Nurofen Forte 400mg N12 coated pills
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Active ingredients
Ibuprofen
Release form
Pills
Composition
Active ingredient: ibuprofen. Concentration of active ingredient (mg): 400 mg
Pharmacological effect
Absorption - high, connection with plasma proteins (mainly albumin) - more than 90%. A high degree of protein binding results in a relatively low volume of distribution (0.1 L / kg). Although ibuprofen is actively associated with albumin, it does not affect drug interactions. The time to reach maximum plasma concentration Ttah - 1-2 hours. The half-life is 2 hours. In the elderly (over 65 years), the half-life of the drug is increased, the total clearance is reduced. According to some data, babies aged 6–18 months have a higher Tmax (3 hours). It is believed that in children the half-life of ibuprofen does not differ significantly from the value established for adults. Eating slows down the absorption of ibuprofen, but does not reduce its bioavailability. When taken with food, Tmax is increased by 30-60 minutes compared with fasting and is 1.5-3 hours. Ibuprofen slowly penetrates into the cavity of the joints, is retained in the synovial tissue, creating in it greater concentrations than in the plasma; The maximum concentration is observed after 5-6 hours after administration. Cerebrospinal fluid shows lower concentrations of ibuprofen compared to plasma. After absorption, about 60% of the pharmacologically inactive R-form slowly transforms into the active S-form in the gastrointestinal tract and liver. It is metabolized in the liver to form 4 metabolites. Excreted by the kidneys (70-90% of the administered dose in the form of ibuprofen and its metabolites; in unchanged form, no more than 1%) and, to a lesser extent, with bile (less than 2%). Excretion of metabolites with urine usually ends 24 hours after the last dose. The total excretion of ibuprofen and its metabolites in the urine is linearly dependent on the dosage. At the age of 2 months, the kidneys are well developed enough to cope with the elimination of ibuprofen by glomerular filtration. The study, which included 49 children aged 3 months to 12 years, showed no age-dependent differences in the rate of absorption and elimination of ibuprofen.
Pharmacokinetics
The drug belongs to nonsteroidal anti-inflammatory drugs (NSAIDs). Nurofen has anesthetic, antipyretic and anti-inflammatory effect. Indiscriminately blocks TsOG1 and TsOG2. The mechanism of action of ibuprofen is due to inhibition of the synthesis of prostaglandins - mediators of pain, inflammation and hyperthermic reaction. A decrease in temperature during fever begins 30 minutes after ingestion, its maximum effect is manifested after 3 hours. The leading analgesic mechanism is the reduction of prostaglandin production of classes E, F and I, biogenic amines, which leads to the prevention of the development of hyperalgesia at the level of changes in the sensitivity of nociceptors. The analgesic effect is most pronounced inflammatory in nature. The analgesic effect is felt within 15 minutes after taking ibuprofen. Anti-inflammatory effect due to inhibition of cyclooxygenase (COX) activity. As a result, the synthesis of prostaglandins in inflammatory foci. This leads to a decrease in the secretion of inflammatory mediators and a decrease in the activity of the exudative and proliferative phases of the inflammatory process.
Indications
Nurofen Forte is used for headaches, migraines, toothache, painful menstruation, neuralgia, back pain, muscle pain, rheumatic pain and pain in the joints. as well as in a feverish state with influenza and catarrhal diseases.
Contraindications
Hypersensitivity to ibuprofen or any of the components that make up the drug. A complete or incomplete combination of asthma, recurrent nasal polyposis and paranasal sinuses, and intolerance to acetylsalicylic acid or other NSAIDs (including a history of). Erosive and ulcerative diseases of the gastrointestinal tract (including gastric ulcer and duodenal ulcer, Crohn's disease, ulcerative colitis) or ulcer bleeding in the active phase or in history (two or more confirmed episodes of peptic ulcer or ulcer bleeding) A bleeding or perforation of a gastrointestinal ulcer in history, provoked by the use of NSAIDs. Severe liver failure or liver disease in the active phase.Severe renal failure (creatinine clearance less than 30 mlmin), confirmed hyperkalemia. Decompensated heart failure. period after aortic shunting. Cerebrovascular or other bleeding. Fructose intolerance, glucose-galactose malabsorption, sucrase-isomaltase deficiency. Hemophilia and other bleeding disorders (including hypocoagulation), hemorrhagic diathesis. Pregnancy (III trimester). Children's age up to 12 years.
Precautionary measures
Nurofen is prescribed with caution in patients with heart failure, arterial hypertension, blood clotting disorders, and renal and / or liver function disorders. Care should be taken when using the drug in patients with bronchial asthma and other obstructive pulmonary diseases due to the risk of bronchospasm. Patients with diseases of the gastrointestinal tract (ulcerative colitis, Crohn's disease) should be carefully prescribed NSAIDs due to the possible exacerbation of these diseases. With caution, the drug is prescribed for elderly patients, since they more often have adverse side effects on NSAIDs, mainly gastrointestinal bleeding and perforation, which can lead to a sharp deterioration. Patients with gastrointestinal toxicity in history, especially elderly patients, should report any unusual abdominal symptom (especially gastrointestinal bleeding), especially if the symptom is observed at the initial stage of taking the drug. If patients with gastrointestinal bleeding develop on the background of the drug, it is urgent to stop taking the drug. The simultaneous use of Nurofen and other NSAIDs, including selective cyclooxygenase-2 inhibitors, should be avoided. Systemic lupus erythematosus, as well as mixed connective tissue diseases contribute to an increased risk of aseptic meningitis. There is some evidence that drugs that inhibit the synthesis of cyclogenase / prostaglandins can cause impaired fertility in women, affecting ovulation. This phenomenon is reversible with drug withdrawal.The drug should not be administered to patients with fructose intolerance, with the syndrome of glucose-galactose malabsorption or sucrase-isomaltase deficiency. Two Nurofen pills contain 25.3 mg of sodium, which should be taken into account in patients who are on a controlled sodium diet. During long-term treatment, it is necessary to control the picture of peripheral blood and the functional state of the liver and kidneys. When symptoms of gastropathy appear, a careful monitoring is shown, including esophagogastroduodenoscopy, complete blood count (hemoglobin determination), fecal occult blood test. If necessary, determine the 17-ketosteroids drug should be canceled 48 hours before the study. Patients should refrain from all activities related to driving and working with moving machinery, as well as from other potentially dangerous activities related to concentration and increased speed of psychomotor reactions. During the period of treatment should refrain from the use of alcoholic beverages. When used in children aged 6 to 12 years, it should be borne in mind that pills can not be divided, and therefore can be used only in those children who have a single dose of at least 1 tablet.
Use during pregnancy and lactation
Use of the drug during pregnancy is possible only under the supervision of a physician. Use of the drug during the I and II trimesters is undesirable, but possible with caution. If Nurofen is used by a woman who is planning a pregnancy, or by a woman in the I and II trimester of pregnancy, then the smallest effective dose and short periods of treatment should be chosen. Use during the III trimester is contraindicated. The use of the drug during lactation is not recommended. In a number of studies, ibuprofen has been found in breast milk at very low concentrations, and its effect on infants is unlikely.
Dosage and administration
For oral administration. Patients with hypersensitivity of the stomach are advised to take the drug with meals. For short term use only. Carefully read the instructions before taking the drug. Adults and children over 12 years old with 1 tablet (400 mg) up to 3 times a day. Tablets should be taken with water.The interval between taking pills should be at least 6 hours. The maximum daily dose is 1200 mg (3 pills). The maximum daily dose for children from 12 to 18 years old is 800 mg (2 pills). If while taking the drug for 2-3 days the symptoms persist or worsen, it is necessary to stop treatment and consult a doctor.
Side effects
The risk of side effects can be minimized if you take the drug in a short course, at the minimum effective dose necessary to eliminate the symptoms. In older people, there is an increased incidence of adverse reactions against the background of the use of NSAIDs, especially gastrointestinal bleeding and perforations, in some cases with a fatal outcome. Side effects are predominantly dose dependent. The following adverse reactions were observed with short-term ibuprofen in doses not exceeding 1200 mg per day (3 pills). In the treatment of chronic conditions and long-term use may cause other adverse reactions. The frequency of adverse reactions was estimated based on the following criteria: very frequent (≥110), frequent (from ≥1100 to less than 110), infrequent (from ≥11000 to less than 1100), rare (from ≥110,000 to less than 11000), very rare (less than 110,000), frequency unknown (data on frequency estimates are not available). Violations of the blood and lymphatic system. Very rare: disorders of blood formation (anemia, leukopenia, aplastic anemia, hemolytic anemia, thrombocytopenia, pancytopenia, agranulocytosis). The first symptoms of such disorders are fever, sore throat, superficial oral ulcers, flu-like symptoms, severe weakness, bleeding from the nose and subcutaneous hemorrhages, hemorrhages and hemorrhages of unknown etiology. Immune system disorders. Infrequent: hypersensitivity reactions - non-specific allergic reactions and anaphylactic reactions, reactions of the respiratory tract (bronchial asthma, including its exacerbation, bronchospasm, shortness of breath, dyspnea), skin reactions (pruritus, urticaria, purpura, Quincke edema, exfoliative and bullama , including toxic epidermal necrolysis (Lyell's syndrome), Stevens-Johnson syndrome, erythema multiforme), allergic rhinitis, eosinophilia. Very rare: severe hypersensitivity reactions, including edema of the face, tongue and larynx, shortness of breath, tachycardia, hypotension (anaphylaxis, angioedema or severe anaphylactic shock).Violations of the gastrointestinal tract. Infrequent: abdominal pain, nausea, dyspepsia (including heartburn, bloating). Rare: diarrhea, flatulence, constipation, vomiting. Very rare: peptic ulcer, perforation or gastrointestinal bleeding, melena, bloody vomiting, in some cases with a lethal outcome, especially in elderly patients, ulcerative stomatitis, gastritis. Frequency unknown: exacerbation of colitis and Crohn's disease. Violations of the liver and biliary tract. Very rare: abnormal liver function, increased activity of "liver" transaminases, hepatitis and jaundice. Disturbances from the kidneys and urinary tract. Very rare: acute renal failure (compensated and decompensated) especially with prolonged use, in combination with an increase in plasma urea concentration and the appearance of edema, hematuria and proteinuria, nephritic syndrome, nephrotic syndrome, papillary necrosis, interstitial nephritis, cystitis. Violations of the nervous system. Infrequent: headache. Very rare: aseptic meningitis. Violations of the cardiovascular system. The frequency is unknown: heart failure, peripheral edema, with long-term use increased risk of thrombotic complications (eg, myocardial infarction), increased blood pressure. Violations of the respiratory system and mediastinal organs. Frequency unknown: bronchial asthma, bronchospasm, shortness of breath. Laboratory indicators: hematocrit or hemoglobin (may decrease), bleeding time (may increase), glucose concentration in blood plasma (may decrease), creatinine clearance (may decrease), plasma creatinine concentration (may increase), liver transaminase activity (may to rise). If you experience side effects, you should stop taking the drug and consult a doctor.
Overdose
Symptoms: abdominal pain, nausea, vomiting, lethargy, headache, tinnitus, metabolic acidosis, coma, acute renal and hepatic failure, gastrointestinal bleeding, low blood pressure (BP), bradycardia, tachycardia, atrial fibrillation, arrest respiration, increased prothrombin time, seizures are rarely possible.Treatment: during the first hour after taking the drug, gastric lavage and taking activated carbon. Alkaline drink, forced diuresis, and symptomatic therapy are also recommended. In the case of frequent or prolonged seizures, it is necessary to use anticonvulsant drugs (diazepam or lorazepam intravenously).
Interaction with other drugs
It is not recommended to take NUROFEN pills with acetylsalicylic acid (aspirin) at the same time, if taking low-dose aspirin (not exceeding 75 mg per day) is not recommended by the doctor, since it increases the risk of adverse side effects. When taken simultaneously, ibuprofen can inhibit the effects of low doses of aspirin on platelet aggregation. You should also avoid taking two or more NSAIDs at the same time, including selective cyclooxygenase-2 inhibitors, as this may increase the risk of side effects. When administered with anticoagulant and thrombolytic drugs (alteplazy, streptokinase, urokinase), the risk of bleeding increases at the same time. Cefamendol, cefaperazon, cefotetan, valproic acid, plicamycin, increase the incidence of hypoprothrombinemia. Cyclosporine and gold preparations increase the effect of ibuprofen on the synthesis of prostaglandins in the kidneys, which is manifested by an increased risk of nephrotoxicity. Ibuprofen increases the plasma concentration of cyclosporine and the likelihood of its hepatotoxic effects. Do not use NSAIDs for 8-12 days after taking mifepristone, as NSAIDs can reduce the effect of mifepristone. At the same time taking NSAIDs and tacrolimus may increase the risk of nephrotoxicity. At the same time taking NSAIDs and zidovudine increases the risk of hematological toxicity. Patients taking NSAIDs and quinolones, increases the risk of seizures. Drugs that block tubular secretion, reduce excretion and increase the plasma concentration of ibuprofen. Inductors of microsomal oxidation (phenytoin, ethanol, barbiturates, rifampicin, phenylbutazone, tricyclic antidepressants) increase the production of hydroxylated active metabolites, increasing the risk of developing severe hepatotoxic reactions.Inhibitors of microsomal oxidation - reduce the risk of hepatotoxic action. Reduces the hypotensive activity of vasodilators, natriuretic in furosemide and hydrochlorothiazide. Reduces the effectiveness of uricosuric drugs, enhances the effect of indirect anticoagulants, antiplatelet agents, fibrinolytics. Strengthens the side effects of mineral corticosteroids, glucocorticosteroids, estrogens, ethanol. Enhances the effect of oral hypoglycemic drugs, sulfonylurea derivatives and insulin. Antacids and colestyramine reduce absorption. Increases blood concentration of digoxin, lithium preparations, methotrexate. Caffeine enhances the analgesic effect.