Ibufenum

General characteristics. Structure:

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

Excipients: RH-40 cremophore, sodium salt of the carboxylated methyl cellulose, magnesium - aluminum silicate (вээгум), sucrose, glycerin, propylene glycol, methylhydroxybenzoate, пропилгидроксибензоат, citric acid monowater, sodium hydrophosphate, orange fragrance, dye: orange yellow, sodium salt of saccharin, кросповидон, the purified water.

Pharmacological properties:

Pharmacodynamics. Ibufenum has febrifugal, soothing, antiinflammatory effect. Febrifugal action consists in blocking of cyclooxygenase 1 and 2 in the cascade of the TsNS arachidonic acid which leads to reduction of synthesis of prostaglandins, to decrease in their concentration in cerebrospinal liquid and to decrease in excitement of the center of thermal control owing to what there is a normalization body temperature.

The effect of fall of temperature at fever begins in 30 min. after reception, its maximum action is shown in 3 hours.

The leading soothing mechanism is decrease in products of prostaglandins (PG) of the classes E, F and I, biogenic amines that leads to the prevention of development of a hyperalgesia at the level of change of sensitivity of nociceptors. Analgetic action is most expressed at pains of inflammatory character.

The antiinflammatory effect is caused by oppression of activity of cyclooxygenase (TsOG). As a result of it synthesis of prostaglandins in the inflammatory centers decreases. It leads to reduction of secretion of mediators of an inflammation and decrease of the activity of an exudative and proliferative phase of inflammatory process.

As all non-steroidal anti-inflammatory drugs the ibuprofen shows antiagregantny activity.

Febrifugal and soothing action is shown earlier and in smaller doses, than antiinflammatory action which comes for 5 - 7 day of treatment.

Pharmacokinetics. After oral administration more than 80% of an ibuprofen are soaked up from a digestive tract, the maximum concentration in a blood plasma is reached in 1 hour.

90% of drug contact proteins of a blood plasma (generally with albumine).

Ibufenum slowly gets into joint cavities.

The period of achievement of the maximum concentration in a blood plasma (TCmax) at reception on an empty stomach – 45 min., at reception after food – 1,5-2,5 hours; in synovial fluid – 2-3 h where big concentration, than in a blood plasma are created.

Drug does not kumulirut in an organism. Ibufenum has two-phase kinetics of elimination with an elimination half-life (T½) of 2-2,5 h.

The ibuprofen, mainly, in a liver is metabolized. Is exposed to presistemny and post-system metabolism. After absorption about 60% pharmacological of inactive R – a form of an ibuprofen are slowly transformed to active S – a form.

60-90% of drug are removed by kidneys in the form of metabolites and products of their connection with glucuronic acid, to a lesser extent, with bile and in an invariable look no more than 1% are allocated. After reception of a single dose drug is completely removed within 24 hours.

Indications to use:

Ibufenum — suspension, is applied at children from 1 to 12 years. It is appointed for decrease in temperature and pain relief. 

As an antipyretic at:

• catarrhal diseases
• acute respiratory viral infections, flu
• quinsy (pharyngitis)
• the children's infections which are followed by fervescence
• postvaccinal reactions;

As anesthetic at:

• dentagra, painful teething
• headache, migraine, neuralgia, muscle, joints pain, at injuries and burns

Route of administration and doses:

Ibufenum is accepted inside, after food. 5 ml of suspension contain 100 mg of an ibuprofen. Before the use to shake up before receiving homogeneous suspension.

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

Age (body weight)	Single dose	Frequency rate of reception	Maximum daily dose
6-12 months (7-9 kg)	2,5 ml (50 mg)	3 times	7,5 ml (150 mg)
1-3 years (10-15 kg)	2,5 ml (50 mg)	3-4 times	7,5-10 ml (150-200 mg)
3-6 years (16-20 kg)	5 ml (100 mg)	3 times	15 ml (300 mg)
6-9 years (21-30 kg)	5 ml (100 mg)	4 times	20 ml (400 mg)
9-12 years (31-41 kg)	10 ml (200 mg)	3 times	30 ml (600 mg)
12 years (more than 41 kg) are more senior	10 ml (200 mg)	4 times	40 ml (800 mg)
It is possible to repeat a dose each 6-8 hour. Not to exceed the maximum daily dose.

 The febrifugal effect of Ibufenum develops in 30 minutes after reception and proceeds within 6-8 hours. In the absence of febrifugal effect within 2 days and analgesic effect within 3 days it is necessary to see a doctor. To children from 6 months to 1 year drug is appointed according to the recommendation of the doctor.

Features of use:

During long-term use, non-steroidal anti-inflammatory drugs can cause injury of a mucous membrane of a stomach, round ulcers and bleeding from a digestive tract.

To take at with caution — cirrhosis with portal hypertensia; a liver and/or renal failure, heart failure, a nephrotic syndrome, a hyperbilirubinemia, a peptic ulcer of a stomach and duodenum (in the anamnesis), gastritis, enteritis, colitis, diseases of blood of not clear etiology (a leukopenia and anemia), pregnancy (the II-III trimester), in the lactation period. At patients with bronchial asthma or other diseases proceeding with a bronchospasm, the ibuprofen can increase risk of manifestation of a bronchospasm. Use of drug for these patients is admissible only on condition of respect for big care, and in case of breath difficulties, it is necessary to see a doctor immediately.

During prolonged treatment of NPVP control of a picture of peripheral blood and a functional condition of a liver and kidneys is necessary. At emergence of symptoms of a gastropathy the careful control including carrying out an ezofagogastroduodenoskopiya, blood test with definition of N, hematocrit, the analysis a calla on the occult blood is shown.

Side effects:

From the alimentary system — nausea, vomiting, a loss of appetite, heartburn, pains in a stomach, a diarrhea, a lock, a meteorism, an abnormal liver function, round ulcers, hemorrhages from a GIT.

Allergic reactions — an itch, rash, a bronkhospastichesky syndrome, allergic rhinitis, a Quincke's edema, Stephen-Johnson's syndrome, a Lyell's disease.

From TsNS — a headache, dizziness, a sleep disorder, uneasiness, drowsiness, depressions, excitement, a vision disorder (a reversible toxic amblyopia, not clear sight or doubling).

From an urinary system — an acute renal failure, allergic nephrite, a nephrotic syndrome (hypostases), a polyuria, cystitis.

From bodies of a hemopoiesis — anemia, thrombocytopenia, an agranulocytosis, a leukopenia. From warmly vascular system: heart failure, tachycardia, increase in the ABP.

As Ibufenum contains sugar, it is necessary to apply with care it to patients with a diabetes mellitus.

In cases of emergence any of the listed side effects it is necessary to stop administration of drug and to consult with the doctor.

Interaction with other medicines:

It is not necessary to apply the Ibuprofen along with other non-steroidal anti-inflammatory drugs (for example, acetylsalicylic acid reduces antiinflammatory action of an ibuprofen and strengthens side effect).

It is necessary to avoid, whenever possible, co-administration of an ibuprofen and diuretics, in view of, on the one hand, easing of diuretic effect and, with another, risk of development of a renal failure.

The ibuprofen weakens action of antihypertensives (angiotensin convertase inhibitors, (3-adrenergic means, tiazid). Brakes hypotensive effect of APF inhibitors, at the same time reducing their allocation by kidneys. The ibuprofen strengthens effect of peroral hypoglycemic means (especially derivative sulphonylurea) and insulin.

Inductors of a microsomal oxidation Phenytoinum, ethanol, barbiturates, зиксорин, rifampicin, phenylbutazone, tricyclic (antidepressants) increase products of hydroxylated active metabolites, increasing risk of development of heavy hepatotoxic reactions.

Inhibitors of a microsomal oxidation — reduce risk of a hepatotoxic action.

Strengthens effect of indirect anticoagulants, antiagregant, fibrinolitik (increase in risk of emergence of hemorrhagic complications). Increases concentration in digoxin blood.

Strengthens toxic action of a methotrexate and drugs of lithium.

Caffeine strengthens analgeziruyushchy effect.

Contraindications:

Individual hypersensitivity to an ibuprofen or other non-steroidal anti-inflammatory drugs (including, acetylsalicylic acid), and also to auxiliary components of drug;
Peptic ulcer of a stomach or duodenum.

The expressed insufficiency of function of a liver, kidneys, cardiovascular system; arterial hypertension.

Hemophilia, hypocoagulation, hemorrhagic diathesis, deficit glyukozo-6-fosfatdegidrogenazy.

Bronkhospastichesky reactions after use of acetylsalicylic acid or other non-steroidal anti-inflammatory drugs (so. наз. "aspirinovy asthma").

Quincke's edema. Nose polyps. Decrease in hearing.

Children's age till 6th month of life (the body weight is lower than 7 kg).

Overdose:

Symptoms: abdominal pains, nausea, vomiting, block, headache, sonitus, depression, drowsiness, metabolic acidosis, coma, hemorrhagic diathesis, lowering of arterial pressure, spasms, apnoea, acute renal failure, abnormal liver functions, tachycardia, bradycardia, fibrillation of auricles. Children up to 5 years are especially inclined to an apnoea, a coma and spasms. The serious effects connected with toxic effect of drug are shown usually after reception of the dose exceeding 400 mg/kg of body weight (i.e. 80 recommended single doses).

In case of suspicion of overdose it is necessary to see a doctor immediately.

Treatment: gastric lavage, absorbent carbon, alkaline drink, symptomatic therapy (correction of BRAIDS, ABP).

Storage conditions:

To store at a temperature from 15 °C to 25 °C, in the place, unavailable to children. Not to apply after the expiry date specified on packaging. A period of validity - 3 years

Issue conditions:

Without recipe

Packaging:

Suspension on 100 g in glass orange bottles. Each bottle is placed together with the application instruction and a measured spoon in individual cardboard boxes.