It is not recommended for rapidly progressive osteoarthritis of the hip and knee joints due to the slow development of the clinical effect of the drug. Route of administration and doses The appointment of diacerein should be carried out by a specialist with experience in the treatment of osteoarthritis. Suggested Dose: One capsule twice daily with meals (morning and evening). Capsules should be swallowed whole and washed down with a glass of water. Because some patients may develop loose stools (diarrhea), it is recommended to start diacerein 50 mg once daily with evening meals for the first 2 to 4 weeks. Then it is possible to use 50 mg twice a day with food, once with a morning meal, the second with an evening meal. The therapeutic effect is observed after 2-4 weeks, a significant clinical improvement occurs after 4-6 weeks, the effect persists for about two months after treatment (the so-called “effect transfer”). As with any long-term treatment, blood tests, including liver enzymes and urinalysis, should be monitored every six months. Given the very good gastroduodenal tolerance, diacerein can be given during the first 2-4 weeks along with NSAIDs or analgesics. Diacerein is not recommended for patients over 65 years of age. Renal insufficiency In patients with moderate renal insufficiency (creatinine 30-49 ml / min), dosage changes are not required. In patients with severe renal insufficiency (creatinine clearance less than 30 ml / min), the dose is reduced by 50%. Elderly There is no need to adjust the dosage for elderly patients. Children and adolescents Use in children and adolescents is not recommended due to lack of data. Use during pregnancy and lactation There are no clinical data on the effect of diacerein during pregnancy. Animal studies do not indicate direct or indirect harmful effects during pregnancy, the fetus, childbirth or postpartum development. A small amount of diacerein derivatives is excreted in breast milk. The effect on the child or breastfeeding has not been determined. Diaflex should not be used by pregnant or lactating women. Precautions During post-registration monitoring, cases of increased activity of liver enzymes in the blood serum and symptomatic acute liver damage have been identified. Before starting treatment, the patient should be asked about concomitant, current and history of liver diseases, conduct an examination to identify violations of the functional state of the liver. Liver diseases are a contraindication to the use of diacerein. It is necessary to monitor laboratory and clinical manifestations of liver damage, take precautions when used simultaneously with other drugs with a risk of developing hepatotoxic reactions. Treatment with diacerein should be discontinued if an increase in liver enzymes is detected or the development of symptoms of liver damage is suspected. The patient should be informed about the signs and symptoms of hepatotoxicity and advised to seek immediate medical attention if symptoms of liver disease are suspected. Patients should be advised to limit their alcohol intake while taking diacerein. Use in Pediatrics The safety and efficacy of the drug in pediatric practice have not been established. The use of the drug in children and adolescents is not recommended due to lack of data. Influence on the ability to drive vehicles and control mechanisms Data on the effect of the drug on the ability to drive vehicles and control mechanisms are not provided. Interaction with other drugs Diacerein may cause diarrhea and hypokalemia. Caution should be exercised when used simultaneously with diuretics (loop and thiazide) and cardiac glycosides (digoxin, digitoxin) due to an increased risk of arrhythmias. Caution should be used in combination with diacerein antacids (salts, oxides and hydroxides of aluminum, calcium and magnesium), as they can reduce the gastrointestinal absorption of diacerein. Between taking Diaflex and antacids, it is desirable to observe an interval of more than 2 hours, if possible. Contraindications Hypersensitivity to diacerein, other anthraquinone drugs or auxiliary components of the drug, colopathy (ulcerative rectocolitis, Crohn’s disease), occlusive or subocclusive syndrome, abdominal pain syndromes for unknown reasons, current liver disease and liver disease in history, children under 15 years of age, pregnancy and lactation period. Be wary appoint patients with irritation of the lower intestine, with chronic renal failure. Composition One capsule contains: Active substance: diacerein 50 mg. Excipients: magnesium stearate, lactose monohydrate. The composition of the capsule shell: gelatin, titanium dioxide, yellow iron oxide. OverdoseSymptoms: diarrhea, weakness, impaired water and electrolyte balance. Treatment: gastric lavage, symptomatic therapy. Side effectGastrointestinal disorders Very often (> 1/10): diarrhea, abdominal pain. Often (>1/100 and 1<10): increased intestinal motility, flatulence. As a rule, with continued treatment, these phenomena weaken. There have been cases of severe diarrhea with dehydration and impaired water and electrolyte balance. Rarely, there is pigmentation of the colon mucosa (melanosis). Hepatobiliary disorders Uncommon (≥1/1000 and 1/100): increased activity of liver enzymes. Skin and subcutaneous tissue disorders Common (>1/100 and 1<10): itching, rash, eczema. Post-marketing observations Hepatobiliary disorders In the post-registration period of observation, cases of acute liver damage were identified, including an increase in the activity of liver enzymes and the development of hepatitis. Most cases were recorded within the first month of using diacerein. It is necessary to ensure the monitoring of the condition of patients for the early detection of symptoms of liver damage. Storage conditions In a place protected from moisture and light at a temperature not exceeding 25 ° C. Keep out of the reach of children. Buy Diaflex capsules 50mg No. 10x3 Price for Diaflex capsules 50mg No. 10x3