Active substanceIbuprofenIbuprofen
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  • Dosage form: & nbsprectal suppositories [for children]
    Composition:

    1 suppository contains:

    Active substance: ibuprofen 60 mg or 125 mg;

    Excipients: fat is solid (Novata BCF PH) 720.00 / 1075.00 mg.

    Description:

    Suppositories white or almost white in torpedo shape.

    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. Besides, ibuprofen reversibly inhibits platelet aggregation. Has analgesic, antipyretic and anti-inflammatory effect. Analgesic effect is most pronounced for inflammatory pains. The drug lasts up to 8 hours.
    Pharmacokinetics:

    Absorption is high, binding to plasma proteins is 90%. Ibuprofen absorbed from the lumen of the rectum, quickly reaching the systemic blood flow. The half-life (T1 / 2) is 2 hours. Slowly penetrates into the cavity of the joints, lingers in the synovial fluid, creating in it large concentrations,than in a blood plasma. After absorption about 60% of pharmacologically inactive Rform is slowly transformed into an active S-form. It is metabolized in the liver. It is excreted by the kidneys (in an unchanged form not more than 1%) and, to a lesser extent, with bile.

    In limited studies ibuprofen was found in breast milk in very low concentrations.

    Indications:

    Ibuprofen 60 mg is used in children aged 3 months to 2 years, ibuprofen 125 mg - from 2 years to 6 years (or older with a body weight of up to 21 kg):

    - as an antipyretic agent for acute respiratory infections (including influenza), childhood infections, post-vaccination reactions and other infectious and inflammatory diseases accompanied by fever.

    - as an anesthetic for pain syndrome of mild to moderate intensity, including headache, toothache, migraine, neuralgia, pain in the ears, sore throat, pain in stretching and other types of pain.

    The drug is recommended for use if oral medication (for oral administration) is not possible or if there is vomiting.

    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 any of the components that make up the drug.

    - the presence of a history of hypersensitivity reactions (bronchial asthma, bronchospasm, rhinitis, rhinosinusitis, recurrent polyposis of the nose or paranasal sinuses, Quincke's edema, urticaria) in response to the use of acetylsalicylic acid or other NSAIDs.

    - bleeding or perforation of the gastrointestinal tract ulcers (GIT) in the history, provoked by the use of NSAIDs.

    - erosive and ulcerative diseases of the gastrointestinal tract (including peptic ulcer of the stomach and duodenum, Crohn's disease, ulcerative colitis) or ulcerative bleeding in the active phase or in the anamnesis (two or more confirmed episodes of peptic ulcer or ulcer bleeding).

    - severe hepatic insufficiency or liver disease in the active phase.

    - severe renal failure (creatinine clearance <30 ml / min), progressive kidney disease, confirmed hyperkalemia.

    - decompensated heart failure, the period after aortocoronary bypass surgery.

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

    - pregnancy (III trimester).

    - the child's body weight is up to 6 kg.

    - proctitis.

    - intracranial hemorrhage.

    Carefully:

    If you have the following conditions before using the drug, you should consult your doctor: simultaneous intake of other NSAIDs, history of a single episode of peptic ulcer or gastric ulcer bleeding, gastritis, enteritis, colitis, 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 somatic diseases, systemic lupus erythematosus or mixed connective tissue disease (Sharpe's syndrome) - increased risk of aseptic meningitis; renal failure, including dehydration (creatinine clearance 30-60 ml / min), fluid retention and swelling, hepatic insufficiency, arterial hypertension and / or heart failure, cerebrovascular disease, dyslipidemia / hyperlipidemia, diabetes mellitus, peripheral arterial disease, blood diseases of unclear etiology (leukopenia, anemia); simultaneous reception of other drugs that can increase the risk of ulcers or bleeding, in particular, oral glucocorticosteroids (including prednisolone), anticoagulants (including warfarin), selective serotonin reuptake inhibitors (including citalopram, fluoxetine, parosetine, sertraline) or antiplatelet agents (in including, acetylsalicylic acid, clopidogrel); pregnancy (I-II trimester), the period of breastfeeding, the elderly.

    Pregnancy and lactation:

    Contraindicated use of the drug in the III trimester of pregnancy. If possible, the use of ibuprofen in I-II trimesters of pregnancy. There is evidence that ibuprofen in small quantities can penetrate into breast milk without any negative consequences for the health of the infant.

    Dosing and Administration:

    For rectal administration. Only for short-term use. Read the instructions carefully before using the product.

    Fever (fever) and pain.

    Dosage depends on the age and weight of the child. The maximum daily dose should not exceed 30 mg / kg of the body weight of the child with intervals between doses of the drug 6-8 hours.

    Children aged 3 to 9 months with a body weight of 5.5 kg to 8.0 kg - 1 suppository (60 mg) to 3 times within 24 hours, not more than 180 mg per day.

    Children aged 9 months to 2 years with a body weight of 8.0 kg to 12.5 kg - 1 suppository (60 mg) to 4 times within 24 hours, not more than 240 mg per day.

    Children aged 2 to 4 years with a body weight of 12.5 kg to 17.0 kg - 1 suppository (125 mg) to 3 times within 24 hours, not more than 375 mg per day.

    Children aged 4 to 6 years with a body weight of 17.0 kg to 20.5 kg - 1 suppository (125 mg) to 4 times a day for 24 hours, not more than 500 mg per day.

    Duration of treatment - no more than 3 days. Do not exceed the indicated dose.

    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.

    Postimmunization fever.

    Children under the age of 1 year - 1 suppository (60 mg). Children over the age of 1 year - 1 suppository (60 mg), if necessary, one more after 6 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.

    To indicate the frequency of side effects, the following classification is used: Often (≥ 1/10), often (≥ 1/100 and <1/10), infrequently (≥ 1/1000 and <1/100), rarely (≥ 1/10000 and <1/1000), rarely (< 1/10000), frequency unknown (can not be estimated from available data).

    From the side of the blood and lymphatic system: rarely: hematopoietic disorders (anemia, leukopenia, aplastic anemia, hemolytic anemia, thrombocytopenia, pancytopenia, agranutocytosis). The first symptoms of such disorders are fever, sore throat, superficial ulcers in the mouth, flu-like symptoms, severe weakness, nosebleeds and subcutaneous hemorrhages, bleeding and bruising of unknown etiology.

    From the immune system: infrequently: hypersensitivity reactions - nonspecific allergic reactions and anaphylactic reactions,response from the respiratory tract (asthma, including its exacerbation, bronchoconstriction, dyspnea, dyspnea), skin reactions (pruritus, urticaria, purpura, angioedema, exfoliative and bullous dermatoses, including toxic epidermal necrolysis, Stevens-Johnson syndrome , erythema multiforme), allergic rhinitis, eosinophilia; rarely: Severe hypersensitivity reactions, including swelling of the face, tongue and throat, shortness of breath, tachycardia, hypotension (anaphylaxis, angioedema or severe anaphylactic shock).

    From the gastrointestinal tract: infrequently: abdominal pain, nausea, dyspepsia; rarely: diarrhea, constipation, flatulence, vomiting; rarely: peptic ulcer, perforation or gastrointestinal bleeding, melena, bloody vomiting, ulcerative stomatitis, gastritis; frequency unknown: exacerbation of ulcerative colitis and Crohn's disease.

    From the urinary and liver systems: rarely: acute renal failure, especially with prolonged use, in combination with increased levels of urea in plasma and the appearance of edemas, papillary necrosis, liver dysfunction, hepatitis.

    From the nervous system: infrequently: headache; rarely: aseptic meningitis (in patients with autoimmune diseases).

    From the cardiovascular system: frequency is unknown: cardiac insufficiency, 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 is unknown: A bronchial asthma, a bronchospasm, a dyspnea or short wind.

    Other: rarely: edema, including peripheral.

    Laboratory indicators: hematocrit or hemoglobin (may decrease), bleeding time (may increase), plasma glucose concentration (may decrease), creatinine clearance (may decrease), plasma creatinine concentration (may increase), activity of "hepatic" transaminases (may increase).

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

    Overdose:

    In children, the symptoms of overdose may occur after taking a dose of the drug, exceeding 200 mg / kg of the child's body weight.

    Symptoms: nausea, vomiting, pain in the epigastric region or, more rarely, diarrhea, tinnitus, headache and gastrointestinal bleeding. In more severe cases, there are manifestations of the central nervous system: drowsiness, rarely - excitation, convulsions, disorientation, coma. In cases of severe poisoning, metabolic acidosis and an increase in prothrombin time, renal failure, damage to liver tissue, lowering blood pressure, respiratory depression and cyanosis may develop. Patients with bronchial asthma may exacerbate this disease.

    Treatment: symptomatic, with mandatory provision of airway patency, monitoring of ECG and basic indicators of vital activity, up to the normalization of the patient's condition. Frequent or prolonged seizures should be stopped with intravenous diazepam or lorazepam. When bronchial asthma worsens, the use of bronchodilators is recommended.

    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 the 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.

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

    - Glucocorticosteroids: an increased risk of ulcers and bleeding of the gastrointestinal tract.

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

    - Cardiac glycosides: simultaneous use of NSAIDs and cardiac glycosides may 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 methotrexate in the blood plasma on the background of the use of NSAIDs.

    - Cyclosporine: increased risk of nephrotoxicity with simultaneous use 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: an increased risk of nephrotoxicity may occur with simultaneous use of NSAIDs and tacrolimus.

    - 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: simultaneous use of NSAIDs and quinolone antibiotics increases the risk of seizures.

    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 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.

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

    Patients who report dizziness, drowsiness, blockage, or visual impairment when taking ibuprofen should avoid driving motor vehicles or controlling mechanisms.

    Form release / dosage:

    Suppositories rectal [for children] 60 mg, 125 mg.

    Packaging:

    5 suppositories per Al / PE strip. 2 strips together with instructions for use are placed in a cardboard box.

    Storage conditions:

    Store at a temperature not exceeding 25 ° C.

    Keep out of the reach of children!

    Shelf life:

    Suppositories 60 mg: 18 months.

    Suppositories 125 mg: 2 years.

    Do not use after the expiration date.

    Terms of leave from pharmacies:Without recipe
    Registration number:LP-004264
    Date of registration:28.04.2017
    Expiration Date:28.04.2022
    The owner of the registration certificate:Beluga, medicines and cosmetics.Beluga, medicines and cosmetics. Croatia
    Manufacturer: & nbsp
    Representation: & nbspBeluga, medicines and cosmetics. Beluga, medicines and cosmetics. Croatia
    Information update date: & nbsp22.05.2017
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