Advil for children - instructions for use, dose, side effects, contraindications

Excipients: sugar syrup [sucrose, water] - 3731.5 mg, equivalent to sucrose - 2500.0 mg, glycerol - 500.00 mg,Sorbitol - 500.0 mg Polysorbate 80 - 15.00 mg Sodium benzoate - 10,00 mg Citric acid - 9.15 mg, 2.50 mg of disodium edetate, xanthan gum, - 25.00 mg, acesulfame potassium - 4 50 mg strawberry flavor - 12.00 mg, flavor - 12.00 mg carmine dye [Ponceau 4R] - 0,50 mg, water- and 5 ml.

Description:Pink suspension with strawberry odor.

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

ATX: & nbsp

M.01.A.E.01 Ibuprofen

Pharmacodynamics:

Ibuprofen has antipyretic, analgesic, anti-inflammatory effect. Antipyretic effect due to blocking of cyclooxygenase (COX) - 1 and 2 in the arachidonic acid cascade central nervous system, which leads to a decrease in the synthesis of prostaglandins (PGs), a decrease in their concentration in cerebrospinal fluid and to decrease the excitation thermoregulatory center. The effect of lowering the temperature at a fever develops within 30 minutes after taking the drug, its maximal effect is manifested through 3 h.

Leading analgesic mechanism is to reduce the production of GHG classes E, F, I and biogenic amines, which leads to the prevention of the development of hyperalgesia at changing the sensitivity of nociceptors.Analgesic effect is most pronounced for inflammatory pains. The analgesic activity of the drug does not apply to the narcotic type.

The anti-inflammatory effect is caused by oppression of COX activity and decreased synthesis of PG in inflammatory foci, which leads to a decrease in the secretion of inflammatory mediators, a decrease in the activity of the exudative and proliferative phase of the inflammatory process.

Like all NSAIDs, ibuprofen exhibits antiaggregant activity.

Pharmacokinetics:

When administered in therapeutic doses ibuprofen characterized by linear pharmacokinetics.

Suction

The maximum concentration in the serum (C max) is reached approximately 1 hour after ingestion of ibuprofen.

After taking a single dose, Cmax is proportional to the dose (after taking a dose of 10 mg / kg, Cmax is 25-50 μg / ml).

When taking with the food, the absorption of ibuprofen is slower.

Distribution

The half-life of ibuprofen is approximately 1-2 hours. The drug does not accumulate in the body. Binding to plasma proteins is about 99%. In the synovial fluid, the concentrations of ibuprofen remain stable for 2-8 hours after taking the drug.The ibuprofen stab in the synovial fluid is about one third of the C max in the plasma.

Metabolism

Ibuprofen is not an inducer of enzymes. About 90% of ibuprofen undergoes metabolism with the formation of inactive metabolites.

Excretion

Excretion is carried out mainly by the kidneys. Ibuprofen is completely eliminated from the body within 24 hours (10% in unchanged form and 90% in the form of inactive metabolites, mainly in the form of conjugates with glucuronic acid).

Impaired renal or hepatic function

In patients with renal or hepatic insufficiency, the kinetic parameters of ibuprofen are almost unchanged. Observed abnormalities are not grounds for dose changes.

Indications:For children from 3 months to 12 years (with a body weight of approximately 40 kg) as an antipyretic agent, including post-vaccination fever, and also as an analgesic for the following conditions: headache, sore throat (with tonsillitis or pharyngitis), pain in ears (especially associated with acute inflammation of the middle ear), with a cold, with teething, toothache, pain in the limbs, with injuries of ligaments, muscles or tendons.

Contraindications:

- Individual hypersensitivity to ibuprofen or other NSAIDs (including acetylsalicylic acid), as well as to the auxiliary components of the drug.

- Complete or incomplete combination of bronchial asthma, recurrent nasal polyposis and paranasal sinuses and intolerance to acetylsalicylic acid or other NSAIDs (including in anamnesis).

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

- Severe renal failure (creatinine clearance less than 30 ml / min), progressive kidney disease, severe hepatic impairment, or active liver disease.

- Confirmed hyperkalemia.

Inflammatory bowel disease.

- Deficiency of sugar / isomaltase.

- Intolerance to fructose, glucose-galactose malabsorption.

- Violation of blood clotting (including hemophilia, lengthening bleeding time, propensity to bleed, hemorrhagic diathesis).

- Pregnancy III trimester (see section "Application during pregnancy and during breast-feeding").

- Severe uncontrolled heart failure.

- Children up to 3 months.

Carefully:

Cirrhosis of the liver with portal hypertension; hepatic and / or renal insufficiency; arterial insufficiency, chronic heart failure; nephrotic syndrome; hyperbilirubinemia; the presence of H.Pylori infection, peptic ulcer of the stomach and duodenum (in the anamnesis); gastritis; enteritis; colitis; blood diseases of unclear etiology (leukopenia and anemia); long-term use of NSAIDs; severe physical illness; simultaneous administration of oral glucocorticosteroids (including prednisolone); anticoagulants (including warfarin), antiaggregants (including clopidogrel).

It is necessary to use the drug with caution in patients with diabetes mellitus, since the composition includes sucrose and sorbitol.

Pregnancy and lactation:

Advil® for children is recommended for use in children.

In case you are pregnant or breastfeeding, it is recommended to consult a doctor before using the drug.

Although the experience of the study of the drug in animals indicates the lack of teratogenic effect in ibuprofen, nevertheless, whenever possible, it should be avoided during pregnancy.

In the third trimester of pregnancy, the use of ibuprofen is contraindicated because of the risk of premature closure of the Botallov duct and subsequent pulmonary hypertension in the fetus. The delay in the onset of labor and the increase in their duration increase the risk of blood loss, which is dangerous for the mother and child (see "Contraindications"). It was found that ibuprofen is defined in breast milk in very low concentrations. The minimum detectable dose (0.0008% of the dose received) in a small degree of probability can have an impact on the child during breastfeeding. For female fertility, see also the section "Special instructions".

Dosing and Administration:

For oral administration.

The recommended daily dose is 20-30 mg / kg body weight, which is divided into 3-4 doses. The daily dose should not exceed 30 mg / kg. The drug should be taken no more often than every 6 hours.

Shake vial vigorously before use.

After taking the drug should be washed with water.

To take the drug should use a syringe dispenser, which is marked in kilograms (one division corresponds to 7.5 mg / kg). To determine the dose:

- For a child weighing up to 25 kg: Fill the syringe to the mark corresponding to the weight of the child's body.

- For a child with a body weight of 25 kg to 40 kg: Fill the syringe to the mark corresponding to 25 kg; then refill the syringe so that the sum of the marks on the divisions corresponds to the mass of the child's body (for example, for a child weighing 30 kg, fill the syringe to 25 kg and then repeatedly to 5 kg);

- For a child with a body weight of more than 40 kg (reached about 12 years), more suitable dosage forms are produced.

Regular intake of the drug avoids fluctuations in temperature and pain.

Duration of use: If the pain persists for more than 5 days or if the temperature lasts longer than 3 days, or if symptoms worsen, you should consult your doctor.

Do not give a double dose, in case of skipping the drug.

Side effects:

When ingesting ibuprofen preparations, the following adverse reactions are described:

Disorders from the gastrointestinal tract:

NSAIDs-gastropathy (abdominal pain, nausea, vomiting, heartburn, dyspepsia, decreased appetite, diarrhea, flatulence,constipation; ulceration of the gastrointestinal mucosa, which in some cases is complicated by perforation and bleeding; exacerbation of chronic colitis and Crohn's disease), irritation or dryness of the oral mucosa, oral pain, ulceration of the gingival mucosa, aphthous stomatitis, pancreatitis, bloating, gastritis, hematemesis, melena.

Disorders from the liver and bile ducts:

a violation of the liver, hepatitis, jaundice.

Disturbances from the respiratory system, chest and mediastinal organs:

shortness of breath, bronchospasm, exacerbation of asthma, wheezing, stridor.

Disorders from the organs of vision:

toxic optic nerve damage, blurred vision or dying, scotoma, dry and irritated eyes, conjunctival edema and eyelids (allergic genesis).

Hearing disorders and labyrinthine disturbances:

hearing loss, vertigo, ringing or tinnitus.

Impaired nervous system:

headache, dizziness, insomnia, anxiety, nervousness and irritability, psychomotor agitation, drowsiness, depression, confusion, hallucinations, impaired cerebral circulation.

Disorders from the cardiovascular system:

heart failure, stenocardia, tachycardia, increased blood pressure, swelling.

The use of such drugs may be associated with a slight increase in the risk of developing acute cardiovascular disorders (myocardial infarction or stroke). The risk increases with high doses and a long time of taking the drug. Do not exceed the recommended dose or duration of use. In the presence of cardiovascular disease, a previous stroke or risk factors (for example, high blood pressure, diabetes, high cholesterol, smoking), you should discuss taking the drug with your doctor.

Disorders from the kidneys and urinary tract:

acute renal failure, papillary necrosis of the kidneys, especially with prolonged use, accompanied by increased serum urea levels and edema, peripheral edema, allergic nephritis, nephrotic syndrome, interstitial nephritis, polyuria, cystitis, hematuria, proteinuria.

Disturbances from the skin and subcutaneous tissues:

skin rash (usually erythematous or urticaria), face swelling, rash, maculopapular rash, itchy skin; angioneurotic edema (Quincke), anaphylactoid reactions, anaphylactic shock, bronchospasm or dyspnea, bullous dermatitis, erythema multiforme exudative, Stevens-Johnson syndrome, toxic epidermal necrolysis (Lyell's syndrome), allergic rhinitis.

Violations from the blood and lymphatic system:

anemia (including hemolytic, aplastic), leukopenia, thrombocytopenia and thrombocytopenic purpura, pancytopenia, agranulocytosis, eosinophilia.

The first symptoms are: fever, sore throat, superficial ulceration of the oral mucosa, influenza-like symptoms, severe fatigue, bleeding and bruising of unknown origin.

Immune system disorders: In patients with autoimmune diseases (systemic lupus erythematosus, mixed connective tissue diseases) during the treatment with ibuprofen, symptoms of aseptic meningitis such as cramps spasm, headache, nausea, vomiting, fever, loss of orientation may occur.

Other violations:

no effect when taking the drug

Laboratory and instrumental data:

- 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)

Overdose:

In case of an unforeseen overdose, stop taking the medication and seek professional help immediately.

In children, taking a dose exceeding 400 mg / kg may cause overdose symptoms. In adults, the symptoms of an overdose are less pronounced. The half-life for an overdose is 1.5-3 hours.

Symptoms

In most patients who have taken clinically significant overestimated doses of NSAIDs, symptoms such as nausea, vomiting, epigastric pain, and diarrhea may develop. Noises in the ears, dizziness, headache and bleeding of the gastrointestinal tract are also possible. In more serious cases of intoxication, there are symptoms of the central nervous system, manifested in drowsiness, severe dizziness, sometimes there may be excitation, disorientation, coma, blocking, depression, acute renal failure, lowering blood pressure.In some cases, patients have convulsions. In severe cases of intoxication, metabolic acidosis and an increase in prothrombin time may be observed, an increase in the MHO (International Normalized Ratio) index. Also, acute violations of kidney and liver function, hyperkalemia, bradycardia, tachycardia, atrial fibrillation, dyspnoea, oppression and respiratory arrest are possible. Asthma exacerbations may be expected in patients with asthma.

Therapy

Standard measures are taken for symptomatic and maintenance therapy, including maintenance of respiratory function, as well as monitoring of cardiac activity and other vital functions. If no more than 1 hour has passed after taking a potentially toxic dose, gastric lavage, intake of activated charcoal inside, abundant alkaline drink and forced diuresis are recommended. With frequent or prolonged convulsions it is recommended to inject intravenously diazepam or lorazepam. When asthma attacks bronchodilators are recommended.

Interaction:

In connection with the description of a number of clinical observations, care should be taken when prescribing to patients taking any of the following drugs.

- Acetylsalicylic acid or other NSAIDs may increase the risk of side effects. Care should be taken if acetylsalicylic acid is taken with coronary artery disease or cerebral circulation disorders, because ibuprofen can reduce the therapeutic effect of acetylsalicylic acid.

- Antihypertensive drugs: ibuprofen weaken the effect of antihypertensive drugs (including slow calcium channel blockers and ACE inhibitors).

- Lithium: ibuprofen slows the excretion of lithium.

- Cardiac glycosides: NSAIDs can enhance the phenomena of heart failure, reduce the rate of glomerular filtration and cause an increase in the level of glycosides in the blood plasma.

- Methotrexate: Methotrexate excretion is slowed. Patients with reduced renal function have a high risk of developing hepatotoxic reactions, even if low doses of methotrexate (<20 mg / week) are used.

- Some antacids may reduce the absorption of ibuprofen from the gastrointestinal tract, which may be important with prolonged administration of ibuprofen.

- Corticosteroids, serotonin reuptake inhibitors: the risk of gastrointestinal bleeding increases.

- Cyclosporine and gold preparations increase the effect of ibuprofen on the synthesis of prostaglandins in the kidneys, which is manifested by an increased risk of nephrotoxicity.

- Mifepristone: Do not prescribe NSAIDs for 8-12 days after mifepristone therapy, since NSAIDs may reduce the effect of mifepristone.

- Diuretics: the effect of thiazide diuretics is reduced.

- An increased risk of hemarthrosis and hematomas in HIV-positive patients and patients with hemophilia simultaneously receiving zidovudine and ibuprofen.

- 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.

- Caffeine increases the analgesic effect.

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

- Myelotoxic drugs increase the manifestation of hematotoxicity of the drug.

- 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.

- Reduces the effectiveness of uricosuric medicines, enhances the effect of antiplatelet agents, fibrinolytic agents, thrombolytic drugs (alteplase, stektokinase, urokinase) (increased risk of hemorrhagic complications), enhances the effect of oral hypoglycemic drugs and insulin.

- Kolestyramin reduces the absorption of ibuprofen.

- Simultaneous reception with serotonin reuptake inhibitors (citalopram, fluoxetine, paroxetine, sertraline) increases the risk of developing gastrointestinal bleeding.

Special instructions:

- The use of ibuprofen may cause severe allergic reactions, including redness of the skin, the appearance of rashes or blisters, toxic epidermal necrolysis.

- In patients with bronchial asthma or allergic diseases in the history of the drug can cause the development of an attack or bronchospasm.

- The risk of unwanted effects can be minimized by using the lowest effective dose and short duration of therapy.

- Ibuprofen should not be prescribed in the last trimester of pregnancy (see the sections on "Application in pregnancy and lactation" and "Contraindications").

It is necessary to consult a doctor before taking another drug from the NSAID group.

During the treatment with any drugs of the NSAID group, there were cases of bleeding from the gastrointestinal tract, ulcerative lesions or perforation with a fatal outcome, regardless of the presence or absence of previous symptoms or the presence in the patient's history of serious diseases of the gastrointestinal tract.

Before taking the drug should consult a doctor if the child does not drink fluids or the loss of fluid occurs due to persistent vomiting or diarrhea.

Patients should always report all symptoms (especially bleeding from the gastrointestinal tract) that occur during therapy. The drug should be discontinued and the doctor should be consulted in case of vomiting with blood or the presence of blood in the feces.

Precautions should be taken in prescribing ibuprofen to patients taking medications that increase the risk of complications from the gastrointestinal tract (including bleeding), such as glucocorticosteroids or anticoagulants (warfarin, acetylsalicylic acid) (see section "Interactions with other drugs"). With the development of symptoms of bleeding GIT or ulcerative lesions in patients taking ibuprofen, the drug should be discontinued. Systemic lupus erythematosus and systemic connective tissue diseases - the risk of developing aseptic meningitis increases (see section "Side effect").

Ibuprofen, due to its pharmacological action, can reduce the diagnostic significance of such symptoms as fever and inflammation and affect the diagnosis of the disease.

There is limited information that drugs inhibiting the synthesis of cyclooxygenase / prostaglandins can cause fertility decline in women through exposure to ovulation. When the drug is canceled, the function is restored.

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 including esophagogastroduodenoscopy, a blood test with determination of hemoglobin, hematocrit, analysis of feces for latent blood is shown.

- To prevent the development of NSAIDs, gastropathy is recommended to be combined with preparations of prostaglandins (misoprostol).

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

- Before starting therapy for patients with a history of arterial hypertension and / or heart failure, care should be taken and consulted with a specialist, since such patients were noted for fluid retention, hypertension, and swelling associated with NSAID administration.

- Long-term use may increase the risk of acute coronary disease or stroke.

- During the period of treatment, ethanol is not recommended.

Form release / dosage:

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

Packaging:200 ml in bottles of dark glass with a screw cap, which protects from accidental opening by children. The bottle and syringe dispenser, graduated in kg, together with the instruction for use are placed in a cardboard 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 expiry date.

Terms of leave from pharmacies:Without recipe

Registration number:LP-002446

Date of registration:05.05.2014

Expiration Date:05.05.2019

The owner of the registration certificate:Pfizer Corporation Austria GmbHPfizer Corporation Austria GmbH Austria

Manufacturer: & nbsp

FAMAR LYON France

Representation: & nbspPfizer H. Si. Pi. CorporationPfizer H. Si. Pi. Corporation

Information update date: & nbsp23.01.2017

Illustrated instructions

Instructions

Advil® for children (Advil®)