Ibuprofen MAX tablets p/o 400mg №10×1

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Ibuprofen MAX tab. 400 mg in a cell. pack No. 10×2.
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: White film-coated tablets, round, with a biconvex surface, scored. Composition Each tablet contains: active ingredient: ibuprofen – 400 mg; excipients: potato starch, magnesium stearate, calcium stearate, povidone, opadra (contains polyvinyl alcohol, partially hydrolyzed; talc; macrogol 3350; titanium dioxide E 171). Pharmacotherapeutic groupNon-steroidal anti-inflammatory and antirheumatic drugs. Derivatives of propionic acid. ATX code: M01AE01. Pharmacological properties Pharmacodynamics Means of non-steroidal structure, which has a pronounced anti-inflammatory, analgesic and antiplatelet effect. The mechanism of action is associated with inhibition of the activity of cyclooxygenase types I and II (selectivity index COX-1:COX-2 = 5.0-10.0:1). As a result, the reactions of the arachidonic cascade of eicosanoid synthesis are blocked and the formation of prostaglandins PgE2, PgF2?, thromboxane TxA2, prostacyclin PgI2 is disrupted. Ibuprofen reduces hyperemia, exudation and capillary permeability in the focus of inflammation. It inhibits the activity of hyaluronidase, inhibits the production of ATP, limiting the energy supply of the inflammatory process. In rheumatic diseases, it has an anti-inflammatory and analgesic effect. It relieves pain at rest and during movement, reduces morning stiffness and swelling of the joints, improves their function. The full anti-inflammatory effect develops on the 5-7th day of regular use. In post-traumatic and postoperative inflammatory processes, it quickly relieves both spontaneous pain and pain that occurs during movement. Reduces inflammatory edema in the wound area. Ibuprofen has an analgesic effect, increases the excitability threshold of the pain centers of the thalamus. It prevents the conduction of pain impulses from extra- and proprioceptive receptors along the Gaulle and Burdach bundles. Reduces the algogenic effect of bradykinin. In the nuclei of the antinociceptive system, ibuprofen enhances the release of kynurenic acid, which inhibits the conduction of pain impulses (due to the effect on AMPA and NMDA receptors), as well as endogenous opiopeptides. Eliminates pains of weak and moderate intensity, which are usually somatic in nature: pain in muscles, joints, tendons, nerve trunks, headache and toothache. Reduces elevated body temperature, but does not affect normal body temperature. This is due to the ability of ibuprofen to reduce the activity of the thermosetting center of the hypothalamus, reduce the effect of endogenous pyrogens on it, and increase heat transfer. The antipyretic effect develops in smaller doses than the anti-inflammatory one and occurs within 30 minutes after the use of ibuprofen, remaining for 6 hours. Ibuprofen disrupts the platelet adhesion (aggregation) reaction and leads to some prolongation of bleeding time. Pharmacokinetics After intramuscular administration, it is well absorbed. Bioavailability is 80%. The maximum concentration in the blood plasma after ingestion on an empty stomach is reached after 0.45–1 h, when taken after a meal – after 2.0–2.5 h. The maximum concentration in the synovial fluid is after 3 h. Therapeutic concentration in plasma is 10– 50 μg / ml, toxic – 100–700 μg / ml. The biological activity of ibuprofen is associated with the S-enantiomer. After absorption, about 60% of the pharmacologically inactive R-form is slowly transformed into the active S-form. In the blood, it is reversibly bound to plasma proteins (about 90-99%). It slowly penetrates into the joint cavity, lingers in the synovial fluid, creating concentrations in it greater than in plasma. The volume of distribution is 0.1 l/kg. Metabolized in the liver with the formation of 3 inactive metabolites. 60-90% of the administered dose is excreted by the kidneys in the urine as metabolites, to a lesser extent excreted in the bile. Excretion of unchanged ibuprofen is less than 1%. The elimination half-life of ibuprofen is 2-2.5 hours, the total clearance is 0.75±0.20 ml/min/kg. In elderly patients, the pharmacokinetics of ibuprofen does not change. Ibuprofen is used as an analgesic and anti-inflammatory drug in the treatment of rheumatoid arthritis (including juvenile rheumatoid arthritis or Still’s disease), ankylosing spondylitis, osteoarthritis and other non-rheumatoid (seronegative) arthropathies. Ibuprofen is indicated for the treatment of non-rheumatic inflammatory conditions of the periarticular tissues such as frozen shoulder (inflammation of the lining of the joint), bursitis, tendinitis, tendovaginitis and low back pain. Ibuprofen can also be used to relieve pain from soft tissue injuries such as sprains. Ibuprofen is also indicated as an analgesic for mild to moderate pain in conditions such as dysmenorrhea, dental or postoperative pain, and for the symptomatic relief of headaches, including migraines. Contraindications – hypersensitivity to ibuprofen or any excipient included in the composition; – a history of bronchospasm, asthma, urticaria or rhinitis after taking acetylsalicylic acid or other non-steroidal anti-inflammatory drugs (NSAIDs); – hemorrhagic diathesis or diseases associated with impaired blood clotting; – disorders of hematopoiesis of unknown origin; – a history of gastrointestinal bleeding or perforation after the appointment of NSAIDs; – present or past recurrent peptic ulcer/bleeding (two or more confirmed episodes); – cerebrovascular bleeding or bleeding of other localization, which is currently available; – severe liver failure; – severe renal failure (with a decrease in the glomerular filtration rate less than 30 ml / min); – severe heart failure (NYHA stage IV); – severe dehydration (due to vomiting, diarrhea or insufficient fluid intake); – III trimester of pregnancy and breastfeeding; – children under 12 years of age or adolescents weighing less than 40 kg. Dosage and administration Apply orally, preferably between meals. In order to minimize the risk of developing adverse reactions, ibuprofen should be taken at the lowest effective dose and for the shortest period necessary to achieve a clinical effect. Ibuprofen MAX is prescribed for adults, as well as for children over 12 years old and weighing 40 kg or more. The dosage regimen is set individually and depends on the indications. Usually, adults and children over 12 years of age (whose body weight is 40 kg or more) ibuprofen is prescribed at an initial dose of 400 mg 1-2 times a day, if necessary, to achieve a therapeutic effect, the dose can be increased to 400 mg 3 times a day. It is not recommended to take more than 3 tablets in 24 hours (1200 mg). In case of missing the next dose of the drug, it is recommended to take the dose in accordance with the prescribed dosing regimen, without doubling the amount of the drug. Patients with renal insufficiency Based on pharmacokinetic data, in patients with mild to moderate renal impairment (creatinine clearance 30-80 ml / min), dose reduction is not required. In severe renal insufficiency (creatinine clearance < 30 ml / min), ibuprofen is contraindicated. Patients with hepatic insufficiency In patients with mild to moderate hepatic impairment, dose reduction is not required (use in severe hepatic impairment is contraindicated). Elderly patients No special dose adjustment is required with preserved renal function. However, given that the elderly are at increased risk of serious adverse reactions, it is recommended that the lowest effective therapeutic dose be given for the shortest possible time. During treatment, regular monitoring is necessary to exclude the occurrence of gastrointestinal bleeding. If renal function is impaired, the dosage should be adjusted individually. If treatment is required for more than 7 days, regular monitoring of kidney function is required. Children Considering that in children the maximum daily dose of ibuprofen is 20 mg/kg, it is inappropriate to prescribe ibuprofen in tablets of 400 mg to children and adolescents weighing less than 40 kg and under 12 years of age. If adults, children and adolescents from 12 to 18 years of age require ibuprofen for more than 3 days, or symptoms worsen, a doctor should be consulted. Side effects Adverse reactions are listed according to the classification of undesirable side effects in accordance with the damage to organs and organ systems and the frequency of development: very frequent (? 1/10), frequent (? 1/100 to < 1/10), infrequent (? 1/1000 to < 1/100), rare (? 1/10000 to < 1/1000), very rare (<1/10000), frequency not known (cannot be estimated from available data). From the gastrointestinal tract: often: dyspepsia, heartburn, abdominal pain, nausea, vomiting, flatulence, diarrhea or constipation, infrequently: ulcers of the stomach and intestines, which may be complicated by bleeding and perforation, ulcerative stomatitis, exacerbation of colitis and Crohn's disease, very rarely: esophagitis, pancreatitis. The risk of gastrointestinal bleeding depends on the dose and duration of ibuprofen use. If acute pain in the abdomen or bloody vomiting occurs, the patient should immediately consult a doctor. Liver and biliary tract disorders: very rare: liver dysfunction, especially with long-term therapy, liver failure, acute hepatitis. Immune system disorders: rarely: hypersensitivity reactions accompanied by rash and itching, as well as asthma attacks (sometimes with a drop in blood pressure), very rarely: severe general hypersensitivity reactions, the symptoms of which may be: swelling of the face, tongue and larynx, shortness of breath, tachycardia, arterial hypotension up to shock, Quincke's edema, bronchospasm and exacerbation of bronchial asthma. Nervous system disorders: Uncommon: Central nervous system disorders such as headache, dizziness, insomnia, agitation, irritability or fatigue. Psychiatric disorders: very rare: psychotic reactions, depression. On the part of the organs of vision: infrequently: visual impairment. Hearing and labyrinth disorders: rarely: tinnitus. Cardiac disorders: very rare: palpitations, heart failure, myocardial infarction. Epidemiological data indicate that the use of ibuprofen, especially at high doses (2400 mg / day), with long-term treatment may increase the risk of arterial thrombosis, which is the cause of myocardial infarction. Vascular disorders: very rare: arterial hypotension. Renal and urinary disorders: very rare: edema, especially in patients with arterial hypertension or renal insufficiency, nephrotic syndrome, interstitial nephritis, which may be accompanied by acute renal failure. In rare cases, there may be damage to the renal tissue (necrosis of the renal papillae) with an increase in the concentration of uric acid in the blood. Therefore, regular monitoring of kidney function is necessary. Skin and subcutaneous tissue disorders: very rare: bullous reactions, including Stevens-Jsonson syndrome and toxic epidermal necrolysis. With chickenpox, in exceptional cases, the development of severe skin infections and complications from the soft tissues is possible. Infectious and parasitic diseases: cases of exacerbation of inflammatory processes of infectious origin (for example, the development of necrotizing fasciitis) associated with the use of non-steroidal anti-inflammatory drugs have been described very rarely. Perhaps this is due to the mechanism of action of NSAIDs. If signs of infection occur or worsen while using ibuprofen, you should immediately consult a doctor. In this case, it can be determined whether there are indications for antibiotic therapy. Also, very rarely, symptoms of aseptic meningitis were observed during treatment with ibuprofen, manifested by neck stiffness, headache, nausea, vomiting, fever, or clouding of consciousness. Patients with autoimmune diseases (systemic lupus erythematosus, mixed collagenosis) are predisposed to the occurrence of such symptoms. Blood and lymphatic system disorders: very rare: hematopoietic disorders (anemia, leukopenia, thrombocytopenia, pancytopenia, agranulocytosis). The first signs may be: fever, sore throat, superficial sores in the mouth, flu-like complaints, severe fatigue, nosebleeds, and bleeding into the skin. In such cases, the patient should stop taking the medicine and consult a doctor. In long-term treatment, a complete blood count should be performed regularly. Precautions For short term treatment only. Due to the increased risk of ulcers and bleeding from the gastrointestinal tract, co-administration of ibuprofen with other NSAIDs (including selective cyclooxygenase-2 (COX-2) inhibitors should be avoided. Elderly There is an increased incidence of adverse reactions in older people , especially gastrointestinal bleeding and perforation of a gastric or duodenal ulcer, which can lead to death.Caution is required in conditions where the use of NSAIDs can lead to a deterioration in the condition of patients: in the presence of systemic lupus erythematosus or other systemic diseases connective tissue due to the risk of developing aseptic meningitis; with disorders of the gastrointestinal tract or with a history of chronic inflammatory bowel diseases (ulcerative colitis, Crohn's disease); with high blood pressure or heart failure; with impaired renal function (t .k in patients with with existing kidney disease, acute renal dysfunction may develop); with dehydration; with impaired liver function; immediately after major surgery; with pollen allergies, nasal polyps and chronic obstructive airway diseases, since these patients are at increased risk of allergic reactions. These reactions can manifest as asthma attacks (so-called analgesic asthma), angioedema, or urticarial rash. Gastrointestinal bleeding, ulceration, and perforation any time of treatment, with no warning symptoms, or with a history of serious gastrointestinal bleeding. The risk of gastrointestinal bleeding is higher with an increase in the dose of NSAIDs in patients with peptic ulcer, especially if it is complicated by hemorrhage or perforation, and in the elderly. These patients should be treated with the lowest tolerated dose. For such patients, combination therapy with protective agents (eg, proton pump inhibitors or misoprostol) should be considered. Patients with gastrointestinal disease, especially if they are elderly, should report any unusual abdominal symptoms (especially gastrointestinal bleeding), especially during the initial stages of treatment. Particular attention should be given to patients receiving concomitant medications that may increase the risk of ulceration or bleeding, such as oral corticosteroids, anticoagulants such as warfarin, selective serotonin reuptake inhibitors, or antiplatelet agents such as aspirin. If gastrointestinal bleeding or ulcers occur in patients receiving ibuprofen, treatment should be discontinued. NSAIDs should be used with caution in patients with ulcerative colitis or Crohn's disease, as exacerbations may occur. Skin reactions In very rare cases, the development of serious skin reactions (some of them fatal), such as exfoliative dermatitis, Stevens-Johnson syndrome, toxic epidermal necrolysis, has been reported. Association with the use of NSAIDs. Patients are at highest risk for these reactions during the first month of treatment. Ibuprofen should be discontinued at the first appearance of a skin rash, mucosal lesions, or any other sign of hypersensitivity. In special cases, against the background of chickenpox, severe infectious complications from the skin and soft tissues can develop. Because an association between these complications and NSAID use cannot be completely ruled out, ibuprofen is not recommended for varicella. Cerebrovascular and cardiovascular effects Epidemiological studies do not suggest a relationship between taking low doses of ibuprofen (? 1200 mg / day) and an increased risk of developing arterial thrombotic events. Patients with uncontrolled hypertension, NYHA class II-III congestive heart failure, established coronary artery disease, peripheral arterial disease, and/or cerebrovascular disease should only be treated with ibuprofen after a careful benefit-risk assessment. Similar considerations should be made before initiating long-term ibuprofen therapy in patients with risk factors for cardiovascular complications (eg, hypertension, hyperlipidemia, diabetes mellitus, smoking). Persons with pathology of the blood system. In patients with impaired hemostasis, careful monitoring of laboratory parameters is necessary. With prolonged use, systematic monitoring of peripheral blood is indicated. With prolonged use of painkillers, headaches may occur, which cannot be treated with an increase in the dose of drugs. In general, frequent, "habitual" use of painkillers, especially the use of a combination of several painkillers, can lead to the development of irreversible kidney damage, accompanied by a risk of kidney failure ("analgesic" nephropathy). Pregnancy The use of ibuprofen during pregnancy is possible only under strict medical indications. The drug should be taken at the lowest effective dose. The use of ibuprofen can adversely affect pregnancy and intrauterine development of the fetus. There may be an increased risk of miscarriage and malformations of the heart and gastrointestinal tract after the use of ibuprofen in early pregnancy. During the first and second trimesters of pregnancy, ibuprofen should be avoided unless absolutely necessary. During the third trimester of pregnancy, the use of ibuprofen is contraindicated. Lactation Ibuprofen passes into breast milk, so when using it, it is necessary to provide for the termination of breastfeeding for the entire period of treatment. Fertility Ibuprofen may have a negative effect on a woman's ability to become pregnant. Ibuprofen should be considered separately for women who have difficulty conceiving and/or who are being treated for infertility. Influence on the ability to drive vehicles and control mechanisms During the period of use, it is necessary to refrain from all types of activities that require increased attention, quick mental and motor reactions, since after taking ibuprofen, side effects such as dizziness, drowsiness, fatigue and visual impairment may occur. During the treatment period, it is not recommended to take alcoholic beverages. Cherry and currant juice, sugar syrup increase the rate of absorption of ibuprofen. When using ibuprofen, there is an increased risk of developing complications from the kidneys in patients in whom the production of prostaglandins has a compensatory role for maintaining renal blood flow (dehydration, impaired renal and hepatic function, heart failure, severe atherosclerosis, taking diuretics, angiotensin-converting enzyme inhibitors, old age ). When prescribing ibuprofen for more than one week to elderly patients, patients with arterial hypertension and diabetes mellitus, monitoring of renal function should be ensured during the first week of administration. When prescribing ibuprofen to patients with chronic heart failure of the functional class III-IV according to the New York classification and chronic renal failure with a glomerular filtration rate of less than 60 ml / min, it is necessary to monitor serum creatinine after 48-72 hours from the start of taking the drug. Interaction with other drugs Antihypertensive, beta-blockers and diuretics: NSAIDs may reduce the effect of antihypertensive drugs such as angiotensin-converting enzyme inhibitors, beta-blockers and diuretics. Diuretics may also increase the risk of NSAID nephrotoxicity. Digoxin, phenytoin, lithium: with simultaneous administration with ibuprofen, an increase in the concentration of these substances in the blood plasma is possible. Control of the concentration of digoxin, lithium and phenytoin with the correct appointment of ibuprofen (maximum within 4 days), as a rule, is not required. When taken concomitantly with corticosteroids, the risk of gastrointestinal ulcers and bleeding increases. Cholestyramine, when co-administered with ibuprofen, may reduce the absorption of ibuprofen in the gastrointestinal tract. Simultaneous administration with lithium salts leads to a decrease in lithium excretion. Methotrexate: NSAIDs can inhibit tubular secretion of methotrexate and reduce the clearance of methotrexate. Cyclosporine: increased risk of nephrotoxicity. Mifepristone: The decrease in the effectiveness of the drug could theoretically be due to the antiprostaglandin effect of NSAIDs. Limited evidence suggests that co-administration of NSAIDs on the day of prostaglandin administration does not adversely affect the effect of mifepristone or prostaglandins on cervical maturation and does not reduce the clinical efficacy of drug-induced abortion. Other analgesics and selective cyclooxygenase-2 inhibitors: it is recommended to avoid the simultaneous use of two or more NSAIDs, including COX-2 inhibitors, as this may increase the risk of side effects. Aspirin: The concomitant use of ibuprofen and aspirin is not recommended due to possible increased side effects, including an increased risk of gastrointestinal ulcers or bleeding. Experimental evidence suggests that ibuprofen may inhibit the effect of low-dose aspirin on platelet aggregation when they are dosed simultaneously. Anticoagulants: NSAIDs may increase the effect of anticoagulants such as warfarin. Fluoroquinolones: Patients taking NSAIDs and quinolones concomitantly may be at increased risk of seizures. Sulfonylureas: ibuprofen may increase the hypoglycemic effect of sulfonylureas. Antiplatelet agents and selective serotonin reuptake inhibitors (SSRIs): Increased risk of gastrointestinal bleeding when co-administered with NSAIDs. Tacrolimus: Possible increased risk of ibuprofen nephrotoxicity when used concomitantly with tacrolimus. Zidovudine: increased risk of haematological toxicity when used concomitantly with zidovudine. Aminoglycosides: NSAIDs may reduce the excretion of aminoglycosides. Plant extracts: Ginkgo biloba may increase the risk of bleeding when used with NSAIDs. CYP2C9 inhibitors: Concomitant use of ibuprofen with CYP2C9 inhibitors may increase the duration of action of ibuprofen (CYP2C9 substrate). It has been shown that the simultaneous administration of ibuprofen with voriconazole and fluconazole (CYP2C9 inhibitors) leads to an increase in the time of action of ibuprofen by approximately 80-100%. Dose reduction of ibuprofen should be considered when co-administered with strong CYP2C9 inhibitors, especially when high doses of ibuprofen are co-administered with voriconazole or fluconazole. OverdoseSymptoms: a typical clinical picture with an overdose of ibuprofen does not develop. Perhaps the appearance of abdominal pain, nausea, vomiting, dizziness, lethargy, drowsiness, depression, headache, hypotension, convulsions, cardiac arrhythmias, acute renal failure, respiratory depression. Treatment: assistance measures include drug withdrawal, supportive and symptomatic therapy aimed at eliminating the disorders that have arisen, and correcting the acid-base state. It is possible to carry out forced diuresis with the simultaneous administration of alkaline drink, activated charcoal, to reduce the reabsorption of ibuprofen. There is no specific antidote. Gastric lavage is effective only in those hours after taking the drug. Upakovka10 tablets in a blister pack of PVC film and aluminum foil. 1 or 2 blister packs together with a leaflet are placed in a pack of cardboard (No. 10x1, No. 10x2). Storage conditions In a place protected from light and moisture, at a temperature not exceeding 25 ° C. Keep out of the reach of children. Shelf life 2 years. Do not use after the expiration date. Terms of releaseBy prescription. Buy Ibuprofen MAX tablets p/o 400mg No. 10x1 Price for Ibuprofen MAX tablets p/o 400mg No. 10x1