Ketonal forte tablets p/o 100mg №20 №1

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Ketonal forte tab. captivity. about 100mg per vial. No. 20 in pack No. 1
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Light blue, round, biconvex film-coated tablets. The main active ingredient Ketoprofen Release form Tablets Dosage Keep out of the reach of children. Store below 25°C. Store in original packaging. Pharmacological action Pharmacodynamics Ketoprofen – the active substance of the drug – inhibits the synthesis of prostaglandins and leukotrienes, blocking the enzyme cyclooxygenase (cyclooxygenase-1 (COX-1) and cyclooxygenase-2 (COX-2)), which catalyzes the synthesis of prostaglandins in the metabolism of arachidonic acid. Ketoprofen stabilizes lysosomal membranes in vitro and in vivo, at high concentrations inhibits the synthesis of leukotrienes in vitro and has anti-bradykinin activity in vivo. The mechanism of antipyretic action of ketoprofen is unknown. Perhaps ketoprofen inhibits the synthesis of prostaglandins in the central nervous system (most likely in the hypothalamus). In some women, ketoprofen reduces the symptoms of primary dysmenorrhea, probably by suppressing the synthesis and / or effectiveness of prostaglandins. Pharmacokinetics Ketoprofen is well absorbed from the gastrointestinal tract. After taking 100 mg of ketoprofen orally, its peak plasma concentration (10.4 μg / ml) is reached in 1 hour 22 minutes. The bioavailability of ketoprofen after oral administration at a dose of 50 mg is 90% and increases linearly with increasing dose. Ketoprofen is a racemic mixture, but the pharmacokinetics of the two enantiomers are similar. 99% of ketoprofen binds to plasma proteins, mainly to the albumin fraction. The volume of distribution in tissues is 0.1-0.2 l / kg. Ketoprofen penetrates into the synovial fluid. Three hours after the appointment of 100 mg of ketoprofen, its plasma concentration is about 3 μg / ml, and the concentration in the synovial fluid is 1.5 μg / ml. After nine hours, its plasma concentration is about 0.3 μg / ml, and the concentration in the synovial fluid is 0.8 μg / ml. This means that ketoprofen slowly penetrates into the synovial fluid and is also slowly excreted from it, while its plasma concentration decreases further. If ketoprofen is taken with food, absorption slows down and plasma concentrations decrease slightly, but bioavailability remains the same. After oral administration of 50 mg of ketoprofen with meals four times a day, a peak concentration of 3.9 μg / ml was reached in 1.5 hours compared to 2.0 μg / ml after two hours when taking ketoprofen on an empty stomach. Equilibrium concentrations of ketoprofen are established 24 hours after its administration. In elderly patients, the equilibrium concentration was reached after 8.7 hours and was 6.3 μg / ml. Ketoprofen is extensively metabolized by hepatic microsomal enzymes. It binds to glucuronic acid and is excreted in this form from the body. After oral administration, its plasma clearance is 1.16 ml / min / kg. Due to its rapid metabolism, its biological half-life is only two hours. Up to 80% of ketoprofen is excreted in the urine, mainly (over 90%) as ketoprofen glucuronide, and about 10% is excreted in the feces. Special groups of patients With liver damage In patients with liver failure, probably due to hypoalbuminemia (free biologically active ketoprofen), the concentration of ketoprofen almost doubles, which requires the appointment of a minimum daily dose that provides a sufficient therapeutic effect. With kidney damage In patients with renal insufficiency, the clearance of ketoprofen is reduced. Therefore, in severe renal insufficiency, a dose reduction is required. Indications for use Ketonal forte is a non-steroidal antirheumatic drug with anti-inflammatory, analgesic and antipyretic effects. It is used to relieve pain in a number of pain syndromes and to treat inflammatory, degenerative and metabolic rheumatic diseases. Indications for use: – rheumatoid arthritis; – ankylosing spondylitis; – acute gout; – osteoarthritis of various localization; – sciatica, sciatica; – myalgia; – tendinitis, tendovaginitis, bursitis, synovitis, capsulitis; – bruises, damage to ligaments, dislocations; – sprains, muscle ruptures – phlebitis, superficial thrombophlebitis, lymphangitis; – painful inflammatory diseases in dentistry, otolaryngology, urology and pulmonology. Method of administration and doses For oral administration. Undesirable effects can be minimized if the drug is taken at the lowest effective dose for the shortest possible time necessary to relieve symptoms. The usual dose is 1-2 tablets per day, between meals. The maximum daily dose of ketoprofen is 200 mg. Before starting treatment at a dose of 200 mg per day, the possible risks and benefits should be carefully weighed. The use of higher doses is not recommended (see also “Special instructions and precautions”). Elderly patients and patients with impaired renal function It is recommended to reduce the initial dose and prescribe maintenance therapy using the lowest effective dose. If the drug is well tolerated, dose adjustments may be considered on an individual basis. Patients with impaired liver function These patients should be closely monitored and the drug should be used at the lowest effective daily dose. Children The safety and efficacy of ketoprofen in children has not been studied. Use during pregnancy and lactation Inhibition of prostaglandin synthesis may have a negative effect on pregnancy and / or development of the embryo / fetus. In the first and second trimesters of pregnancy, the drug should not be prescribed unless absolutely necessary. If Ketonal forte is used by a woman who is trying to become pregnant or is in the first or second trimester of pregnancy, the dose should be as low as possible and the duration of treatment as short as possible. In the third trimester of pregnancy, the use of Ketonal forte is contraindicated. There are no data on the penetration of the drug into milk. It is not recommended to prescribe Ketonal forte to nursing mothers. Precautions Avoid the simultaneous use of the drug with NSAIDs, including selective COX-2 inhibitors. The elderly are more likely to experience adverse reactions to NSAIDs, especially gastrointestinal bleeding and perforation, which can be fatal (see Doses and Administration). Gastrointestinal bleeding, ulceration, and perforation Gastrointestinal bleeding, ulceration, or perforation, which may be fatal, is described for all NSAIDs and may occur at any time during treatment, with or without prior symptoms or severe gastrointestinal disease. tract in history. Ketonal forte may be associated with a high risk of severe gastrointestinal toxicity, which is characteristic of some other NSAIDs, especially when taking high doses (see also “Doses and method of administration” and “Contraindications”). The risk of gastrointestinal bleeding, ulcers or perforation increases with increasing doses of NSAIDs, in patients with a history of peptic ulcer, especially complicated by bleeding or perforation (see “Contraindications”), as well as in the elderly. Treatment of these patients should be initiated at the lowest available dose. For these patients, as well as for patients co-administering low-dose acetylsalicylic acid or other drugs that increase the risk of gastrointestinal complications, combination therapy with protective drugs (eg, misoprostol or proton pump blockers) should be considered (see below and “Interaction with other medicinal products and other forms of interaction”). Patients with a history of gastrointestinal toxicity, especially the elderly, should report any unusual abdominal symptoms (especially gastrointestinal bleeding), especially at the start of treatment. Particular care should be taken when co-administered with drugs that can increase the risk of ulcers or bleeding, for example, oral corticosteroids, anticoagulants (eg, warfarin), selective serotonin reuptake inhibitors or antiplatelet agents such as acetylsalicylic acid (see “Interaction with other medicinal products and other forms of interaction”). If patients develop gastrointestinal bleeding or ulcers during treatment with Ketonal forte, the drug should be discontinued. NSAIDs should be used with caution in patients with a history of gastrointestinal disease (ulcerative colitis, Crohn’s disease), as they may experience exacerbations of these diseases (see “Side Effects”). Cardiovascular and cerebrovascular effects. Patients with a history of arterial hypertension and / or congestive heart failure of mild to moderate severity require appropriate monitoring and consultation, since fluid retention and edema have been reported with the use of NSAIDs. The use of some NSAIDs (especially at high doses and with long-term treatment) may be associated with an increased risk of arterial thrombosis (eg, myocardial infarction or stroke) (see “Special Instructions and Precautions”). There are insufficient data to rule out such a risk for ketoprofen. In patients with uncontrolled arterial hypertension, congestive heart failure, established diagnosis of coronary heart disease, peripheral arterial disease and / or cerebrovascular disease, treatment with Ketonal forte should be carried out only after a thorough assessment of the benefits and risks. Similarly, it is necessary to proceed before prescribing long-term treatment for patients with risk factors for cardiovascular diseases (eg arterial hypertension, hyperlipidemia, diabetes mellitus, smoking). Patients suffering from bronchial asthma in combination with chronic rhinitis, chronic sinusitis and / or nasal polyposis are more likely to experience allergic reactions after taking acetylsalicylic acid and / or NSAIDs than other patients. The appointment of Ketonal forte can cause an attack of bronchial asthma or bronchospasm, especially in patients with allergies to acetylsalicylic acid or NSAIDs (see “Contraindications”). In patients with heart failure, cirrhosis and nephrotic syndrome, as well as in patients taking diuretics, and in patients with chronic renal failure, especially the elderly, renal function should be carefully monitored at the beginning of treatment. In such patients, the appointment of Ketonal forte can cause a decrease in renal blood flow due to inhibition of prostaglandin synthesis and lead to decompensation of kidney function. In patients with abnormal liver function tests or a history of liver disease, blood transaminase levels should be monitored periodically, especially during prolonged therapy. Rare cases of jaundice and hepatitis have been described in connection with the use of ketoprofen. Treatment should be discontinued if visual disturbances occur, such as blurred vision. The drug is prescribed with caution to persons suffering from alcohol dependence. Severe skin reactions associated with the use of NSAIDs (some of them fatal), such as exfoliative dermatitis, Stevens-Johnson syndrome and toxic epidermal necrolysis, are extremely rarely described (see “Side effects”). The greatest risk of developing these reactions is at the beginning of the course of treatment; in most cases, reactions occur in the first month of treatment. Ketonal forte should be discontinued at the first appearance of a skin rash, mucosal lesions, or other signs of hypersensitivity. Ketonal forte may mask signs and symptoms of infectious diseases, such as fever. Before extensive surgical interventions, the drug must be canceled. The use of Ketonal forte can reduce fertility, so it is not recommended for women planning a pregnancy. In women who have difficulty getting pregnant or who are being examined for infertility, discontinuation of Ketonal forte should be considered. Ketonal forte tablets contain lactose. Therefore, they should not be taken by patients with hereditary galactose intolerance, lactase deficiency or malabsorption of glucose and galactose. Interaction with other drugs Not recommended combinations of drugs Other NSAIDs (including selective cyclooxygenase-2 inhibitors) and high doses of salicylates: increased risk of ulcers and bleeding in the gastrointestinal tract. Anticoagulants (heparin and warfarin) and inhibitors of platelet aggregation (eg, ticlopidine, clopidogrel): increased risk of bleeding (see “Special instructions and precautions”). If necessary, joint use requires close medical supervision. Lithium: Risk of increased plasma lithium levels, which can sometimes reach toxic levels due to decreased renal excretion of lithium. If necessary, the concentration of lithium in plasma should be carefully monitored and the dose of lithium should be adjusted during and after treatment with NSAIDs. Methotrexate at doses greater than 15 mg/week: increased risk of hematotoxicity of methotrexate, especially if used at high doses (>15 mg/week), which is probably due to the displacement of methotrexate from protein binding and a decrease in its renal clearance. Combinations requiring caution Diuretics: Patients taking diuretics, especially those with dehydration, have an increased risk of renal failure due to a decrease in renal blood flow due to inhibition of prostaglandin synthesis. Such patients need to adequately compensate for fluid deficiency before the start of the joint use of such drugs, and at the beginning of treatment, monitor kidney function (see “Special Instructions and Precautions”). Angiotensin-converting enzyme (ACE) inhibitors and angiotensin II receptor antagonists. In patients with impaired renal function (eg, patients with dehydration or the elderly), the concomitant use of an ACE inhibitor or angiotensin II receptor antagonist and drugs that inhibit cyclooxygenase may cause additional deterioration in renal function, including possible acute renal failure. Methotrexate at doses below 15 mg / week: in the first weeks of combined treatment, it is necessary to monitor the detailed blood picture once a week. In case of any impairment of renal function and in elderly patients, monitoring should be carried out more often. Corticosteroids: increased risk of ulcers or bleeding in the gastrointestinal tract (see “Special instructions and precautions”). Pentoxifylline: Increases the risk of bleeding. More frequent clinical monitoring and more frequent control of bleeding time are needed. Combinations to consider Antihypertensive drugs (beta-blockers, ACE inhibitors, diuretics): ketoprofen reduces the effect of antihypertensive drugs (inhibition of the synthesis of vasodilatory prostaglandins). Thrombolytics: increased risk of bleeding. Selective serotonin reuptake inhibitors: increased risk of gastrointestinal bleeding (see “Special instructions and precautions”). Probenecid: Co-administration of probenecid may significantly reduce the plasma clearance of ketoprofen. Combinations that should also be noted Cyclosporine, tacrolimus: risk of additive nephrotoxicity, especially in elderly patients. Contraindications – Hypersensitivity to ketoprofen or any of the excipients of the drug; – a history of rhinitis, bronchospasm, bronchial asthma, urticaria or allergic-type reactions after the use of ketoprofen or similar active substances, such as other non-steroidal anti-inflammatory drugs (NSAIDs) or salicylates (eg, acetylsalicylic acid); in such patients, severe (in rare cases fatal) anaphylactic reactions are described (see “Side effect”); – severe heart failure; – treatment of pain in the perioperative period during coronary artery bypass grafting (CABG); – chronic dyspepsia in history; – peptic ulcer in the acute phase, as well as gastrointestinal bleeding, ulcer or perforation in history; – predisposition to bleeding; – severe impairment of kidney function; – severe liver dysfunction; – the last trimester of pregnancy (see “Pregnancy and lactation”); – children. Composition Each tablet contains 100 mg of ketoprofen. Excipients Tablet core: magnesium stearate, anhydrous colloidal silicon dioxide, povidone, corn starch, purified talc, lactose monohydrate. Tablet shell: hypromellose E464, macrogol 400, indigotin blue dye E132, titanium dioxide E171, purified talc, carnauba wax. Overdose Cases of an overdose of ketoprofen at a dose of up to 2.5 g have been described. In most cases, the observed symptoms were benign and limited to lethargy, drowsiness, nausea, vomiting and epigastric pain. There is no specific antidote for Ketoprofen overdose. If a significant overdose is suspected, gastric lavage and symptomatic and supportive therapy are recommended to eliminate dehydration. You also need to control diuresis and correct acidosis (if it develops). With the development of renal failure, hemodialysis may be effective in removing the drug circulating in the blood. Side effects In connection with treatment with non-selective NSAIDs, edema, high blood pressure and heart failure have been reported. If severe side effects occur, treatment should be discontinued. Adverse effects are distributed according to the classes of organ systems, according to the frequency of occurrence and descending severity: very frequent (≥ 1/10); frequent (≥ 1/100, <1/10); infrequent (≥ 1/1000, <1/100); rare (≥ 1/10,000, <1/1,000); very rare (< 1/10,000); frequency not set (frequency cannot be determined from available data). Blood and lymphatic system disorders - Rare: posthemorrhagic anemia; - Frequency not established: agranulocytosis, thrombocytopenia, bone marrow failure. Immune system disorders - Frequency not established: anaphylactic reactions (including shock). Psychiatric disorders - Frequency not established: Mood variability. Nervous system disorders - Uncommon: headache, dizziness, drowsiness; - Rare: paresthesia; - Frequency not established: convulsions, dysgeusia. On the part of the organ of vision - Rare: blurred vision (see "Special instructions and precautions"). Hearing and labyrinth disorders - Rare: ringing in the ears. Cardiac disorders - Frequency not established: heart failure. Vascular disorders - Frequency not established: arterial hypertension, vasodilation. Respiratory, thoracic and mediastinal disorders - Rare: bronchial asthma; - Frequency not established: bronchospasm (especially in patients with known hypersensitivity to acetylsalicylic acid and other NSAIDs), rhinitis. Gastrointestinal disorders - Common: dyspepsia, nausea, abdominal pain, vomiting; - Infrequent: constipation, diarrhea, flatulence, gastritis; - Rare: stomatitis, peptic ulcer; - Frequency not established: exacerbation of ulcerative colitis and Crohn's disease, gastrointestinal bleeding and perforation, melena, hematemesis. The most common adverse reactions include reactions from the gastrointestinal tract. Perhaps the development of peptic ulcers, perforations and bleeding in the gastrointestinal tract, which sometimes, especially in elderly patients, can be fatal (see "Special instructions and precautions"). Liver and biliary tract disorders - Rare: hepatitis, transaminase elevation, elevated serum bilirubin due to hepatitis. Skin and subcutaneous tissue disorders - Uncommon: rash, itching; - Frequency not established: photosensitivity reaction, alopecia, urticaria, angioedema, bullous reactions, including Stevens-Johnson syndrome and toxic epidermal necrolysis. Renal and urinary tract disorders - Frequency not established: acute renal failure, tubulointerstitial nephritis, nephritic syndrome, abnormal kidney function tests. General disorders and disorders at the injection site - Infrequent: edema; - Frequency not established: fatigue. Laboratory and instrumental data - Rare: weight gain. Data show that the use of a number of non-selective NSAIDs (especially at high doses and for a long time) may be associated with an increased risk of arterial thrombosis (for example, myocardial infarction or stroke) (see "Special Instructions and Precautions"). Storage conditionsKeep out of the reach of children. Store below 25°C. Store in original packaging. Buy Ketonal forte tablets p/o 100mg №20 №1 Price for Ketonal forte tablets p/o 100mg №20 №1