Ibuklin Junior® (Ibuclin Junior)

Composition Pharmacodynamics Indications Carefully Contraindications Dosing and Administration Side effects Form release / dosage
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Active substanceIbuprofen + ParacetamolIbuprofen + Paracetamol
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    • Dosage form: & nbsptablets, dispersible [for children]
    Composition:

    Each tablet is dispersible [for children] contains:

    active substances: ibuprofen 100 mg, paracetamol 125 mg

    Excipients: microcrystalline cellulose 20 mg, corn starch 59.04 mg, lactose 5 mg, sodium carboxymethyl starch (type A) 30 mg, crimson dye (Ponso 4R) (E124) 0.2 mg, glycerol 2 mg, silicon dioxide colloid 5 mg, flavor orange DC 100 pH 1.6 mg, pineapple flavors DC 106 PH 2.5 mg, peppermint mint oil 0.66 mg, aspartame 10 mg, magnesium stearate 1 mg, talc 3 mg.

    Description:The tablets are flat-cylindrical, pink in color with interspaces with a facet and a risk on one side and a fruity mint smell.
    Pharmacotherapeutic group:Analgesic combined (NSAIDs + analgesic anesthetic)
    ATX: & nbsp

    M.01.A.E.51   Ibuprofen in combination with other drugs

    Pharmacodynamics:

    Combined drug, the effect of which is due to its constituent components.

    Ibuprofen - non-steroidal anti-inflammatory drug (NSAID), has analgesic, anti-inflammatory, antipyretic effect. Inhibiting cycloxygenase (COX) 1 and 2, disrupts the metabolism of arachidonic acid, reduces the number of prostaglandins (mediators of pain, inflammation and hyperthermia), both in the inflammatory focus and in healthy tissues, suppresses the exudative and proliferative phases of inflammation.

    Paracetamol - indiscriminately blocks COX, mainly in the central nervous system, weakly affects the water-salt metabolism and mucosa of the gastrointestinal tract (GI tract). Has analgesic and antipyretic effect. In inflamed tissues, peroxidases neutralize the effect of paracetamol on COX 1 and 2, which explains the low anti-inflammatory effect. The effectiveness of the combination is higher than that of the individual components.
    Pharmacokinetics:

    Ibuprofen.

    Absorption is high, quickly and almost completely absorbed from the gastrointestinal tract (GIT). The time to reach the maximum concentration (TСmах)

    after oral administration - about 1-2 hours. The connection with blood plasma proteins is more than 90%. Half-life (T1/2) - about 2 hours Slowly penetrates into the joint cavity, accumulates in the synovial fluid, creating in it higher concentrations than in the blood plasma. After absorption, about 60% of the pharmacologically inactive R-form is slowly transformed into an active S-form. Exposed to metabolism. More than 90% is excreted by the kidneys (unchanged not more than 1%) and, to a lesser extent, with bile in the form of metabolites and their conjugates.

    Paracetamol.

    Absorption is high, the association with plasma proteins is less than 10% and slightly increases with an overdose. Sulfate and glucuronide metabolites do not bind to plasma proteins even at relatively high concentrations. The value of Cmax - 5-20 μg / ml, TСmах - 0,5-2 hours. It is evenly distributed in the liquid medium of the body. Penetrates through the blood-brain barrier.

    About 90-95% of paracetamol is metabolized in the liver with the formation of inactive conjugates with glucuronic acid (60%), taurine (35%) and cysteine ​​(3%), as well as a small amount of hydroxylated and deacetylated metabolites.A small part of the drug is hydroxylated by microsomal enzymes with the formation of highly active N-acetyl-n-benzoquinonimine, which binds to the sulfhydryl groups of glutathione. When depletion of glutathione stores in the liver (with an overdose) enzyme systems of hepatocytes can be blocked, leading to the development of their necrosis.

    T1/2 2-3 hours. It is excreted by the kidneys, mainly in the form of glucuronide and sulfate conjugates (less than 5% in unchanged form). Breast milk penetrates less than 1% of the accepted dose of paracetamol. In children, the ability to form conjugates with glucuronic acid is lower than in adults.

    Indications:

    Feverish syndrome.

    Pain syndrome of mild or moderate intensity of various etiologies: dental, pain, pain with sprains, dislocations, fractures.

    As an auxiliary medicine for the treatment of pain and febrile syndrome with sinusitis, tonsillitis, acute infectious and inflammatory diseases of the upper respiratory tract (pharyngitis, tracheitis, laryngitis).
    Contraindications:Increased individual sensitivity to the components of the drug (including other NSAIDs),gastric ulcer and duodenal ulcer in an exacerbation phase, full or partial combination of asthma, recurrent nasal polyposis and paranasal sinuses and intolerance to acetylsalicylic acid or other NSAIDs (including history), severe renal impairment (creatinine clearance less than 30 mL / min) , lesions of the optic nerve, genetic absence of glucose-6-phosphate dehydrogenase, diseases of the blood system, period after aortocoronary shunting, progressive kidney disease, severe hepatic nedos atochnost or active liver disease, confirmed hyperkalemia, active gastrointestinal bleeding, inflammatory bowel disease, children (up to 3 years).
    Carefully:Chronic heart failure, cerebrovascular disease, dyslipidemia / hyperlipidemia, diabetes mellitus, peripheral arterial disease, smoking, CC less than 60 ml / min, ulcerative lesions of the gastrointestinal tract in history, presence of infection Helicobacter pylori, long-term use of NSAIDs, alcoholism, severe somatic diseases, simultaneous intake of oral glucocorticosteroids (including,prednisolone), anticoagulants (including warfarin), antiplatelet agents (including acetylsalicylic acid, clopidogrel), selective serotonin reuptake inhibitors (including citalopram, fluoxetine, paroxetine, sertraline).
    Pregnancy and lactation:

    If you need to use the drug Ibuklin® during pregnancy and lactation (breastfeeding), you should carefully weigh the expected benefit of therapy for the mother and the potential risk to the fetus or child. If necessary, in the first trimester of pregnancy should be deleted long-term use of the drug Ibuklin®.

    If you need a short-term use of the drug Ibuklin® during lactation, the termination of breastfeeding is usually not required. AT experimental research The embryotoxic, teratogenic and mutagenic action of the components of the drug Ibuklin® has not been established.
    Dosing and Administration:

    The drug is taken internally. Before use, the Ibuqueline® tablet should be dissolved in 5 ml (1 teaspoon) of water. The daily dose of the drug is taken in 2-3 divided doses. The minimum time interval between taking the drug is 4 hours.

    Children older than 3 years.

    Single dose - 1 tablet. The daily dose depends on the age and weight of the child: 3-6 years (13-20 kg) - 3 tablets per day; 6-12 years (20-40 kg) - up to 6 tablets per day. In case of violations of the kidney or liver function, the interval between doses should be at least 8 hours.

    The drug should not be taken for more than 5 days as an anesthetic and for more than 3 days as an antipyretic without the supervision of a doctor.

    Side effects:

    In therapeutic doses, the drug is usually well tolerated.

    From the digestive system: rarely - dyspeptic phenomena, with

    long-term use in high doses - hepatotoxic effect.

    On the part of the hematopoiesis system: rarely - thrombocytopenia, leukopenia, pancytopenia, neutropenia, agranulocytosis.

    Allergic reactions: rarely - skin rash, itching, hives.

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

    Overdose:

    Symptoms: gastrointestinal disorders (abdominal pain, diarrhea, nausea, vomiting, anorexia, epigastric pain), an increase in prothrombin time, bleeding after 12-48 hours, retardation, drowsiness, depression, headache, tinnitus,violation of consciousness, disturbance of the heart rhythm, lowering of arterial pressure, manifestations of hepato- and nephrotoxicity, convulsions, possibly development of hepatonecrosis.

    Treatment: gastric lavage for the first 4 hours; alkaline drink, forced diuresis; Activated carbon inside, the introduction of donators SH-groups and precursors of glutathione-methionine synthesis 8-9 hours after an overdose and N-acetylcysteine ​​inside or intravenously - after 12 hours, antacid preparations; hemodialysis; symptomatic therapy. The need for additional therapeutic measures (further introduction of methionine, intravenous administration N-acetylcysteine) is determined depending on the concentration of paracetamol in the blood, as well as on the time elapsed after its administration.
    Interaction:

    With the simultaneous use of the drug Ibuklin® with drugs, it is possible to develop various interaction effects.

    Long-term combined use with paracetamol increases the risk of developing nephrotoxic effects.

    The combination with ethanol, glucocorticosteroids, corticotropin increases the risk of erosive and ulcerative lesions of the digestive tract.

    Ibuprofen enhances the action of direct (heparin) and indirect (coumarin and indanedione derivatives) anticoagulants, thrombolytic agents (alteplase, anestreplase, streptokinase, urokinase), antiplatelet agents, colchicine - the risk of hemorrhagic complications increases.

    Strengthens the hypoglycemic effect of insulin and oral hypoglycemic drugs.

    Weaken the effects of antihypertensive drugs and diuretics (by inhibiting the synthesis of renal prostaglandins).

    Increases the concentration in the blood of digoxin, lithium and methotrexate.

    Caffeine increases the analgesic effect of ibuprofen.

    Cyclosporine and gold preparations increase nephrotoxicity.

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

    Antacids and colestramine reduce the absorption of the drug.

    Myelotoxic drugs promote the manifestation of hematotoxicity of the drug.

    Special instructions:

    The expediency of using the drug as an antipyretic agent is decided in each case, depending on the severity, nature and tolerability of the febrile syndrome.

    Ibuprofen may mask objective signs of infectious diseases, so ibuprofen therapy in patients with infectious diseases should be administered with caution.

    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.

    At simultaneous application of anticoagulants of indirect action it is necessary to supervise parameters of a coagulating system of blood.

    It is necessary to avoid joint intake of the drug Ibuklin® with other NSAIDs.

    With prolonged (more than 5 days) drug intake, control of peripheral blood and the functional state of the liver is necessary.

    The drug may distort the results of laboratory tests in quantitative determination of glucose, uric acid in the blood serum, 17-ketosteroids (it is necessary to cancel the drug 48 hours prior to the study).
    Effect on the ability to drive transp. cf. and fur:

    During treatment, the patient should refrain from engaging in potentially dangerous activities requiring increased attention and speed of psychomotor reactions.

    Form release / dosage:Tablets are dispersible [for children] 100 mg + 125 mg.
    Packaging:For 10 tablets in a blister of PVC / A1. For 1.2 or 20 blisters packaged in a pack of cardboard along with instructions for use and a spoon for the preparation of a slurry.
    Storage conditions:

    In the dark place at a temperature of not more than 25 ° C.

    Store in inaccessible place for children!

    Shelf life:5 years. Do not use after the expiry date printed on the package.
    Terms of leave from pharmacies:On prescription
    Registration number:П N011252 / 02
    Date of registration:18.07.2011 / 02.10.2017
    The owner of the registration certificate:Dr. Reddy's Laboratories Ltd.Dr. Reddy's Laboratories Ltd. India
    Manufacturer: & nbsp
    Representation: & nbspDR REDDY'S LABORATORIS LTD. DR REDDY'S LABORATORIS LTD. India
    Information update date: & nbsp18.10.2017
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