Active substanceIbuprofenIbuprofen
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  • Dosage form: & nbspsuspension for ingestion for children
    Composition:In 100 ml contains:

    Active substance: ibuprofen in terms of 100% substance - 2.00 g.

    Excipients: sodium benzoate, sorbitol, citric acid monohydrate,sodium citrate pentasecylhydrate (sodium citrate trisubstituted 5,5-water), propylene glycol, xanthan gum, polysorbate 80, flavoring (cherry, orange), sodium saccharinate dihydrate, purified water.

    Description:White or almost white suspension of syrupy consistency with a fruity smell.
    Pharmacotherapeutic group:Non-steroidal anti-inflammatory drug (NSAID)
    ATX: & nbsp

    M.01.A.E.01   Ibuprofen

    Pharmacodynamics:The mechanism of action of ibuprofen, a derivative of propionic acid from the group of nonsteroidal anti-inflammatory drugs (NSAIDs), is due to inhibition of the synthesis of prostaglandins - mediators of pain, inflammation and hyperthermia. Non-selectively blocks cyclooxygenase 1 (COX-1) and cyclooxygenase 2 (COX-2), which inhibits the synthesis of prostaglandins. Has analgesic, antipyretic and anti-inflammatory effect. Analgesic effect is most pronounced for inflammatory pains. Ibuprofen reversibly inhibits platelet aggregation.
    Pharmacokinetics:

    Suction. Absorption is high, quickly and almost completely absorbed from the gastrointestinal tract.The time to reach the maximum concentration on admission on an empty stomach - 45 minutes, at reception after meal - 1,5-2,5 hours. When taking the drug after eating, the absorption decreases slightly.

    Distribution. The connection with blood plasma proteins is about 90%. Slowly penetrates into the joint cavity, is retained in the synovial fluid, creating in it greater concentrations than in the plasma.

    Metabolism. It is metabolized in the liver. After absorption about 60% of pharmacologically inactive Rform of ibuprofen is slowly transformed into an active S-form.

    Excretion. The half-life (T1 / 2) is 2-2.5 hours. It is excreted by the kidneys (in an unchanged form not more than 1%) and, to a lesser extent, with bile.

    Indications:

    Applied in children from 3 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 for pain syndrome of mild or moderate intensity, including for toothache, headache, migraine, neuralgia, pain in the ears, sore throat, ligament pain, muscle pain, rheumatic pain, joint pain.The drug 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 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 the anamnesis).

    - Erosive and ulcerative diseases of the gastrointestinal tract (including peptic ulcer of the stomach and duodenum in the acute stage, peptic ulcer).

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

    - Confirmed hyperkalemia.

    - Inflammatory bowel disease (ulcerative colitis, Crohn's disease).

    - Violation of blood clotting (including hemophilia, prolonged bleeding time, a tendency to bleed, hemorrhagic diathesis).

    - Gastrointestinal bleeding.

    - Intracranial hemorrhage.

    - Severe uncontrolled heart failure, condition after aortocoronary bypass surgery.

    - Intolerance to fructose, glucose-galactose malabsorption (due to the presence of sorbitol in the composition).

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

    - Children up to 3 months.

    Carefully:Simultaneous reception of other NSAIDs, history of a single episode of peptic ulcer of stomach and duodenum or ulcerative bleeding of the gastrointestinal tract, gastritis, enteritis, colitis, the presence of infection Helicobacter pylori, ulcerative colitis; A bronchial asthma or allergic diseases in a stage of an exacerbation or in the anamnesis - development of a bronchospasm is possible; severe physical illness; systemic lupus erythematosus or other autoimmune diseases of connective tissue (increased risk of developing aseptic meningitis); renal failure, including dehydration (creatinine clearance 30-60 ml / min), fluid retention and swelling, hypertension and / or heart failure, liver failure, cerebrovascular disease,dyslipidemia / hyperlipidemia, diabetes mellitus, peripheral arterial disease, unclear etiology (leukopenia, anemia); simultaneous administration of other drugs that may increase the risk of ulcers or bleeding, in particular, oral glucocorticosteroids (including prednisolone), anticoagulants (including warfarin), selective serotonin reuptake inhibitors (including citalopram, fluoxetine, paroxetine, sertraline) or antiplatelet agents (including acetylsalicylic acid, clopidogrel); pregnancy (I-II trimester), the period of breastfeeding.
    Pregnancy and lactation:

    Ibuprofen suspension is recommended for use in children.

    In case you are pregnant or breast-feeding, 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.

    AT III 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.
    Dosing and Administration:

    For oral administration. 5 ml of the drug contain 100 mg of ibuprofen (20 mg of ibuprofen in 1 ml).

    Shake the bottle thoroughly before use to obtain a uniform suspension. To measure the dosage of the drug is attached a measuring spoon or measuring cup. The dose of ibuprofen for children is calculated according to age and body weight. The maximum daily dose is not more than 30 mg per kg of body weight of the child with intervals between doses of the drug of 6-8 hours.

    Fever (fever) and pain:

    Children aged 3-6 months (the weight of the child is more than 5 kg): 2.5 ml (50 mg) 3 times for 24 hours, not more than 7.5 ml (150 mg) per day.

    Children aged 6-12 months (weight 6-10 kg): 2.5 ml (50 mg) 3-4 times for 24 hours, not more than 10 ml (200 mg) per day.

    Children aged 1-3 years (weight 10-15 kg): 5 ml (100 mg) 3 times for 24 hours, not more than 15 ml (300 mg) per day.

    Children aged 4-6 years (weight of child 15-20 kg): for 7.5 ml (150 mg) 3-4 times within 24 hours, not more than 22.5 ml (450 mg) per day.

    Children aged 7-9 years (weight 21-29 kg): 10 ml (200 mg) 3 times for 24 hours, not more than 30 ml (600 mg) per day.

    Children aged 10-12 years (weight of the child 30-40 kg): for 15 ml (300 mg) 3 times for 24 hours, not more than 45 ml (900 mg) per day.

    Do not exceed the indicated dose!

    Duration of treatment - no more than 3 days as an antipyretic and not more than 5 days as an anesthetic.

    If symptoms persist or worsen during 24 hours (for children aged 3-5 months) or for 3 days (in children 6 months and older), stop treatment and consult a doctor.

    Post-vaccination reactions:

    Children under the age of 1 year: 2.5 ml (50 mg) of the drug.

    Children aged 1 year, if necessary, additionally 2.5 ml (50 mg) after 6 hours.

    Do not use more than 5 ml (100 mg) for 24 hours.

    Side effects:

    The risk of side effects can be minimized if you take the drug with a short course, at the lowest effective dose needed to eliminate the symptoms.

    Side effects are predominantly dose-dependent.

    The following adverse reactions were noted with a short-term intake of ibuprofen in doses not exceeding 1200 mg / day. In the treatment of chronic conditions and with prolonged use, other side reactions may occur.

    According to the WHO, adverse reactions are classified according to their frequency of development as follows: very frequent (≥1 / 10), often (from ≥1 / 100 to <1/10), infrequent (from ≥1 / 1000 to <1/100 ), rare (from ≥1 / 10,000 to <1/1000), very rare (<1/10 000); frequency is unknown - according to available data, it was not possible to establish the frequency of occurrence.

    From the side of the blood and lymphatic system:

    - very rare: disturbances of hematopoiesis (anemia, leukopenia, aplastic anemia, hemolytic anemia, thrombocytopenia, pancytopenia, agranulocytosis). The first symptoms of such disorders are fever, sore throat, superficial oral ulcers, flu-like symptoms, severe weakness, nosebleeds and bruising, bleeding, and bruising of unknown etiology.

    From the immune system:

    - infrequent hypersensitivity reactions - nonspecific allergic reactions and anaphylactic reactions,reactions from the respiratory tract (bronchial asthma, including its aggravation, bronchospasm, dyspnea, dyspnea), skin reactions (itching, urticaria, purpura, Quincke's edema, exfoliative and bullous dermatoses, including toxic epidermal necrolysis (Lyell's syndrome), Stevens-Johnson syndrome, erythema multiforme), eosinophilia.

    - very rare: severe hypersensitivity reactions, including swelling of the face, tongue and larynx, dyspnea, tachycardia, hypotension (anaphylaxis, Quincke's edema or severe anaphylactic shock).

    From the gastrointestinal tract:

    - infrequent: abdominal pain, nausea, indigestion.

    - rare: diarrhea, flatulence, constipation, vomiting.

    - very rare: peptic ulcer, perforation or gastrointestinal bleeding, melena, bloody vomiting, ulcerative stomatitis, gastritis.

    - frequency unknown: exacerbation of ulcerative colitis and Crohn's disease.

    From the liver and bile ducts:

    - very rare: violations of the liver.

    From the side of the kidneys and urinary tract:

    - very rare: acute renal failure (compensated and uncompensated), especially with prolonged use, in combination with an increase in the concentration of urea in the blood plasma and the appearance of edema, papillary necrosis.

    From the nervous system:

    - infrequent: headache.

    - very rare: aseptic meningitis (in patients with autoimmune diseases).

    From the cardiovascular system:

    - frequency unknown: heart failure, peripheral edema, with prolonged use increased risk of thrombotic complications (eg, myocardial infarction, stroke), increased blood pressure.

    From the respiratory system and mediastinal organs:

    - frequency unknown: bronchial asthma, bronchospasm, dyspnea.

    Other:

    - very rare: edema, including peripheral.

    Laboratory indicators:

    - hematocrit or hemoglobin (may decrease);

    - bleeding time (may increase);

    - the concentration of glucose in the blood plasma (may decrease);

    - clearance of creatinine (may decrease);

    - plasma concentration of creatinine (may increase);

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

    If these or other side effects occur, discontinue use and consult a doctor.

    Overdose:

    In case you accidentally exceeded the recommended dose, consult a doctor immediately.

    Symptoms of overdose: abdominal pain, nausea, vomiting, headache, tinnitus, metabolic acidosis, coma, acute renal failure, lowering of blood pressure, bradycardia, tachycardia.

    Treatment: gastric lavage (only within the first hour after an overdose), reception of activated charcoal, alkaline drink, forced diuresis, symptomatic therapy.

    Interaction:

    It should be avoided simultaneous use of ibuprofen with the following medicines:

    - Acetylsalicylic acid: with the exception of low doses of acetylsalicylic acid (not more than 75 mg per day) prescribed by a doctor, since joint application may increase the risk of side effects. With simultaneous application ibuprofen reduces the anti-inflammatory and antiplatelet effect of acetylsalicylic acid (it is possible to increase the incidence of acute coronary insufficiency in patients receiving small doses of acetylsalicylic acid as antiplatelet agent after the onset of ibuprofen administration).

    - Other NSAIDs, including selective COX-2 inhibitors: simultaneous use of two or more drugs from the NSAID group should be avoided because of the possible increase in the risk of side effects.

    Use with caution simultaneously with the following medicines:

    - Anticoagulants and thrombolytic drugs: NSAIDs can enhance the effect of anticoagulants, in particular, warfarin and thrombolytic drugs.

    - Hypotensive drugs (angiotensin-converting enzyme (ACE) inhibitors and angiotensin II antagonists) and diuretics: NSAIDs may decrease the effectiveness of the drugs of these groups. Diuretics and ACE inhibitors can increase the nephrotoxicity of NSAIDs.

    - Glucocorticosteroids: increased risk of gastrointestinal ulcers and gastrointestinal bleeding.

    - Antiaggregants and selective serotonin reuptake inhibitors: an increased risk of gastrointestinal bleeding.

    - Cardiac glycosides: simultaneous administration of NSAIDs and cardiac glycosides can lead to worsening of heart failure, a decrease in glomerular filtration rate and an increase in the concentration of cardiac glycosides in blood plasma.

    - Lithium preparations: there are data on the probability of an increase in the concentration of lithium in blood plasma against the background of NSAIDs.

    - Methotrexate: There are data on the probability of increasing the concentration of methotrexate in plasma of blood on the background of the application of NSAIDs.

    - Cyclosporine: increased risk of nephrotoxicity with simultaneous administration of NSAIDs and cyclosporine.

    - Mifepristone: NSAIDs should be started no earlier than 8-12 days after taking mifepristone, because NSAIDs may reduce the effectiveness of mifepristone.

    - Tacrolimus: with simultaneous administration of NSAIDs and tacrolimus, an increased risk of nephrotoxicity may occur.

    - Zidovudine: simultaneous use of NSAIDs and zidovudine may lead to an increase in hematotoxicity. There is evidence of an increased risk of hemarthrosis and hematoma in HIV-positive patients with hemophilia who received co-treatment with zidovudine and ibuprofen.

    - Antibiotics of the quinolone series: in patients receiving co-treatment with NSAIDs and quinolone antibiotics, an increased risk of seizures is possible.

    Special instructions:

    It is recommended to take the drug as short a course as possible and at the minimum effective dose necessary to eliminate symptoms.

    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 appear, careful monitoring including esophagogastroduodenoscopy, a blood test with 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.

    During the period of treatment, ethanol is not recommended.

    The drug can be used in children with diabetes mellitus. it does not contain sugar. Does not contain dyes.

    Patients with renal insufficiency should consult with a doctor before using the drug, since there is a risk of impairment of the functional state of the kidneys.

    Precautions should be taken while taking medications that increase the risk of complications from the gastrointestinal tract (including bleeding), such as glucocorticosteroids or anticoagulants (warfarin, acetylsalicylic acid) (see "Interactions with other drugs").

    Patients with hypertension, including anamnesis and / or chronic heart failure, should consult with a doctor before using the drug, because the drug can cause fluid retention, increased blood pressure and swelling.

    Effect on the ability to drive transp. cf. and fur:

    There is no information about the adverse effects of the drug on the ability to drive vehicles and serve mechanisms that require increased concentration and speed of psychomotor reactions.

    Form release / dosage:

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

    Packaging:

    100 ml in bottles of orange or dark glass. To 150 ml, 200 ml into bottles of dark glass. The bottle with a measuring spoon or a measuring cup and instruction for use is placed in a pack of cardboard.

    Storage conditions:

    In the dark 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.

    Terms of leave from pharmacies:Without recipe
    Registration number:LP-004270
    Date of registration:28.04.2017
    Expiration Date:28.04.2022
    The owner of the registration certificate:TATHIMFARMPREPARATY, JSC TATHIMFARMPREPARATY, JSC Russia
    Manufacturer: & nbsp
    Information update date: & nbsp02.06.2017
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