Artoxan-Reb pills p/o 20mg №10×1

Name:
Artoxan-reb tablets. Forms of release Tablets. MNNtenoxicam.
Description:
: Film-coated tablets, yellow, round, biconvex. Composition 1 coated tablet contains: active substance: tenoxicam – 20.0 mg; excipients: lactose monohydrate, corn starch 1500, partially pregelatinized, talc, magnesium stearate. Shell composition: polyvinyl alcohol, partially hydrolysed, titanium dioxide (E171), macrogol/polyethylene glycol, talc, iron oxide yellow (E172), tartrazine (E102), orange yellow S / Sunset FCF (E110). Pharmacotherapeutic groupNon-steroidal anti-inflammatory and antirheumatic drugs. Oxycams. ATC code: M01AC02 Pharmacological properties Pharmacodynamics Artoxan-Reb is a non-steroidal anti-inflammatory drug (NSAID) that has analgesic, anti-inflammatory, antipyretic effects, and also inhibits platelet aggregation. Tenoxicam reduces prostaglandin biosynthesis by inhibiting cyclooxygenase 1 (COX 1) and cyclooxygenase 2 (COX 2), which has been demonstrated both in vitro (sheep seminal gland) and in vivo (protection of mice from arachidonic acid-induced toxicity). In vitro studies of cyclooxygenase isoenzymes derived from human COS7 cells have shown that tenoxicam inhibits cyclooxygenase 1 (COX 1) and cyclooxygenase 2 (COX 2), approximately equally, i.e. the ratio of COX 1 / COX 2 is 1 ,34. In vitro studies of leukocyte peroxidase suggest that tenoxicam may act as an active oxygen scavenger at the site of inflammation. Artoxan-Reb is a potent in vitro inhibitor of human metalloproteases (stromelysin and collagenase), which cause cartilage destruction. Another possible mechanism of action is a decrease in nitrite levels, indicating an alteration in nitric oxide (NO) metabolic pathways. These pharmacological effects explain, at least in part, the therapeutic effect of Artoxan-Reb in the treatment of painful inflammatory and degenerative diseases of the musculoskeletal system. Pharmacokinetics Tenoxicam has a long-term effect, a single daily dose is effective. Absorption Tenoxicam is rapidly and completely absorbed in unchanged form after oral administration. Reception simultaneously with food reduces the rate, but does not affect the amount of absorption of tenoxicam. At the recommended dose of 20 mg once daily, steady-state plasma concentrations are reached within 10 to 15 days with no unexpected accumulation. The mean steady-state concentration is 11 mg/L with tenoxicam 20 mg orally once daily, and the concentration does not change even after treatment for up to 4 years. As expected, plasma concentrations at steady state were 6 times higher than after a single dose. The pharmacokinetics of tenoxicam is linear in the studied dose range from 10 to 100 mg. Distribution Tenoxicam penetrates well into the synovial fluid, achieving concentrations approximately half that in plasma. In the blood, more than 99% of tenoxicam binds to albumin. Metabolism and excretion Tenoxicam is excreted primarily by the metabolic route. About 2/3 of the administered dose is excreted in the urine (mainly in the form of an inactive 5-hydroxypyridyl metabolite), and the rest in the bile (most in the form of a glucuronic conjugate of the hydroxymetabolite). Less than 1% of the administered dose is excreted in the urine as unchanged tenoxicam. The mean half-life of tenoxicam is approximately 72 hours (range 59 to 74 hours). The total plasma clearance is 2 ml/min. Pharmacokinetics in different groups of patients No age-related changes in the pharmacokinetics of tenoxicam have been found, although individual variability is usually greater in the elderly. Differences in the pharmacokinetics of tenoxicam have not been established, despite individual changes in the tendency to increase these characteristics in older patients. Studies in the elderly and patients with renal insufficiency or liver cirrhosis confirm that there is no need for dose adjustment to achieve similar plasma concentrations observed in healthy patients. Elderly patients with rheumatic diseases show the same kinetic profile as healthy volunteers. Due to the high degree of binding of tenoxicam to plasma proteins, care must be taken with a marked decrease in plasma albumin levels (see section “Precautions”). Indications for use Artoxan-Reb is indicated for the relief of pain and inflammation in osteoarthritis and rheumatoid arthritis. Artoxan-Reb is also used for short-term treatment of acute diseases of the musculoskeletal system, including sprains, dislocations and other soft tissue injuries. Method of application and dosage Adult patients. The recommended dose is 20 mg per day. It is desirable to take at the same time every day during or after meals, drinking plenty of fluids. Higher doses should not be used, since this does not always achieve a significantly more pronounced therapeutic effect, and the risk of adverse events increases. Undesirable effects can be minimized by using the smallest effective dose for the shortest possible time. Duration of therapy. Treatment of acute disorders of the musculoskeletal system usually does not exceed 7 days. In exceptional cases, the duration of therapy may be extended up to 14 days. At sufficiently low concentrations of albumin in the blood plasma (for example, nephrotic syndrome) or at high concentrations of bilirubin, use with caution, due to the high affinity of tenoxicam for plasma proteins. Elderly patients. Prescribe with caution, because against the background of concomitant treatment or impaired renal, hepatic or cardiovascular system, the likelihood of side effects increases compared with younger patients. During the treatment of NSAIDs, it is necessary to regularly monitor patients for gastrointestinal bleeding. Children. There is insufficient information on the use of tenoxicam in children. Patients with impaired renal and hepatic function. Tenoxicam may be used with caution in patients with mild to moderate renal and hepatic impairment (see Precautions section). Due to the high level of plasma protein binding to tenoxicam, caution should be exercised with a significant decrease in plasma albumin concentrations (for example, with nephrotic syndrome) or with high levels of bilirubin. Available information is insufficient to provide dosage recommendations for tenoxicam in patients with pre-existing hepatic impairment. Tenoxicam is contraindicated in severe renal (creatinine clearance < 30 ml / min) and liver failure (see section "Contraindications"). Side effects Artoxan-Reb is usually well tolerated, most side effects are short-term and disappear without stopping treatment. Adverse reactions are classified according to the frequency of occurrence: very often (≥ 1/10), often (≥ 1/100, < 1/10), infrequently (≥ 1/1000, < 1/100), rarely (≥ 1/10,000, < 1/1000), very rare (< 1/10 000) and the frequency is unknown (the frequency cannot be established from the available data). On the part of the blood and lymphatic system: the frequency is unknown - agranulocytosis, anemia, aplastic and hemolytic anemia, thrombocytopenia, leukopenia, non-thrombocytopenic purpura, eosinophilia. From the immune system: the frequency is unknown - allergic reactions, such as asthma attacks, anaphylactic reactions, Quincke's edema. From the digestive system: very often - dyspepsia, nausea, vomiting, pain and discomfort in the abdomen, constipation, diarrhea, flatulence, indigestion, discomfort in the epigastric region, stomatitis; often - gastrointestinal bleeding, ulceration or perforation, peptic ulcer, sometimes fatal, especially in elderly patients, vomiting with blood, melena, constipation, diarrhea, gastritis, dry mouth, ulcerative stomatitis, exacerbation of colitis and Crohn's disease; very rarely - pancreatitis. From the side of the liver and biliary tract: infrequently - an increase in the level of liver enzymes; frequency unknown - jaundice, hepatitis. From the side of metabolism: often - anorexia; rarely - metabolic disorders (for example, weight loss or increase, hyperglycemia.) From the nervous system: often - headache, dizziness; frequency unknown - paresthesia, drowsiness. Mental disorders: rarely - a violation (for example, asomnia), depression, psychomotor hyperactivity / agitation, anxiety reactions; frequency unknown - hallucinations, confusion. On the part of the organs of hearing and balance: rarely - vertigo; frequency unknown - ringing in the ears. On the part of the organs of vision: the frequency is unknown - visual disturbances (decrease in visual acuity and clarity), swelling of the eyes, blurred vision, eye irritation. From the side of the cardiovascular system: rarely - palpitations, thrombotic events (for example, myocardial infarction or stroke); frequency unknown - heart failure, vasculitis, hypertension. On the part of the respiratory system, chest and mediastinum: rarely - bronchospasm, asthma in exacerbation, shortness of breath; frequency unknown - nosebleeds. On the part of the skin and soft tissues: infrequently - erythema, itching, exanthema, rash, urticaria; rarely - vesiculo-bullous reactions; very rarely - severe skin adverse reactions: Stevens-Johnson syndrome and toxic epidermal necrolysis; frequency unknown - photosensitive reactions. On the part of the reproductive system and mammary gland: cases of female infertility due to inhibition of the synthesis of cyclooxygenase / prostaglandin by tenoxicam. From the side of the kidneys and urinary tract: infrequently - an increase in the level of urea or the content of creatinine in the blood; frequency unknown - nephrotoxicity (for example, interstitial nephritis, nephrotic syndrome and renal failure, increased levels of urea or blood creatinine). General disorders and local reactions: infrequently - fatigue, swelling; frequency unknown - a feeling of general malaise. You should consult a doctor if you experience the above adverse reactions, as well as reactions not listed in this leaflet. Contraindications hypersensitivity to the active substance or any of the auxiliary components; a history of gastrointestinal bleeding or perforation associated with previous cases of NSAID treatment, as well as cases of symptoms of asthma, rhinitis or urticaria when taking aspirin or other non-steroidal anti-inflammatory drugs (there is a possibility of cross-sensitivity with acetylsalicylic acid or other non-steroidal anti-inflammatory drugs); active peptic ulcer/bleeding or a history of recurrent ulcer/bleeding (two or more separate episodes of proven ulceration or bleeding); severe gastritis, inflammatory bowel disease such as Crohn's disease, ulcerative colitis; severe heart failure (NYHA III-IV stage), condition after coronary artery bypass grafting; severe renal or hepatic insufficiency; blood diseases; pregnancy and lactation (see subsections "Pregnancy", "Lactation"); childhood. Precautions Do not use Artoxan-Reb with other NSAIDs, including selective ooxygenase-2 cycle inhibitors. Undesirable effects can be minimized by using the lowest effective dose for the minimum period of time. This medicinal product contains lactose and should not be used in patients with rare hereditary problems of galactose intolerance, the Lapp lactase deficiency, or glucose-galactose malabsorption. Due to the presence of azo dyes, Artoxan-Reb can cause allergic reactions. Cardiovascular and cerebrovascular effects Appropriate monitoring and counseling of patients with hypertension and/or mild to moderate congestive heart failure is recommended, as fluid retention and edema have been reported with NSAIDs. The results of clinical studies and epidemiological data indicate that the use of some NSAIDs (especially at high doses and long-term treatment) may be associated with a slight increase in the risk of arterial thrombotic events (for example, myocardial infarction or stroke). Available data are insufficient to rule out such a risk with tenoxicam. Therefore, long-term treatment with tenoxicam in patients with risk factors for cardiovascular disease, as well as patients with uncontrolled hypertension, congestive heart failure, established coronary heart disease, peripheral arterial disease and / or cerebrovascular disease is possible only after careful consideration of the case. Similar recommendations should be taken into account before starting long-term treatment in patients with risk factors for cardiovascular disease (such as arterial hypertension, hyperlipidemia, diabetes mellitus, smoking). Renal and hepatic insufficiency The use of NSAIDs can cause a dose-dependent decrease in the formation of prostaglandin and the occurrence of provoked renal failure. Patients taking diuretics and the elderly are at greater risk of this reaction. Such patients are monitored for renal function. Isolated cases of elevated serum transaminase levels or other indicators of liver function have been reported. In most cases, data exceeding the normal range of values were weak and transient. With a significant or persistent deviation, the use of the drug Artoxan-Reb should be discontinued and repeated tests should be carried out. Special care must be taken when treating patients with existing liver disease. In rare cases, NSAIDs can cause interstitial nephritis, glomerulonephritis, papillary necrosis, and nephrotic syndrome. Such substances inhibit the synthesis of renal prostaglandin, which plays an auxiliary role in maintaining renal perfusion in patients with reduced blood flow and blood volume. The use of NSAIDs in these patients can cause clinical renal decompensation with a return to the state observed before the start of therapy, after discontinuation of treatment. Patients with existing kidney disease (including patients with diabetes and impaired renal function), nephrotic syndrome, increased interstitial fluid volume, liver disease, heart failure, as well as patients undergoing concomitant treatment with diuretics or potentially nephrotoxic agents are at greatest risk of such a reaction. In such patients, close monitoring of renal, hepatic, and cardiac function should be established. The applied dosage should be minimal. Dermatological effects Serious skin reactions, including exfoliative dermatitis, Stevens-Johnson syndrome and toxic epidermal necrolysis, have been very rarely reported with NSAIDs. The risk of developing such reactions is highest at the beginning of treatment: the first manifestation was noted during the first month of therapy. At the first sign of a skin rash, mucosal lesions or other signs of hypersensitivity, the drug should be discontinued. Elderly Patients Elderly patients have an increased incidence of adverse reactions to NSAIDs, especially gastrointestinal bleeding and perforation. Special care should be taken and regular monitoring of elderly patients should be carried out to detect possible interactions with concomitant drugs and to monitor the functions of the kidneys, liver and cardiovascular system, which may be affected by NSAIDs. Impaired fertility in women The use of the drug may impair the fertility of women, so its use is not recommended for women planning pregnancy. Gastrointestinal bleeding, ulceration and perforation Care must be taken when using NSAIDs in patients with a history of gastrointestinal disease. Gastrointestinal bleeding, ulceration and perforation have been reported with all NSAIDs at any time during the treatment period with or without warning symptoms or previous serious gastrointestinal events. The risk of gastrointestinal bleeding, ulceration or perforation increases with increasing doses of NSAIDs in patients with a history of ulcer, especially complicated by bleeding or perforation, and in elderly patients. Treatment of such patients should begin with the lowest possible dose. For such patients, treatment in combination with protective agents (eg, misoprostol or proton pump inhibitors) should be considered, as for patients taking concomitant low-dose aspirin or other drugs that may increase the risk of gastrointestinal damage. Patients with a history of gastrointestinal toxicity, especially elderly patients, should report unusual abdominal symptoms (particularly gastrointestinal bleeding), especially during the initial stages of treatment. Caution must be exercised when treating patients concomitantly taking drugs that can increase the risk of ulcers or bleeding, which include corticosteroids, anticoagulants (such as warfarin), selective serotonin reuptake inhibitors or antiplatelet agents (such as aspirin). Patients taking tenoxicam and presenting with gastrointestinal symptoms should be closely monitored. If a peptic ulcer or gastrointestinal bleeding occurs, the drug should be discontinued immediately. The use of NSAIDs in patients with gastrointestinal diseases (ulcerative colitis, Crohn's disease) can cause an exacerbation of the disease (see section "Contraindications"). Hematological effect Tenoxicam reduces platelet aggregation and may increase bleeding time. This should be taken into account when treating patients undergoing major surgery (eg, joint replacement) and if bleeding time needs to be determined. Ophthalmological effects Adverse ocular effects have been reported with the use of NSAIDs. For this reason, patients who experience visual impairment during treatment with tenoxicam should undergo an ophthalmological examination. Respiratory disorders Caution should be exercised in the treatment of patients with or with a history of asthma, as NSAIDs have been reported to cause bronchospasm in such patients. Antipyretic Effect As with other anti-inflammatory drugs, Artoxan-Reb may mask the usual signs of infection. Laboratory tests NSAIDs inhibit the synthesis of prostaglandins in the kidneys and, as a result, may have an undesirable effect on renal hemodynamics and on the water-salt balance. When prescribing tenoxicam, it is necessary to properly monitor the condition, especially kidney and heart function (blood urea nitrogen, creatinine, edema development, weight gain, etc.), in patients with risk factors for developing renal failure, such as previous kidney disease, impaired renal function in patients with diabetes mellitus, cirrhosis of the liver, chronic heart failure, dehydration, or concomitant treatment with potentially nephrotoxic drugs, diuretics, and corticosteroids. These groups of patients are at particular risk in the peri- and postoperative periods during major surgery due to the possibility of severe blood loss. Therefore, they require careful monitoring in the postoperative and recovery periods. Due to the high degree of binding of tenoxicam to plasma proteins, care must be taken with a significant decrease in plasma albumin concentrations. Systemic lupus erythematosus and mixed connective tissue disease Patients with systemic lupus erythematosus and mixed connective tissue diseases may be at increased risk of developing aseptic meningitis. Influence on the ability to drive vehicles and work with mechanisms Patients experiencing adverse reactions such as vertigo, dizziness, drowsiness, fatigue or visual impairment should refrain from driving a car or operating mechanisms. Pregnancy The safety of the use of the drug Artoxan-Reb during pregnancy and lactation has not been established, for this reason, the use of the drug during pregnancy and lactation is not recommended. Congenital anomalies caused by the use of NSAIDs in humans have been reported, but their frequency is low, and a definite pattern of their occurrence has not been found. Due to the known effects of NSAIDs on the fetal cardiovascular system (risk of closure of the ductus arteriosus), the use of NSAIDs in the third trimester of pregnancy is contraindicated. The onset of labor may be delayed, and their duration may increase; there is also a trend towards increased bleeding in the mother and child. The use of NSAIDs in the first two trimesters of pregnancy and during childbirth is possible only in cases where the potential benefit to the patient outweighs the potential risk to the fetus. Lactation In the course of studies, the number of which to date is small, it has been found that NSAIDs pass into breast milk in very low concentrations. If possible, the use of NSAIDs should be avoided during breastfeeding. Although there is no evidence of adverse reactions, if tenoxicam is strictly necessary for a breastfeeding woman, breastfeeding should be discontinued. Overdose Symptoms Symptoms of an NSAID overdose typically include nausea, vomiting, epigastric pain, rarely diarrhea, gastrointestinal bleeding, tinnitus, headache, blurred vision, and dizziness. There have been isolated cases of more serious toxicity after ingestion of the drug at an increased dose; they include convulsions, irritation, drowsiness with hypotension, dyspnea, coma with electrolyte imbalance, and renal failure. A possible effect is an exacerbation of asthma. Treatment Treatment is symptomatic. In case of an overdose, you should stop taking the drug, may be prescribed: gastric lavage, ingestion of activated charcoal, antacids, proton pump inhibitors. The use of activated charcoal can only be considered within one hour of taking an overdose of the drug. There are no specific antidotes. The effectiveness of gastric lavage is not clear. Dialysis does not completely remove NSAIDs from the bloodstream. A good diuresis must be ensured to maintain the desired level of hydration. The function of the liver and kidneys should be carefully monitored. It is necessary to monitor patients for at least four hours after ingestion of the drug at an increased dose. Frequent and prolonged convulsions should be treated with intravenous diazepam. Other measures may be taken depending on the clinical condition of the patients. Interaction with other drugs Other analgesics, including selective cyclooxygenase-2 inhibitors The simultaneous use of two or more NSAIDs (including aspirin) should be avoided, as this may increase the risk of unwanted side effects. Acetylsalicylic acid and salicylates Salicylates are able to replace protein-bound tenoxicam, thereby increasing the clearance and volume of distribution of tenoxicam. The simultaneous use of salicylates with the drug Artoxan-Reb should be avoided, as this may increase the risk of unwanted side effects (mainly gastrointestinal). Antacids and H2-receptor antagonists Antacids may reduce the rate, but not the extent, of tenoxicam absorption. These differences are not of clinical significance. With the parallel use of cimetidine, no interactions were observed. Anticoagulants Tenoxicam is highly bound to serum albumin and, like all NSAIDs, may enhance the anticoagulant effect of warfarin and other anticoagulants. Careful monitoring of the effects of anticoagulants and oral glycemic agents is recommended, especially during the initial stages of treatment with Artoxan-Reb. Interaction with digoxin was not observed. In healthy subjects, no clinically significant interaction was observed between tenoxicam and low molecular weight heparin. Oral antidiabetic agents Tenoxicam does not significantly affect the clinical effect of the oral antidiabetic agents glibornuride, glibenclamide, tolbutamide. However, as with other NSAIDs, careful monitoring of patients is recommended while taking oral antidiabetic agents. Cholestyramine Cholestyramine may increase the clearance and decrease the half-life of tenoxicam. Dextromethorphan Concomitant use of tenoxicam and dextromethorphan may increase the analgesic effect compared to monotherapy. Antiplatelet agents and selective serotonin reuptake inhibitors (SSRIs) When used simultaneously with NSAIDs, the risk of gastrointestinal bleeding increases. Antihypertensive agents Tenoxicam and other NSAIDs may reduce the effect of antihypertensive agents. Cardiac glycosides NSAIDs can exacerbate heart failure, reduce glomerular filtration rate and increase the level of cardiac glycosides in blood plasma when used in parallel. Cyclosporine As with other NSAIDs, caution should be exercised when taking cyclosporine concomitantly, as this increases the risk of nephrotoxicity. Corticosteroids As with other NSAIDs, caution should be exercised when taking corticosteroids concomitantly, as this increases the risk of ulcers or gastrointestinal bleeding. Diuretics The effect of diuretics is reduced. NSAIDs can cause sodium, potassium, and fluid retention and can interfere with the natriuretic action of diuretics, which may increase the risk of NSAID nephrotoxicity. These features should be taken into account when treating patients with impaired cardiac function or hypertension, since these effects can cause a worsening of the patient's condition. Lithium NSAIDs have been reported to reduce the excretion of lithium. When prescribing tenoxicam to a patient taking lithium, the level of lithium should be monitored more frequently, and the patient should be warned about sufficient fluid intake and symptoms of lithium intoxication. Methotrexate The concomitant use of methotrexate requires caution, as NSAIDs reduce the elimination of methotrexate, thereby increasing the risk of its toxicity. Mifepristone Do not use NSAIDs within 8-12 days after taking mifepristone, as NSAIDs may reduce the effectiveness of the latter. Penicillamine and parenteral gold No clinically significant interactions were observed in a small number of patients treated with parenteral penicillamine or gold. Quinolones Animal data suggest that NSAIDs may increase the risk of seizures caused by quinolone antibiotics. Patients receiving NSAIDs and quinolones may be at an increased risk of seizures. Tacrolimus The use of NSAIDs in conjunction with tacrolimus may increase the risk of nephrotoxicity. Zidovudine The use of NSAIDs in conjunction with zidovudine increases the risk of hematological toxicity. There is evidence of an increased risk of hemarthrosis and hematoma in HIV-positive patients with hemophilia receiving concomitant zidovudine and ibuprofen. Others Co-administration of probenecid and tenoxicam may increase the plasma concentration of tenoxicam. The clinical significance of this observation has not been established. Storage conditions and shelf life Store in a place protected from moisture at a temperature not exceeding 25 ° C. Keep out of the reach of children! Shelf life 3 years. Do not use after the expiry date stated on the package. Conditions of leave By doctor's prescription. Packing 10 tablets in a blister pack made of PVC/PVDC film and flexible packaging based on aluminum foil. 1 blister pack with a leaflet in a cardboard pack. Buy Artoxan-Reb tablets p/o 20mg No. 10x1