In children, symptoms of overdose may occur after taking a dose exceeding 400 mg/kg. In adults, the dose-dependent effect of overdose is less pronounced. T1/2 the drug in case of overdose is 1.5–3 hours.
Symptoms: nausea, vomiting, epigastric pain, or less commonly, diarrhea, tinnitus, headache, and gastrointestinal bleeding. In more severe cases, there are manifestations from the central nervous system: drowsiness, rarely-agitation, convulsions, disorientation, coma. In cases of severe poisoning, metabolic acidosis and increased PV, renal failure, damage to liver tissue, decreased blood pressure, respiratory depression and cyanosis may develop. In patients with bronchial asthma, an exacerbation of this disease is possible.
Treatment: symptomatic, with mandatory airway patency, ECG monitoring and basic vital signs until the patient's condition is normalized. Oral administration of activated charcoal or gastric lavage for 1 hour after taking a potentially toxic dose of ibuprofen is recommended. If ibuprofen has already been absorbed, an alkaline drink may be prescribed in order to remove the acidic ibuprofen derivative by the kidneys, forced diuresis. Frequent or prolonged seizures should be stopped by intravenous administration of diazepam or lorazepam. When bronchial asthma worsens, the use of bronchodilators is recommended
Symptoms: abdominal pain, nausea, vomiting, lethargy, drowsiness, depression, headache, tinnitus, metabolic acidosis, coma, acute renal failure, decreased blood pressure, bradycardia, tachycardia, atrial fibrillation, respiratory arrest.
Treatment: gastric lavage (only within an hour after ingestion), administration of activated charcoal, alkaline drinking, forced diuresis, symptomatic therapy (correction of acid-base state, blood pressure).
Cases of overdose of cream or gel are not described.
Treatment: In case of accidental ingestion, it is necessary to clear the stomach (induce vomiting, prescribe activated charcoal) and consult a doctor. Further treatment, if necessary, is symptomatic.
Symptoms: abdominal pain, nausea, vomiting, lethargy, drowsiness, depression, headache, tinnitus, metabolic acidosis, coma, acute renal failure, low blood pressure, brady/tachycardia, atrial fibrillation, respiratory arrest.
Treatment: gastric lavage (only within 1 hour after ingestion), activated charcoal, alkaline drink, forced diuresis, symptomatic therapy (correction of SCC, blood pressure).
Symptoms: abdominal pain, nausea, vomiting, lethargy, headache, tinnitus, depression, drowsiness, metabolic acidosis, hemorrhagic diathesis, decreased blood pressure, acute renal failure, impaired liver function, tachycardia, bradycardia, atrial fibrillation, convulsions, apnea and coma (especially characteristic of children under 5 years of age).
Treatment: gastric lavage, administration of activated charcoal, alkaline drinking, symptomatic therapy (correction of CSF, blood pressure).
In children, symptoms of overdose may occur after taking a dose exceeding 400 mg/kg. In adults, the dose-dependent effect of overdose is less pronounced. T1/2 the drug in case of overdose is 1.5–3 hours.
Symptoms: nausea, vomiting, epigastric pain, or, less commonly, diarrhea, tinnitus, headache, and gastrointestinal bleeding. In more severe cases, there are manifestations from the central nervous system: drowsiness, rarely-agitation, convulsions, disorientation, coma. In cases of severe poisoning, metabolic acidosis and increased PV, renal failure, damage to liver tissue, decreased blood pressure, respiratory depression and cyanosis may develop. In patients with bronchial asthma, an exacerbation of this disease is possible.
Treatment: symptomatic, with mandatory airway patency, ECG monitoring and basic vital signs until the patient's condition is normalized.
Oral administration of activated charcoal or gastric lavage for 1 hour after taking a potentially toxic dose of ibuprofen is recommended. If ibuprofen has already been absorbed, an alkaline drink may be prescribed in order to remove the acidic ibuprofen derivative by the kidneys, forced diuresis. Frequent or prolonged seizures should be stopped by intravenous administration of diazepam or lorazepam. When bronchial asthma worsens, the use of bronchodilators is recommended.
There are no known cases of overdose associated with intravenous administration of ibuprofen to premature newborns.
However, an overdose has been described in children treated with ibuprofen for oral administration.
Symptoms: central nervous system depression, convulsions, gastrointestinal disorders, bradycardia, hypotension, shortness of breath, impaired renal function and hematuria. Cases of massive overdose (after taking doses of more than 1000 mg/kg), accompanied by coma, metabolic acidosis and passing renal failure, have been described. One case of fatal overdose was reported: after taking a dose of 469 mg / kg in a 16-month-old child due to respiratory arrest, the development of convulsive syndrome and subsequent aspiration pneumonia.
Treatment: symptomatic therapy. After the standard treatment, all patients recovered.
3 years
hypersensitivity to ibuprofen or any of the components that make up the drug,
complete or incomplete combination of bronchial asthma, recurrent polyposis of the nose and paranasal sinuses and intolerance to acetylsalicylic acid or other NSAIDs (including in the anamnesis),
erosive and ulcerative diseases of the gastrointestinal tract (including gastric and duodenal ulcer, Crohn's disease, ulcerative colitis) or ulcerative bleeding in the active phase or history (two or more confirmed episodes of peptic ulcer disease or ulcerative bleeding),
bleeding or perforation of a gastrointestinal ulcer in the anamnesis, provoked by the use of NSAIDs,
severe liver failure or active liver disease,
severe renal insufficiency (creatinine Cl <30 ml / min), confirmed hyperkalemia,
decompensated heart failure,
the period after coronary artery bypass grafting,
cerebrovascular or other bleeding,
fructose intolerance, glucose-galactose malabsorption, sucrose-isomaltase deficiency,
hemophilia and other blood clotting disorders (including hypocoagulation), hemorrhagic diathesis,
pregnancy (third trimester),
children under 6 years of age.
With caution: concomitant use of other NSAIDs, a history of a single episode of gastric and duodenal ulcer or ulcerative bleeding of the gastrointestinal tract, gastritis, enteritis, colitis, the presence of infection Helicobacter pylori, ulcerative colitis, bronchial asthma or allergic diseases in the acute stage or history-possible development of bronchospasm, systemic lupus erythematosus or mixed connective tissue disease (Sharp's syndrome) - increased risk of aseptic meningitis, kidney failure, t.tsch. dehydration (creatinine Cl <30-60 ml/min), nephrotic syndrome, hepatic insufficiency, cirrhosis of the liver with portal hypertension, hyperbilirubinemia, arterial hypertension and/or heart failure, cerebrovascular diseases, blood diseases of unknown etiology (leukopenia and anemia), severe somatic diseases, dyslipidemia/hyperlipidemia, diabetes mellitus, peripheral artery diseases, smoking, frequent alcohol consumption, concomitant use of drugs that may increase the risk of ulcers or bleeding, in particular, oral corticosteroids (in t.tsch. prednisone), anticoagulants (in t.tsch. warfarin), SSRI (in t.tsch. citalopram, fluoxetine, paroxetine, sertraline) or antiplatelet agents (in t.tsch. acetylsalicylic acid, clopidogrel), pregnancy I-II trimesters, breastfeeding period, elderly age, age under 12 years
Hypersensitivity to any of the ingredients that make up the drug, as well as to acetylsalicylic acid or other NSAIDs in the anamnesis. Erosive and ulcerative diseases of the gastrointestinal tract (including acute gastric and duodenal ulcers, Crohn's disease, ulcerative colitis), "aspirin" asthma, hemophilia and other blood clotting disorders (including hypocoagulation), hemorrhagic diathesis, bleeding of any etiology, glucose-6-phosphate dehydrogenase deficiency, pregnancy, lactation, children under 12 years of age, diseases of the optic nerve.
With caution: in the elderly, with heart failure, arterial hypertension, cirrhosis of the liver with portal hypertension, hepatic and / or renal insufficiency, nephrotic syndrome, hyperbilirubinemia, gastric ulcer and duodenal ulcer (in the anamnesis), gastritis, enteritis, colitis, blood diseases of unknown etiology (leukopenia and anemia).
Common for cream and gel
hypersensitivity to ibuprofen, other components of the drug and other NSAIDs,
wet dermatoses, eczema,
violations of the integrity of the skin (including infected abrasions and wounds) at the site of application of the cream/gel.
Optional for cream
pregnancy, lactation,
children under 14 years of age.
Optional for gel
bronchial asthma, urticaria, rhinitis, provoked by taking acetylsalicylic acid,
pregnancy (third trimester),
children under 12 years of age.
With caution: pregnancy (I-II trimester), lactation period.
Hypersensitivity, erosive and ulcerative diseases of the gastrointestinal tract (including peptic ulcer, Crohn's disease-non — specific ulcerative colitis), diseases of the optic nerve, scotoma, amblyopia, color vision disorder, hearing loss, vestibular pathology, "aspirin" asthma (provoked by taking acetylsalicylic acid or other NSAIDs), heart failure, edema, arterial hypertension, blood clotting disorders (including hypocoagulation), hemophilia, leukopenia, hemorrhagic diathesis, glucose−6-phosphate dehydrogenase deficiency, pregnancy (third trimester).
Hypersensitivity (including to acetylsalicylic acid or other NSAIDs), peptic ulcer of the stomach and duodenum, severe insufficiency of the liver, kidneys, cardiovascular system, arterial hypertension, hemophilia, hypocoagulation, hemorrhagic diathesis, glucose-6−phosphate dehydrogenase deficiency, bronchospastic reactions after the use of acetylsalicylic acid or other NSAIDs ("aspirin asthma"), edema Quincke, nasal polyps, hearing loss, infancy (up to 6 months, with a body weight of less than 7 kg).
Hypersensitivity, peptic ulcer of the stomach and duodenum," aspirin " triad, attacks of bronchial asthma (including in the anamnesis), childhood (up to 12 years), pregnancy, breast-feeding (suspend).
hypersensitivity to ibuprofen or any of the components that make up the drug,
complete or incomplete combination of bronchial asthma, recurrent polyposis of the nose and paranasal sinuses and intolerance of acetylsalicylic acid or other NSAIDs,
bleeding or perforation of a gastrointestinal ulcer in the anamnesis, provoked by the use of NSAIDs,
erosive and ulcerative diseases of the gastrointestinal tract (including gastric and duodenal ulcer, Crohn's disease, ulcerative colitis) or ulcerative bleeding in the active phase or in the anamnesis (two or more confirmed episodes of peptic ulcer disease or ulcerative bleeding),
severe liver failure or active liver disease,
severe renal insufficiency (creatinine Cl <30 ml / min), confirmed hyperkalemia,
decompensated heart failure, the period after coronary artery bypass grafting,
cerebrovascular or other bleeding,
hemophilia and other blood clotting disorders (including hypocoagulation), hemorrhagic diathesis,
pregnancy (W trimester),
fructose intolerance,
the child's body weight is up to 5 kg.
With caution: in the presence of the conditions specified in this section, before using the drug, you should consult a doctor — simultaneous use of other NSAIDs, the presence of a single episode of gastric ulcer or ulcerative bleeding of the gastrointestinal tract, gastritis, enteritis, colitis, the presence of infection Helicobacter pylori, ulcerative colitis, bronchial asthma or allergic diseases in the acute stage or in the anamnesis-possible development of bronchospasm, severe somatic diseases, systemic lupus erythematosus or mixed connective tissue disease (Sharpe's syndrome) — increased risk of aseptic meningitis, kidney failure, t.tsch. with dehydration (creatinine Cl 30-60 ml / min), fluid retention and edema, liver failure, hypertension and / or heart failure, cerebrovascular diseases, dyslipidemia/hyperlipidemia, diabetes mellitus, peripheral artery diseases, blood diseases of unknown etiology (leukopenia, anemia), concomitant use of other drugs that may increase the risk of ulcers or bleeding, in particular, oral corticosteroids (in t.tsch. prednisone), anticoagulants (in t.tsch. warfarin), SSRI (in t.tsch. citalopram, fluoxetine, paroxetine, sertraline) or antiplatelet agents (in t.tsch. acetylsalicylic acid, clopidogrel), pregnancy (I-II trimester), breastfeeding, old age
hypersensitivity to ibuprofen or any excipient of the drug,
life-threatening infection,
clinically pronounced bleeding, especially intracranial or gastrointestinal bleeding,
thrombocytopenia or blood clotting disorder,
significant renal impairment,
a congenital heart defect in which an open ductus arteriosus is a prerequisite for satisfactory pulmonary or systemic blood flow (for example, pulmonary artery atresia, severe Fallot tetrad, severe aortic coarctation),
diagnosed or suspected necrotizing enterocolitis.
With caution - in case of suspected infectious diseases.
Concomitant use of ibuprofen with the following drugs should be avoided
Acetylsalicylic acid: with the exception of low doses of acetylsalicylic acid (no more than 75 mg/day), prescribed by a doctor, since co-administration may increase the risk of side effects. With simultaneous use of ibuprofen reduces the anti-inflammatory and antiplatelet effect of acetylsalicylic acid (it is possible to increase the frequency of acute coronary insufficiency in patients receiving small doses of acetylsalicylic acid as an antiplatelet agent after starting ibuprofen).
Other NSAIDs, in particular selective COX-2 inhibitors: The simultaneous use of two or more drugs from the NSAID group should be avoided due to the possible increase in the risk of side effects.
Use with caution at the same time with the following drugs
Anticoagulants and thrombolytic drugs: NSAIDs can increase the effect of anticoagulants, in particular warfarin and thrombolytic drugs.
Antihypertensive agents (ACE and ARA II inhibitors) and diuretics: NSAIDs can reduce the effectiveness of these groups of drugs. In some patients with impaired renal function (for example, in patients with dehydration or elderly patients with impaired renal function), concomitant administration of ACE inhibitors or ARA II and COX inhibitors may lead to deterioration of renal function, including the development of acute renal failure (usually reversible).
These interactions should be considered in patients taking coxibs simultaneously with ACE inhibitors or ARA II. In this regard, the combined use of the above drugs should be prescribed with caution, especially for the elderly. It is necessary to prevent dehydration in patients, and to consider monitoring renal function after the start of such combined treatment and periodically in the future.
Diuretics and ACE inhibitors may increase the nephrotoxicity of NSAIDs.
GCS: increased risk of gastrointestinal ulcers and gastrointestinal bleeding.
Antiplatelet Agents and SSRIs: increased risk of gastrointestinal bleeding.
Cardiac glycosides: concomitant administration of NSAIDs and cardiac glycosides can lead to exacerbation of heart failure, a decrease in GFR and an increase in the concentration of cardiac glycosides in blood plasma.
Lithium preparations: there are data on the probability of an increase in the concentration of lithium in the blood plasma against the background of the use of NSAIDs.
Methotrexate: there are data on the probability of an increase in the concentration of methotrexate in blood plasma against the background of NSAID use.
Cyclosporine: increased risk of nephrotoxicity with concomitant administration of NSAIDs and cyclosporine.
Mifepristone: NSAIDs should be started no earlier than 8-12 days after taking mifepristone, since NSAIDs can reduce the effectiveness of mifepristone.
Tacrolimus: concomitant administration of NSAIDs and tacrolimus may increase the risk of nephrotoxicity.
Zidovudine: concomitant use of NSAIDs and zidovudine may lead to increased hematotoxicity. There is evidence of an increased risk of hemarthrosis and hematomas in HIV-positive patients with hemophilia who received co-treatment with zidovudine and ibuprofen.
Quinolone antibiotics: Patients receiving co-treatment with NSAIDs and quinolone antibiotics may have an increased risk of seizures.
Myelotoxic drugs: increased hematotoxicity.
Cefamandol, cefoperazone, cefotetan, valproic acid, plicamycin: increased frequency of hypoprothrombinemia.
Drugs that block tubular secretion: reduced excretion and increased plasma concentration of ibuprofen.
Inducers of microsomal oxidation (phenytoin, ethanol, barbiturates, rifampicin, phenylbutazone, tricyclic antidepressants): increased production of hydroxylated active metabolites, increased risk of severe intoxication.
Microsomal oxidation inhibitors: reducing the risk of hepatotoxic effects.
Oral hypoglycemic drugs and insulin, sulfonylurea derivatives: strengthening the effect of drugs.
Antacids and colestyramia: reduced absorption.
Uricosuric drugs: decrease in the effectiveness of drugs.
Caffeine: increased analgesic effect.
The effectiveness of furosemide and thiazide diuretics may be reduced due to sodium retention associated with inhibition of prostaglandin synthesis in the kidneys.
Anadin (NSAID) may enhance the effect of oral anticoagulants, so concomitant use is not recommended.
When co-administered with acetylsalicylic acid, ibuprofen reduces its antiplatelet effect (it is possible to increase the frequency of acute coronary insufficiency in patients receiving small doses of acetylsalicylic acid as an antiplatelet agent).
Anadin (NSAID) may reduce the effectiveness of antihypertensive drugs.
In the literature, isolated cases of increased plasma concentrations of digoxin, phenytoin and lithium have been described while taking ibuprofen.
Anadin (NSAID) (like other NSAIDs) should be used with caution in combination with acetylsalicylic acid or other NSAIDs and corticosteroids (this increases the risk of adverse effects of the drug on the gastrointestinal tract).
Anadin (NSAID) may increase the concentration of methotrexate in the plasma.
Combined treatment with zidovudine and Anadin (NSAID)om may increase the risk of hemarthrosis and hematoma in HIV-infected patients suffering from hemophilia.
The combined use of Anadin (NSAID) a and tacrolimus may increase the risk of developing nephrotoxic effects due to a reduction in the synthesis of PG in the kidneys.
Ibuprofen increases the hypoglycemic effect of oral hypoglycemic agents and insulin, it may be necessary to adjust the dose.
Cream. You should consult your doctor before using the drug, if any other drugs are used.
Gel. Drug interactions with other drugs are not described. However, it should be borne in mind that even with topical use, ibuprofen has a systemic effect and, theoretically, when used simultaneously with other NSAIDs, side effects may increase.
Inducers of microsomal oxidation (ethanol, barbiturates, rifampicin, tricyclic antidepressants) increase the production of hydroxylated active metabolites, increasing the risk of severe hepatotoxic reactions. Microsomal oxidation inhibitors reduce the risk of hepatotoxic effects. Reduces the hypotensive activity of vasodilators, in t.tsch. slow calcium channel blockers and ACE inhibitors), natriuretic and diuretic activity of furosemide and hypothiazide, the effectiveness of uricosuric drugs. Increases the effect of antiplatelet agents, fibrinolytics (increased risk of hemorrhagic complications), oral hypoglycemic agents and insulin. When interacting with mineral - and glucocorticosteroids, colchicine, estrogen, ethanol, it is possible to manifest an ulcerogenic effect with the development of bleeding. Antacids and cholestyramine reduce the absorption of ibuprofen. Increases the concentration of digoxin, phenytoin, methotrexate, lithium in the blood plasma. Caffeine increases the analgesic effect. When administered concomitantly with acetylsalicylic acid, it reduces the overall anti-inflammatory effect. When prescribed with thrombolytic agents (alteplase, streptokinase, urokinase), the risk of bleeding increases simultaneously. Cefamandol, cefaperazone, cefotetan, valproic acid, plicamycin increase the frequency of hypoprothrombinemia. Cyclosporine and gold preparations enhance the effect of ibuprofen on the synthesis of PG in the kidneys and increase nephrotoxicity. Ibuprofen increases the plasma concentration of cyclosporine and the likelihood of its hepatotoxic effects. Drugs that block the tubular secretion, reduce the excretion and increases the plasma concentration of ibuprofen. Concomitant use with potassium-sparing diuretics increases the risk of hyperkalemia, with other NSAIDs-the risk of side effects from the gastrointestinal tract
It should not be combined with other NSAIDs (acetylsalicylic acid reduces the anti-inflammatory effect and increases the side effects). When taken simultaneously with diuretics, the diuretic effect decreases and the risk of developing renal failure increases. Weakens the effect of antihypertensive drugs in t.tsch. ACE inhibitors (simultaneously reduces their excretion by the kidneys), beta-adrenergic agents, thiazides. Increases the effect of oral hypoglycemic agents (especially sulfonylurea derivatives) and insulin, indirect anticoagulants, antiplatelet agents, fibrinolytics (increases the risk of hemorrhagic complications), the toxic effect of methotrexate and lithium preparations, increases the concentration of digoxin in the blood
Inducers of microsomal oxidation (phenytoin, ethanol, barbiturates, zixorin, rifampicin, phenylbutazone, tricyclic antidepressants) increase the risk of severe hepatotoxic complications (increase the production of hydroxylated active metabolites), inhibitors of microsomal oxidation — reduce. Caffeine increases the pain-relieving effect.
Reduces the diuretic and natriuretic effects of thiazide diuretics. Indirect anticoagulants increase the risk of bleeding.
Concomitant use of ibuprofen with the following drugs should be avoided
Acetylsalicylic acid: with the exception of low doses of acetylsalicylic acid (no more than 75 mg/day), prescribed by a doctor, since co-administration may increase the risk of side effects. With simultaneous use of ibuprofen reduces the anti-inflammatory and antiplatelet effect of acetylsalicylic acid (it is possible to increase the frequency of acute coronary insufficiency in patients receiving small doses of acetylsalicylic acid as an antiplatelet agent after starting ibuprofen).
Other NSAIDs, including selective COX-2 inhibitors: The simultaneous use of two or more drugs from the NSAID group should be avoided due to the possible increase in the risk of side effects.
Use with caution at the same time with the following drugs
Anticoagulants and thrombolytic drugs: NSAIDs can increase the effect of anticoagulants, in particular, warfarin and thrombolytic drugs.
Antihypertensive agents (ACE inhibitors and angiotensin II antagonists) and diuretics: NSAIDs can reduce the effectiveness of these groups of drugs. Diuretics and ACE inhibitors may increase the nephrotoxicity of NSAIDs.
GCS: increased risk of gastrointestinal ulcers and gastrointestinal bleeding.
Antiplatelet Agents and SSRIs: increased risk of gastrointestinal bleeding.
Cardiac glycosides: concomitant administration of NSAIDs and cardiac glycosides may exacerbate heart failure, reduce glomerular filtration rate, and increase the concentration of cardiac glycosides in blood plasma.
Lithium preparations: there are data on the probability of an increase in the concentration of lithium in the blood plasma against the background of the use of NSAIDs.
Methotrexate: there are data on the probability of an increase in the concentration of methotrexate in blood plasma against the background of NSAID use.
Cyclosporine: increased risk of nephrotoxicity with concomitant administration of NSAIDs and cyclosporine.
Mifepristone: NSAIDs should be started no earlier than 8-12 days after taking mifepristone, since NSAIDs can reduce the effectiveness of mifepristone.
Tacrolimus: concomitant administration of NSAIDs and tacrolimus may increase the risk of nephrotoxicity.
Zidovudine: concomitant use of NSAIDs and zidovudine may lead to increased hematotoxicity. There is evidence of an increased risk of hemarthrosis and hematomas in HIV-positive patients with hemophilia who received co-treatment with zidovudine and ibuprofen.
Quinolone antibiotics: Patients receiving co-treatment with NSAIDs and quinolone antibiotics may have an increased risk of seizures.
Ibuprofen, like other NSAIDs, can interact with the following drugs:
- diuretics: ibuprofen may weaken the effects of diuretics, in patients with dehydration, diuretics may increase the risk of nephrotoxicity of NSAIDs,
- anticoagulants: ibuprofen may increase the effect of anticoagulants and increase the risk of bleeding,
- GCS: ibuprofen may increase the risk of gastrointestinal bleeding,
- nitric oxide: since both drugs inhibit platelet function, their combination theoretically increases the risk of bleeding,
- other NSAIDs: the simultaneous use of two or more NSAIDs should be avoided due to the increased risk of adverse reactions,
- aminoglycosides: Since ibuprofen may reduce the clearance of aminoglycosides, concomitant administration of these drugs may increase the risk of nephrotoxicity and ototoxicity.
Incompatibility
This drug should not be mixed with other drugs.
Anadin Solution (NSAID)® it should not come into contact with acidic solutions, such as solutions of certain antibiotics or diuretics. Between infusions of various drugs, it is necessary to flush the infusion system.
Do not use chlorhexidine to disinfect the neck of the ampoule, because the Anadin solution (NSAID)® incompatible with this connection. To disinfect the ampoule before use, it is recommended to use 60% ethyl alcohol. After disinfection of the neck of the ampoule with an antiseptic, the ampoule should be completely dried and only then opened to exclude the interaction of the antiseptic with the Anadin solution (NSAID)®.
This drug should not be mixed with other drugs other than 0.9% (9 mg/ml) sodium chloride solution for injection or 5% (50 mg/ml) glucose solution.
To prevent significant changes in pH caused by the presence of acidic drugs that may have remained in the infusion system, before and after the administration of Anadin (NSAID)® it is necessary to flush the infusion system with 1.5-2 ml of 0.9% (9 mg/ml) sodium chloride solution or 5% (50 mg/ml) glucose solution for injection.
Tablet contents:
Maize starch
Pregelatinised starch
Colloidal silica anhydrous
Stearic acid
Tablet Coating:
Sucrose
Macrogol 6000
Perfectamyl gel
Povidone K30
Polysorbate 80
Talc
Calcium carbonate
Titanium dioxide
Carnauba wax
Printing Ink:
Shellac, iron oxide black (E172), propylene glycol, and ammonium hydroxide
Capsules
The risk of side effects can be minimized if the drug is taken in a short course, at the minimum effective dose necessary to eliminate the symptoms.
In the elderly, there is an increased frequency of adverse reactions against the background of the use of NSAIDs, especially gastrointestinal bleeding and perforation, in some cases with a fatal outcome. Side effects are predominantly dose-dependent. The following adverse reactions were observed with short-term administration of ibuprofen at doses not exceeding 1200 mg / day (6 Tables). In the treatment of chronic conditions and long-term use, other adverse reactions may occur.
The frequency of adverse reactions is estimated based on the following criteria: very common (≥1/10), common (≥1/100 to <1/10), infrequent (≥1/1000 to <1/100), rare (≥1/10000 to <1/1000), very rare (<1/10000), frequency unknown (no data available for frequency estimation).
From the blood and lymphatic system: very rarely-hematopoietic disorders (anemia, leukopenia, aplastic anemia, hemolytic anemia, thrombocytopenia, pancytopenia, agranulocytosis). The first symptoms of such disorders are fever, sore throat, superficial ulcers in the mouth, flu-like symptoms, severe weakness, nosebleeds and subcutaneous hemorrhages, bleeding and bruising of unknown etiology.
On the part of the immune system:
From the gastrointestinal tract: infrequently-abdominal pain, nausea, dyspepsia (including heartburn, bloating), rarely-diarrhea, flatulence, constipation, vomiting, very rarely-peptic ulcer, perforation or gastrointestinal bleeding, melena, bloody vomiting, in some cases fatal, especially in elderly patients, ulcerative stomatitis, gastritis, the frequency is unknown-exacerbation of colitis and Crohn's disease.
From the liver and biliary tract: very rarely-impaired liver function, increased activity of hepatic transaminases, hepatitis and jaundice.
From the kidneys and urinary tract: very rarely-acute renal failure (compensated and decompensated), especially with prolonged use, in combination with an increase in the concentration of urea in the blood plasma and the appearance of edema, hematuria and proteinuria, nephritic syndrome, nephrotic syndrome, papillary necrosis, interstitial nephritis, cystitis.
From the nervous system: infrequently-headache, very rarely-aseptic meningitis.
From the CCC side: the frequency is unknown — heart failure, peripheral edema, with prolonged use, the risk of thrombotic complications (for example, myocardial infarction), increased blood pressure.
From the respiratory system and mediastinal organs: the frequency is unknown — bronchial asthma, bronchospasm, shortness of breath.
Laboratory parameters: hematocrit or Hb (may decrease), bleeding time (may increase), plasma glucose concentration (may decrease), creatinine clearance (may decrease), plasma creatinine concentration (may increase), hepatic transaminase activity (may increase).
If side effects occur, stop taking the drug and consult a doctor.
From the gastrointestinal tract: NSAIDs-gastropathy (abdominal pain, nausea, vomiting, heartburn, decreased appetite, diarrhea, flatulence, constipation, rarely — ulceration of the gastrointestinal mucosa, which in some cases are complicated by perforation and bleeding), irritation or dryness of the oral mucosa, pain in the mouth, ulceration of the gum mucosa, aphthous stomatitis, pancreatitis.
From the side of the hepatobiliary system: hepatitis.
From the respiratory system: shortness of breath, bronchospasm.
On the part of the senses: hearing impairment (hearing loss, ringing or noise in the ears).
From the central and peripheral nervous system: headache, dizziness, insomnia, anxiety, nervousness and irritability, psychomotor agitation, drowsiness, depression, confusion, hallucinations, rarely-aseptic meningitis (more often in patients with autoimmune diseases).
From the cardiovascular system: heart failure, tachycardia, increased blood pressure.
From the urinary system: acute renal failure, allergic nephritis, nephrotic syndrome (edema), polyuria, cystitis.
Allergic reactions: skin rash (usually erythematous or urticular), pruritus, Quincke's edema, anaphylactoid reactions, anaphylactic shock, bronchospasm or dyspnea, fever, erythema multiforme (including Stevens-Johnson syndrome), toxic epidermal necrolysis (Lyell's syndrome), eosinophilia, allergic rhinitis.
From the side of the hematopoietic organs: anemia (including hemolytic, aplastic), thrombocytopenia and thrombocytopenic purpura, agranulocytosis, leukopenia.
On the part of the visual organs: toxic damage to the optic nerve, blurred vision or double vision, scotoma, dry and irritated eyes, swelling of the conjunctiva and eyelids (allergic origin).
The risk of ulceration of the gastrointestinal mucosa, bleeding (gastrointestinal, gingival, uterine, hemorrhoid), visual disturbances (color vision disorders, scotomas, optic nerve damage) increases with prolonged use of the drug in large doses.
Changes in laboratory parameters: bleeding time (may increase), serum glucose concentration (may decrease), creatinine clearance (may decrease), hematocrit or hemoglobin (may decrease), serum creatinine concentration (may increase), hepatic transaminase activity (may increase).
Usually the drug is well tolerated. In rare cases, there may be temporary signs of local irritation of the skin in the form of redness, swelling, rashes, itching of the skin, burning and tingling sensations. In the case of hypersensitivity to NSAIDs, bronchospasm may occur. With prolonged use of the drug in particularly sensitive patients, it is possible to develop systemic side effects, if they occur, stop using the drug and consult a doctor.
From the gastrointestinal tract: nausea, vomiting, NSAIDs-gastropathy (decreased appetite, pain and discomfort in the epigastric region, abdominal pain), irritation, dryness of the oral mucosa or pain in the oral cavity, ulceration of the gum mucosa, aphthous stomatitis, pancreatitis, constipation/diarrhea, flatulence, digestive disorders, possibly erosive — ulcerative lesions and bleeding from the gastrointestinal tract, impaired liver function.
From the nervous system and sensory organs: headache, drowsiness, anxiety, nervousness, irritability, psychomotor agitation, confusion, hallucinations, aseptic meningitis (more often in patients with autoimmune diseases), hearing impairment, tinnitus, reversible toxic amblyopia, blurred vision or double vision, dry and irritated eyes, conjunctival and eyelid edema (allergic origin), scotoma.
From the cardiovascular system and blood (hematopoiesis, hemostasis): heart failure, tachycardia, increased blood pressure, eosinophilia, anemia, including hemolytic, thrombocytopenic purpura, agranulocytosis, leukopenia.
From the respiratory system: shortness of breath, bronchospasm, allergic rhinitis.
From the genitourinary system: edematous syndrome, impaired renal function, acute renal failure, allergic nephritis, polyuria, cystitis.
Allergic reactions: skin rash (erythematous, urticaria), pruritus, urticaria, Quincke's edema, anaphylactic reactions, including anaphylactic shock, multiform exudative erythema (including Stevens-Johnson syndrome), toxic epidermal necrolysis.
Other: increased sweating, fever.
From the central nervous system: headache, dizziness, sleep disturbance, anxiety, drowsiness, depression, agitation, visual impairment (reversible toxic amblyopia, blurred vision, or double vision).
From the side of the hematopoietic organs: heart failure, tachycardia, increased blood pressure, anemia, thrombocytopenia, agranulocytosis, leukopenia.
From the gastrointestinal tract: nausea, vomiting, decreased appetite, heartburn, abdominal pain, diarrhea, constipation, flatulence, impaired liver function, peptic ulcers, stomach bleeding.
From the urinary system: acute renal failure, allergic nephritis, nephrotic syndrome (edema), polyuria, cystitis.
Allergic reactions: itching, rash, bronchospastic syndrome, allergic rhinitis, Quincke's edema, Stephen-Johnson syndrome, Lyell's syndrome.
Dyspeptic disorders, gastrointestinal bleeding, thrombocytopenia, allergic reactions.
The risk of side effects can be minimized if the drug is taken in a short course, at the minimum effective dose necessary to eliminate the symptoms.
Side effects are predominantly dose-dependent. The following adverse reactions were observed with short-term administration of ibuprofen at doses not exceeding 1200 mg / day. In the treatment of chronic conditions and with prolonged use, other adverse reactions may occur.
The frequency of adverse reactions is estimated based on the following criteria: very common (≥1/10), common (≥1/100 to <1/10), infrequent (≥1/1000 to <1/100), rare (≥1/10000 to <1/1000), very rare (<1/10000), frequency unknown (no data available for frequency estimation).
From the blood and lymphatic system: very rare-hematopoietic disorders (anemia, leukopenia, aplastic anemia, hemolytic anemia, thrombocytopenia, pancytopenia, agranulocytosis). The first symptoms of such disorders are fever, sore throat, superficial ulcers in the mouth, flu-like symptoms, severe weakness, nosebleeds and subcutaneous hemorrhages, bleeding and bruising of unknown etiology.
On the part of the immune system: infrequently-hypersensitivity reactions-non-specific allergic reactions and anaphylactic reactions, reactions from the respiratory tract (bronchial asthma, t.tsch. its exacerbation, bronchospasm, shortness of breath, dyspnea), skin reactions (itching, urticaria, purpura, Quincke's edema, exfoliative and bullous dermatoses, in t.tsch. toxic epidermal necrolysis, Lyell's syndrome, Stevens-Johnson syndrome, erythema multiforme), allergic rhinitis, eosinophilia, very rare-severe hypersensitivity reactions, in t.tsch. edema of the face, tongue and larynx, shortness of breath, tachycardia, hypotension (anaphylaxis, Quincke's edema or severe anaphylactic shock)
From the gastrointestinal tract: infrequently-abdominal pain, nausea, dyspepsia, rarely-diarrhea, flatulence, constipation, vomiting, very rarely-peptic ulcer, perforation or gastrointestinal bleeding, melena, bloody vomiting, ulcerative stomatitis, gastritis, frequency unknown-exacerbation of ulcerative colitis and Crohn's disease.
From the liver and biliary tract: very rarely-liver function disorders.
From the kidneys and urinary tract: very rarely-acute renal failure (compensated and decompensated), especially with prolonged use, in combination with an increase in the concentration of urea in the blood plasma and the appearance of edema, papillary necrosis.
From the nervous system: infrequently-headache, very rarely-aseptic meningitis (in patients with autoimmune diseases).
From the CCC side: the frequency is unknown — heart failure, peripheral edema, with prolonged use, the risk of thrombotic complications (for example, myocardial infarction, stroke), increased blood pressure.
From the respiratory system and mediastinal organs: the frequency is unknown — bronchial asthma, bronchospasm, shortness of breath.
Other: very rarely — edema, including peripheral.
Laboratory parameters: hematocrit or Hb (may decrease), bleeding time (may increase), plasma glucose concentration (may decrease), creatinine clearance (may decrease), plasma creatinine concentration (may increase), hepatic transaminase activity (may increase). If side effects occur, stop taking the drug and consult a doctor.
From the blood system: blood clotting disorders that lead to bleeding, such as intestinal and intracranial bleeding, respiratory disorders, and pulmonary bleeding.
From the digestive system: obstruction and perforation of the intestine.
The part of the kidney: decrease in the volume of formed urine, the presence of blood in the urine. Currently, data are available for approximately 1,000 premature newborns, found in the ibuprofen literature and obtained in clinical trials of the drug Anadin (NSAID)®. The causes of adverse events observed in premature newborns are difficult to assess, since they can be associated with both the hemodynamic consequences of an open ductus arteriosus and the direct effects of ibuprofen.
The described adverse events are listed below, classified by organ system and frequency. The frequency of events was determined as follows: very often (>1/10), often (>1/100, <1/10), rarely (>1/1000, <1/100).
From the circulatory and lymphatic system: very often — thrombocytopenia, neutropenia.
From the nervous system: often-intraventricular hemorrhage, periventricular leukomalacia.
From the respiratory system, chest and mediastinal organs: very often — bronchopulmonary dysplasia, often-pulmonary bleeding, rarely-hypoxemia (occurred within 1 hour after the first infusion with normalization of the condition within 30 minutes after inhalation with nitric oxide).
From the kidneys and urinary tract: often-oliguria, fluid retention, hematuria, rarely-acute renal failure.
Gastrointestinal disorders: often-necrotizing enterocolitis, perforation of the intestine, rarely-gastrointestinal bleeding.
Deviations from the norm of laboratory research data: very often-an increase in the concentration of creatinine in the blood, a decrease in the concentration of sodium in the blood.
No relevant information additional to that already contained elsewhere in the SmPC.
headache,
migraine,
toothache,
painful menstruation,
neuralgia,
back pain,
muscle pain,
rheumatic pain,
joint pain,
feverish conditions with flu and colds.
Fever syndrome of various origins, pain syndrome of various etiologies (including sore throat, headache, migraine, toothache, neuralgia, postoperative pain, post-traumatic pain, primary algodismenorrhea), inflammatory and degenerative diseases of the joints and spine (including rheumatoid arthritis, ankylosing spondylitis).
inflammatory and degenerative diseases of the musculoskeletal system: joint syndrome with exacerbation of gout, arthritis (rheumatoid, psoriatic, gouty), brachiopathic periarthritis, ankylosing spondylitis (Bekhterev's disease), deforming osteoarthritis, osteochondrosis with radicular syndrome, sciatica, tendinitis, tendovaginitis, bursitis, lumbago, sciatica,
muscle pain (myalgia) of rheumatic and non-rheumatic origin,
injuries (sports, industrial, domestic) without violating the integrity of the skin (dislocations, sprains or tears of muscles and ligaments, bruises, post-traumatic edema of soft tissues).
Rheumatoid arthritis, osteoarthritis, joint syndrome with exacerbation of gout, psoriatic arthritis, ankylosing spondylitis, spondylosis, neuralgia, myalgia, tendinitis, bursitis, tendovaginitis, Charcot-Marie-Toute neural amyotrophy (peroneal muscle atrophy), sprain, hematomas, sciatica, traumatic damage to soft tissues and the musculoskeletal system, feverish conditions of various origins (including after immunization), with influenza and ARVI.
As an auxiliary agent for infectious and inflammatory diseases of the ENT organs (tonsillitis, pharyngitis, laryngitis, sinusitis, rhinitis), pelvic inflammatory processes, adnexitis, algodismenorrhea, postoperative pain syndrome, headache and toothache, panniculitis.
As an antipyretic: for colds, acute respiratory viral infections, influenza, sore throat (pharyngitis), childhood infections accompanied by fever, post-vaccination reactions.
As a painkiller: for toothache, painful teething, headache, migraine, neuralgia, muscle pain, joint pain, injuries and burns.
Rheumatoid arthritis, ankylosing spondylitis, extra-articular rheumatism, osteoarthritis, brachiopathic periarthritis( capsulitis), bursitis, tendinitis, tendosynovitis, lumbar pain, postoperative, traumatic, toothache, headache (including migraine), dysmenorrhea, fever in infectious and inflammatory diseases.
For children from 3 months to 12 years:
as a symptomatic treatment as an antipyretic for acute respiratory infections (including influenza), childhood infections, other infectious and inflammatory diseases and post-vaccination reactions accompanied by an increase in body temperature,
as a symptomatic analgesic for pain of mild or moderate intensity, including toothache, headache, migraine, neuralgia, ear pain, sore throat, sprain pain, muscle pain, rheumatic pain, joint pain and other types of pain.
The drug is intended for symptomatic therapy, reducing pain and inflammation at the time of use, and does not affect the progression of the disease.
Treatment of hemodynamically significant open ductus arteriosus in premature infants with a gestational age of less than 34 weeks.
The mechanism of action of ibuprofen, a propionic acid derivative from the NSAID group, is due to the inhibition of the synthesis of PG-mediators of pain, inflammation and hyperthermic reaction. Selectively blocks COX-1 and COX-2, thereby inhibiting the synthesis of PG. It has a rapid directed action against pain (analgesic), antipyretic and anti-inflammatory. In addition, ibuprofen reversibly inhibits platelet aggregation. The analgesic effect of the drug lasts up to 8 hours.
Selectively blocks COX-1 and -2 and has an inhibitory effect on the synthesis of PG.
The analgesic effect is most pronounced in inflammatory pain. The analgesic activity of the drug does not belong to the narcotic type. Exhibits antiplatelet activity.
The analgesic effect when using Anadin (NSAID)a develops 10-45 minutes after administration.
Cream It has a local analgesic, anti-inflammatory and decongestant effect.
Gel it has a local analgesic and anti-inflammatory effect.
Common for cream and gel
It suppresses the production of inflammatory mediators. Selectively blocks COX-1 and COX-2 and has an inhibitory effect on the synthesis of PGE2, prostacycline (PGI2) and thromboxane (TV2). The analgesic effect is most pronounced in inflammatory pain. Causes a decrease or disappearance of pain, including pain at rest and when moving, reduces morning stiffness and swelling of the joints. Helps to increase the volume of movements. In addition to the anti-inflammatory effect, ibuprofen reduces platelet aggregation at the site of inflammation, as well as the migration of white blood cells and the release of lysosomal enzymes in the area of inflammation.
The mechanism of action of ibuprofen, a propionic acid derivative from the NSAID group, is due to the inhibition of the synthesis of PG-mediators of pain, inflammation and hyperthermic reaction. Selectively blocks COX-1 and COX-2, thereby inhibiting the synthesis of PG. In addition, ibuprofen reversibly inhibits platelet aggregation. It has analgesic, antipyretic and anti-inflammatory effects. The analgesic effect is most pronounced in inflammatory pain. The effect of the drug lasts up to 8 hours.
Ibuprofen has anti-inflammatory, analgesic and antipyretic activity. Ibuprofen is a racemic mixture of S ( )-and R (-) - enantiomers. Researches in vivo and in vitro Evidence suggests that the clinical activity of ibuprofen is associated with the S( )-enantiomer. Ibuprofen is a non-selective COX inhibitor that causes a decrease in the synthesis of PG.
Since PG delays the closure of the ductus arteriosus after birth, it is believed that the suppression of COX is the main mechanism of action of ibuprofen when used for this indication.
Absorption — high, quickly and almost completely absorbed from the gastrointestinal tract. After taking the drug on an empty stomach Cmax ibuprofen in the blood plasma is reached after 45 minutes. Taking the drug with food may increase Tmax up to 1-2 hours.
The binding to plasma proteins is 90%. Slowly penetrates into the joint cavity, lingers in the synovial fluid, creating greater concentrations in it than in the blood plasma. In the cerebrospinal fluid, lower concentrations of ibuprofen are found compared to blood plasma. After absorption, about 60% of the pharmacologically inactive R-form is slowly transformed into the active S-form. Undergoes metabolism in the liver.
T1/2 — 2 hours. It is excreted in the urine (in unchanged form no more than 1%) and to a lesser extent with bile. In limited studies, ibuprofen has been found in very low concentrations in breast milk.
When taken orally, it is well absorbed from the gastrointestinal tract. When using Anadin (NSAID)a Withmax ibuprofen in plasma is approximately 25 or 40 mcg / ml and is reached approximately 15-30 minutes after taking the drug on an empty stomach at a dose of 200 or 400 mg, respectively. Approximately 99% bound to plasma proteins. It is slowly distributed in the synovial fluid and is excreted from it more slowly than from the plasma. It is metabolized in the liver mainly by hydroxylation and carboxylation of the isobutyl group. The metabolites are pharmacologically inactive. It has a two-phase elimination kinetics. T1/2 from the plasma is 1-2 hours. Up to 90% of the dose can be detected in the urine in the form of metabolites and their conjugates. Less than 1% is excreted unchanged in the urine and, to a lesser extent, in the bile.
When applying the cream/gel to the skin, ibuprofen penetrates into deeper tissues (subcutaneous tissue, muscles, joints, synovial fluid) and reaches therapeutic concentrations in them. The therapeutic effect in the area of application is achieved by direct distribution through the skin in the target tissue. In a small amount, it is determined in the blood plasma. With the recommended method of application, the concentration in the synovial fluid is about 2 micrograms/ml.
It is well absorbed when taken orally (absorption decreases slightly when taken after a meal). After absorption, about 60% of the pharmacologically inactive R-form is slowly transformed into the active S-form (the biological activity is associated with the S-enantiomer). Cmax in the blood plasma, when taken on an empty stomach, it is reached in 45 minutes, when taken after a meal - in 1.5–2.5 hours, in the synovial fluid, where a greater concentration is created than in the blood plasma-2-3 hours. Binding to blood proteins-90%. Undergoes presystemic and postsystemic metabolism in the liver. Slowly penetrates into the joint cavity, lingers in the synovial fluid. It is excreted by the kidneys (in unchanged form no more than 1%) and with bile (to a lesser extent). T1/2 - 2-2. 5 hours (for retard forms-up to 12 hours). In elderly patients, the pharmacokinetic parameters do not change.
After oral administration, more than 80% is absorbed from the gastrointestinal tract. Cmax in blood plasma, it is achieved when taken on an empty stomach - after 45 minutes, when taken after a meal after 1.5-2.5 hours. Protein binding — 90%. It slowly penetrates into the joint cavity, but in the synovial fluid it creates higher concentrations than in the blood plasma (Cmax in the synovial fluid, it is reached after 2-3 hours). It is mainly metabolized in the liver. Undergoes pre-and post-systemic metabolism. After absorption, about 60% of the pharmacologically inactive R-form is slowly transformed into the active S-form. It is excreted by the kidneys (60-90% in the form of metabolites and products of their combination with glucuronic acid, to a lesser extent — with bile, in unchanged form — no more than 1%). It has a two-phase elimination kinetics with T1/2 2-2. 5 hours, after taking a single dose, it is completely eliminated within 24 hours. The antipyretic effect of Ibufen develops after 30 minutes and lasts 6-8 hours.
Absorption — high, quickly and almost completely absorbed from the gastrointestinal tract (binding to plasma proteins-90%). After taking the drug on an empty stomach in adults, ibuprofen is detected in the blood plasma after 15 minutes, Cmax ibuprofen in the blood plasma is reached after 60 minutes. Taking the drug with a meal may increase Tmax up to 1-2 hours T1/2 — 2 hours. Slowly penetrates into the joint cavity, lingers in the synovial fluid, creating greater concentrations in it than in blood plasma. After absorption, about 50% of the pharmacologically inactive R-form is slowly transformed into the active S-form. Undergoes metabolism in the liver. It is excreted by the kidneys in an unchanged form of no more than 1% and, to a lesser extent, with bile.
In clinical studies, ibuprofen has been found in very low concentrations in breast milk.
Cmax The plasma level after the first and last maintenance dose is about 35-40 mg / l, regardless of the gestational and postnatal age of the children. After 24 hours after the last dose of 5 mg/kg, the residual concentrations are about 10-15 mg/l.
Plasma concentrations of the S-enantiomer are significantly higher than those of the R-enantiomer, reflecting the rapid chiral inversion of the R-form to the S-form in a ratio similar to that observed in adults (approximately 60%). The apparent volume of distribution is on average 200 ml / kg (62-350 ml/kg, according to various studies). The central volume of distribution may depend on the status of the duct and decrease as the duct closes.
The rate of elimination of ibuprofen in newborns is significantly lower than in adults and older children. T1/2 it is about 30 h (16-43 h). As the gestational age increases, at least at the age of 24-28 weeks, the clearance of both enantiomers increases. Most ibuprofen, like other NSAIDs, is associated with plasma albumin, although this binding is significantly less pronounced in neonatal plasma (95%) than in adult plasma (99%). In the serum of newborns, ibuprofen competes with bilirubin for binding to albumin, so that at high concentrations of ibuprofen, the free fraction of bilirubin can increase.
In premature infants, ibuprofen significantly reduces the concentration of PG and their metabolites in the plasma, especially PGE2 and 6-keto-PGF1- alpha. In newborns who received 3 doses of ibuprofen, low concentrations of PG persisted for up to 72 hours, while 72 hours after the administration of only 1 dose of ibuprofen, a repeated increase in the concentration of PG was observed.
February 2018
Anadin (NSAID)
Pfizer Consumer Healthcare Ltd
Ramsgate Road
Sandwich
Kent
CT13 9NJ
United Kingdom
At a temperature not exceeding 25 °C.
Keep out of reach of children.
Shelf life of the drug Bonifen5 лет.Do not use after the expiration date indicated on the package.
1 tablet, coated, contains ibuprofen 200 mg, in a contour cell package of 6 pcs., in a box of 2 packages.
PL 00165/0136
Ibuprofen
Caution is required in patients with certain conditions:
- Systemic lupus erythematosus as well as those with mixed connective tissue disease due to increased risk of aseptic meningitis.
- Gastrointestinal disorders and chronic inflammatory intestinal disease as these conditions may be exacerbated (ulcerative colitis, Crohn's disease).
- Caution is required prior to starting treatment in patients with a history of hypertension and or heart/failure. Oedema, hypertension and/or cardiac impairment as renal function may deteriorate and/or fluid retention occur.
- Renal impairment as renal function may deteriorate.
- Hepatic dysfunction.
Undesirable effects may be minimised by using the minimum effective dose for the shortest possible duration to control symptoms (see GI and cardiovascular risks below).
The elderly are at increased risk of the serious consequences of adverse reactions especially gastrointestinal bleeding and perforation which may be fatal.
Bronchospasm may be precipitated in patients suffering from or with a previous history of bronchial asthma or allergic disease.
Use with concomitant NSAIDs including cyclo-oxygenase-2 specific inhibitors should be avoided .
Cardiovascular and cerebrovascular effects
Clinical studies suggest that use of ibuprofen, particularly at high doses (2400 mg/day) may be associated with a small increased risk of arterial thrombotic events (for example myocardial infarction or stroke).
Overall, epidemiological studies do not suggest that low dose ibuprofen (e.g. ≤1200mg daily) is associated with an increased risk of arterial thrombotic events.
Patients with uncontrolled hypertension, congestive heart failure (NYHA II-III), established ischaemic heart disease, peripheral arterial disease, and/or cerebrovascular disease should only be treated with ibuprofen after careful consideration and high doses (2400 mg/day) should be avoided.
Careful consideration should also be exercised before initiating long-term treatment of patients with risk factors for cardiovascular events (e.g. hypertension, hyperlipidaemia, diabetes mellitus, smoking), particularly if high doses of ibuprofen (2400 mg/day) are required.
There is some evidence that drugs, which inhibit cyclooxygenase/ prostaglandin synthesis, may cause impairment of female fertility by an effect on ovulation. This is reversible on withdrawal of treatment.
Gastro-intestinal (GI) bleeding, ulceration, or perforation, which can be fatal, has been reported with all NSAIDs at any time during treatment, with or without warning symptoms or a previous history of serious GI effects (including ulcerative colitis, Crohn's disease).
The risk of GI bleeding, ulceration or perforation is higher with increasing NSAID doses, in patients with a history of ulcer, particularly if complicated with haemorrhage or perforation , and in the elderly. These patients should commence treatment on the lowest dose available.
Patients with a history of GI toxicity, particularly when elderly, should report any unusual abdominal symptoms (especially GI bleeding) particularly in the initial stages of treatment.
Caution should be advised in patients receiving concomitant medications which could increase the risk of gastrotoxicity or bleeding, such as corticosteroids, or anticoagulants such as warfarin, selective serotonin uptake inhibitors or anti-platelet agents such as aspirin.
Where GI bleeding or ulceration occurs in patients receiving ibuprofen, the treatment should be withdrawn immediately.
Dermatological
Serious skin reactions, some of them fatal, including exfoliative dermatitis, Stevens-Johnson syndrome, and toxic epidermal necrolysis, have been reported very rarely in association with the use of NSAIDs. Patients appear to be at highest risk for these reactions early in the course of therapy: the onset of the reaction occurring in the majority of cases within the first month of treatment. Ibuprofen should be discontinued at the first appearance of skin rash, mucosal lesions, or any other sign of hypersensitivity.
Patients with rare hereditary problems of fructose intolerance should not take this medicine as this product contains sucrose.
Each tablet contains 67mg of sucrose. This should be taken into account in patients with diabetes mellitus.
There is a risk of renal impairment in dehydrated children and adolescents, between the ages of 12-18 year olds.
The label will include:
12-18 years: if symptoms worsen, or persist for more than 3 days, or you get new symptoms consult your doctor.
Adults: if symptoms worsen, or persist for more than 10 days, or you get new symptoms consult your pharmacist or doctor.
Read the enclosed leaflet before taking this product.
Do not take if you:
- have ever had a stomach ulcer, perforation or bleeding
- are allergic to ibuprofen (or anything else in this medicine), aspirin or other related painkillers
- are taking other NSAID painkillers, or aspirin with a daily dose above 75mg
- are in the last 3 months of pregnancy.
Speak to a pharmacist or your doctor before taking if you:
- have asthma, diabetes, high cholesterol, high blood pressure, had a stroke, heart, liver, kidney or bowel problems
- are a smoker
- are pregnant
None expected at recommended doses and duration of therapy.
Inside, washed down with water. Patients with hypersensitivity of the stomach are recommended to take the drug with a meal. For short-term use only. Before taking the drug, you should carefully read the instructions.
Adults and children over 12 years of age: inside 1 table. (200 mg) up to 3-4 times a day. To achieve a faster therapeutic effect in adults, the dose can be increased to 2 tablets (400 mg) up to 3 times a day.
Children from 6 to 12 years: 1 table (200 mg) up to 3-4 times a day, the drug can be taken only if the child's body weight is more than 20 kg.
The interval between taking the tablets should be at least 6 hours.
The maximum daily dose for adults is 1200 mg (6 tables).
The maximum daily dose for children from 6 to 18 years is 800 mg (4 tables).
If the symptoms persist or worsen after taking the drug for 2-3 days, you should stop treatment and consult a doctor.
Inside. 1 tablet 2-3 times a day.
Inside.
Tablets-washed down with a glass of water (200 ml), during meals. The initial dose for adults and children over 12 years of age is 400 mg, if necessary — 400 mg every 4-6 hours, the maximum daily dose is 1200 mg. The duration of therapy is no more than 7 days.
Granules - the contents of the bag are dissolved in 50-100 ml of water and taken immediately after cooking during or after a meal. Adults and children over 12 years of age — bags of 200 mg: 4-6 pcs./day, 400 mg-2-3 pcs./day, 600 mg-1-3 pcs./day. The maximum daily dose when using bags of 200 and 400 mg — 1200 mg, 600 mg-2400 mg.
To overcome morning stiffness in patients with arthritis, it is recommended to take the first dose immediately after waking up.
In patients with impaired renal, hepatic, or cardiac function, the dose should be reduced.
Externally.
Cream. Apply to the skin in the area of the painful area 3-4 times a day and rub with light movements until the drug is completely absorbed. A strip of cream with a length of 4-10 cm is used, depending on the area of the affected surface.
The duration of treatment depends on the severity of the disease and the nature of the damage and is on average 2-3 weeks.
Gel. A strip of gel 5-10 cm long is applied to the area of damage and carefully rubbed with light movements until completely absorbed 3-4 times a day.
The duration of treatment depends on the severity of the disease and the nature of the damage and is on average 2-3 weeks.
Inside, after eating, the effervescent tablet should be completely dissolved in a glass of water (the resulting solution is immediately drunk). The dose is prescribed individually so that the desired therapeutic effect is obtained with the use of the lowest possible dose.
Adults and children over 12 years old. For acute pain-200-400 mg every 4-6 hours, for fever-an initial dose of 200 mg every 4-6 hours, if necessary — 400 mg every 4-6 hours, for rheumatoid arthritis-2.4–3.2 g/day in 4-6 doses. The maximum daily dose is 40 mg / kg.
Children from 6 months to 12 years old. With fever-5-10 mg / kg/day in 4-5 doses, treatment should not last more than 3 days without consulting a doctor, with juvenile rheumatoid arthritis, children weighing less than 20 kg-400 mg/day in 4-5 doses, body weight 20-30 kg-600 mg / day, body weight 30-40 kg-800 mg/day, more than 40 kg-dosage as for adults.
Effervescent tablets are recommended for children over 6 years of age and adults.
Inside, after the meal. The average single dose is 5-10 mg/kg of body weight 3-4 times a day. Children aged 6 months-1 year (7-9 kg) - 2.5 ml (50 mg) 3 times a day, the maximum daily dose is 7.5 ml (150 mg). 1-3 years (10-15 kg) - 2.5 ml (50 mg) 3-4 times a day, the maximum daily dose is 7.5-10 ml (150-200 mg). 3-6 years old (16-20 kg) — 5 ml (100 mg) 3 times a day, the maximum daily dose is 15 ml (300 mg). 6-9 years old (21-30 kg) — 5 ml (100 mg) 4 times a day, the maximum daily dose is 20 ml (400 mg). 9-12 years old (31-41 kg) — 10 ml (200 mg) 3 times a day, the maximum daily dose is 30 ml (600 mg). Older than 12 years (more than 41 kg) - 10 ml (200 mg) 4 times a day, the maximum daily dose is 40 ml (800 mg). The dose can be repeated every 6-8 hours.Do not exceed the maximum daily dose. Children from 6 months to 1 g. the drug is prescribed on the recommendation of a doctor.
Inside, after a meal, with a small amount of liquid, in several doses, 2 tablets. at one time 1 time a day (in the evening or before going to bed). In severe conditions, the daily dose is increased by 1 table. for reception in the morning in addition to the evening dose.
Inside. Nurofen® for children-a suspension specially designed for children.
Patients with hypersensitivity of the stomach are recommended to take the drug with a meal.
For short-term use only.
Read the instructions carefully before taking the drug.
Shake the bottle thoroughly before use. To accurately measure the dose of the drug, a convenient measuring syringe is attached. 5 ml of the drug contains 100 mg of ibuprofen or 20 mg of ibuprofen in 1 ml.
Using a measuring syringe
Insert the measuring syringe firmly into the neck of the bottle. Turn the bottle upside down and gently pull the plunger down, drawing the suspension into the syringe to the desired mark. Return the bottle to its original position and remove the syringe by gently turning it. Place the syringe in the oral cavity and slowly press the plunger, gently releasing the suspension.
After use, rinse the syringe in warm water and dry it out of the reach of the child.
Fever (fever) and pain
The dosage for children depends on the age and body weight of the child. The maximum daily dose should not exceed 30 mg / kg with intervals between doses of the drug 6-8 hours. Children aged 3-6 months (child weight from 5 to 7.6 kg) - 2.5 ml (50 mg) up to 3 times for 24 hours, no more than 7.5 ml (150 mg) per day.
Children aged 6-12 months, (child weight 7.7–9 kg): 2.5 ml (50 mg) up to 3-4 times within 24 hours, no more than 10 ml (200 mg) per day. Children aged 1-3 years (child weight 10-16 kg): 5 ml (100 mg) up to 3 times for 24 hours, no more than 15 ml (300 mg) per day.
Children aged 4-6 years (child weight 17-20 kg): 7.5 ml (150 mg) up to 3 times for 24 hours, no more than 22.5 ml (450 mg) per day.
Children aged 7-9 years (child weight 21-30 kg): 10 ml (200 mg) up to 3 times for 24 hours, no more than 30 ml (600 mg) per day.
Children aged 10-12 years, (child weight 31-40 kg): 15 ml (300 mg) up to 3 times for 24 hours, no more than 45 ml (900 mg) per day.
The duration of treatment is no more than 3 days. Do not exceed the specified dose.
If symptoms persist or worsen when taking the drug for 24 hours (in children aged 3-5 months) or for 3 days (in children aged 6 months and older), it is necessary to stop treatment and consult a doctor.
Post-immunization fever
Children under the age of 6 months: 2.5 ml (50 mg) of the drug. If necessary, another 2.5 ml (50 mg) after 6 hours. Do not use more than 5 ml (100 mg) for 24 hours.
In/in.
Treatment with Anadin (NSAID)® It should only be performed in the neonatal intensive care unit under the supervision of an experienced neonatologist. The course of treatment is 3 doses with an interval of 24 hours.
The dose of ibuprofen is selected depending on the body weight:
- 1st injection — 10 mg / kg,
- 2nd and 3rd injections — 5 mg/kg.
The drug Anadin (NSAID)® It is prescribed in the form of a short 15-minute infusion, preferably in undiluted form. If necessary, the injected volume can be adjusted with a sodium chloride solution of 9 mg / ml (0.9%) for injection or a glucose solution of 50 mg/ml (5%) for injection. The remaining unused solution should be discarded.
When determining the total volume of the administered solution, the total daily volume of the prescribed liquid should be taken into account.
If after the 1st or 2nd dose the child develops anuria or obvious oliguria, the next dose is prescribed only after the restoration of normal diuresis. If the ductus arteriosus remains open 24 hours after the last injection or re-opens, a second course consisting of 3 doses may be prescribed, as described above.
If the condition does not change after the second course of treatment, surgical treatment of the open ductus arteriosus may be required.
Not applicable.
31/03/2011
