Keyver tablets p/o 25mg №10×1

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Caver tab. p / o 25 mg in a blister. in pack. No. 10х1
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Tablets of a round form with a biconvex surface, white or almost white color with a risk on one side, film-coated. The main active ingredient dexketoprofen Release form Tablets Dosage 25 mg Pharmacological properties Pharmacodynamics Dexketoprofen trometamol is a propionic acid salt that has analgesic, anti-inflammatory and antipyretic effects and belongs to the class of non-steroidal anti-inflammatory drugs (NSAIDs). The mechanism of its action is based on a decrease in the synthesis of prostaglandins due to the inhibition of cyclooxygenase. In particular, the conversion of arachidonic acid into cyclic endoperoxides PGG2 and PGH2 is inhibited, from which prostaglandins PGE1, PGE2, PGF2a, PGD2, as well as prostacyclin PGI2 and thromboxanes TxA2 and TxB2 are formed. In addition, inhibition of prostaglandin synthesis may affect other inflammatory mediators, such as kinins, which may also indirectly affect the main effect of the drug. The inhibitory effect of dexketoprofen trometamol on COX-1 and COX-2 isoenzymes of cyclooxygenase has been found in animals and humans. Clinical studies have shown that dexketoprofen trometamol has an effective analgesic effect that develops 30 minutes after the drug is used and lasts 4-6 hours. Pharmacokinetics After oral administration of dexketoprofen trometamol, the maximum plasma concentration (Cmax) is reached after an average of 30 minutes (15-60 minutes). The distribution time and half-life of dexketoprofen trometamol are 0.35 and 1.65 hours, respectively. Due to the high degree of binding to plasma proteins (99%), the average volume of distribution of dexketoprofen trometamol is less than 0.25 l / kg. Excretion of dexketoprofen trometamol occurs mainly due to glucuronidation and subsequent excretion by the kidneys. After the use of dexketoprofen trometamol, only the S-(+)-enantiomer is detected in the urine, which proves the absence of its inversion into the R-(+)-enantiomer in the human body. When studying the pharmacokinetics of multiple doses, it was shown that after the last use of dexketoprofen trometamol, the value of the area under the bioavailability curve (AUC) was not higher than after its single use, which proves the absence of cumulation of the drug. When using dexketoprofen trometamol with food, the AUC values do not change, but the Cmax value decreases, and the absorption rate also decreases (tmax increases). Indications for use Symptomatic treatment of mild to moderate pain, such as musculoskeletal pain, painful menstruation (dysmenorrhea), toothache. Dosage and administration The tablet can be divided into equal halves. Adults Depending on the type and intensity of pain, the recommended dose is 12.5 mg (½ coated tablet) every 4-6 hours or 25 mg (1 coated tablet) every 8 hours. The daily dose should not exceed 75 mg. Adverse events can be minimized by using the lowest effective dose for the shortest possible time necessary to eliminate symptoms. Keyver® is not intended for long-term therapy; treatment continues as long as there are symptoms. Simultaneous ingestion of food reduces the rate of absorption of the active substance, so it is recommended to take the drug at least 30 minutes before meals with a sufficient amount of liquid (for example, a glass of water). Elderly patients It is recommended to start treatment with low doses. The daily dose is 50 mg. With good tolerability of the drug, the dose can be increased to the usual. For mild to moderate hepatic impairment, treatment should be initiated at the lowest recommended dose and under close medical supervision. The daily dose is 50 mg. With mild renal impairment For patients with mild renal impairment (creatinine clearance 50-80 ml / min), the initial daily dose should be reduced to 50 mg. Keyver tablets should not be used in patients with moderate to severe renal insufficiency (creatinine clearance <50 ml/min). Use in children and adolescents Studies of the effects of dexketoprofen in children and adolescents have not been conducted. Therefore, Keyver® should not be used in children and adolescents, as its safety and efficacy have not been established. Precautions Use Keyver® with caution in patients with a history of allergic reactions. The simultaneous use of the drug with other NSAIDs, including cyclooxygenase-2 inhibitors, should be avoided. Undesirable effects of the drug can be minimized by using the minimum effective dose for the shortest possible period of time necessary to eliminate symptoms. Gastrointestinal Disorders Peptic ulcers with or without perforation and bleeding (even fatal) may develop in the gastrointestinal tract when drugs of the NSAID class are used. These adverse events can occur at any time during treatment, with or without warning symptoms, regardless of a history of severe gastrointestinal disturbances. If gastrointestinal bleeding or peptic ulcer develops while using dexketoprofen, therapy with the drug should be stopped immediately. The risk of developing the above-mentioned adverse events increases in proportion to the increase in the dose of NSAIDs, as well as in patients with a history of gastric or duodenal ulcers and in the elderly. During the use of the drug, the doctor should carefully monitor the condition of patients, given the possible occurrence of gastrointestinal bleeding. Before starting the use of dexketoprofen trometamol in the presence of a patient's history of esophagitis, gastritis and / or peptic ulcer, as in the case of other NSAIDs, make sure that these diseases are in remission. Patients with gastrointestinal symptoms and a history of gastrointestinal disease should be monitored for possible gastrointestinal disturbances, especially bleeding. To reduce the risk of developing adverse reactions from the digestive tract, the doctor may prescribe drugs that have a protective effect on the mucous membrane of the digestive tract (misoprostol, proton pump inhibitors). This also applies to patients who need concomitant administration of low doses of acetylsalicylic acid or other agents that increase the risk of developing complications from the digestive system. Patients should be informed that in the event of any discomfort in the abdomen (primarily gastrointestinal bleeding), especially at the beginning of treatment, they should inform the doctor. Renal impairment Should be used with caution in patients with impaired renal function. In these patients, the use of NSAIDs can lead to deterioration of kidney function, fluid retention and edema. Caution should be exercised when using dexketoprofen in patients using diuretics and prone to hypovolemia, since there is an increased risk of nephrotoxicity of the drug. During treatment, adequate fluid intake should be ensured to prevent dehydration and possibly an increase in renal toxicity associated with it. Like all NSAIDs, dexketoprofen can increase urea nitrogen and creatinine levels. As with other prostaglandin synthesis inhibitors, this may be associated with adverse effects on the renal system, which can lead to glomerular nephritis, interstitial nephritis, renal papillary necrosis, nephrotic syndrome and acute renal failure. Elderly patients are more likely to suffer from impaired renal function. Hepatic impairment Use with caution in patients with hepatic impairment. As with other NSAIDs, dexketoprofen may cause a short-term slight increase in some liver parameters, as well as a significant increase in ALT and AST levels. With a corresponding increase in these indicators, therapy should be discontinued. Elderly patients are more likely to suffer from impaired liver function. Cardiovascular system and cerebral circulation Appropriate monitoring and recommendations are necessary for patients with a history of arterial hypertension and / or heart failure of mild or moderate severity. Particular care is required when prescribing the drug to patients with a history of heart disease, in particular, in those who had previous episodes of heart failure. These patients are at increased risk of developing heart failure, as fluid retention and edema associated with NSAIDs have been reported. Clinical and epidemiological data suggest that the use of certain NSAIDs (especially at high doses and with long-term treatment) slightly increases the risk of developing arterial thromboembolism (eg, myocardial infarction, stroke). There is not enough data to exclude such a risk when taking dexketoprofen. For patients with uncontrolled arterial hypertension, decompensated heart failure, manifesting coronary heart disease, obliterating endarteritis, cerebrovascular disorders, dexketoprofen should be prescribed only after a thorough assessment of the ratio of expected benefits and possible risks of such therapy. Using the same principle, evaluate the advisability of prescribing long-term therapy with dexketoprofen in patients with risk factors for cardiovascular diseases, such as hyperlipidemia, arterial hypertension, diabetes mellitus, and if the patient smokes. All non-selective NSAIDs can inhibit platelet aggregation and prolong bleeding time through inhibition of prostaglandin synthesis. Therefore, the use of dexketoprofen in patients receiving other therapies that interfere with hemostasis, such as warfarin or other coumarins or heparins, is not recommended. Elderly patients are more likely to suffer from impaired cardiovascular function. Skin reactions The use of NSAIDs has been, in rare cases, associated with serious skin reactions, sometimes fatal, including reactions such as exfoliative dermatitis, Stevens-Johnson syndrome and toxic epidermal necrolysis. The risk of developing these conditions is greatest in the initial phase of therapy, in most cases the onset of reactions occurred during the first month of treatment. At the first sign of a skin rash, mucosal lesions or other indications of hypersensitivity, the drug should be discontinued immediately. Additional information Special care is required in patients with: congenital disorders of porphyrin metabolism (eg, acute intermittent porphyria) dehydration immediately after major surgery. If the doctor considers that long-term therapy with dexketoprofen is necessary, it is necessary to regularly check the function of the liver and kidneys, as well as the blood. Severe acute hypersensitivity reactions (eg, anaphylactic shock) have been observed in very rare cases. Treatment should be discontinued at the first sign of severe hypersensitivity reactions after taking dexketoprofen. Depending on the symptoms, any medical procedures should be initiated by healthcare professionals. Patients with asthma associated with chronic rhinitis, chronic sinusitis and/or nasal polyposis are at a higher risk of developing allergy to acetylsalicylic acid and/or NSAIDs than the rest of the population. The administration of this drug may cause asthma attacks or bronchospasm, especially in patients who are allergic to acetylsalicylic acid or NSAIDs. Chickenpox can cause serious infectious complications of the skin and soft tissues. To date, the role of NSAIDs in worsening the course of these infections cannot be ruled out. Thus, it is desirable to avoid the use of dexketoprofen in varicella. Dexketoprofen should be used with caution in patients with hematopoietic disorders, systemic lupus erythematosus or mixed connective tissue disease. Like other NSAIDs, dexketoprofen may mask the symptoms of infectious diseases. Use in children and adolescents The use of the drug in children and adolescents has not been studied, so patients in this age group are not recommended to prescribe dexketoprofen. Application during pregnancy or lactation Keyver® is contraindicated in the III trimester of pregnancy and during lactation. The drug can be used during the I and II trimesters of pregnancy in case of urgent need, only if the potential benefit outweighs the potential risk to the fetus. Reduce the dose and duration of treatment to the lowest possible level. Inhibition of prostaglandin synthesis may adversely affect pregnancy and/or the development of the embryo and fetus. In accordance with epidemiological studies, the use of drugs that inhibit the synthesis of prostaglandins in the early stages of pregnancy increases the risk of miscarriage, heart disease, gastroschisis. If it is necessary to use dexketoprofen trometamol, women planning pregnancy should be given the lowest possible dose with the shortest duration of therapy. Against the background of the use of prostaglandin synthesis inhibitors in the III trimester of pregnancy, the fetus may experience such abnormalities: cardiovascular toxicity, for example, premature closure of the arterial duct and hypertension in the pulmonary artery system; kidney dysfunction, which can progress and turn into renal failure with the development of oligohydramnios. In the mother at the end of pregnancy and in the infant, the following phenomena are possible: an increase in bleeding time due to the suppression of platelet aggregation, even when using the drug in low doses; inhibition of the contractile activity of the uterus, which leads to a delay and delay in labor. There are no data on penetration into breast milk. The ability to influence the reaction rate when driving vehicles or working with other mechanisms When using dexketoprofen, dizziness and fatigue are possible, which may affect the ability to drive vehicles and work with other mechanisms. Interaction with other drugs The following drug interactions generally characterize drugs of the NSAID class. Combinations that are not recommended for use with Keyver® Other NSAIDs, including salicylates in high doses (more than 3 g / day): increased risk of peptic ulcers due to synergistic action. Heparin and indirect anticoagulants (for example, warfarin): the effect of anticoagulants is enhanced, which can lead to an increase in bleeding time; if it is not possible to avoid such a combination, close monitoring of the patient's condition with appropriate monitoring of laboratory parameters is necessary. Corticosteroids: increased risk of peptic ulcers and bleeding in the digestive tract. Lithium preparations: the level of lithium in the blood rises up to toxic values due to a decrease in its excretion by the kidneys. Methotrexate when used in high doses (15 mg / week or more): increases the level of methotrexate in the blood by reducing its excretion by the kidneys, which leads to toxic effects on the blood system. Hydantoin and sulfonamides: the toxicity of these substances increases. Combinations requiring caution with Keyver Diuretics, ACE inhibitors, aminoglycoside antibiotics and angiotensin II receptor antagonists. Dexketoprofen weakens the effect of diuretics and other antihypertensive agents. In some patients with impaired renal function (for example, with dehydration or in elderly patients with impaired renal function), the condition may worsen with the simultaneous use of agents that inhibit the action of cyclooxygenase with ACE inhibitors, angiotensin II receptor antagonists and antibiotics of the aminoglycoside group. As a rule, this deterioration is reversible. When using dexketoprofen concomitantly with any diuretic, care must be taken to ensure that the patient is adequately hydrated and to monitor renal function during treatment. Methotrexate when used in low doses (less than 15 mg / week): it is possible to increase the toxic effect on the blood system by reducing its excretion by the kidneys; if it is necessary to use such a combination, weekly monitoring of the blood picture is necessary, especially in the presence of even a slight decrease in kidney function, as well as in elderly patients. Pentoxifylline: The risk of bleeding increases, so the patient must be monitored and bleeding time monitored. Zidovudine: there is a risk of an increase in the toxic effect of zidovudine on erythropoiesis (toxic effect on reticulocytes), up to the development of severe anemia, a week after the use of NSAIDs, therefore, in the first 1-2 weeks after the start of NSAID therapy, it is necessary to conduct a blood test with counting the number of reticulocytes. Sulfonylureas: NSAIDs may increase the hypoglycemic effect of sulfonylurea drugs by displacing them from their association with blood proteins. Combinations that require attention when used with the drug Keiver® Beta-blockers: their antihypertensive effect may decrease due to inhibition of prostaglandin synthesis. Cyclosporine and tacrolimus: increased toxic effect of these drugs on the kidneys due to the effect of NSAIDs on the synthesis of prostaglandins; when using this combination, kidney function should be monitored regularly. Thrombolytic drugs: increased risk of bleeding. Platelet aggregation inhibitors and selective serotonin reuptake inhibitors: increased risk of peptic ulcers and bleeding in the digestive tract. Probenecid: an increase in the concentration of dexketoprofen in the blood plasma by reducing the level of its renal tubular secretion and glucuronidation; in this case, it is necessary to carry out a dose adjustment of dexketoprofen. Cardiac glycosides: their concentration in blood plasma may increase. Mifepristone: a decrease in its effectiveness due to a decrease in the synthesis of prostaglandins, so NSAIDs should not be used within 8-12 days after the use of mifepristone. Quinolines: their use in high doses in combination with NSAIDs increases the risk of seizures. Contraindications Hypersensitivity to dexketoprofen, any other non-steroidal anti-inflammatory drug or any of the excipients of the drug. The use of patients in whom substances with a similar mechanism of action, for example, acetylsalicylic acid and other NSAIDs, cause attacks of bronchial asthma, bronchospasm, acute rhinitis or lead to the development of nasal polyps, urticaria or angioedema. Active phase peptic ulcer / bleeding in the digestive tract or suspicion of their presence, recurrent course of peptic ulcer / bleeding in the digestive tract in history (at least 2 confirmed facts of ulcers or bleeding), as well as chronic dyspepsia. Bleeding or perforation in the digestive tract in history associated with the use of NSAIDs. Bleeding in the digestive tract, other bleeding in the active phase, or increased bleeding. Crohn's disease or ulcerative colitis. Bronchial asthma in history. Severe heart failure. Moderate or severe renal impairment (creatinine clearance <50 ml/min). Severe liver dysfunction (10-15 points on the Child-Pugh scale). Hemorrhagic diathesis or other blood clotting disorders. During the third trimester of pregnancy and during lactation. Known phototoxic and photoallergic reactions during treatment with ketoprofen or fibrates. Severe dehydration (due to vomiting, diarrhea or insufficient fluid intake). Active ingredient: 1 tablet contains dexketoprofen (in the form of dexketoprofen trometamol) 25 mg; excipients: microcrystalline cellulose, pregelatinized starch, corn starch, sodium starch glycolate, glycerol distearate; shell composition Aquarius Prime BAP218010 white: hypromellose, titanium dioxide (E 171), polyethylene glycol. Overdose Symptoms of overdose are unknown. Similar drugs cause disorders of the digestive tract (vomiting, anorexia, abdominal pain) and the nervous system (drowsiness, vertigo, disorientation, headache). Treatment In case of accidental overdose, symptomatic treatment should be started immediately, according to the clinical condition of the patient. If an adult patient or child has taken a dose of more than 5 mg / kg of body weight, activated charcoal should be used within 1 hour. Hemodialysis can be used to remove dexketoprofen. Storage conditions Store in a place protected from light at a temperature not exceeding 25 ° C. Keep out of the reach of children. Best before date. 2 years. Do not use the drug after the expiration date indicated on the package. Buy Keyver tablets p/o 25mg No. 10x1