Ibufenum

Ibufenum – non-steroidal anti-inflammatory drug (NPVS).

Form of release and structure

Dosage form – suspension for intake: orange color, with an orange smell, division into a liquid layer and a deposit (after agitation they mix up and make homogeneous suspension) is possible (on 100 g in dark glass bottles, in a cardboard pack 1 bottle complete with a measured spoon; on 100 g in plastic bottles, in a cardboard pack 1 bottle complete with the dosing syringe).

Active ingredient: an ibuprofen, in 5 ml of suspension – 100 mg.

Additional substances: a macrogoal глицерилгидроксистеарат, methylparahydroxybenzoate, phosphate sodium a dihydrate, глицерол, sucrose, a karmelloza of sodium, sodium saccharinate, пропилпарагидроксибензоат, aluminum magnesium silicate (вээгум), кросповидон, propylene glycol, citric acid monohydrate, dye a sunset yellow (E110), fragrance orange, the water purified.

Indications to use

Ibufenum is applied to treatment of children.

As an antipyretic:

• Catarrhal diseases;
• Acute respiratory viral infections, including flu;
• Quinsy (tonsillitis);
• Children's infectious diseases;
• Postvaccinal reactions.

As anesthetic at a pain syndrome of various origin of weak and moderate intensity:

• Painful teething, dentagra;
• Headache, migraine;
• Ear-ache at an inflammation of a middle ear;
• Muscle and joints pain owing to musculoskeletal system injuries;
• Neuralgia.

Drug is intended for symptomatic therapy, it reduces pain and an inflammation during its use, does not render on progressing of a disease of influence.

Contraindications

Absolute:

• Full or incomplete combination of bronchial asthma, the nose recuring a polypose and okolonosovy bosoms with intolerance of acetylsalicylic acid or other NPVS (in the anamnesis including);
• Active disease of a liver, heavy liver failure;
• The progressing diseases of kidneys, heavy renal failure (clearance of creatinine less than 30 ml/minute);
• Inflammatory diseases of intestines;
• Erosive and ulcer diseases of bodies of digestive tract (including a peptic ulcer of a stomach and a 12-tiperstny gut in an aggravation phase, a round ulcer, ulcer colitis, a disease Krone);
• Glyukozo-galaktozny malabsorption, intolerance of fructose;
• Deficit of invertase/isomaltase;
• The confirmed hyperpotassemia;
• Blood coagulation disturbances (including tendency to bleedings, lengthening of a bleeding time, hemophilia, hemorrhagic diathesis);
• Children's age up to 3 months;
• Hypersensitivity to drug components, acetylsalicylic acid or other NPVS.

Relative (at the following diseases / states treatment of Ibufenum should be carried out with extra care in connection with risk of development of complications):

• Diabetes mellitus;
• Peptic ulcer of a stomach and 12-tiperstny gut in the anamnesis;
• Existence of an infection of Helicobacter pylori;
• Enteritis;
• Gastritis;
• Colitis;
• Liver and/or renal failure;
• Cirrhosis with portal hypertensia;
• Nephrotic syndrome;
• Heavy somatopathies;
• Diseases of blood of not clear etiology (leukopenia and anemia);
• Hyperbilirubinemia;
• Arterial hypertension, chronic heart failure;
• Children's age of 3-6 months;
• Prolonged use of NPVS;
• Simultaneous use of peroral glucocorticosteroids (including Prednisolonum), antiagregant (including klopidogret), anticoagulants (including warfarin).

Route of administration and dosage

Ibufenum should be accepted inside, after food. Just before reception the bottle should be shaken up. For exact dosing in a set the measured spoon or the syringe is applied.

The single dose makes 5-10 mg on each kilogram of body weight. Frequency rate of reception – to 4 times in bucketed days 6-8 hours. The most admissible daily dose – 20-30 mg/kg.

The recommended dosing modes depending on age and the child's weight:

• 6-12 months (body weight of 7,7-9 kg): on 2,5 ml 3 times a day;
• 1-3 years (10-15 kg): on 2,5 ml 3-4 times a day;
• 4-6 years (16-20 kg): on 5 ml 3 times a day;
• 7-9 years (21-29 kg): on 5 ml 4 times a day;
• 10-12 years (30-41 kg): on 10 ml 3 times a day.

Children aged from 3 up to 6 months Ibufenum can give only to destination the attending physician. The daily dose for them should not exceed 5 ml of suspension. At postvaccinal reactions appoint 2,5 ml, in 6 hours – 2,5 more ml.

Duration of use of drug depending on indications: decrease in the increased body temperature – up to 3 days, stopping of a pain syndrome – no more than 5 days.

Use of Ibufenum complete with the measured syringe:

• To open a bottle: to press a cap, pressing down and to turn counterclockwise;
• To insert the syringe into a bottle mouth opening;
• It is vigorous to shake up a bottle;
• To turn a bottle upside down and, carefully moving the syringe piston down, to pour in contents before achievement of a necessary mark in a scale;
• To turn a bottle in a starting position and accurately rotating movements to take the doser;
• To arrange the syringe in an oral cavity of the child and, slowly pressing the piston, to enter suspension;
• To close a bottle a cap, to wash out the doser clear water and to dry up.

Side effects

• From respiratory system: asthma, bronchospasm;
• From bodies of a hemopoiesis: agranulocytosis, Werlhof's disease, leukopenia, thrombocytopenia, anemia (including aplastic and hemolitic);
• From the alimentary system: aphthous stomatitis, dryness of a mucous membrane of an oral cavity, an ulceration of a mucous membrane of gums and digestive tract (sometimes is complicated by perforation and bleeding), the NPVS-gastropathy (a loss of appetite, a meteorism, diarrhea, an abdominal pain, pain and discomfort in epigastric area, heartburn, nausea, vomiting), a lock, pancreatitis, hepatitis;
• From cardiovascular system: increase in arterial pressure, tachycardia, development or aggravation of heart failure;
• From a nervous system: drowsiness, sleep disorder, psychomotor arousing, depression, irritability, uneasiness, confusion of consciousness, dizziness, hallucinations, headache; seldom – aseptic meningitis (is more often at patients with autoimmune diseases);
• From an urinary system: allergic nephrite, cystitis, polyuria, nephrotic syndrome (hypostases), acute renal failure;
• From sense bodys: dryness and irritation of eyes, disturbance of color sight, amblyopia, scotoma, illegibility of sight or diplopia, chemosis and century (allergic genesis), reversible toxic optic neuritis, ring or sonitus, decrease in hearing;
• Allergic reactions: skin rash (erythematic or small tortoiseshell), skin itch, fever, bronchospasm, anaphylactoid reactions, Quincke's disease, acute anaphylaxis, allergic rhinitis, eosinophilia, toxic epidermal necrolysis, mnogoformny exudative erythema;
• Others: sweating strengthening.

Special instructions

At prolonged use of Ibufenum it is necessary to control a pattern of peripheral blood, a functional condition of kidneys and a liver.

At bronchial asthma or other diseases which can be followed by a bronchospasm the ibuprofen can cause development of a bronchospasm. For this reason at these patients drug has to be used only with respect for big care. In case of difficulty of breath it is necessary to see a doctor urgently.

For the prevention of development of the NPVS-gastropathy Ibufenum is recommended to be combined with prostaglandin E drugs (for example, mizoprostoly). At emergence of symptoms of a disease the careful control of a condition of the patient including the analysis a calla on the occult blood, blood test with definition of hemoglobin and a hematocrit, carrying out an ezofagogastroduodenoskopiya is necessary.

For decrease in risk of development of side effects from digestive tract Ibufenum should be accepted in a minimal effective dose during minimum possible short period.

Patients who are directed to a research on definition of 17 ketosteroids in 48 hours should cancel an ibuprofen.

During treatment it is recommended to avoid administration of drugs, containing ethanol, and also performance of the tasks requiring special attention and speed of reactions.

Sick diabetes mellitus it is necessary to consider that 1 ml of suspension contains about 0,34 g of sucrose or about 0,03 HE. Thus, the minimum single dose of Ibufenum (2,5 ml) contains 0,85 g of sucrose (0,075 XE), in the maximum single dose (15 ml) – 5,13 g of sucrose (0,45 XE).

Medicinal interaction

• Other NPVS (including acetylsalicylic acid): antiinflammatory action of an ibuprofen decreases, side effects amplify (such combination is contraindicated);
• Diuretics: their action is weakened, the risk of development of a renal failure increases (such combination is recommended to be avoided whenever possible);
• Vazodilatatora (including inhibitors of an angiotensin-converting enzyme): their hypotensive activity decreases;
• Peroral hypoglycemic means (especially derivative sulphonylurea) and insulin: their effect amplifies;
• Inductors of a microsomal oxidation (phenylbutazone, rifampicin, Phenytoinum, tricyclic antidepressants, barbiturates, ethanol): the risk of development of heavy hepatotoxic reactions increases;
• Colestyraminum, antiacid means: absorption of an ibuprofen decreases;
• Valproic acid, цефоперазон, пликамицин, цефамандол, цефотетан: frequency of development of a prothrombinopenia increases;
• Gold drugs, cyclosporines: nephrotoxicity of an ibuprofen increases;
• Means with myelotoxic action: manifestations of a gematotoksichnost of an ibuprofen amplify;
• Cyclosporine: its plasma concentration and probability of development of hepatotoxic effects increases;
• The drugs blocking canalicular secretion: removal decreases and plasma concentration of an ibuprofen increases;
• Antiagreganta, indirect anticoagulants, fibrinolitik: their action amplifies, the risk of development of hemorrhagic complications increases;
• Caffeine: the analgeziruyushchy effect of an ibuprofen amplifies;
• Digoxin, methotrexate, lithium drugs: their concentration in blood increases.

Terms and storage conditions

To store at a temperature up to 25 ºС in the place protected from light unavailable to children.

Period of validity – 3 years, after the first opening of a bottle – 6 months.