Ibufenum

General characteristics. Structure:

Active agent - an ibuprofen of 100 mg.

Excipients: a macrogoal глицеролгидроксистеарат, xanthane gum, глицерол, Natrium benzoicum, citric acid monohydrate, phosphate sodium a dihydrate or phosphate sodium dodecahydrate, sodium saccharinate, мальтитол liquid, orange fragrance, the purified water.

Pharmacological properties:

Pharmacokinetics. At oral administration more than 80% of an ibuprofen are absorbed from digestive tract, reaching the maximum concentration in a blood plasma in 1 hour. Meal slows down absorption of an ibuprofen, but does not reduce its biological availability. At reception of an ibuprofen in the form of suspension by children in a dose of 10 mg/kg, its maximum concentration in blood makes 55 mkg/ml. The ibuprofen at reception with food is soaked up more slowly: (t max) at the same time for 30-60 minutes longer, than at reception on an empty stomach also makes 1,5-3 hours.

The ibuprofen contacts proteins of a blood plasma more than for 99%. The main proteins connecting medicine is albumine. The volume of distribution of an ibuprofen makes about 0,12 l/kg of body weight at adults, but at children with the increased body temperature 11 years it higher are younger and makes about 0,2 l/kg of body weight. High extent of linkng with proteins limits the speed of penetration of an ibuprofen into synovial and spinal liquids. Therefore the ibuprofen slowly gets into synovial fluid, keeping in it a long time therapeutic concentration. Medicine biotransformirutsya, mainly, in a liver. 70-90% of the accepted dose are removed with urine in the form of metabolites and products of their conjugation with glucuronic acid.

The rest of a dose is removed with a stake in not changed look and also in the form of metabolites. Medicine does not kumulirutsya in an organism. Elimination half-life 2 – 2,5 hours.

Pharmacodynamics. The ibuprofen is derivative propionic acid, having febrifugal, analgeziruyushchy and antiinflammatory effect. The mechanism of action of an ibuprofen is caused, first of all, by suppression of biosynthesis of prostaglandins due to decrease of the activity of cyclooxygenase (TsOG) – the enzyme regulating transformation of arachidonic acid into prostaglandins, prostacyclin and thromboxane. At the same time as a result of irreversible braking of a cyclooxygenase way of metabolism of arachidonic acid formation of prostaglandins decreases. Decrease in concentration of prostaglandins in the place of an inflammation is followed by reduction of formation of bradikinin, endogenous pyrogens, other biologically active agents, radicals of oxygen and NO. All this leads to decrease of the activity of inflammatory process (antiinflammatory effect of an ibuprofen) and is followed by reduction of painful reception (analgeziruyushchy effect). Reduction of concentration of prostaglandins in cerebrospinal liquid leads to normalization of body temperature (antipyretic effect). The effect of fall of temperature begins in 30 min. after reception, its maximum action is shown in 3 hours.

Ibufenum D - suspension has febrifugal, soothing, antiinflammatory effect. Reduces manifestation of such symptoms as: the increased body temperature, pain and hypostasis, by influence in the place of their emergence.

Indications to use:

Ibufenum D is intended for use in complex therapy for children in the following cases:

- acute respiratory viral infections;

- flu;

- quinsy (pharyngitis);

- the children's infections which are followed by fervescence;

- postvaccinal reactions;

- an ear-ache at an inflammation of a middle ear;

- dentagra, painful teething;

- headache, migraine;

- muscle, joints pains;

- musculoskeletal system injuries.

Route of administration and doses:

For oral administration.

5 ml of suspension contain 100 mg of an ibuprofen.

Before the use to shake up before receiving homogeneous suspension.

Medicine is accepted after food, with a plentiful amount of water.

For exact dosing of suspension the doser (a spoon or the syringe) is applied to a bottle.

The dose is established depending on age and the body weight of the child.

The single dose of the drug Ibufenum D makes 5 – 10 mg/kg of body weight of the child 3-4 times a day. The maximum daily dose of suspension makes 20-30 mg/kg of body weight, no more. Drug is appointed in single doses according to the scheme given below:

Babies from 3 to 6 months (5-7,6 kg): 3 times on 2,5 ml within a day (that corresponds to 150 mg of an ibuprofen / in days).

Babies from 6 to 12 months (7,7-9 kg): from 3 to 4 times on 2,5 ml within a day (that corresponds to 150 mg-200 of mg of an ibuprofen / in days).

Children from 1 year to 3 years (10-15 kg): 3 times on 5 ml within a day (that corresponds to 300 mg of an ibuprofen / in days).

Children from 4 to 6 years (16-20 kg): 3 times on 7,5 ml within a day (that corresponds to 450 mg of an ibuprofen / in days).

Children from 7 to 9 years (21-29 kg): 3 times on 10 ml within a day (that corresponds to 600 mg of an ibuprofen / in days).

Children from 10 to 12 years (30-40 kg): 3 times on 15 ml within a day (that corresponds to 900 mg of an ibuprofen / in days). Not to exceed the specified dose.

It is possible to repeat a dose each 6-8 hours, with observance of an interval at least 4 hours between the next doses.

Children up to 6 months can use medicine after consultation with the doctor according to his recommendations. It is not necessary to exceed the recommended dose.

At postvaccinal reation at children from 3rd to 6 months, on doctor's orders.

Treatment duration:

- no more than 3 days as an antipyretic;

- no more than 5 days as anesthetic.

If fever remains more than 3 days, it is necessary to consult with the doctor.

The application instruction of the doser in the form of the syringe:

1. To unscrew a cap at a bottle (to press, pressing down, and to turn counterclockwise).

2. To strongly press the doser into a bottle mouth opening.

3. It is vigorous to shake up contents of a bottle.

4. To fill the doser, the bottle needs to be turned upside down, and then to carefully move the doser piston down, to pour in contents before achievement of a desirable mark in a scale.

5. To turn a bottle in a starting position and to take from it the doser, carefully turning off it.

6. The tip of the doser to arrange in an oral cavity of the child, and then, slowly pressing the piston, to enter doser contents.

7. After use the bottle should be closed, screwing up a cover, and to wash out the doser water and to dry up.

Features of use:

At emergence of any side effects it is necessary to stop use of drug and to tell the doctor.

It is necessary to estimate estimated advantage and possible risk before to appoint to the child Ibufen D if the child: aged from 3 up to 6 months.

Before administration of drug Ibufenum D it is necessary to consult with the doctor if earlier were confirmed:

- bronchial asthma, small tortoiseshell;

- diseases of a liver and kidneys;

- a peptic ulcer of a stomach and duodenum in the anamnesis.

Drug does not contain sugar therefore it can be applied at the persons having diabetes.

Drug does not contain dyes and can be applied at children inclined to allergic reactions to dyes in the recommended dizirovka.

It is necessary to observe extra care at persons with hereditary intolerance of fructose.

Use of an ibuprofen in the first 6 months of pregnancy demands care and is allowed exclusively on doctor's orders, after assessment of presumable advantage and possible risks. Not to apply an ibuprofen in the last trimester of pregnancy.

The ibuprofen can be allocated in small amounts with breast milk. Cases of emergence of side effects in babies are not known, however, it is recommended to stop breastfeeding during treatment by an ibuprofen.

There is no information on contraindications to management of transport and service of mechanisms during administration of drug Ibufenum.

Side effects:

Usually drug is well transferred, however its use for some persons can cause side effects from a digestive tract, such as feeling of discomfort in a stomach, nausea, vomiting, abdominal pains, a loss of appetite.

Treat rare side effects:

- nonspecific allergic and anaphylactic reactions;

- the reactions from a respiratory organs which are shown a bronchospasm or suffocation, an exacerbation of asthma;

- skin reactions in the form of rashes, an itch, a small tortoiseshell, a purpura, vasculomotor hypostasis, very seldom violent dermatosis, an exudative erythema, an epidermal necrolysis;

- thrombocytopenia, anemia, leukopenia;

- digestive tract erosive cankers;

- headaches, dizziness, insomnia, excitability, irritability, drowsiness, depression, sonitus.

Interaction with other medicines:

Ibuprofen (just as other medicines groups of non-steroidal anti-inflammatory drugs) should not be used along with following medicines:

- acetylsalicylic acid, paracetamol or other non-steroidal anti-inflammatory drugs – the risk of emergence of side effects from digestive tract increases;

- anti-hypertensive medicines and diuretics – medicines from group of non-steroidal anti-inflammatory drugs can cause decrease in efficiency of action of these means;

- anticoagulants – not numerous clinical data specify that nesteroydny antiinflammatory drugs can strengthen effect of the medicines lowering coagulability of blood;

- by lithium and a methotrexate – it is proved that nesteroydny antiinflammatory drugs - can cause increase in concentration in plasma, both lithium, and a methotrexate;

- proofs of increase in a bleeding time at the patients accepting at the same time an ibuprofen and a zidovudine exist a zidovudine –.

Contraindications:

- individual hypersensitivity to any component of drug, and also to others nonsteroid antiinflammatory medicinal drugs;

- manifestations ever before allergy symptoms in the form of cold, skin rashes or bronkhospastichesky reactions after use of acetylsalicylic acid or other non-steroidal anti-inflammatory drugs;

- a peptic ulcer of a stomach and duodenum in an aggravation phase, ulcer colitis, a disease Krone;

- the expressed insufficiency of function of a liver, kidneys;

- blood diseases: hemophilia, hypocoagulation, hemorrhagic diathesis;

- III trimester of pregnancy;

- children's age up to 3 months.

Overdose:

In case of reception of the highest dose of medicine, than it is recommended, it is necessary to see a doctor or the druggist immediately.

Symptoms: strengthening of simtom of side effects, abdominal pains, nausea, vomiting, headache, sonitus, acute renal failure, bradycardia.

Treatment: there is no specific antidote, a gastric lavage and, if necessary, correction of electrolytic disturbances, alkaline drink, symptomatic therapy is applied a maintenance therapy.

Storage conditions:

To store in original packaging at a temperature from 15 °C to 25 °C. To store in the place, unavailable to children!

Issue conditions:

Without recipe

Packaging:

On 120 ml in glass bottles with the screwing-up cover with a guarantee ring and a spoon doser or on 120 ml in plastic bottles with the screwing-up cover with a guarantee ring and the shpritsom-doser. Each bottle with the instruction is placed in a cardboard box.