Ibuprofen tablets p/o 200mg №10×5

Name Ibuprofen tabl. Composition One tablet contains: active ingredient: ibuprofen – 200 mg; excipients: potato starch, magnesium stearate, calcium stearate, povidone, opadra series 85 (G) (including polyvinyl alcohol, partially hydrolyzed; talc; macrogol 3350 (polyethylene glycol); lecithin (soy); titanium dioxide E 171). Pharmacotherapeutic groupNon-steroidal anti-inflammatory and antirheumatic drugs. Derivatives of propionic acid. ATX code: M01AE01. Pharmacological properties Pharmacodynamics Ibuprofen is a derivative of propionic acid and has analgesic, anti-inflammatory, antipyretic effects. Inhibits cyclooxygenase I and II, blocking the synthesis of prostaglandins. Experimental data show that ibuprofen can inhibit the effects of low doses of aspirin when taken concomitantly. In one study, when a single dose of ibuprofen 400 mg was taken within 8 hours before or within 30 minutes after taking aspirin (81 mg), there was a decrease in the effect of aspirin on thromboxane formation and platelet aggregation. However, the limitations of these data and uncertainty regarding extrapolation of ex vivo data implies that there are no firm conclusions for regular ibuprofen use and clinically significant effects are not likely with occasional ibuprofen use. Pharmacokinetics Ibuprofen is rapidly absorbed from the gastrointestinal tract, the maximum plasma concentration is observed 1-2 hours after ingestion. The half-life is about 2 hours. Ibuprofen is metabolized in the liver, excreted by the kidneys unchanged or in the form of conjugates. Excretion by the kidneys is rapid and complete. Ibuprofen binds well to plasma proteins. 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 processes of the periarticular tissues, such as “frozen” shoulder (inflammation of the joint membrane), bursitis, tendonitis, tendovaginitis and 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. Ibuprofen is used as an antipyretic. Contraindications Ibuprofen is contraindicated in patients with hypersensitivity to the active or excipients of the drug. Ibuprofen should not be used in patients who have previously experienced hypersensitivity reactions (eg, asthma, urticaria, angioedema, or rhinitis) after taking ibuprofen, aspirin, or other NSAIDs. Ibuprofen is also contraindicated in patients with a history of gastrointestinal bleeding or perforation associated with previous ibuprofen therapy. Ibuprofen should not be used in patients with recurrent peptic ulcer or gastrointestinal bleeding (two or more episodes of proven ulceration or bleeding). Ibuprofen should not be administered to patients with conditions associated with an increased bleeding tendency. Ibuprofen is contraindicated in patients with severe heart failure, liver and kidney failure. Ibuprofen is contraindicated during the last trimester of pregnancy. Route of administration and doses For oral administration. It is advisable to use during or after a meal with water. Tablets should be swallowed whole, not chewed, broken or crushed to avoid discomfort and irritation of the throat. Side effects can be minimized by using the lowest effective dose for a short time. For the treatment of rheumatoid arthritis, ankylosing spondylitis, osteoarthritis, non-rheumatoid (seronegative) arthropathies, non-rheumatic inflammatory processes of the periarticular tissues (“frozen” shoulder, bursitis, tendinitis, tendovaginitis and back pain): Adults: the recommended dosage of ibuprofen is 1200-1800 mg per day , in several steps. Some patients may take 600-1200 mg of ibuprofen per day. In severe or acute conditions, the dosage can be increased, provided that the total daily dose does not exceed 2400 mg, in divided doses. Children: The daily dose of ibuprofen is 20 mg/kg of body weight, taken in divided doses. In juvenile rheumatoid arthritis, the dose may be increased to 40 mg/kg body weight in divided doses. Not recommended for children weighing less than 7 kg. Elderly patients: at increased risk of side effects. If NSAIDs are required, ibuprofen should be used at the lowest effective dose for the shortest duration. The patient should regularly check the absence of gastrointestinal bleeding while taking NSAIDs. In the presence of renal or hepatic insufficiency, the dosage should be determined individually. For the relief of mild to moderate pain in dysmenorrhea, postoperative pain, symptomatic treatment of headaches: Children, adolescents 12-18 years old and adults: 1-2 tablets, if necessary, up to 3 times a day. The period between doses of the drug should be at least 4 hours. Do not take more than 6 tablets per day. As an antipyretic: 1 tablet, as needed, up to 3 times daily. Side effects From the gastrointestinal tract: the most commonly observed adverse reactions are gastrointestinal. Peptic ulcer, perforation or gastrointestinal bleeding, sometimes fatal, especially in the elderly. Nausea, vomiting, diarrhea, flatulence, constipation, dyspepsia, abdominal pain, melena, hematemesis, ulcerative stomatitis, exacerbation of colitis and Crohn’s disease have been reported after ibuprofen use. Rarely developed gastritis. Rarely – perforation of the wall of the gastrointestinal tract. Very rarely – pancreatitis. From the immune system: hypersensitivity reactions have been reported after taking NSAIDs. In particular: non-specific allergic reaction and anaphylaxis; violation of the reactivity of the respiratory tract (asthma, bronchospasm or shortness of breath); a variety of skin manifestations (rash of various types, itching, urticaria, purpura, Quincke’s edema and, less commonly, exfoliative and bullous dermatoses (including Stevens-Johnson syndrome, toxic epidermal necrolysis and erythema multiforme)). From the side of the cardiovascular system: edema, hypertension and manifestations of heart failure have been reported in the treatment of NSAIDs. Epidemiological data suggest that the use of ibuprofen, especially at high doses (2400 mg/day), in long-term treatment, may cause a slight increase in the risk of arterial thrombosis causing myocardial infarction or stroke. From the blood and lymphatic system: leukopenia, thrombocytopenia, neutropenia, agranulocytosis, aplastic anemia and hemolytic anemia. Mental disorders: insomnia, anxiety, depression, confusion, hallucinations. Nervous system disorders: optic neuritis, headache, paresthesia, dizziness, drowsiness. Infections and invasions: rhinitis and aseptic meningitis (especially in patients with pre-existing autoimmune disorders such as systemic lupus erythematosus and mixed connective tissue diseases) with symptoms of neck stiffness, headache, nausea, vomiting, fever or confusion. On the part of the organ of vision: visual impairment and toxic neuropathy of the optic nerve. From the ear and vestibular apparatus: hearing loss, tinnitus and dizziness. On the part of the hepatobiliary system: abnormal liver function, liver failure, hepatitis and jaundice On the part of the skin and subcutaneous tissue: Stevens-Johnson syndrome and toxic epidermal necrolysis (very rarely), photosensitivity reactions. From the side of the kidneys and urinary tract: impaired renal function and toxic nephropathy in various forms, including interstitial nephritis, nephrotic syndrome and renal failure. General disorders: malaise, fatigue. Precautions Like other NSAIDs, ibuprofen may mask the symptoms of an infection. The use of ibuprofen in combination with other NSAIDs, including selective cyclooxygenase-2 inhibitors, should be avoided due to an increased risk of ulcers or bleeding. Elderly patients: Elderly patients have an increased incidence of adverse reactions to NSAIDs, especially gastrointestinal bleeding and perforation, which can be fatal. Bleeding, ulceration, or perforation, which can be fatal, has been reported with all NSAIDs. The risk of gastrointestinal bleeding, ulceration or perforation increases with increasing dose of NSAIDs, especially in patients with a history of peptic ulcer disease, as well as in elderly patients. These patients should start treatment with the lowest dose. Combination therapy with protective agents (eg, misoprostol, proton pump inhibitors) should be considered for these patients and for patients requiring aspirin or other agents that may increase the risk of gastrointestinal bleeding. Patients with a history of gastrointestinal disease, in particular the elderly, should report any unusual stomach pain (especially gastrointestinal bleeding), especially at the initial stage of treatment. Caution should be exercised when taking the drug in patients with concomitant drug therapy that increases the risk of ulcers or bleeding (oral corticosteroids, anticoagulants such as warfarin, serotonin reuptake inhibitors or antiplatelet drugs such as aspirin). If gastrointestinal bleeding or ulcers occur in patients taking ibuprofen, treatment should be discontinued. NSAIDs should be used with caution in patients with a history of ulcerative colitis or Crohn’s disease. Patients with or with a history of asthma should be cautious when taking ibuprofen. In patients with cardiac disorders, impaired liver function, elderly patients, and those taking diuretics, it is necessary to monitor renal function. Ibuprofen should be used with caution in patients with a history of heart failure and hypertension. Appropriate monitoring and consultation is necessary for patients with hypertension and / or moderate heart failure, as fluid retention and edema are possible when taking NSAIDs. Epidemiological data indicate that the use of ibuprofen, especially at high doses (2400 mg daily) for a long time, may be associated with a slight increase in the risk of arterial thrombotic events such as myocardial infarction or stroke. In general, epidemiological studies do not suggest that low-dose ibuprofen (eg, <1200 mg daily) is associated with an increased risk of arterial thromboembolic events, in particular myocardial infarction. Patients with uncontrolled hypertension, congestive heart failure, ischemic heart disease, peripheral arterial disease, or cerebrovascular disease should take ibuprofen after careful counseling. Such counseling should be given prior to initiating treatment in patients with risk factors for cardiovascular disease (eg, hypertension, hyperlipidaemia, diabetes mellitus, smoking). Ibuprofen should be used with caution in patients with significant dehydration. Like other NSAIDs, long-term use of ibuprofen can lead to papillary renal necrosis and other pathological renal changes. In connection with the use of NSAIDs, the development of serious skin reactions, some with a fatal outcome, including exfoliative dermatitis, Stevens-Johnson syndrome, toxic epidermal necrolysis, is possible. In most cases, these reactions occurred within the first month of treatment. The drug should be discontinued at the first appearance of a skin rash, mucosal injury or signs of hypersensitivity. Ibuprofen, like other NSAIDs, affects platelet aggregation and increases bleeding time. Aseptic meningitis is observed in relatively rare cases in patients taking ibuprofen. Aseptic meningitis is more likely to occur in patients with systemic lupus erythematosus and connective tissue disease, but has also been reported in patients without chronic disease. The drug can lead to impaired female fertility, which should be taken into account by women who have difficulty conceiving. Pregnancy Suppression of prostaglandin synthesis can adversely affect pregnancy and fetal development. Data from epidemiological studies show an increased risk of miscarriage and malformations of the heart and gastrointestinal tract after the use of prostaglandin synthesis inhibitors in early pregnancy. It has been shown in animals that the administration of prostaglandin synthesis inhibitors leads to an increase in pre- and post-implantation mortality of the embryo and fetus. In addition, in animals treated with inhibitors of prostaglandin synthesis during organogenesis, the frequency of various malformations, including those of the cardiovascular system, increases. During the first and second trimesters of pregnancy, ibuprofen should be avoided unless absolutely necessary. When planning pregnancy, in the first or second trimesters of pregnancy, the dose of ibuprofen prescribed should be as low as possible, and the duration of treatment as short as possible. During the third trimester of pregnancy, the use of any inhibitors of prostaglandin synthesis can lead to the following: cardiopulmonary toxicity (with premature closure of the ductus arteriosus and pulmonary hypertension); impaired renal function, which can progress to renal failure with oligohydramnios. At the end of pregnancy, prostaglandin synthesis inhibitors may put mother and newborn at risk due to: the possibility of prolonging bleeding time; inhibition of uterine contractions, which can lead to delayed or prolonged labor. Therefore, ibuprofen is contraindicated during the third trimester of pregnancy. Lactation Limited studies have found that NSAIDs can be observed in breast milk at very low concentrations. While taking NSAIDs, breastfeeding should be avoided whenever possible. Influence on the ability to drive vehicles and other potentially dangerous mechanisms After taking NSAIDs, side effects may occur, such as dizziness, drowsiness, fatigue and visual impairment. Patients should refrain from all activities that require increased attention, rapid mental and motor reactions Interaction with other drugs Care should be taken in patients taking any of the following drugs. Antihypertensives, beta-blockers, and diuretics: NSAIDs may reduce the effect of antihypertensive drugs such as angiotensin-converting enzyme (ACE) inhibitors, beta-blockers, and diuretics. Diuretics may also increase the risk of NSAID nephrotoxicity. Cardiac glycosides: NSAIDs may exacerbate heart failure, reduce glomerular filtration rate (GFR), and increase plasma concentrations of cardiac glycosides. Cholestyramine: When administered concomitantly with ibuprofen, it may reduce the absorption of ibuprofen from the gastrointestinal tract. Lithium: 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 medical termination of pregnancy. Other analgesics and selective cyclooxygenase-2 (COX-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 the possible increase in 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. Corticosteroids: There is an increased risk of gastrointestinal ulcers and bleeding when taking corticosteroids with NSAIDs. Anticoagulants: NSAIDs may increase the effect of anticoagulants such as warfarin. Quinolone antibiotics: Patients taking NSAIDs and quinolones concomitantly may be at increased risk of seizures. Sulfonylureas: NSAIDs may enhance the hypoglycemic effect of sulfonylureas. Antiplatelet agents and selective serotonin reuptake inhibitors (SSRIs): increased risk of gastrointestinal bleeding when co-administered with NSAIDs. Cyclosporine: Possible increased risk of nephrotoxicity when NSAIDs are used concomitantly with cyclosporine. Zidovudine: increased risk of haematological toxicity when NSAIDs are co-administered with zidovudine. There is an increased risk of hematomas in HIV (+) patients receiving concomitant treatment with zidovudine and ibuprofen. Aminoglycosides: NSAIDs may reduce the excretion of aminoglycosides. Herbal 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. Overdose Toxicity: Signs and symptoms of toxicity are generally not observed at doses below 100 mg/kg in children and adults. However, in some cases, maintenance therapy may be necessary. In children, signs and symptoms of toxicity are observed when taking ibuprofen at a dose of 400 mg / kg and above. Symptoms: Most patients taking significant amounts of ibuprofen developed symptoms within 4-6 hours. The most common symptoms of an overdose are nausea, vomiting, abdominal pain, lethargy, and drowsiness. Symptoms from the central nervous system: headache, tinnitus, dizziness, convulsions, loss of consciousness. Rare: nystagmus, metabolic acidosis, hypothermia, renal effects, gastrointestinal bleeding, coma, apnea, diarrhea, central nervous system and respiratory depression. Confusion, agitation, loss of consciousness, and cardiovascular toxicity, including hypotension, bradycardia, and tachycardia, have also been noted. In cases of significant overdose, renal failure and liver damage are possible. A significant overdose is usually well tolerated if no other drugs have been taken. Treatment: symptomatic. Within an hour after an overdose, it is necessary to take activated charcoal, as well as gastric lavage (adults). Kidney and liver function should be carefully monitored. Forced diuresis is shown. Patients should be observed within 4 hours of taking potentially toxic doses of ibuprofen. Frequent or prolonged seizures can be treated with intravenous diazepam. Other treatments may be prescribed based on the patient's clinical symptoms. Upakovka10 tablets in a blister pack of PVC film and aluminum foil. 3 or 5 blister packs in a carton pack together with a leaflet (No. 10? 3, No. 10? 5). For a hospital 500 blister packs in a cardboard box along with 10 instructions. Storage conditions In a place protected from light and moisture, at a temperature not exceeding 30? Keep out of the reach of children. Shelf life 3 years. Do not use after the expiration date. Conditions for dispensing from pharmaciesWithout a prescription. Buy Ibuprofen tablets p/o 200mg No. 10x5