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

Shell accessories: silicon dioxide colloid (aerosil) - 3.35 mg, vanillin 0.0015 mg, beeswax 0.02 mg, gelatin 0.32 mg, azorubin dye 0.0085 mg, magnesium carbonate basic 39.57 mg , wheat flour - 17.37 mg, povidone (plastidone K-17) - 1.50 mg, sucrose - 144.96 mg, titanium dioxide - 2.90 mg.

Description:The tablets covered with a cover, from light pink up to pink color, round, biconcave form. On the cross-section, two layers are visible: the nucleus is white; Sheath - from light pink to pink.

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

ATX: & nbsp

M.01.A.E.01 Ibuprofen

Pharmacodynamics:

The drug belongs to non-steroidal anti-inflammatory drugs (NSAIDs). Has analgesic, antipyretic and anti-inflammatory effect. Non-selectively blocks COX1 and COX2.

The mechanism of action of ibuprofen is due to inhibition of the synthesis of prostaglandins - mediators of pain, inflammation and hyperthermia.

Pharmacokinetics:Absorption is high, quickly and almost completely absorbed from the digestive tract. The maximum concentration C (max) of ibuprofen in plasma is achieved 1-2 hours after taking the drug. The connection with plasma proteins is more than 90%, T1 / 2 (half-life) - 2 hours.Slowly penetrates into the joint cavity, lingers in the synovial tissue, creating in it greater concentrations than in the plasma. After absorption, about 60% of the pharmacologically inactive R-form is slowly transformed into an active S-form. Exposed to metabolism. It is excreted by the kidneys (in an unchanged form not more than 1%) and, to a lesser extent, with bile.

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, myalgia, postoperative pain, posttraumatic pain, primary algodismenorea)

- Feverish syndrome with "colds" and infectious diseases.

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 to any of the ingredients that make up the drug.

Hypersensitivity to acetylsalicylic acid or other NSAIDs, incl. anamnestic data on an attack of bronchial obstruction, rhinitis,urticaria after taking acetylsalicylic acid or other NSAIDs; complete or incomplete syndrome of acetylsalicylic acid intolerance (rhinosinusitis, urticaria, polyps of the nasal mucosa, bronchial asthma).

- Erosive and ulcerative diseases of the gastrointestinal tract in the stage of exacerbation (including peptic ulcer of the stomach and duodenum, Crohn's disease, ulcerative colitis).

- Inflammatory bowel disease.

- Hemophilia and other disorders of blood clotting (including hypocoagulation), hemorrhagic diathesis.

- The period after aortocoronary bypass surgery.

- Gastrointestinal bleeding and intracranial hemorrhage.

- Severe hepatic impairment or active liver disease.

- Progressive kidney disease.

- Severe renal failure with creatinine clearance less than 30 ml / min, confirmed hyperkalemia.

- Pregnancy.

- Children under 6 years.

Carefully:Elderly age, heart failure, arterial hypertension, ischemic heart disease, cerebrovascular disease, dyslipidemia, diabetes mellitus, peripheral arterial disease, smoking,frequent alcohol use, liver cirrhosis with portal hypertension, hepatic and / or renal insufficiency with creatinine clearance less than 60 ml / min, nephrotic syndrome, pserbilirubinemia, stomach and duodenal ulcer (in the anamnesis), H. pylori infection, gastritis; enteritis, colitis, blood diseases of unclear etiology (leukopenia and anemia), lactation period, long-term use of NSAIDs, severe somatic diseases, simultaneous intake of oral GCS (incl. prednisolone), anticoagulants (incl. warfarin), antiplatelet agents (incl. acetylsalicylic acid, clopidogrel), selective serotonin reuptake inhibitors (incl. citalopram, fluoxetine, paroxetine, sertraline).

Pregnancy and lactation:Contraindicated in pregnancy, during lactation - with caution.

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 or 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 dyspnea, fever, multiple exudative erythema (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:

- time of bleeding (may increase)

- the concentration of glucose in the serum (may decrease)

- clearance of creatinine (may decrease)

- Hematocrit or hemoglobin (may decrease)

- serum creatinine concentration (may increase)

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

If side effects occur, stop taking the medication and consult a doctor.

Overdose:

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

Treatment: gastric lavage (only for 1 hour after intake), Activated carbon, alkaline drink, forced diuresis, symptomatic therapy.

Interaction:

It is not recommended simultaneous reception of ibuprofen with acetylsalicylic acid and other NSAIDs. With simultaneous appointment ibuprofen reduces the anti-inflammatory and angiagregant action of acetylsalicylic acid (possibly increasing the incidence of acute coronary insufficiency in patients receiving small doses of acetylsalicylic acid as an antiplatelet agent after taking ibuprofen). When administered with anticoagulant and thrombolytic drugs (alteplase, streptokinase, urokinase), the risk of bleeding increases at the same time. Simultaneous reception with serotonin reuptake inhibitors (citalopram, fluoxetine, paroxetine, sertraline) increases the risk of developing serious gastrointestinal bleeding.

Cefamandol, cefaperazone, cefotetan, valproic acid, plikamycin, increase the frequency of hypoprothrombinemia. Cyclosporin and gold preparations increase the effect of ibuprofen on the synthesis of prostasandins 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. Microsomal oxidation inductors (phenytoin, ethanol, barbiturates, 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 hepagotoxic action. Reduces the hypotensive activity of vasodilators, natriuretic and diuretic in furosemide and hydrochloroazide. Reduces the effectiveness of uricosuric drugs, enhances the effect of indirect anticoagulants, antiplatelet agents, fibrinolytic agents (increased risk of hemorrhagic disorders), enhances ulcerogenic effects with bleeding mineralogicosteroid, pococorticosteroid, colchicine, estrogens, ethanol.Strengthens the effect of oral hypoglycemic drugs and insulin derivatives of sulfonylurea. Antacids and kolsggiramin reduce absorption. Increases the concentration in the blood of digoxin, lithium preparations, methotrexate. Caffeine strengthens the analgesic effect.

Special instructions:

The drug should be treated at the lowest effective dose, the minimum possible short course. During long-term treatment, control of the peripheral blood picture and the functional state of the liver and kidneys is necessary. When symptoms of gastropathy are shown, careful monitoring including esophagogastroduodenoscopy, a general blood test (determination of hemoglobin), and analysis of feces for latent blood are shown.

If it is necessary to determine 17-ketosteroids, the drug should be discontinued 48 hours before the test.

Patients should refrain from all activities requiring increased attention, rapid mental and motor reaction. During the period of treatment, ethanol is not recommended.

Effect on the ability to drive transp. cf. and fur:Patients should refrain from all activities that require increased attention,rapid mental and motor reaction.

Form release / dosage:

The tablets covered with a cover of 200 mg.

Packaging:

For 10 tablets in a planar cell package.

1, 2, 3 or 5 contour mesh packages together with the instruction for use are placed in a pack of cardboard.

Contoured cell packs, together with an equal number of instructions for use, are placed directly in the group pack.

Storage conditions:

At a temperature not higher than 25 ° C. Keep out of the reach of children!

Shelf life:3 years. Do not use after the expiry date printed on the package.

Terms of leave from pharmacies:Without recipe

Registration number:LS-001674

Date of registration:18.03.2011 / 20.03.2015

Expiration Date:Unlimited

The owner of the registration certificate:TATHIMFARMPREPARATY, JSC TATHIMFARMPREPARATY, JSC Russia

Manufacturer: & nbsp

TATHIMFARMPREPARATY, JSC Russia

Information update date: & nbsp19.10.2017

Illustrated instructions

Instructions

Ibuprofen (Ibuprofen)