Ibuprofen - instructions for use, dose, side effects, contraindications

Auxiliary substances (shell): sugar (sucrose) - 150.7483 mg; wheat flour - 47.1 mg; polyvinylpyrrolidone low molecular weight (povidone) - 1.707 mg; vanillin - 0.0004 mg; gelatin medical - 0.324 mg; dye azorubin (acidic red 2C for pharmaceutical purposes) - 0.0103 mg; wax - 0.044 mg; oil vaseline - 0,066mg.

Description:The tablets covered with a cover, pink color, round, biconcave form.

Pharmacotherapeutic group:Non-steroidal anti-inflammatory drug (NSAID)

ATX: & nbsp

M.01.A.E.01 Ibuprofen

Pharmacodynamics:

Ibuprofen is a derivative of propionic acid and has analgesic, antipyretic and anti-inflammatory effects due to the indiscriminate blockade of cyclooxygenases 1 and 2 and has an inhibitory effect on the synthesis of prostaglandins.

The analgesic effect is most pronounced for inflammatory pains.

The analgesic activity of the drug does not apply to the narcotic type.

Like all NSAIDs, ibuprofen exhibits antiaggregant activity.

Pharmacokinetics:It is well absorbed from the gastrointestinal tract (GIT). Absorption slightly decreases when taking the drug after a meal.TSmax at reception on an empty stomach - 45 minutes, at reception after meal - 1,5-2,5 ч, a synovial liquid - 2-3 ч (where creates more concentration, than in plasma). The connection with plasma proteins is approximately 99%. Ibuprofen is metabolized in the liver mainly by hydroxylation and carboxylation of the isobutyl group. In the metabolism of the drug takes part isoenzyme CYP2C9. After absorption about 60% of pharmacologically inactive Rform of ibuprofen - slowly transformed into an active S-form. Ibuprofen has a two-phase kinetics of elimination. The half-life period (T1 / 2) from the plasma is 2-3 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 urine and, to a lesser extent, with bile. Ibuprofen fully output in 24 hours.

Indications:

- Inflammatory diseases of the joints and spine (including rheumatoid arthritis, ankylosing spondylitis, osteoarthritis, gouty arthritis).

- Moderate pain syndrome of various etiologies (including headache, migraine, toothache, neuralgia, postoperative pain, post traumatic pain, menstrual pain, muscle pain).

- Feverish syndrome for colds and flu.

It is intended for symptomatic therapy, reducing pain and inflammation at the time of use, the progression of the disease is not affected.

Contraindications:Hypersensitivity (including other non-steroidal anti-inflammatory drugs), complete or incomplete combination of bronchial asthma, recurrent nasal polyposis and paranasal sinuses and intolerance to acetylsalicylic acid or other non-steroidal anti-inflammatory drugs (including history), erosive and ulcerative lesions of the gastrointestinal tract and duodenal ulcers, active gastrointestinal bleeding, inflammatory bowel disease (Crohn's disease, ulcerative colitis) in the phase of exacerbation, tia elaya liver and heart failure; period after aortocoronary shunting; severe renal failure (creatinine clearance less than 30 ml / min), progressive kidney disease, active liver disease, confirmed hyperkalemia, pregnancy (III trimester), children under 6 years of age, sugar deficiency / isomaltase, glucose-galactose malabsorption.

Carefully:Elderly age, heart failure, ischemic heart disease, cerebrovascular disease, dyslipidemia / hyperlipidemia, peripheral arterial disease, smoking, hypertension, liver cirrhosis with portal hypertension, hepatic insufficiency, chronic renal failure (creatinine clearance 30-60 ml / min), hyperbilirubinemia , nephrotic syndrome, the presence of Helicobacter pylori infection, gastric and duodenal ulcer (in the anamnesis), gastritis, enteritis, colitis, blood diseases of unclear etiolo (including leukopenia and anemia), prolonged use of nonsteroidal anti-inflammatory drugs, alcoholism, severe somatic diseases, simultaneous administration of oral glucocorticosteroids (including prednisolone), anticoagulants (including warfarin), antiplatelet agents (including clopidogrel), selective inhibitors of re-uptake Serotonin (including citalopram, fluoxetine, paroxetine, sertraline); pregnancy (I-II) trimester, lactation period, children age from 6 to 12 years, diabetes (one tablet of ibuprofen contains 150.7483 mg of sugar).

Pregnancy and lactation:Contraindicated in the III trimester of pregnancy. Use of the drug in the I-II trimesters of pregnancy and during lactation should be carefully monitored by a physician.

Dosing and Administration:

Ibuprofen is prescribed for adults and children over 12 years inside, in tablets of 200 mg 3-4 times a day. To achieve a rapid therapeutic effect, the dose can be increased to 400 mg (2 tablets) 3 times a day. When the therapeutic effect is achieved, the daily dose of the drug is reduced to 600-800 mg. Take the morning dose before meals, drinking with a sufficient amount of water (for a faster absorption of the drug). The remaining doses are taken throughout the day after meals.

The maximum daily dose is 1200 mg (do not take more than 6 tablets in 24 hours). Repeated dose should not be taken more than 4 hours. The duration of the drug use without consulting a doctor is no more than 5 days.

Do not use in children younger than 12 years old without consulting a doctor. Children from 6 to 12 years: 1 tablet no more than 4 times a day; the drug can be used only in the case of a child's body weight of more than 20 kg. The interval between taking the tablets is at least 6 hours (daily dose is not more than 30 mg / kg).

Side effects:

- Gastrointestinal tract (GIT)

NSAIDs-gastropathy (abdominal pain, nausea, vomiting, heartburn, decreased appetite, diarrhea, flatulence, constipation, rarely - ulceration of the gastrointestinal mucosa, which in some cases is complicated by perforation and bleeding); irritation or dryness of the oral mucosa, pain in the mouth, ulceration of the gingival mucosa, aphthous stomatitis, pancreatitis.

- Hepatobiliary system

Hepatitis.

- Respiratory system

Shortness of breath, bronchospasm.

- Sense organs

Hearing impairment: hearing loss, ringing and tinnitus;

visual impairment: toxic damage to the optic nerve, blurred vision or double vision, scotoma, dryness and irritation of the eyes, edema of the conjunctiva and eyelids (allergic genesis).

- 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).

- The cardiovascular system

Heart failure, tachycardia, increased blood pressure.

- Urinary system

Acute renal failure, allergic nephritis, nephrotic syndrome (edema), polyuria, cystitis.

- Allergic reactions

Skin rash (usually erythematous or urticaria), itchy skin, Quincke's edema, anaphylactoid reactions, anaphylactic shock, bronchospasm or dyspnoea, fever, erythema multiforme exudative (including Stevens-Johnson syndrome), toxic epidermal necrolysis (Lyell's syndrome), eosinophilia, allergic rhinitis.

- Hematopoietic organs

Anemia (including hemolytic, aplastic), thrombocytopenia and thrombocytopenic purpura, agranulocytosis, and leukopenia.

- Other

Increased sweating. The risk of ulceration of the mucous membrane of the gastrointestinal tract, bleeding (gastrointestinal, gingival, uterine, hemorrhoidal), visual impairment (color vision, scotoma, amblyopia) increases with prolonged use in large doses.

- Laboratory indicators:

- bleeding time (may increase)

-concentration of glucose in serum (may decrease)

-Creativity of the creatinine (may decrease)

-hematocrit or hemoglobin (may decrease)

- serum creatinine concentration (may increase)

-activity of "liver" transaminases (may increase).

Overdose:

Symptoms: abdominal pain, nausea, vomiting, retardation, drowsiness, depression, headache, tinnitus, metabolic acidosis, coma, acute renal failure, lowering of blood pressure, hyperkalemia, bradycardia, tachycardia, atrial fibrillation, respiratory arrest.

Treatment: gastric lavage (effective only for 1 hour after intake), Activated carbon, alkaline drink, forced diuresis, symptomatic therapy (correction of acid-base state, blood pressure).

Interaction:

Inductors of microsomal oxidation (phenytoin, ethanol, barbiturates, rifampicin, phenylbutazone, tricyclic antidepressants) increase the production of hydroxylated active metabolites, increasing the risk of developing severe hepatotoxic reactions.

Inhibitors of microsomal oxidation reduce the risk of hepatotoxic action. Reduces the hypotensive activity of vasodilators (including slow calcium channel blockers and angiotensin converting enzyme inhibitors), natriuretic and diuretic - furosemide and hydrochlorothiazide.

Reduces the effectiveness of uricosuric medicines, increases the effect of indirect anticoagulants, antiplatelet agents, fibrinolytic agents (increased risk of hemorrhagic complications), ulcerogenic effects with bleeding of glucocorticosteroids, colchicine, estrogens, ethanol; enhances the effect of oral hypoglycemic drugs and insulin.

Antacids and colestramine reduce the absorption of ibuprofen.

Increases the concentration in the blood of digoxin, lithium and methotrexate.

Caffeine increases the analgesic effect.

With simultaneous appointment ibuprofen reduces the anti-inflammatory and anti-aggregative effect of acetylsalicylic acid (possibly increasing the incidence of acute coronary insufficiency in patients receiving low doses of acetylsalicylic acid as antiplatelet agent after the onset of ibuprofen intake).

When prescribed with anticoagulant and thrombolytic drugs (alteplase, streptokinase, urokinase) simultaneously increases the risk of bleeding.

Cefamandol, cefaperazone, cefotetan, valproic acid, plikamycin increase the frequency of hypoprothrombinemia.

Myelotoxic drugs increase the manifestation of hematotoxicity of the drug.

Cyclosporine and gold preparations increase the effect of ibuprofen on the synthesis of prostaglandins in the kidneys, which is manifested by increased nephrotoxicity. Ibuprofen increases the plasma concentration of cyclosporine and the likelihood of its hepatotoxic effects.

Drugs that block tubular secretion, reduce excretion and increase the plasma concentration of ibuprofen.

Special instructions:

During treatment, it is necessary to monitor the picture of peripheral blood and the functional state of the liver and kidneys.

When symptoms of gastropathy appear, careful monitoring is performed, including esophagogastroduodenoscopy, a blood test with determination of hemoglobin (Hb), hematocrit, analysis of feces for latent blood. To prevent the development of IPPP-gastropathy it is recommended to combine with preparations of prostaglandins (misoprostol). If it is necessary to determine 17-ketosteroids, the drug should be discontinued 48 hours before the test.

During the period of treatment, ethanol is not recommended.To reduce the risk of developing adverse events on the part of the gastrointestinal tract, a minimum effective dose should be used with the minimum possible short course. One tablet of ibuprofen contains 150.7483 mg of sugar, which should be considered when treating patients with diabetes mellitus.

Effect on the ability to drive transp. cf. and fur:During the treatment period, care must be taken when driving vehicles and engaging in other potentially hazardous activities requiring increased attention and speed of psychomotor reactions.

Form release / dosage:

The tablets covered with a cover of 200 mg.

Packaging:

For 10 tablets in a contour mesh package made of PVC and foil.

2, 5 or 10 contour packs, together with instructions for use, are placed in a pack of cardboard.

Storage conditions:

In a dry, protected from light place at a temperature of no higher than 25 ° C.

Keep out of the reach of children.

Shelf life:

3 years.

Do not use after the expiration date printed on the package.

Terms of leave from pharmacies:Without recipe

Registration number:P N000192 / 01

Date of registration:23.03.2012

Expiration Date:Unlimited

The owner of the registration certificate:MOSHIMFARM PREPARATES them. N.А.Semashko, OJSC MOSHIMFARM PREPARATES them. N.А.Semashko, OJSC Russia

Manufacturer: & nbsp

MOSHIMFARM PREPARATES them. NA Semashko OJSC Russia

Representation: & nbspMOSHIMFARM PREPARATES them. NA Semashko OJSC MOSHIMFARM PREPARATES them. NA Semashko OJSC Russia

Information update date: & nbsp19.10.2017

Illustrated instructions

Instructions

Ibuprofen (Ibuprofen)