Ibuclin Junior, dispersible pills 100 mg +125 mg 20 pcs.

Composition

Each dispersible tablet [for children] contains:active ingredients:ibuprofen 100 mg, paracetamol 125 mgsupport substances:microcrystalline cellulose 20 mg, corn starch 59.04 mg, lactose 5 mg, sodium carboxymethyl starch (Type A) 30 mg, red dye (Ponceau 4R) (E 124) 0.2 mg, glycerol 2 mg, colloidal silicon dioxide 5 mg, orange flavor DC 100 PH* 1.6 mg, pineapple flavor DC 106 PH** 2.5 mg, peppermint leaf oil 0.66 mg, aspartame 10 mg magnesium stearate 1 mg, talc 3 mg. * Composition of orange flavor DC 100 PH: gum arabic 81-86%; aromatic additive 13-18%; butylhydroxyanisole less than 0.01%. ** The flavor of pineapple DC 106 PH: lactose 52-57%; gum Arabic 31-36%; aromatic additive, natural identical 4-9%; propylene glycol, less than 2%; aromatic additive faux less than 2%;aromatic natural Supplement for less than 2%; aromatic addition of less than 0.1%.

Pharmacological action

Pharmacodynamically the drug, which is due to its constituent components. Ibuprofen is a nonsteroidal anti-inflammatory drug (NSAID) that has analgesic, anti-inflammatory, and antipyretic effects. Inhibiting cyclooxygenase (COX) 1 and 2, disrupts the metabolism of arachidonic acid, reduces the amount of prostaglandins (mediators of pain, inflammation and hyperthermic reaction) both in the focus of inflammation and in healthy tissues, it suppresses the exudative and proliferative phases of inflammation. Paracetamol indiscriminately blocks COX, mainly in the central nervous system, has little effect on water-salt metabolism and the mucous membrane of the gastrointestinal tract (GIT). It has analgesic and antipyretic effects. 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 individual components. Pharmacokinetics of Ibuprofen. Absorption – high, quickly and almost completely absorbed from the gastrointestinal tract (GIT). The time to reach the maximum concentration (TCmax) after oral administration is about 1-2 hours. The relationship with plasma proteins is more than 90%. The half-life (T1 / 2) is about 2 hours. It slowly penetrates the joint cavity, accumulates in the synovial fluid, creating higher concentrations in it than in the blood plasma. After absorption, about 60% of the pharmacologically inactive R-form is slowly transformed into the active S-form. It is metabolized. More than 90% is excreted by the kidneys (no more than 1% unchanged) and, to a lesser extent, with bile in the form of metabolites and their conjugates. Paracetamol. Absorption is high, plasma protein binding is less than 10% and increases slightly with overdose. The sulfate and glucuronide metabolites do not bind to plasma proteins even in relatively high concentrations. The value of Cmax is 5-20 mcg / ml, TCmax is 0.5-2 hours. It is fairly evenly distributed in the body’s liquid media. Penetrates the blood-brain barrier. About 90-95% of paracetamol is metabolized in the liver to form inactive conjugates with glucuronic acid (60%), taurine (35%) and cysteine (3%), as well as small amounts of hydroxylated and deacetylated metabolites. A small portion of the drug is hydroxylated by microsomal enzymes to form the highly active N-acetyl-n-benzoquinonimine, which binds to the sulfhydryl groups of glutathione. When glutathione reserves in the liver are depleted (in case of overdose), the 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% – unchanged). Less than 1% of the taken dose of paracetamol passes into breast milk. In children, the ability to form conjugates with glucuronic acid is lower than in adults.

Indications

Febrile syndrome. Pain syndrome of mild or moderate intensity of various etiologies: toothache, sprain pain, dislocations, fractures. As an auxiliary drug for the treatment of pain and fever syndrome in sinusitis, tonsillitis, acute infectious and inflammatory diseases of the upper respiratory tract (pharyngitis, tracheitis, laryngitis).

Use during pregnancy and lactation

Ibuclin Junior is not recommended for children under 3 years of age,

pregnant women and during lactation.

Contraindications

Increased individual sensitivity to the components of the drug (including other NSAIDs), stomach and duodenal ulcer in the acute phase, complete or incomplete combination of bronchial asthma, recurrent nasal and paranasal sinus polyposis and intolerance to acetylsalicylic acid or other NSAIDs (including in the anamnesis), severe renal failure (creatinine clearance less than 30 ml/min), optic nerve damage, genetic lack of glucose 6-diseases of the blood system, the period after coronary artery bypass grafting, progressive kidney diseases, severe liver failure or active liver disease, confirmed hyperkalemia, active gastrointestinal bleeding, inflammatory bowel diseases, children (up to 3 years).

Side effects

In therapeutic doses, the drug is usually well tolerated. From the digestive system: rarely dyspeptic phenomena, with prolonged use in high doses, hepatotoxic effect. From the hematopoietic system: rarely thrombocytopenia, leukopenia, pancytopenia, neutropenia, agranulocytosis. Allergic reactions: rarely skin rash, pruritus, urticaria. If side effects occur, you should stop taking the drug and consult a doctor.

Interaction

With the simultaneous use of the drug Ibuclin with drugs, various interaction effects may develop.

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

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

Ibuprofen enhances the effect of direct (heparin) and indirect (coumarin and indandione derivatives) anticoagulants, thrombolytic agents (alteplase, anistreplase, streptokinase, urokinase), antiplatelet agents, colchicine – increases the risk of hemorrhagic complications.

Increases the hypoglycemic effect of insulin and oral hypoglycemic drugs.

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

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

Caffeine enhances the analgesic effect of ibuprofen.

Cyclosporine and gold preparations increase nephrotoxicity.

Cefamandol, cefoperazone, cefotetan, valproic acid, and plicamycin increase the incidence of hypoprothrombinemia.

Antacids and colestyramine reduce the absorption of the drug.

Myelotoxic drugs contribute to the manifestation of hematotoxicity of the drug.

How to take, course of administration and dosage

The drug is taken orally. Before use, the Ibuclin Junior ® tablet should be dissolved in 5 ml (1 teaspoon) of water. The daily dose of the drug is taken in 2-3 doses. The minimum time interval between taking the drug is 4 hours. Children over 3 years old. 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 impaired renal or hepatic function, the interval between doses of the drug should be at least 8 hours. The drug should not be taken for more than 5 days as an analgesic and more than 3 days as an antipyretic without the supervision of a doctor.

Overdose

Symptoms:

gastrointestinal disorders (abdominal pain, diarrhea, nausea, vomiting, anorexia, epigastric pain), increased prothrombin time, bleeding after 12-48 h, lethargy, drowsiness, depression, headache, tinnitus, disturbance of consciousness, cardiac arrhythmias, lowering blood pressure, manifestations of hepato – and nephrotoxicity, seizures may develop hepatonecrosis.

Treatment:

gastric lavage during the first 4 hours; alkaline drinking, forced diuresis; activated charcoal inside, administration of SH-group donors and glutathione – methionine synthesis precursors 8-9 hours after overdose and N-acetylcysteine inside or intravenously after 12 hours, antacids; hemodialysis; symptomatic therapy.

The need for additional therapeutic measures (further administration of methionine, intravenous administration of N-acetylcysteine) is determined depending on the concentration of paracetamol in the blood, as well as on the time elapsed after taking it.

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 can mask the objective signs of infectious diseases, so ibuprofen therapy in patients with infectious diseases should be prescribed with caution. To reduce the risk of gastrointestinal adverse events, the minimum effective dose should be used in the shortest possible course. With the simultaneous use of indirect anticoagulants, it is necessary to monitor the parameters of the blood coagulation system. If the drug is taken for a long time (more than 5 days), it is necessary to monitor peripheral blood and the functional state of the liver.The drug may distort the results of laboratory tests in the quantitative determination of glucose, uric acid in blood serum,17-ketosteroids (it is necessary to cancel the drug 48 hours before the study).

Form of production

Pills.

Storage conditions

Store in a dry place, protected from light, at a temperature not exceeding 25 °C

Shelf life

5 years

Active ingredient

: Ibuprofen, Paracetamol

Conditions of release from pharmacies

By prescription

Dosage form

tablets for resorption

Purpose

Children over 3 years of age, Children as prescribed by a doctor

Indications

Bruises, Flu, SARS, Painful Menstruation, Toothache, Joint Pain, Neuralgia, Headache, Sprains and Sprains, Myalgia, Colds, Fever

Weight

Weight: 19 gr.