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

Excipients: Kollidon 90 F (3.4 mg, 6.8 mg), microcrystalline cellulose (68 mg, 136 mg), talc (6.8 mg, 13.6 mg), crospovidone (collidine CML) (10, 2 mg, 12 , 4 mg), calcium stearate (3.4 mg, 6.8 mg), silicon dioxide colloid (aerosil) (10.2 mg, 20.4 mg), corn starch (38.0 mg, 76.0 mg) ;

Sheath: (3.77 mg, 7.54 mg), talc (0.41 mg, 0.82 mg), titanium dioxide (1.16 mg, 2.32 mg), propylene glycol (0.55 mg; 1.1 mg), macrogol-4000 (polyethylene glycol-4000, polyethylene oxide-4000) (1.11 mg, 2.22 mg).

Description:Tablets dosage of 200 mg - white or almost white, round biconvex tablets, covered with a film membrane.

Tablets dosage of 400 mg - white or almost white, biconvex tablets oval-shaped, film-coated.

On the cross-section, one layer of white or almost white color is visible.

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

ATX: & nbsp

M.01.A.E.01 Ibuprofen

Pharmacodynamics:Has anti-inflammatory, antipyretic and analgesic effect. Suppresses anti-inflammatory factors, reduces platelet aggregation. Oppresses cyclooxygenases 1 and 2 types, disrupts the metabolism of arachidonic acid, reduces the number of prostaglandins both in healthy tissues and in the focus of inflammation, suppresses the exudative and proliferative phases of inflammation. Reduces pain sensitivity in the focus of inflammation. It causes a weakening or disappearance of the pain syndrome, incl.with pain in the joints at rest and during movement, a decrease in morning stiffness and swelling of the joints, contributes to an increase in the volume of movements. Antipyretic effect is due to a decrease in the excitability of the thermoregulatory centers of the intermediate brain.

Pharmacokinetics:

Ibuprofen quickly and almost completely absorbed from the gastrointestinal tract, its maximum concentrations in the plasma are reached 1-2 hours after ingestion, in synovial fluid - after 3 hours, binds to plasma proteins by 99%.

Slowly penetrates into the joint cavity, lingers in the synovial tissue, creating in it greater concentrations than in the plasma. Metabolism of ibuprofen occurs mainly in the liver. The half-life period (T1 / 2) from the plasma is 2-3 hours. It is excreted by the kidneys in the form of metabolites (in an unchanged form, no more than 1% is excreted), to a lesser extent - with bile. Ibuprofen fully output in 24 hours.

Indications:

Ibuprofen tablets are used for symptomatic treatment, including tension headache and migraine, articular, muscle pain, back pain, loin, radiculitis, pain in case of ligament damage, toothache,with painful menstruation, febrile conditions, with "colds", flu, with rheumatoid arthritis, osteoarthritis.

Non-steroidal anti-inflammatory drugs are designed for simptomatic therapy, reducing pain and inflammation at the time of use, and the progression of the disease is not affected.

Contraindications:

- hypersensitivity to any of the ingredients that make up the drug;

- 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 other non-steroidal anti-inflammatory drug (complete or incomplete acetylsalicylic acid intolerance syndrome - rhinosinusitis, urticaria, polyps of the nasal mucosa, bronchial asthma);

- liver failure or active liver disease;

- renal failure (creatinine clearance less than 30 ml / min), progressive kidney disease;

- confirmed hyperkalemia;

- hemophilia and other disorders of blood clotting (including hypocoagulation), hemorrhagic diathesis;

- in the period after aorto-coronary bypass surgery;

- pregnancy (III trimester);

- Children's age: up to 6 years and from 6 to 12 years (with a body weight of less than 20 kg) - for tablets 200 mg; up to 12 years - for tablets 400 mg.

Carefully:Elderly age, congestive heart failure, cerebrovascular diseases, arterial hypertension, ischemic heart disease, dyslipidemia / hyperlipidemia, diabetes mellitus, peripheral arterial disease, nephrotic syndrome, creatinine clearance less than 30-60 ml / min, hyperbilirubinemia, peptic ulcer and duodenal ulcer (history), presence of Helicobacter pylori infections, gastritis, enteritis, colitis, prolonged use of NSAIDs, blood diseases of unclear etiology (leukopenia and anemia), pregnancy (I-II) trimester, n Lactation, smoking, frequent alcohol use (alcoholism), severe somatic diseases, concomitant therapy with the following drugs: anticoagulants (for example, warfarin), antiplatelet agents (e.g., acetylsalicylic acid; clopidogrel), oral glucocorticosteroids (eg: prednisolone), selective serotonin reuptake inhibitors (eg, citalopram, fluoxetine, paroxetine, sertraline).

Dosing and Administration:

Adults, seniors 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) for 24 hours.

Tablets should be swallowed by washing with water, preferably during or after a meal. Do not take more than 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 a physician.

Do not use in children younger than 12 years old without consulting a doctor.

Children from 6 to 12 years (with a body weight of more than 20 kg): 1 tablet 200 mg not more than 4 times a day. The interval between taking the tablets is at least 6 hours.

Side effects:

In recommended doses, the drug usually does not cause side effects.

Gastrointestinal tract (GIT): NSAIDs-gastropathy (abdominal pain, nausea, vomiting, heartburn, decreased appetite, diarrhea, flatulence, constipation, 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 gingival mucosa, aphthous stomatitis, pancreatitis.

Hepatobiliary system: hepatitis.

Respiratory system: shortness of breath, bronchospasm.

Sense organs:

Hearing impairment: hearing loss, ringing or tinnitus;

visual impairment: toxic damage to the optic nerve, blurred 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, 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 dyspnea, fever, erythema multiforme exudative (including Stevens-Johnson syndrome), toxic epidermal necrolysis (Lyell's syndrome), eosinophilia, allergic rhinitis.

Hematopoiesis: anemia (including haemolytic, aplastic), thrombocytopenia and thrombocytopenic purpura, agranulocytosis, leukopenia.

Other: increased sweating.

Laboratory indicators:

- bleeding time (may increase)

- serum glucose concentration (may decrease)

- clearance of creatinine (may decrease)

- hematocrit or hemoglobin (may decrease)

- serum creatinine concentration (may increase)

- activity of "liver" transaminases (may increase)

If taking the drug caused a change in your normal condition, stop taking Ibuprofen tablets and consult a doctor immediately.

Overdose:

Do not exceed the indicated dose. If you exceed the dose, contact your doctor or nearest medical institution immediately. Bring the package of the drug with you.

Symptoms: Abdominal pain, nausea, vomiting, lethargy, sleepiness, depression, headache, tinnitus, metabolic acidosis, coma, acute renal failure, decreased blood pressure, bradycardia, tachycardia, atrial fibrillation, respiratory arrest. Treatment: gastric lavage (only for an hour after ingestion), Activated carbon, alkaline drink, forced diuresis, symptomatic therapy (correction of acid-base state, blood pressure).

Interaction:

In therapeutic doses ibuprofen does not enter into significant interactions with widely used drugs.

Inductors of microsomal oxidation enzymes in the liver (phenytoin, ethanol, barbiturates, flumecinol, rifampicin, phenylbutazone, tricyclic antidepressants) increase the production of hydroxylated active metabolites, increasing the risk of severe intoxication. Inhibitors of microsomal oxidation - reduce the risk of hepatotoxic action.

Reduces hypotensive activity vasodilator and natriuretic effect of furosemide and hydrochlorothiazide.

Reduces the effectiveness of uricosuric drugs.It enhances the action of anticoagulants, antiplatelet agents, fibrinolytics (which increases the risk of bleeding): Enhances mineralokortikosteroidov side effects, glucocorticoids (increased risk of gastrointestinal bleeding), estrogens, ethanol; enhances the hypoglycemic effect of sulfonylurea derivatives.

Antacids and colestramine reduce the absorption of ibuprofen.

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

Simultaneous administration of other NSAIDs increases the incidence of side effects.

Caffeine increases analgesic (anesthetic) effect.

With simultaneous appointment ibuprofen reduces inflammatory and antiplatelet effect of acetylsalicylic acid (may increase the incidence of acute coronary insufficiency in patients receiving as antiplatelet agents acetylsalicylic acid, low dose, after initiation of ibuprofen).

Cefamandol, cefoperazone, cefotetan, valproic acid, plikamycin increase the frequency of hypoprothrombinemia with simultaneous administration.

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:

With long-term use, control of the peripheral blood picture and the functional state of the liver and kidneys is necessary.

To reduce the risk of developing adverse events from the gastrointestinal tract, a minimally effective dose should be used. When symptoms of gastropathy appear, careful monitoring including esophagogastroduodenoscopy, blood analysis with determination of hemoglobin and hematocrit, analysis of feces for latent blood is shown. If it is necessary to determine 17-ketosteroids, the drug should be discontinued 48 hours before the test.

During the period of treatment should refrain from taking alcohol and activities,requiring increased concentration of attention and speed of psychomotor reactions.

Effect on the ability to drive transp. cf. and fur:During the treatment should refrain from taking alcohol and activities that require increased concentration and speed of psychomotor reactions.

Form release / dosage:

Film coated tablets 200 mg, 400 mg.

Packaging:10 tablets in a contour mesh box made of polyvinylchloride film and aluminum foil printed lacquered. 50 tablets in cans of polymeric.

Each jar, 2.5 or 10 contour squares with instruction for use is placed in a pack of cardboard.

Storage conditions:In dry, dark place at a temperature of no higher than 30 ° 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:LP-000125

Date of registration:11.01.2011

The owner of the registration certificate:SYNTHESIS, JSC Joint-stock Kurgan Society of Medical Preparations and Products SYNTHESIS, JSC Joint-stock Kurgan Society of Medical Preparations and Products Russia

Manufacturer: & nbsp

SYNTHESIS, OJSC Russia

Information update date: & nbsp11.01.2011

Illustrated instructions

Instructions

Ibuprofen (Ibuprofen)