Oxyten tablets p/o 20mg №10×1

Name:
Oxyten.
Description:
Beige, coated tablets. The main active ingredient is Tenoxicam. Release form Tablets. Dosage Pharmacological group Non-steroidal anti-inflammatory and antirheumatic drugs. Oxycams. Pharmacodynamics Oxyten is a non-steroidal anti-inflammatory drug (NSAID), which has a pronounced and long-term analgesic, anti-inflammatory, and antipyretic effect. As with other NSAIDs, the exact mechanism of action is not known, but it may be multifactorial and include inhibition of prostaglandin synthesis and a decrease in leukocyte accumulation at the site of inflammation. Pharmacokinetics Oxyten is a long-acting drug, a single daily dose is effective. The drug 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 the drug Oxyten. Tenoxicam penetrates well into the synovial fluid, while reaching concentrations of about half that in plasma. The mean plasma half-life is about 72 hours. When using the recommended dose – 20 mg once a day – the equilibrium plasma concentration is maintained for 10-15 days, with no unexpected accumulation observed. Tenoxicam is strongly bound to plasma proteins. Tenoxicam is excreted from the body mainly by the metabolic route. About 2/3 of the administered dose is excreted in the urine (in the form of an inactive 5-hydroxy pyridyl metabolite), and the rest in the bile (in the form of a glucuronic conjugate of the hydroxy metabolite). No changes in the pharmacokinetics of the drug Oxyten depending on the age of the patients were observed, despite individual changes in the tendency to increase such characteristics in older patients. Oxyten is indicated for the relief of pain and inflammation in osteoarthritis and rheumatoid arthritis. Oxyten is also used for short-term treatment of acute diseases of the musculoskeletal system, including sprains, dislocations and other soft tissue injuries. Dosage and administrationAdults: The recommended dose is 20 mg per day. Take preferably at the same time every day during or after meals with water. 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. 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. Elderly patients: Prescribe with caution, because. against the background of concomitant treatment or disorders of the kidneys, liver or cardiovascular system, the likelihood of side effects increases in comparison with younger patients. If it is necessary to use tenoxicam, the lowest effective dose and the shortest possible treatment period should be prescribed. During the treatment of NSAIDs during the first 4 weeks, it is necessary to regularly monitor patients for gastrointestinal bleeding. Children: There is insufficient information on the use of tenoxicam in children. At sufficiently low concentrations of albumin in the blood plasma (eg, nephrotic syndrome) or at high concentrations of bilirubin, use with caution, due to the high affinity of tenoxicam for plasma proteins. In renal insufficiency, patients with a creatinine clearance of more than 25 ml / min require careful medical supervision without adjusting the dosing regimen. In patients with creatinine clearance less than 25 ml / min, it is used with caution due to the lack of sufficient information on the use of tenoxicam in such patients. In patients with impaired liver function, it is used with caution due to the lack of sufficient information on the use of tenoxicam in such patients. Use during pregnancy and lactation Pregnancy: Inhibition of prostaglandin synthesis may affect the course of pregnancy and / or fetal development. Data from epidemiological studies suggest an increased risk. Congenital anomalies caused by the use of NSAIDs have been reported, but their frequency is low, and a definite pattern of their occurrence has not been found. Taking into account 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. In the third trimester of pregnancy, all inhibitors of prostaglandin synthesis can expose the fetus to: cardiopulmonary toxicity (with premature closure of the ductus arteriosus and pulmonary hypertension); renal dysfunction, which may progress to renal failure with oligohydramnios. At the same time, the mother at the end of pregnancy and the newborn may experience: an increase in bleeding time, antiplatelet effects that can occur even from low doses; inhibition of uterine contractions, which may delay or prolong labor. Therefore, tenoxicam is contraindicated in the third trimester of pregnancy. Lactation: Few studies have found that NSAIDs pass into breast milk at very low concentrations. If possible, the use of NSAIDs should be avoided during breastfeeding. Precautions Do not use Oxyten with other NSAIDs, including selective cyclooxygenase-2 inhibitors. Undesirable effects can be minimized by using the lowest effective dose for the minimum period of time. Cardiovascular and cerebrovascular effects Appropriate monitoring and counseling of patients with mild to moderate hypertension and/or 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 vascular 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 hypertension, hyperlipidemia, diabetes mellitus, smoking). Cardiovascular, renal and hepatic insufficiency The use of NSAIDs can cause a dose-dependent decrease in prostaglandin formation and the occurrence of provoked renal failure. Patients taking diuretics and the elderly are at greater risk of this reaction. Such patients should be 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 Oxyten 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), nephritic 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. NSAIDs should be used with caution in patients with a history of heart failure or hypertension. 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 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 concomitantly used 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 can disrupt 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. With all NSAIDs, gastrointestinal bleeding, ulceration, and perforation have been reported 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, such as oral 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. NSAIDs should be used with caution in patients with gastrointestinal diseases (ulcerative colitis, Crohn’s disease) in history, since exacerbation of these diseases is possible. 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. Ophthalmic effect 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 when treating patients with or with a history of asthma, as NSAIDs have been reported to cause bronchospasm in such patients. Systemic lupus erythematosus and mixed connective tissue disease: Patients with systemic lupus erythematosus and mixed connective tissue disease may be at increased risk of developing aseptic meningitis. 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 Oxyten tablets 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. It is recommended to carefully monitor the effects of anticoagulants and oral glycemic agents, especially during the initial stages of treatment with Oxyten. Interaction with digoxin was not observed. In healthy subjects, no clinically significant interaction was observed between tenoxicam and low molecular weight heparin. 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 the 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 co-administering corticosteroids, 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 lithium excretion. In the presence of tenoxicam, a patient taking lithium should have their lithium levels monitored more frequently, and the patient should be warned about adequate fluid intake and symptoms of lithium intoxication. Methotrexate: Caution should be exercised when taking methotrexate in parallel, since in this case the risk of increasing its toxicity increases, since NSAIDs weaken the excretion of methotrexate. Mifepristone: NSAIDs should not be used within 8 to 12 days after taking mifepristone, as NSAIDs may reduce the effectiveness of the latter. NSAIDs, selective cyclooxygenase-2 inhibitors, salicylates: The concomitant use of two or more NSAIDs (including aspirin) should be avoided as this may increase the risk of adverse effects. Salicylates are able to displace tenoxicam from protein binding sites and thus increase the clearance and volume of distribution of Oxyten. Concurrent treatment with salicylates or other NSAIDs should be avoided due to an increased risk of adverse reactions (particularly gastrointestinal). Penicillamine and parenteral gold: No clinically significant interaction was 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: When NSAIDs are used in conjunction with tacrolimus, the risk of nephrotoxicity may be increased. Zidovudine: When using NSAIDs together 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. Influence on the ability to drive a car and other mechanisms. Patients experiencing adverse events such as vertigo, dizziness, drowsiness, fatigue or visual disturbances should refrain from driving or operating machinery. Contraindications Hypersensitivity, erosive and ulcerative lesions of the gastrointestinal tract (including history), gastrointestinal bleeding (including history), severe gastritis; complete or incomplete combination of bronchial asthma, recurrent polyposis of the nose and paranasal sinuses and intolerance to acetylsalicylic acid or other non-steroidal anti-inflammatory drugs (NSAIDs) (including history); hemophilia, hypocoagulation, liver and / or kidney failure, inflammatory diseases of the gastrointestinal tract, progressive kidney disease, active liver disease, condition after coronary artery bypass grafting; confirmed hyperkalemia, hearing loss, pathology of the vestibular apparatus, deficiency of glucose-6-phosphate dehydrogenase; blood diseases, pregnancy, lactation. Composition Each film-coated tablet contains 20 mg tenoxicam; Excipients: lactose monohydrate, corn starch, talc, magnesium stearate, hypromellose, titanium dioxide (E171), yellow iron oxide (E172). Overdose No cases of serious overdose of Oxyten tablets have been reported. There are no specific recommendations for overdose, but it may be appropriate to use H2-histamine receptor blockers. Gastric lavage should be performed as soon as possible after ingestion of the drug in an increased dose, while the patient must be carefully observed and general supportive measures should be taken if necessary. Side effects In most patients, side effects are short-term and disappear without stopping treatment. The most frequently observed adverse events from the gastrointestinal tract. Cardiovascular and cerebrovascular effects: NSAID-induced edema, hypertension and heart failure have been reported. Rarely, palpitations and shortness of breath have been observed. The results of clinical studies and epidemiological data indicate that the use of some NSAIDs (especially at high doses and long-term treatment) may lead to an increased risk of arterial thrombotic events. Dermatological effects: Some NSAIDs have reported photosensitivity and bullous reactions, including Stevens-Johnson syndrome and toxic epidermal necrolysis (very rare). Gastrointestinal effects: The most common side effects can be observed from the gastrointestinal tract when taking NSAIDs. These include dyspepsia, nausea, vomiting, abdominal pain and discomfort, constipation, diarrhoea, flatulence, indigestion, epigastric discomfort, melena, hematemesis, ulcerative stomatitis, anorexia, exacerbation of colitis and Crohn’s disease. As with other NSAIDs, there is a risk of peptic ulceration, perforation and gastrointestinal bleeding, especially in elderly patients. The occurrence of gastritis was less often noted. The development of pancreatitis has been very rarely reported. Hematological effects: When using NSAIDs, a decrease in hemoglobin is possible, not associated with gastrointestinal bleeding. Anemia, aplastic and hemolytic anemia, thrombocytopenia and non-thrombocytopenic purpura, leukopenia, neutropenia and eosinophilia have been reported. Nosebleeds have been reported infrequently. In rare cases, agranulocytosis has been observed. Liver disorders: Liver dysfunction. As with other NSAIDs, there may be changes in various parameters of liver function. In some patients, during the period of treatment, an increase in serum transaminase levels is possible. Despite the low frequency of occurrence of such reactions, with a significant or persistent deviation of the results of the analysis of liver function from the norm, the development of signs and symptoms of liver disease, or the occurrence of systemic manifestations (for example, eosinophilia, rash), the drug should be discontinued. Hepatitis and jaundice have been reported. Hypersensitivity: The following hypersensitivity reactions have been reported in the treatment of NSAIDs: a) Non-specific allergic reactions and anaphylaxis; b) Increased airway reactivity, including asthma, asthma exacerbation, bronchospasm or dyspnea; c) A variety of skin disorders, including rashes of various types. Angioedema, pruritus and purpura have been reported. Rarely, nail disorders, alopecia, erythema, urticaria, and photosensitivity reactions have been reported. As with other NSAIDs, exfoliative and bullous dermatoses have occurred, which include epidermal necrolysis, erythema multiforme, and Stevens-Johnson syndrome. Rarely, vesiculobullous reactions and vasculitis have been reported. Metabolic disorders: Rarely, metabolic disorders such as weight loss or weight gain and hyperglycemia have been reported. Neurological and Sense Organ Disorders: Visual disturbances, optic neuritis, eye oedema, blurred vision and eye irritation have been reported. Ophthalmoscopy and slit lamp examination revealed no changes in the eyes. General malaise and tinnitus may occur. Reports of other less common effects including paresthesia and aseptic meningitis (especially in patients with pre-existing autoimmune diseases such as systemic lupus erythematosus and mixed connective tissue disease) with symptoms such as neck stiffness, headache, nausea, vomiting, fever or loss of orientation. Dizziness, malaise, fatigue and hypersomnia. Rarely reported on the occurrence of headache, drowsiness, insomnia, depression, nervousness, sleep disturbances, clouding of consciousness, paresthesia and vertigo. Renal disorders: Various forms of nephrotoxicity have been reported, including interstitial nephritis, nephrotic syndrome, and renal failure. Reversible increases in blood urea nitrogen and blood creatinine have been observed. If side effects occur, tell your doctor about it. This applies to all possible side effects, including those not described in this manual. Storage conditionsStore at a temperature of 15-25°C, protected from light. Keep out of the reach of children. Buy Oxyten tablets p/o 20mg No. 10×1