Ibuprofen Welfarm, 400 mg 20 pcs
€6.92 €6.06
Pharmacotherapeutic group: Non-steroidal anti-inflammatory drug (NSAID).
The ATC code: M01AE01
Pharmacological properties
Pharmacodynamics
The mechanism of action of ibuprofen, a propionic acid derivative of the group of nonsteroidal anti-inflammatory drugs, is due to inhibition of the synthesis of prostatic glandins – mediators of pain, inflammation and hyperthermia. It indiscriminately blocks cyclooxygenase 1 (COX-1) and cyclooxygenase 2 (COX-2), thus inhibiting the synthesis of prostaglandins. It has a fast directed effect against pain (analgesic), antipyretic and anti-inflammatory effects. In addition, ibuprofen reversibly inhibits platelet aggregation. The analgesic effect of the drug lasts up to 8 hours.
Pharmacokinetics
Ibuprofen is quickly and almost completely absorbed from the gastrointestinal tract, its maximum plasma concentrations are reached 1-2 hours after oral administration, in synovial fluid – 3 hours, it is 99% bound to plasma proteins.
It penetrates slowly into the joint cavity, stays in the synovial tissue, creating higher concentrations in it than in plasma.
The metabolism of ibuprofen occurs mainly in the liver. The elimination half-life (T1/2) from plasma is 2-3 hours. It is excreted by kidneys as metabolites (not more than 1% is excreted unchanged), to a lesser degree – with bile. Ibuprofen is completely eliminated in 24 hours.
Indications
Ibuprofen is used for headaches, migraines, toothaches, painful menstruation, neuralgia, back pain, muscle pain, rheumatic pain and joint pain; as well as in case of fever due to influenza and colds.
Pharmacological effect
Pharmacotherapeutic group: non-steroidal anti-inflammatory drug (NSAID).
ATX code: M01AE01
Pharmacological properties
Pharmacodynamics
The mechanism of action of ibuprofen, a derivative of propionic acid from the group of non-steroidal anti-inflammatory drugs, is due to inhibition of the synthesis of prostaglandins – mediators of pain, inflammation and hyperthermic reaction. Indiscriminately blocks cyclooxygenase 1 (COX-1) and cyclooxygenase 2 (COX-2), as a result of which it inhibits the synthesis of prostaglandins. It has a rapid, targeted effect against pain (analgesic), antipyretic and anti-inflammatory effects. In addition, ibuprofen reversibly inhibits platelet aggregation. The analgesic effect of the drug lasts up to 8 hours.
Pharmacokinetics
Ibuprofen is quickly and almost completely absorbed from the gastrointestinal tract, its maximum concentrations in plasma are reached 1-2 hours after oral administration, in synovial fluid – after 3 hours, and is 99% bound to plasma proteins.
Slowly penetrates into the joint cavity, lingers in the synovial tissue, creating higher concentrations in it than in plasma.
Metabolism of ibuprofen occurs primarily in the liver. The half-life (T1/2) from plasma is 2-3 hours. It is excreted by the kidneys in the form of metabolites (no more than 1% is excreted unchanged) and, to a lesser extent, with bile. Ibuprofen is completely eliminated within 24 hours.
Special instructions
It is recommended to take the drug for the shortest possible course and in the minimum effective dose necessary to eliminate symptoms. If you need to take the drug for more than 10 days, you must consult a doctor.
In patients with bronchial asthma or an allergic disease in the acute stage, as well as in patients with a history of bronchial asthma/allergic disease, the drug may provoke bronchospasm.
Use of the drug in patients with systemic lupus erythematosus or mixed connective tissue disease is associated with an increased risk of developing aseptic meningitis.
During long-term treatment, monitoring of the peripheral blood picture and the functional state of the liver and kidneys is necessary. When symptoms of gastropathy appear, careful monitoring is indicated, including esophagogastroduodenoscopy, a complete blood count (hemoglobin determination), and a stool test for occult blood. If it is necessary to determine 17-ketosteroids, the drug should be discontinued 48 hours before the study. During the treatment period, ethanol intake is not recommended.
Patients with renal failure should consult a doctor before using the drug, as there is a risk of deterioration in the functional state of the kidneys.
Patients with hypertension, including a history of hypertension and/or chronic heart failure, should consult a physician before using the drug, as the drug may cause fluid retention, increased blood pressure and edema.
Information for women planning pregnancy: the drug suppresses cyclooxygenase and prostaglandin synthesis, affects ovulation, disrupting female reproductive function (reversible after discontinuation of treatment).
Effect on the ability to drive vehicles, operate machinery Patients who experience dizziness, drowsiness, lethargy or blurred vision when taking ibuprofen should avoid driving vehicles or operating machinery.
Active ingredient
Ibuprofen
Composition
For one tablet:
Active ingredient: ibuprofen – 400.0 mg;
Excipients: povidone K90 (Kollidon 90 F), microcrystalline cellulose MS-101, talc, crospovidone (Kollidon CL, Kollidon CL-M), calcium stearate, colloidal silicon dioxide (Aerosil), corn starch.
Shell composition: [dry film coating mixture containing hypromellose, titanium dioxide, macrogol or hypromellose (hydroxypropyl methylcellulose), titanium dioxide, macrogol 6000 (polyethylene glycol 6000, polyethylene oxide 6000)].
Contraindications
– hypersensitivity to ibuprofen or any of the components included in 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 a history);
– erosive and ulcerative diseases of the gastrointestinal tract (including gastric and duodenal ulcers, Crohn’s disease, ulcerative colitis) or ulcerative bleeding in the active phase or in history (two or more confirmed episodes of peptic ulcer or ulcerative bleeding);
– a history of bleeding or perforation of a gastrointestinal ulcer caused by the use of NSAIDs;
– severe liver failure or active liver disease;
– severe renal failure (creatinine clearance <30 ml/min), confirmed hyperkalemia;
– decompensated heart failure; period after coronary artery bypass surgery;
– cerebrovascular or other bleeding;
– hemophilia and other bleeding disorders (including hypocoagulation), hemorrhagic diathesis;
– pregnancy (III trimester);
– children’s age: up to 6 years – for tablets 200 mg; up to 12 years – for tablets 400 mg.
With caution
If you have the conditions listed in this section, you should consult your doctor before using the drug.
Concomitant use of other NSAIDs, a history of a single episode of gastric and duodenal ulcers or gastrointestinal ulcerative bleeding; gastritis, enteritis, colitis, the presence of Helicobacter pylori infection, ulcerative colitis; bronchial asthma or allergic diseases in the acute stage or in history – bronchospasm may develop; systemic lupus erythematosus or mixed connective tissue disease (Sharpe’s syndrome) – increased risk of aseptic meningitis; renal failure, including dehydration (creatinine clearance less than 30-60 ml/min), nephrotic syndrome, liver failure, liver cirrhosis 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, peripheral arterial disease, smoking, frequent alcohol consumption, phenylketonuria or phenylalanine intolerance, concomitant use of drugs that may increase the risk of ulcers or bleeding, in particular oral corticosteroids (including prednisolone), anticoagulants (including warfarin), selective serotonin reuptake inhibitors (including acetylsalicylic acid, clopidogrel), pregnancy I-II trimester, breastfeeding period, old age.
Side Effects
The risk of side effects can be minimized if the drug is taken in a short course, at the minimum effective dose required to eliminate symptoms.
In older people, there is an increased incidence of adverse reactions due to the use of NSAIDs, especially gastrointestinal bleeding and perforation, in some cases fatal.
Side effects are predominantly dose-dependent. In particular, the risk of gastrointestinal bleeding depends on the dose range and duration of treatment.
The following adverse reactions were observed with short-term use of ibuprofen in doses not exceeding 1200 mg/day (6 tablets – 200 mg; 3 tablets – 400 mg). When treating chronic conditions and with long-term use, other adverse reactions may occur.
The incidence of adverse reactions was assessed based on the following criteria: very common (≥ 1/10), common (from ≥ 1/100 to < 1/10), uncommon (from ≥ 1/1000 to < 1/100), rare (from ≥ 1/10000 to < 1/1000), very rare (< 1/10000), frequency unknown (no frequency estimates available).
Blood and lymphatic system disorders
Very rare: hematopoietic disorders (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, nosebleeds and subcutaneous hemorrhages, bleeding and bruising of unknown etiology.
Immune system disorders
Uncommon: hypersensitivity reactions – nonspecific allergic reactions and anaphylactic reactions, reactions from the respiratory tract (bronchial asthma, including its exacerbation, bronchospasm, shortness of breath, dyspnea), skin reactions (itching, urticaria, purpura, Quincke’s edema, exfoliative and bullous dermatoses, including toxic epidermal necrolysis syndrome Lyell), Stevens-Johnson syndrome, erythema multiforme), allergic rhinitis, eosinophilia.
Very rare: severe hypersensitivity reactions, including swelling of the face, tongue and larynx, shortness of breath, tachycardia, hypotension (anaphylaxis, angioedema or severe anaphylactic shock).
Gastrointestinal disorders
Uncommon: abdominal pain, nausea, dyspepsia (including heartburn, bloating).
Rare: diarrhea, flatulence, constipation, vomiting.
Very rare: peptic ulcer, perforation or gastrointestinal bleeding, melena, hematemesis, in some cases fatal, especially in elderly patients, ulcerative stomatitis, gastritis.
Frequency unknown: exacerbation of colitis and Crohn’s disease.
Disorders of the liver and biliary tract
Very rare: liver dysfunction, increased activity of liver transaminases, hepatitis and jaundice.
Renal and urinary tract disorders
Very rare: acute renal failure (compensated and decompensated), especially with long-term 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.
Nervous system disorders
Uncommon: headache.
Very rare: aseptic meningitis.
Cardiovascular disorders
Frequency unknown: heart failure, peripheral edema, with long-term use there is an increased risk of thrombotic complications (for example, myocardial infarction), increased blood pressure.
Disorders 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);
– plasma glucose concentration (may decrease);
– creatinine clearance (may decrease);
– plasma creatinine concentration (may increase);
– activity of “liver” transaminases (may increase).
If side effects occur, you should stop taking the drug and consult a doctor.
Interaction
The simultaneous 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 per day) prescribed by a doctor, since combined use may increase the risk of side effects. With simultaneous use, ibuprofen reduces the anti-inflammatory and antiplatelet effect of acetylsalicylic acid (an increase in the incidence of acute coronary insufficiency in patients receiving small doses of acetylsalicylic acid as an antiplatelet agent is possible after starting ibuprofen);
– other NSAIDs, in particular selective COX-2 inhibitors: simultaneous use of two or more drugs from the NSAID group should be avoided due to a possible increased risk of side effects;
Use with caution simultaneously with the following medications:
– anticoagulants and thrombolytic drugs: NSAIDs can enhance the effect of anticoagulants, in particular warfarin and thrombolytic drugs;
– antihypertensive drugs (ACE inhibitors and angiotensin II antagonists) and diuretics: NSAIDs may reduce the effectiveness of drugs in these groups. In some patients with impaired renal function (eg, dehydrated patients or elderly patients with impaired renal function), co-administration of ACE inhibitors or angiotensin II antagonists and cyclooxygenase inhibitors may lead to a deterioration of renal function, including the development of acute renal failure (usually reversible). These interactions should be considered in patients taking coxibs concomitantly with ACE inhibitors or angiotensin II antagonists. In this regard, the combined use of the above drugs should be prescribed with caution, especially in the elderly. It is necessary to prevent dehydration in patients, and consider monitoring renal function after initiation of this combination treatment and periodically thereafter. Diuretics and ACE inhibitors may increase the nephrotoxicity of NSAIDs;
– glucocorticosteroids: increased risk of gastrointestinal ulcers and gastrointestinal bleeding;
– antiplatelet agents and selective serotonin reuptake inhibitors: increased risk of gastrointestinal bleeding.
– cardiac glycosides: simultaneous administration of NSAIDs and cardiac glycosides can lead to worsening heart failure, a decrease in glomerular filtration rate and an increase in the concentration of cardiac glycosides in the blood plasma;
– lithium preparations: there is evidence of the likelihood of an increase in the concentration of lithium in the blood plasma during the use of NSAIDs;
– methotrexate: there is evidence of the likelihood of an increase in the concentration of methotrexate in the blood plasma during the use of NSAIDs;
– cyclosporine: increased risk of nephrotoxicity with simultaneous administration of NSAIDs and cyclosporine;
– mifepristone: NSAIDs should be started no earlier than 8-12 days after taking mifepristone, since NSAIDs may reduce the effectiveness of mifepristone;
– tacrolimus: with simultaneous administration of NSAIDs and tacrolimus, the risk of nephrotoxicity may increase;
– zidovudine: simultaneous 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 concomitant treatment with zidovudine and ibuprofen;
– quinolone antibiotics: in patients receiving concomitant treatment with NSAIDs and quinolone antibiotics, the risk of seizures may increase;
– myelotoxic drugs: increased hematotoxicity;
– cefamandole, cefoperazone, cefotetan, valproic acid, plicamycin: increased incidence of hypoprothrombinemia;
– drugs that block tubular secretion: decreased 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 developing severe intoxications;
– microsomal oxidation inhibitors: reducing the risk of hepatotoxicity;
– oral hypoglycemic drugs and insulin, sulfonylurea derivatives: increased effect of drugs;
– antacids and cholestyramine: decreased absorption;
– uricosuric drugs: decreased effectiveness of drugs;
– caffeine: enhanced analgesic effect.
Overdose
Do not exceed the indicated dose. If you have exceeded the dose, consult your doctor or the nearest medical facility immediately. Take the drug package with you.
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 administration), activated charcoal, alkaline drinking, forced diuresis, symptomatic therapy (correction of acid-base status, blood pressure).
Storage conditions
In a place protected from light at a temperature not exceeding 25 ° C. Keep out of reach of children.
Shelf life
3 years.
Do not use after expiration date.
Manufacturer
Velfarm LLC, Russia
Shelf life | 3 years. Do not use after the expiration date. |
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Conditions of storage | In a place protected from light at a temperature not exceeding 25 oC. Keep out of the reach of children. |
Manufacturer | Welfarm, Russia |
Medication form | pills |
Brand | Welfarm |
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