Ibuprofen 400 instructions for use. General characteristics. Compound. International non-proprietary name

The composition of Ibuprofen in the form suppositories includes 60 mg of active substance, solid fat.

Compound tablets: ibuprofen (200 or 500 mg), potato starch, magnesium stearate, aerosil, vanillin, beeswax, edible gelatin, azorubine color. magnesium hydroxycarbonate, wheat flour, low molecular weight povidone, sucrose, titanium dioxide.

AT ointments and gel the active substance is contained in a concentration of 50 mg / g, in suspension - at a concentration of 20 mg / ml.

Auxiliary components of the gel: ibuprofen (50 mg / g), ethanol, propylene glycol, , carbomer 940, triethanolamine, neroli and lavender oil, methyl parahydroxybenzoate, purified water.

Auxiliary components of the ointment: dimethyl sulfoxide, macrogol 400 and 1500.

Release form

• ointment Ibuprofen 5% (25 g);
• Ibuprofen tablets p / o 200 and 400 mg;
• gel Ibuprofen 5% (20 and 50 g);
• candles Ibuprofen 60 mg;
• children's Ibuprofen in the form of oral suspension (20 mg/ml 100 ml).

ATC code for suspension, rectal suppositories, tablets - M01AE01, for external therapy (ointment and gel) - M02AA13.

pharmachologic effect

Anti-inflammatory, antipyretic, analgesic.

Pharmacodynamics and pharmacokinetics

The effects of the drug are due to the suppression of Pg biosynthesis by inhibiting the COX enzyme.

If a ductus botulinum opened and 24 hours after the last dose or re-opened, it is allowed to prescribe a second course, which also consists of 3 doses of the drug. If in this case it is not possible to achieve closure of the duct, the child may need surgical treatment.

Overdose

Overdose is accompanied by:

• pain in the abdomen;
• lethargy;
• nausea/vomiting;
• tinnitus;
• drowsiness;
• headache;
• depression
• metabolic acidosis ;
• bradycardia ;
• hypotension ;
• atrial fibrillation;
• stopping breathing.

Treatment: gastric lavage (preferably within 1 hour after taking the drug), appointment enterosorbents , forced diuresis , plentiful alkaline drinking, symptomatic therapy, the purpose of which is the correction of gastric and intestinal bleeding, blood pressure, acid-base balance, etc.

Interaction

Drugs that induce microsomal oxidation increase the production of hydroxylated active metabolic products and thus increase the risk of developing serious hepatotoxic reactions. Drugs that inhibit microsomal oxidation, on the contrary, reduce it.

Ibuprofen reduces sodium and diuretic activity and , efficiency hypotensive and uricosuric drugs (including ACE inhibitors and BMKK), antiplatelet and anti-inflammatory action e ASK.

Potentiates action antiplatelet agents , indirect anticoagulants , fibrinolytics , and oral forms of hypoglycemic drugs , ulcerogenic action with bleeding GCS and ISS.

The absorption of the drug is reduced in combination with cholestyramine and antacids . Gain analgesic effect promotes caffeine . In combination with thrombolytics and anticoagulants increases the risk of bleeding.

cefotetan , , Cefamandol , Plikamycin and increase the incidence of deficiency prothrombin (clotting factor) in the blood.

Myelotoxic drugs contribute to strengthening hematotoxicity ibuprofen. Au preparations and enhance the effect of the drug on the synthesis of Pg in the kidneys, resulting in an increase in its nephrotoxicity . In turn, Ibuprofen increases the concentration cyclosporine in blood plasma and hepatotoxicity .

Drugs blocking tubular secretion increase the concentration of ibuprofen in the blood plasma and reduce its excretion.

Terms of sale

Without recipe.

Recipe in Latin for tablets:

Rep.: Tab. Ibuprofeni 0.2 №30.
D.S. 1 tab. 3 r / d.

Storage conditions

Store at temperatures up to 25 degrees Celsius.

Best before date

Tablets and suspension are suitable for use within 3 years after the date of issue, gel, ointment and suppositories - within 2 years.

special instructions

At severe pathologies of the musculoskeletal system it is advisable to combine external therapy with oral forms of NSAIDs.

During the period of Ibuprofen use, it is necessary to monitor changes in kidney / liver function and peripheral blood patterns.

When symptoms appear NSAID gastropathy the patient needs a blood test to determine the hematocrit and Hb, a stool test for occult blood, esophagogastroduodenoscopy . To prevent development gastropathy Ibuprofen should be combined with PgE preparations.

If it is necessary to determine 17-KS, the drug is canceled 48 hours before the study.

Patients taking Ibuprofen should refrain from any activity that requires a high concentration of attention and speed of mental / motor reactions.

It should be remembered that this remedy to reduce the likelihood of adverse reactions from the digestive system should be used in the minimum effective dose and for the shortest possible course.

Alcohol compatibility

Alcohol is contraindicated during treatment with Ibuprofen.

Ibuprofen during pregnancy and lactation

Ibuprofen is the drug of choice for pain and fever during pregnancy, since it is safer for a woman's body during this period of time than most others. analgesics and antipyretics .

In the first 2 trimesters of pregnancy, it does not adversely affect the development of the fetus, does not provoke bleeding (unlike ) and does not pose a risk of miscarriage.

In the last trimester of pregnancy, Ibuprofen is contraindicated.

First, the drug inhibits the contraction of the muscles of the uterus. Secondly, its use can lead to closure Botallova duct and development pulmonary hypertension The child has. Thirdly, the drug tends to block the hormones responsible for the birth process.

Ibuprofen during breastfeeding does not affect the quality and secretion of milk, so it can be used to treat lactating women.

Ibuprofen.

Release form

Pink film-coated tablets, biconvex; two layers are visible in cross section.

pharmachologic effect

Non-steroidal anti-inflammatory agent.

Indication for use

Symptomatic treatment:

• tension headache and migraine;
• joint, muscle pain,
• pain in the back, lower back, sciatica;
• pain due to ligament injury;
• toothache;
• painful menstruation;
• febrile conditions with colds, flu;
• rheumatoid arthritis, osteoarthritis.

NSAIDs are intended for symptomatic therapy, reducing pain and inflammation at the time of use, do not affect the progression of the disease.

Dosage and administration

Adults, the elderly and children over 12 years of age: in tablets of 200 mg 3-4 times a day; in tablets of 400 mg 2-3 times a day. The daily dose is 1200 mg (do not take more than 6 tablets of 200 mg (or 3 tablets of 400 mg) within 24 hours. Tablets should be swallowed with water, preferably during or after meals. Do not take more often than after 4 hours. Do not exceed the indicated dose! The course of treatment without consulting a doctor should not exceed 5 days.

If symptoms persist, consult your physician.

Do not use in children under 12 years of age without consulting a doctor. Children from 6 to 12 years of age (weighing more than 20 kg): 1 tablet 200 mg no more than 4 times / day. The interval between taking the tablets is at least 6 hours.

Contraindications

• erosive and ulcerative changes in the mucous membrane of the stomach or duodenum, active gastrointestinal bleeding;
• inflammatory bowel disease in the acute phase, incl. ulcerative colitis;
• anamnestic data on an attack of bronchial obstruction, rhinitis, urticaria after taking acetylsalicylic acid or another non-steroidal anti-inflammatory drug (complete or incomplete syndrome of acetylsalicylic acid intolerance - rhinosinusitis, urticaria, polyps of the nasal mucosa, bronchial asthma);
• liver failure or active liver disease;
• renal failure (CC less than 30 ml / min), progressive kidney disease;
• confirmed hyperkalemia;
• hemophilia and other blood clotting disorders (including hypocoagulation), hemorrhagic diathesis;
• in the period after coronary artery bypass grafting;
• pregnancy (III trimester);
• children's age: up to 6 years and from 6 to 12 years (weighing less than 20 kg) - for 200 mg tablets; up to 12 years - for tablets 400 mg;
• hypersensitivity to any of the ingredients that make up the drug.

With caution: old age, congestive heart failure, cerebrovascular disease, arterial hypertension, coronary heart disease, dyslipidemia / hyperlipidemia, diabetes mellitus, peripheral arterial disease, nephrotic syndrome, CC less than 30-60 ml / min, hyperbilirubinemia, gastric and duodenal ulcer intestines (history), the presence of Helicobacter pylori infections, gastritis, enteritis, colitis, long-term use of NSAIDs, blood diseases of unknown etiology (leukopenia and anemia), pregnancy (I-II) trimester, lactation period, smoking, frequent alcohol use (alcoholism) , severe medical illness, concomitant therapy with the following drugs: anticoagulants (eg, warfarin), antiplatelet agents (eg, acetylsalicylic acid; clopidogrel), oral glucocorticosteroids (eg, prednisolone), selective serotonin reuptake inhibitors (eg, citalopram, fluoxetine, paroxetine, sertraline ).

special instructions

With prolonged use, it is necessary to control the picture of peripheral blood and the functional state of the liver and kidneys. To reduce the risk of developing adverse events from the gastrointestinal tract, the minimum effective dose should be used. When symptoms of gastropathy appear, careful monitoring is indicated, including esophagogastroduodenoscopy, a blood test with the determination of hemoglobin and hematocrit, and a fecal occult blood test. If it is necessary to determine 17-ketosteroids, the drug should be discontinued 48 hours before the study. activities that require increased concentration of attention and speed of psychomotor reactions.

Storage conditions

In a dry, dark place at a temperature not exceeding 30°C. Keep out of reach of children.

Manufacturer: Merkle GmbH

Anatomical-therapeutic-chemical classification: ibuprofen

Registration number: No. RK-LS-5 No. 014622

Date of registration: 15.10.2014 - 15.10.2019

Instruction

• Russian

Ibuprofen-Teva

Tradename

Ibuprofen-Teva

International non-proprietary name

Ibuprofen

Dosage form

Coated tablets, 200 mg and 400 mg

Withleaving

One tablet contains

active substance- ibuprofen 200 mg and 400 mg,

Excipients: modified corn starch, croscarmellose sodium, hypromellose, stearic acid, anhydrous colloidal silicon, shell: hypromellose, Macrogol 8000, titanium dioxide (E 171)

Description

Round, biconvex, white film-coated tablets

Pharmacotherapeutic group

Anti-inflammatory and antirheumatic drugs. Non-steroidal anti-inflammatory drugs. propionic acid derivatives. Ibuprofen

ATX code M01AE01

Pharmacological properties

Pharmacokinetics

Ibuprofen is rapidly absorbed from the gastrointestinal tract, peak serum concentrations are reached within 1-2 hours after ingestion. Ibuprofen actively binds to plasma proteins. The half-life is about 2 hours. Ibuprofen is metabolized in the liver to two inactive metabolites and excreted along with the metabolites via the kidneys. Excretion by the kidneys is both rapid and complete.

Pharmacodynamics

Ibuprofen is a propionic acid derivative with analgesic, anti-inflammatory and antipyretic effects. It is believed that the therapeutic effects of the drug are due to its inhibitory effect on the cyclooxygenase enzyme, which leads to a pronounced decrease in the synthesis of prostaglandins.

Experimental data suggest that ibuprofen may suppress the effect of low doses of acetylsalicylic acid on platelet aggregation when both drugs are given concomitantly. In one study, with a single dose of ibuprofen at a dose of 400 mg within 8 hours before or 30 minutes after taking acetylsalicylic acid in the form of an immediate release of the drug (at a dose of 81 mg), the effect of acetylsalicylic acid on the formation of thromboxane or platelet aggregation was reduced. Although there is uncertainty regarding the extrapolation of these data to the clinical situation, the possibility that regular, long-term use of ibuprofen may reduce the cardioprotective effect of low doses of acetylsalicylic acid cannot be ruled out. With irregular use of ibuprofen, the effect is not considered clinically significant.

Indications for use

Rheumatoid arthritis, including juvenile arthritis or Still-Choffard disease, ankylosing spondylitis, osteoarthritis, and other non-rheumatoid (seronegative) arthropathies

Extra-articular rheumatic and periarticular lesions such as humeroscapular periarthritis (capsulitis), bursitis, tendonitis, tendosynovitis, and low back pain

Soft tissue injuries, such as sprains and strains of ligaments

Reduction of mild to moderate pain, such as primary dysmenorrhea, dental and postoperative pain, symptomatic treatment of headache, including migraine

Dosage and administration

In order to minimize the risk of developing adverse reactions, ibuprofen should be taken at the lowest effective dose and for the shortest period necessary to achieve a clinical effect.

Adults and children over 12 years old: The recommended dose of ibuprofen is 1200-1800 mg daily, divided into several doses. For some patients, 600-1200 mg per day may be sufficient. In severe and acute cases, it is possible to increase the dose until the end of the acute phase of the disease. In this case, the maximum daily dose should not exceed 2400 mg, divided into several doses.

Elderly people: The elderly are at an increased risk of serious adverse reactions. Undesirable effects can be minimized by using the lowest effective dose for the shortest period of time.

It is necessary to monitor gastrointestinal bleeding. In case of impaired liver or kidney function, the dose of the drug should be selected individually.

For oral administration. Patients with a sensitive stomach are advised to take the drug with food. If the drug is taken after a meal, the onset of action of ibuprofen may be delayed. The drug should be taken with plenty of liquid. Tablets should be swallowed whole, without chewing, breaking, or dissolving to avoid discomfort in the mouth and irritation in the throat.

Side effects

Gastrointestinal disorders. The most frequently observed side effects are gastrointestinal: peptic ulcers, perforation or gastrointestinal bleeding, sometimes fatal, especially in the elderly. Nausea, vomiting, diarrhea, flatulence, constipation, dyspepsia, abdominal pain, melena, hematoemesis, ulcerative stomatitis, gastrointestinal bleeding, and exacerbation of colitis and Crohn's disease. Gastritis, duodenal ulcer, gastric ulcer and gastrointestinal perforation have not been frequently observed.

From the side of the immune system: hypersensitivity reactions in the form of a nonspecific allergic reaction and anaphylaxis, respiratory tract reactivity, including asthma, exacerbation of asthma, bronchospasm or dyspnea, skin diseases, including rashes of various types, itching, urticaria, purpura, angioedema, very rarely- erythema, bullous dermatoses (including Stevens-Johnson syndrome and toxic epidermal necrolysis).

Heart disease and vascular disorders: edema, hypertension and heart failure. Clinical studies suggest that the use of ibuprofen in particular at a high dose (2400 mg per day) may be associated with a slight increase in the risk of arterial thrombotic complications such as myocardial infarction or stroke.

Infections and infestations: Runny nose and aseptic meningitis (especially in patients with existing autoimmune disorders such as systemic lupus erythematosus and mixed connective tissue diseases) with symptoms of neck stiffness, headache, nausea, vomiting, fever or disorientation.

There are cases of exacerbation of inflammation caused by infections with the use of NSAIDs. If signs of infection develop or worsen while using ibuprofen, a doctor should be contacted immediately.

: in exceptional cases, severe skin infections and complications of soft tissues due to chickenpox infection are possible.

Possible adverse reactions associated with taking ibuprofen are listed below in order of decreasing frequency of occurrence within each system or organ. Adverse reactions are distributed by frequency: very common ≥ 1/10, frequent ≥1/100 and ≤1/10, infrequent ≥1/1000 and ≤ 1/100, rare ≥1/10000 and ≤ 1/1000, very rare ≤ 1 /10000.

Infections and infestations

Infrequently: rhinitis

Rarely: aseptic meningitis

Disorders of the hematopoietic and lymphatic system

Rareabout: leukopenia, thrombocytopenia, neutropenia, agranulocytosis, aplastic anemia, hemolytic anemia

Immune system disorders

Rarely: anaphylactic reactions

Psychiatric disorders

Infrequently: insomnia, anxiety

Rarely: depression and confusion

Nervous System Disorders

Often: headache, dizziness

Infrequently: parasthesia, drowsiness

Rarely: optic neuritis

visual impairment

Infrequently: blurred vision

Rarely: toxic optic neuropathy

Vestibular disorders

Infrequently: hearing loss, noise or ringing in the ears, vertigo

Gastrointestinal Disorders

Often: dyspepsia, nausea, vomiting, abdominal pain, diarrhea, flatulence, constipation, melena, hematemesis, gastrointestinal bleeding

Infrequently: gastritis, duodenal ulcer, gastric ulcer, ulcerative stomatitis, gastrointestinal perforation

Very rarely: pancreatitis

Unknown: colitis and Crohn's disease

Hepatobiliary disorders

Infrequently: hepatitis, jaundice, liver dysfunction

Very rarely: liver failure

Skin infection and soft tissue disorders :

Often: rash

Infrequently: urticaria, pruritus, purpura, angioedema, photosensitivity

Very rarely: severe skin reactions, eg, erythema multiforme, bullous reactions, including Stevens-Johnson syndrome, and toxic epidermal necrolysis

Urinary system disorders

Infrequently: toxic nephropathy in various forms, including interstitial nephritis, nephrotic syndrome, renal failure

General violations

Often: fatigue

Rarely: edema

Cardiac disorders

Very rarely: heart failure, myocardial infarction

Vascular disorders

Very rarely: arterial hypertension

Contraindications

Hypersensitivity to the active substance or other components of the drug

Asthma, urticaria or other allergic reactions after taking acetylsalicylic acid or other non-steroidal anti-inflammatory drugs (NSAIDs) in history

History of gastrointestinal bleeding or perforation associated with NSAIDs

Acute or previous ulcerative colitis, Crohn's disease, recurrent peptic ulcer, or gastrointestinal bleeding (history of two independent confirmed episodes of ulcerative lesions or bleeding)

Conditions associated with an increased risk of bleeding

severe heart failure

severe liver failure

Severe renal failure (glomerular filtration rate< 30 мл/мин)

Third trimester of pregnancy, lactation

Children's age up to 12 years

drug interaction

Caution should be exercised when co-administered with the following drugs due to possible drug interactions in some patients.

Antihypertensive drugs, β-blockers and diuretics. NSAIDs may reduce the effect of antihypertensive drugs such as ACE inhibitors, angiotensin II receptor antagonists, β-blockers and diuretics. Diuretics may also increase the risk of NSAID nephrotoxicity.

cardiac glycosides. NSAIDs can exacerbate heart failure, decrease glomerular filtration rate, and increase plasma levels of cardiac glycosides.

Cholestyramine.The simultaneous appointment of ibuprofen and cholestyramine may reduce the absorption of ibuprofen in the gastrointestinal tract. However, the clinical significance of this is unknown.

Lithium. NSAIDs may reduce lithium excretion.

Methotrexate. NSAIDs can suppress tubular secretion of methotrexate and reduce the clearance of methotrexate.

Cyclosporine. NSAIDs increase the risk of nephrotoxicity.

mifepristone. The decrease in drug efficacy could theoretically be due to the antiprostaglandin properties of NSAIDs. Limited data suggest that co-administration of NSAIDs on the day of prostaglandin administration does not alter the effect of mifepristone or prostaglandin on cervical maturation or uterine contractility and does not reduce the clinical efficacy of medical abortion.

COX-2 inhibitors and other NSAIDs. Co-administration with other NSAIDs, including selective COX-2 inhibitors, should be avoided due to the risk of additional effects.

Acetylsalicylic acid. As with the appointment of other drugs containing NSAIDs, the simultaneous use of ibuprofen and acetylsalicylic acid is usually not recommended due to the risk of increasing adverse reactions. Experimental data suggest that ibuprofen can inhibit the effect of low doses of acetylsalicylic acid on platelet aggregation when administered concomitantly. However, due to the limitations of these data and the uncertainty about the possibility of extrapolating them to the clinical situation, no clear conclusion can be made regarding the regular use of ibuprofen and the likely clinical effects of irregular ibuprofen.

Corticosteroids. Increased risk of gastrointestinal ulcers or bleeding when administered with NSAIDs.

Anticoagulants. NSAIDs may enhance the effects of anticoagulants such as warfarin.

Quinolone antibiotics. Animal data indicate that NSAIDs may increase the risk of seizures associated with quinolones. Patients taking both NSAIDs and quinolones have an increased risk of developing seizures.

Sulfonylurea. NSAIDs can potentiate the effects of sulfonylurea drugs. Rarely, the development of hypoglycemia has been reported in patients taking sulfonylurea when prescribing ibuprofen.

Antiplatelet drugs and selective serotonin reuptake inhibitors. NSAIDs increase the risk of gastrointestinal bleeding.

Tacrolimus. There may be an increased risk of nephrotoxicity when NSAIDs are given to patients taking tacrolimus.

Zidovudine. NSAIDs increase the risk of hematological toxicity. There is evidence of an increased risk of developing hemarthroses and hematomas in HIV-positive patients with hemophilia when prescribing ibuprofen while taking zidovudine.

Aminoglycosides. NSAIDs may reduce the excretion of aminoglycosides.

Herbal extracts. Ginkgo biloba may potentiate the risk of bleeding associated with NSAIDs.

CYP2C9 inhibitors. Co-administration of ibuprofen with CYP2C9 inhibitors may increase the exposure of ibuprofen (CYP2C9 substrate). One study showed that voriconazole and fluconazole (CYP2C9 inhibitors) increased S(+)-ibuprofen exposure by approximately 80-100%. Dose reduction of ibuprofen should be considered when co-administered with CYP2C9 inhibitors, especially when high doses of ibduprofen are administered to patients taking voriconazole or fluconazole.

special instructions

Undesirable effects can be minimized by using the lowest effective dose for the shortest period of time.

As with other NSAIDs, ibuprofen may mask the symptoms of an infection.

Elderly patients

In elderly patients, the incidence of adverse reactions with NSAIDs is higher, especially gastrointestinal bleeding and perforation, which can be fatal.

Use in children

There is a risk of kidney failure in dehydrated children and adolescents.

Gastrointestinal bleeding, ulceration and perforation

The development of gastrointestinal bleeding, ulcers or perforation can be with the use of all NSAIDs at any time during treatment. These adverse reactions can be fatal and develop with or without warning symptoms, regardless of a history of serious gastrointestinal disease. The risk of developing gastrointestinal bleeding, ulcers or perforation is higher with increasing doses of ibuprofen in patients with an ulcer, especially complicated by a history of bleeding or perforation, and in elderly patients. Such patients should begin treatment at the lowest available dose. Consideration should be given to concomitant administration of protective drugs (eg, misoprostol or proton pump inhibitors) to such patients, as well as to patients concomitantly taking low-dose acetylsalicylic acid or other drugs that increase the risk of gastrointestinal damage. Simultaneous administration of ibuprofen and other NSAIDs, including selective ones, should be avoided. cyclooxygenase-2 (COX-2) inhibitors, due to an increased risk of ulceration and bleeding.

Patients, especially the elderly, with a history of gastrointestinal disease should report any unusual abdominal symptoms (especially gastrointestinal bleeding) during the initial stages of treatment. Caution should be given to ibuprofen in patients receiving concomitant treatment with drugs that may increase the risk of ulcers or bleeding, such as oral corticosteroids, anticoagulants such as warfarin, selective serotonin reuptake inhibitors or antiplatelet drugs, such as acetylsalicylic acid. If gastrointestinal bleeding or ulcers develop in a patient receiving ibuprofen, the drug should be discontinued.

Respiratory disorders

With caution, ibuprofen should be prescribed to patients suffering from bronchial asthma, chronic rhinitis or allergic diseases, as well as to patients with a history of these diseases, since it has been reported that ibuprofen can cause bronchospasm, urticaria, angioedema in such patients.

Impaired function of the heart, kidneys and liver

The use of NSAIDs can lead to deterioration of kidney function. Taking multiple analgesics daily at the same time further increases the risk of worsening kidney function. Patients with impaired function of the heart, kidneys and liver, taking diuretics and elderly patients should use the minimum effective dose of the drug for a short period of time and monitor renal function, especially in patients receiving long-term treatment.

Cardiovascular and cerebrovascular effects

Ibuprofen should be used with caution in patients with a history of heart failure or hypertension, as edema has been reported with ibuprofen.

Clinical studies suggest that the use of ibuprofen, especially at high doses (2400 mg per day), may be associated with a slight increase in the risk of arterial thrombotic complications such as myocardial infarction or stroke. The results of epidemiological studies do not suggest an association between low dose ibuprofen (≤ 1200 mg daily) and an increased risk of arterial thromboembolic events.

In patients with uncontrolled arterial hypertension, congestive heart failure, diagnosed coronary heart disease, peripheral arterial disease and/or cerebrovascular disease, ibuprofen should be prescribed after a careful assessment of the situation, avoiding high doses (2400 mg/day), as well as before starting long-term therapy with ibuprofen in patients with risk factors for the development of cardiovascular disease (such as arterial hypertension, hyperlipidemia, diabetes mellitus, smoking).

Renal effects

Caution should be exercised when initiating ibuprofen treatment in patients with significant dehydration. As with the appointment of other NSAIDs, long-term use of ibuprofen can lead to papillary necrosis of the kidneys and other pathological changes in the kidneys. Renal toxicity has also been observed in patients in whom renal prostaglandins played a compensatory role in maintaining renal perfusion. The administration of NSAIDs to such patients may cause a dose-dependent decrease in prostaglandin formation and, secondarily, a decrease in renal blood flow, which may lead to renal failure. Patients with impaired renal function, heart failure, liver dysfunction, diuretics and angiotensin-converting enzyme (ACE) inhibitors, as well as elderly patients, are at high risk of developing such a reaction. Discontinuation of NSAIDs is usually accompanied by the restoration of the condition that preceded treatment.

Dermatological effects

Very rarely, serious skin reactions, some of which can be fatal, have been reported with NSAIDs, including exfoliative dermatitis, Stevens-Johnson syndrome, and toxic epidermal necrolysis. Presumably, the greatest risk of developing these reactions exists at the beginning of treatment. In most cases, the onset of the reaction occurs within the first month of therapy. Ibuprofen should be discontinued at the first appearance of a skin rash, mucosal injury, or any other sign of hypersensitivity.

Hematological effects

Ibuprofen, like other NSAIDs, can inhibit platelet aggregation and prolong bleeding time in healthy individuals.

Aseptic meningitis

In rare cases, aseptic meningitis has developed in patients receiving ibuprofen. Although this is more likely in patients with systemic lupus erythematosus and other connective tissue diseases, the development of this complication has also been reported in patients without concomitant chronic diseases. Pregnancy and lactation

Inhibition of prostaglandin synthesis can adversely affect the course of pregnancy and / or the development of the embryo / fetus. Data from epidemiological studies suggest an increased risk of miscarriage and the development of heart defects and gastroschisis after the use of prostaglandin synthesis inhibitors in early pregnancy. It is assumed that the risk increases with increasing dose and duration of therapy. Ibuprofen should not be given during the first and second trimesters of pregnancy unless absolutely necessary. If ibuprofen is prescribed to women planning a pregnancy, or in the first or second trimester of pregnancy, the lowest possible dose should be used for the shortest possible period of time. The use of any prostaglandin inhibitors during the third trimester of pregnancy may affect the fetus, causing cardiopulmonary toxicity (with premature closure of the ductus arteriosus and pulmonary hypertension); renal dysfunction, which may progress to renal failure with oligohydramnios. At the end of pregnancy, prostaglandin synthesis inhibitors can affect the condition of the mother and newborn child with a possible lengthening of bleeding time, inhibition of uterine contractility, which may be accompanied by a delay and prolongation of labor. Thus, the use of ibuprofen in the third trimester of pregnancy is contraindicated.

Application during lactation

In a limited number of studies, ibuprofen has been detected in breast milk at very low concentrations. Ibuprofen is not recommended for women who are breastfeeding.

Features of the influence of the drug on the ability to drive a vehicle or potentially dangerous mechanisms

Treatment with ibuprofen may affect the reaction time of patients, which should be taken into account when increased attention is required, for example, when driving a car or operating equipment.

Overdose

Signs and symptoms of overdose in adults have not generally been observed at doses below 100 mg/kg. However, in some cases, supportive measures may be required. In children, signs of overdose appear after taking a dose of 400 mg / kg or higher.

Symptoms.

In most patients, overdose symptoms develop within 4-6 hours after taking a significant amount of ibuprofen. The most common overdose symptoms include: nausea, vomiting, abdominal pain, lethargy and drowsiness.

Manifestations from the central nervous system (CNS): headache, ringing in the ears, dizziness, convulsions and loss of consciousness. Rarely, nystagmus, metabolic acidosis, hypothermia, renal symptoms, gastrointestinal bleeding, coma, apnea, diarrhea, and CNS and respiratory depression have been reported. Disorientation, agitation, cardiovascular toxicity, including the development of arterial hypotension, bradycardia and tachycardia, have been reported. In cases of significant overdose, renal failure and liver damage may develop. A significant overdose is usually well tolerated if no other drugs have been taken.

Treatment. Symptomatic. Within one hour after taking a potentially toxic dose, it is necessary to take activated charcoal, gastric lavage. It is necessary to provide diuresis with the control of kidney and liver function. Patients should be observed for at least 4 hours after taking potentially toxic amounts of the drug.

Pain is a protective reaction of the body and a signal to a person that inside, most likely, something went wrong. But sometimes it is unbearable to endure it, and besides, it is often not necessary. There are many modern drugs that allow you to quickly stop pain attacks. One of them is Ibuprofen (400 mg), the instructions for use of which recommend taking it to relieve discomfort in a variety of diseases.

general information

There is a large class of drugs that belong to non-steroidal anti-inflammatory drugs. They eliminate pain and have an antipyretic effect. Also, these drugs reduce the severity of the inflammatory process, and the effect of them is quite fast. One of these drugs is Ibuprofen (400 mg). Instructions for use recommends taking it for pain of various nature and elevated body temperature.

The tool refers to fast-acting drugs that relieve symptoms, but, unfortunately, do not eliminate the causes of the disease. Therefore, most often "Ibuprofen" is part of the complex therapy of various diseases. It allows a person to endure the recovery process much easier due to the fact that the clinical picture against the background of his admission becomes less pronounced. In parallel with it, etiotropic treatment is prescribed, that is, one that affects the true nature of the disease.

Forms of release and composition

The first thing that catches your eye when you open the package of the drug "Ibuprofen" (400 mg) is the instructions for use. The composition of the drug is as follows:

• active substance - ibuprofen;
• additional components (may differ depending on the manufacturer) - silicon dioxide, corn starch, magnesium stearate, titanium dioxide, talc, sodium carboxymethyl starch, povidone K30, macrogol 4000, hypromellose, microcrystalline cellulose.

Each tablet has a special feature that makes it possible to divide the medication into 2 equal halves. This is very convenient in cases where you need to take, say, 200 or 600 mg of ibuprofen at the same time.

Means with prolonged use, unfortunately, adversely affect the mucous membrane of the digestive system, this also applies to the drug "Ibuprofen". Instructions for use of the tablet (400 mg) recommends taking it after meals so that the stomach does not succumb to the irritating effect of the drug.

The mechanism of action of the drug

During inflammation, prostaglandins (physiologically active substances) are actively formed in the tissues, an increased level of which brings pain to a person. The reaction of their synthesis is accelerated by the enzymes cyclooxygenases of the 1st and 2nd type (COX-1 and COX-2).

Non-steroidal anti-inflammatory drugs inhibit the formation of these catalysts, and the amount of prostaglandins decreases rapidly, since the reaction is not so intense. Ibuprofen (400 mg) also has this mechanism of action. Instructions for use, description of the drug in pharmaceutical reference books indicate that the remedy effectively eliminates pain, relieves inflammation and lowers the overall body temperature. The maximum concentration of the active substance is observed 1-2 hours after taking the tablet inside. The drug is excreted from the body mainly with urine, and accumulates in the body in plasma and periarticular fluid.

The advantage of tablets over other dosage forms

"Ibuprofen" is available in different doses and dosage forms. It is presented in syrups, tablets, suspensions and capsules. But if we consider "Ibuprofen" (400 mg), the instructions for use of which involve oral administration, then in this dosage it is available only in tablets. This type of medicine has certain advantages:

• ease of use;
• the absence of an unpleasant aftertaste of the active substance due to the shell and additional components;
• persistent effect;
• exact dosage.

The use of tablets does not require the participation of medical personnel (as in the case of injections, for example) and compliance with sterility conditions. Ibuprofen tablets are medium in size, easy to swallow with a small amount of water.

Indications for use

The most comprehensive document that describes the indications for the use of the drug "Ibuprofen" - instructions for use. Tablets (400 mg) are usually prescribed to the patient for such symptoms and diseases:

• migraine;
• painful menstruation;
• inflammation and pinched nerves;
• increased body temperature;
• toothache;
• stiffness and discomfort in the joints with arthritis, arthrosis and non-rheumatic inflammation;
• muscle pain;
• inflammation of the ligaments;
• rheumatoid processes;
• inflammation of the uterine appendages;
• ankylosing spondylitis;
• manifestations of SARS, tonsillitis, bronchitis.

The agent can be used as part of complex therapy in patients with It reduces the amount of protein in the urine and reduces the intensity of pain. The medicine helps to reduce discomfort in the postoperative period, although it cannot act as the only analgesic in this case.

"Ibuprofen" (400 mg): instructions for use, analogues of the drug

Tablets with this dosage are available under the following trade names:

• "MIG-400".
• Nurofen Forte.
• "Faspic".
• "Brufen".
• "Burana".
• Ibuprom Max.
• Ibuprofen Nycomed.

There is also a high-quality domestic drug "Ibuprofen Hemofarm" (400 mg). Instructions for use assumes its use according to the following scheme:

• with pain of moderate severity - 1 tablet 3 times a day;
• with rheumatoid inflammation of the joints - 2 tablets three times a day;
• with muscle pain and diseases of the ligaments - 1.5 tablets 2-3 times a day;
• with Bechterew's disease - 1-1.5 tablets up to 4 times a day.

These recommendations are standard for taking ibuprofen 400 mg tablets from any manufacturer. To reduce the temperature, the amount of the drug is calculated based on the weight of the patient. If the mark on the thermometer has reached 39.2, you need to drink the remedy from a ratio of 10 mg / kg of a person’s weight (if the value is less, then 5 mg / kg of the patient’s body weight is enough).

Contraindications

Not all people can safely use Ibuprofen tablets (400 mg). Instructions for the use of contraindications indicate the following:

• peptic ulcers of the digestive system;
• gastritis and chronic inflammation of the intestine during periods of exacerbation;
• bronchial asthma;
• severe liver dysfunction (for example, cirrhosis or deep damage to the blood vessels of this organ);
• age up to 12 years;
• last trimester of pregnancy;
• high blood pressure;
• swelling;
• diseases of the ophthalmic nerves;
• color perception disorders due to ophthalmic diseases;
• individual intolerance to the components of the drug;
• heart failure;
• poor blood clotting.

During lactation, ibuprofen passes into breast milk, but in very low doses. It is necessary to cancel the natural feeding of a newborn due to the appointment of this drug to the mother only in cases where the woman has long-term drug therapy.

What is dangerous overdose

Before treatment, it is advisable to find out such information about the Ibuprofen (400 mg) remedy: instructions for use, release form and contraindications. But it is important to read about the safe doses of the drug, because their excess can lead to sad consequences. Between doses, it is important to maintain a minimum interval of 6 hours; you should not drink these pills more often because of the high risk of side effects on the body. The daily dose of the drug in any case should not exceed 2.4 g.

Symptoms of taking an excess amount of medication:

• nausea (sometimes vomiting is possible);
• headache;
• visual impairment;
• lowering blood pressure;
• abdominal pain;
• dizziness;
• labored breathing;
• bluing of the skin.

There is no specific counteracting agent, therefore, if alarming symptoms occur, the patient needs to wash the stomach, provide fresh air and immediately call an ambulance.

Compatibility with other drugs

Not all medicines are compatible with each other. They can enhance the side effects of each other or weaken their effectiveness. No exception in this respect and the drug "Ibuprofen" (400 mg). Instructions for use warns that the medicine should not be taken with such medicines:

• means for the treatment of hypertension (it reduces their activity and can cause an increase in blood pressure);
• "Furosemide" and diuretic drugs similar in action (ibuprofen makes their action difficult);
• anticancer drugs (since ibuprofen enhances their toxic effect on the body).

When treating with the drug, you should not drink alcohol, since this combination leads to an undesirable side effect of Ibuprofen and enhances the harmful effects of alcoholic beverages.

Reviews of doctors

Doctors say that ibuprofen is one of the safest representatives of non-steroidal anti-inflammatory drugs. On its basis, a huge number of over-the-counter drugs with high efficiency are produced. Doctors noticed that those patients who took into account all contraindications and did not exceed the recommended dosages only benefited from taking the medicine.

Instructions for use Ibuprofen
Buy Ibuprofen tab po 400mg №30 Hemofarm
Dosage forms
400mg tablets, 0.4g film-coated tablets, 400mg film-coated tablets, 400mg film-coated tablets
Manufacturers
Hemofarm (Serbia)
Group
Anti-inflammatory drugs - derivatives of propionic acid
Compound
Active ingredient: Ibuprofen.
International non-proprietary name
Ibuprofen
Synonyms
Bolinet, Bolinet Lingval, Bonifen, Bren, Brufen SR, Dolgit, Ibalgin, Ibuprofen Lannacher, Ibuprofen-Akos, Ibuprofen-Verte, Ibuprofen-Teva, Ibuprofen-Hemofarm, Ibufen, MIG 400, Nurofen, Nurofen for children, Nurofen UltraCap, Nurofen forte, Nurofen Express, Nurofen Express Lady, Nurofen Express Neo, Pedea, Faspic
pharmachologic effect
Anti-inflammatory, analgesic, antipyretic. Non-selectively inhibits two cyclooxygenase isoenzymes. The maximum concentration is created after 0.5-1 h. It slowly penetrates into the joint cavity, but lingers in the synovial tissue, creating higher concentrations in it than in plasma. undergoes biotransformation. Excreted by the kidneys. The anti-inflammatory effect is associated with a decrease in vascular permeability, an improvement in microcirculation, a decrease in the release of inflammatory mediators from cells, and a suppression of the energy supply of the inflammatory process. The analgesic effect is due to a decrease in the intensity of inflammation, a decrease in the production of bradykinin and its algogenicity. A decrease in the excitability of the heat-regulating centers of the diencephalon results in an antipyretic effect. With a single dose, the effect lasts up to 8 hours. It has an antipyretic effect, the severity of which depends on the initial body temperature and dose. Reversibly inhibits platelet aggregation.
Indications for use
Rheumatoid arthritis, reactive synovitis in osteoarthritis deformans, psoriatic arthritis, acute articular attack in gout, ankylosing spondylitis (Bechterew's disease), cervical spondylosis, Barre-Lieu syndrome (cervical migraine, vertebral artery syndrome), lumbodynia, sciatica, thoracic radicular syndrome, bursitis , tendovaginitis, myalgia, neuralgic amyotrophy, occipital and intercostal neuralgia, sprains of the ligamentous apparatus, hematomas, injuries, pain in the area of ​​the surgical wound, toothache, surgical operations in the oral cavity, panniculitis, tonsillitis, pharyngitis, laryngitis, sinusitis, rhinitis, bronchitis, pneumonia, inflammatory processes in the small pelvis, dysalgomenorrhea, colds, acute respiratory viral infections, feverish conditions, postural hypotension when taking antihypertensive drugs, nephrotic syndrome (to reduce the severity of proteinuria).
Contraindications
Hypersensitivity, peptic ulcer of the stomach and duodenum in the acute phase, ulcerative colitis, "aspirin" asthma, leukopenia, thrombocytopenia, hemorrhagic diathesis, severe liver and kidney dysfunction, portal hypertension, arterial hypertension, heart failure, optic nerve disease, scotoma, amblyopia, color vision disorder, pregnancy, breastfeeding.
Side effect
Dyspeptic disorders (nausea, heartburn, anorexia, vomiting, discomfort in the epigastric region, flatulence, diarrhea, obstipation), erosive and ulcerative lesions of the gastrointestinal tract with signs of gastrointestinal bleeding, headache, dizziness, tinnitus, insomnia, agitation, visual disturbances (veil before the eyes, change in color vision), fluid retention, edema, increased blood pressure, thrombocytopenia, granulocytopenia, hemolytic anemia, Quincke's edema, broncho-obstructive syndrome, skin allergic reactions.
Interaction
Reduces the antihypertensive activity of ACE inhibitors, natriuretic - furosemide and hypothiazide. May increase the toxicity of methotrexate and lithium preparations. When combined with coumarin-type anticoagulants and alcohol increases the risk of hemorrhagic complications, with tableted glucocorticoids - the risk of gastrointestinal bleeding. It is not recommended to use simultaneously with acetylsalicylic acid or other NSAIDs, antidiabetic drugs, phenytoin and hormonal contraceptives. Increases the concentration of digoxin in plasma. Caffeine enhances the analgesic effect of ibuprofen.
Method of application and dosage
Inside, after meals, adults 400-600 mg 3-4 times a day. With rheumatoid arthritis - 800 mg 3 times / day. Children over 12 years old - 20-40 mg / kg in divided doses (3-4 times a day); to reduce body temperature of 39.2 ° C and above - at the rate of 10 mg / kg, if the temperature is below 39.2 ° C - 5 mg / kg. With dysmenorrhea - 400-600 mg with an interval of 4-6 hours.
Overdose
Symptoms: abdominal pain, nausea, vomiting, lethargy, drowsiness, depression, headache, tinnitus, metabolic acidosis, coma, acute renal failure, hypotension, bradycardia, tachycardia, atrial fibrillation and respiratory arrest. Treatment: gastric lavage (only during the first hour after ingestion), activated charcoal (to reduce absorption), alkaline drinking, forced diuresis and symptomatic therapy (correction of acid-base status, blood pressure, gastrointestinal bleeding).
special instructions
Given the possibility of developing NSAID-gastropathy, it is prescribed with caution to the elderly with a history of stomach ulcers and other gastrointestinal diseases, gastrointestinal bleeding, with simultaneous therapy with glucocorticoids, other NSAIDs and for long-term therapy. When symptoms of gastropathy appear, careful monitoring is indicated (including esophagogastroduodenoscopy, a blood test with the determination of hemoglobin, hematocrit, fecal occult blood analysis). To prevent the development of NSAID gastropathy, it is recommended to combine it with PGE preparations (misoprostol). It is prescribed with caution in childhood (up to 12 years), patients with severe impaired liver and kidney function (regular monitoring of bilirubin, transaminases, creatinine, kidney concentration is required), arterial hypertension and chronic heart failure (daily monitoring of diuresis, body weight , blood pressure). If visual impairment occurs, the dose should be reduced or the drug should be discontinued. The use of alcoholic beverages during treatment is not recommended.
Storage conditions
List B. In a place protected from light at room temperature.