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

Excipients - polysorbate 80 - 3.0 mg, glycerol - 500.0 mg, sorbitol - 1050.0 mg, sodium saccharate -1.5 mg, citric acid - 7.5 mg, xanthan gum - 30.0 mg,0.5 M solution of sodium hydroxide - 1.071 g, 0.5 M solution of hydrochloric acid - 0.982 g, methyl parahydroxybenzoate - 5.0 mg, propyl parahydroxybenzoate -1.5 mg, flavoring orange -1.0 mg, water

Purified to 5 ml.

Description:Homogeneous white or almost white color viscous suspension with the smell of orange.

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

ATX: & nbsp

M.01.A.E.01 Ibuprofen

Pharmacodynamics:Has analgesic, antipyretic and anti-inflammatory effects due to indiscriminate blockade of cyclooxygenase (COC and COX2) and have an inhibitory effect on the synthesis of prostaglandins; analgesic effect is most pronounced for inflammatory pains; like all NSAIDs, ibuprofen exhibits antiaggregant activity. The effect of the drug is due to the inhibition of the synthesis of prostaglandins due to the blocking of the enzyme cyclooxygenase. Suppresses the aggregation of platelets. With long-term use has a desensitizing effect.

Pharmacokinetics:It is well absorbed from the digestive tract. Absorption slightly decreases when taking the drug after a meal.TSmax when taken on an empty stomach - 45 minutes, after meals - 1.5-2.5 h, in synovial fluid - 2-3 h (where it creates more concentrations than in the plaza). Communication with plasma proteins by 90%. Exposed to the systemic and post-systemic metabolism in the liver. After absorption, about 60% of the pharmacologically inactive R-form of ibuprofen is slowly transformed into an active S-form. The isozyme CYP2C9 is involved in the metabolism of the drug. It has a two-phase kinetics of elimination from T1 / 2 2-2.5 h (for retard forms - up to 12 h). It is excreted by the kidneys (in an unchanged form not more than 1%) and to a lesser extent - with bile.

Indications:

Ibuprofen for children is used from 6 months to 12 years as an antipyretic agent for acute respiratory infections, influenza, childhood infections, post-vaccination reactions and other infectious and inflammatory diseases accompanied by fever. The drug is used as an anesthetic for pain syndrome of mild or moderate intensity, including headache and toothache, migraine, neuralgia, pain in the ears and throat, pain in stretching and other types of pain.

Contraindications:Hypersensitivity,erosive and ulcerative diseases of the gastrointestinal tract (GIT) in the stage of exacerbation (including peptic ulcer and duodenal ulcer, ulcerative colitis, Crohn's disease), complete or incomplete combination of bronchial asthma, recurrent nasal polyposis and paranasal sinuses and intolerance acetylsalicylic acid or other non-steroidal anti-inflammatory drugs (including history), blood clotting disorders (including hemophilia, prolonged bleeding time, a tendency to bleeding, hemorrhagic diarrhea тез), active gastrointestinal bleeding; severe renal failure (creatinine clearance less than 30 ml / min), progressive kidney disease, severe hepatic insufficiency or active liver disease, condition after aortocoronary shunting, confirmed hyperkalaemia, inflammatory bowel disease, hereditary fructose intolerance because of the composition of the drug is sorbitol.

Carefully:Take with cirrhosis of the liver with portal hypertension; hepatic and / or renal insufficiency, heart failure, nephrotic syndrome,Hyperbilirubinemia, peptic ulcer of the stomach and duodenum (in the anamnesis), gastritis, enteritis, colitis, blood diseases of unclear etiology (leukopenia and anemia), pregnancy (II-III trimester), lactation. If it is necessary to determine 17-ketosteroids, the drug should be discontinued 48 hours before the test; during the treatment is not recommended the use of ethanol; 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. In patients with bronchial asthma or other diseases that occur with bronchospasm, ibuprofen may increase the risk of manifestation of bronchospasm. The use of the drug in these patients is permissible only under the condition of great care, and in case of difficulty breathing, you should immediately consult a doctor.

Pregnancy and lactation:With caution during pregnancy (II-III trimester) and lactation.

Dosing and Administration:

Ibuprofen is used orally after a meal. Shake before use to obtain

homogeneous suspension.

Children from 6 to 12 months (7-9 kg) 3 to 4 times 2.5 ml each day;

Children about 1 year to 3 years (10-15 kg) 3 times 5 ml per day;

Children from 3 to 6 years (16-20 kg) 3 times 7.5 ml during the day;

Children from 6 to 9 years (21-29 kg) 3 times 10 ml during the day:

Children from 9 to 12 years (30-40 kg) 3 times 15 ml during the day;

When postvaccinal reactions in infants from 3 to 6 months:

Breast children from 3 to 6 months (5-7.6 kg): 2 x 2.5 ml each for a day (2.5 ml should be taken, if necessary, 2.5 ml after 6 hours if necessary). The duration of treatment with fever is no more than 3 days, with pain - no more than 5 days.

Side effects:

from the digestive system: NSAIDs - gastropathy (nausea, vomiting, abdominal pain, heartburn, decreased appetite, diarrhea, flatulence, pain and discomfort in the epigastric region), ulceration of the gastrointestinal mucosa (in some cases complicated by perforation and bleeding); irritation, dryness of the oral mucosa or pain in the mouth, ulceration of the gingival mucosa, aphthous stomatitis, pancreatitis, constipation, hepatitis;

from the respiratory system: shortness of breath, bronchospasm;

from the senses: hearing loss, ringing or noise in the ears, reversible toxic optic neuritis, blurred vision or diplopia, dryness and irritation of the eyes, edema of the conjunctiva and eyelids (allergic genesis), scotoma;

from the nervous system: headache, dizziness, insomnia, anxiety, nervousness and irritability, agitation, drowsiness, depression, confusion, hallucinations, rare - aseptic meningitis (usually in patients with autoimmune diseases);

from the cardiovascular system: development or exacerbation of congestive heart failure, tachycardia, increased blood pressure;

from the urinary system: acute renal insufficiency, allergic nephritis, nephrotic syndrome (edema), polyuria, cystitis; allergic reactions: skin rash (typically erythematous, urticaria), pruritus, angioedema, anaphylactoid reactions, anaphylactic shock, bronchoconstriction, fever, exudative erythema multiforme (including Stevens-Johnson syndrome), toxic epidermal necrolysis (Lyell's syndrome), eosinophilia , allergic rhinitis;

from the hematopoiesis: anemia (including hemolytic, aplastic), thrombocytopenia and thrombocytopenic purpura, agranulocytosis, leukopenia; other: increased sweating; risk of ulceration of the gastrointestinal mucosa,bleeding (gastrointestinal, gingival, uterine, hemorrhoidal), visual impairment (color vision, scotoma, amblyopia) increases with prolonged use in large doses.

Overdose:

Symptoms overdose of ibuprofen in children: abdominal pain, nausea, vomiting, retardation, headache, tinnitus, depression, drowsiness, metabolic acidosis, coma, hemorrhagic diathesis, lowering of blood pressure, convulsions, apnea, acute renal failure, liver dysfunction, tachycardia , bradycardia. atrial fibrillation, forced diuresis. Children under 5 lay especially prone to apnea, coma and convulsions.

Serious consequences associated with the toxic effect of the drug manifest themselves usually after taking a dose exceeding 400 mg / kg body weight (ie, 80 recommended single doses). In case of suspected overdose, you should immediately consult a doctor.

Treatment with an overdose: gastric lavage, activated carbon reception, alkaline drink, symptomatic therapy (correction of CBS, blood pressure).

Interaction:

Do not use ibuprofen simultaneously with other non-steroidal anti-inflammatory drugs (for example, acetylsalicylic acid reduces the anti-inflammatory effect of ibuprofen and increases the side effect). If possible, avoid simultaneous administration of ibuprofen and diuretics, due, on the one hand, to a weakening of the diuretic effect and, on the other, to the risk of developing renal failure. Ibuprofen weakens the effect of antihypertensive agents (angiotensin converting enzyme inhibitors, adrenergic agents, thiazides). It inhibits the hypotensive effect of ACE inhibitors, while reducing their release by the kidneys. Ibuprofen enhances the effect of oral hypoglycemic agents (especially sulfonylurea derivatives) and insulin. Microsomal oxidation inductors phenytoin, ethanol, barbiturates, zixorin, rifampicin, phenylbutazone, grytsiklicheskie (antidepresanty) increase the production of hydroxylated active metabolites, increasing the risk of severe hepatoxic reactions. Inhibitors of microsomal oxidation - reduce the risk of hepatotoxic effects.Strengthens the effect of indirect anticoagulants, antiaggregants, fibrinolytic drugs (increased risk of hemorrhagic complications). Increases the concentration in the blood of digoxin. Increases the toxic effect of methotrexate and lithium preparations. Caffeine strengthens the analgesic effect.

Special instructions:

During long-term use, non-steroidal anti-inflammatory drugs can cause damage to the gastric mucosa, peptic ulcers and bleeding from the digestive tract.

During the long-term treatment of NSAIDs, control of the peripheral blood picture and the functional state of the liver and kidneys is necessary. When symptoms of gastropathy appear, careful monitoring including esophagogastroduodenoscopy, a blood test with the determination of Hb, hematocrit, and analysis of feces for latent blood are shown.

Form release / dosage:

Suspension for oral administration (for children) 100 mg / 5 ml.

Packaging:For 90 ml, 100 ml, 110 ml, 115 ml or 125 ml in bottles or cans of orange glass with a screw mouth, sealed with polyethylene plugs and screwed on

lids made of polymer materials or aluminum caps with perforations.

For 90 ml, 100 ml, 110 ml, 115 ml or 125 ml in bottles made of brown glass, sealed with lids made of polymer materials.

Each vial or jar, together with an instruction for use and a measuring cup or measuring spoon or dosing syringe, is 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:2 years. Do not use after expiry date!

Terms of leave from pharmacies:Without recipe

Registration number:LP-001651

Date of registration:13.04.2012

The owner of the registration certificate:ECOLAB, CJSC ECOLAB, CJSC Russia

Manufacturer: & nbsp

ECOLAB, CJSC Russia

Information update date: & nbsp08.04.2013

Illustrated instructions

Instructions

Ibuprofen (Ibuprofen)