Ибуфен®Д forte

General characteristics. Structure:

Active agent: ibuprofen of 200 mg / 5 ml.

Pharmacological properties:

Ibuprofen — derivative propionic acid. Has anesthetic, febrifugal and antiinflammatory effect.
The mechanism of action of an ibuprofen is caused, first of all, by oppression of biosynthesis of prostaglandins due to decrease of the activity of 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). Decrease in concentration of prostaglandins in cerebrospinal liquid leads to normalization of body temperature (febrifugal effect).
The effect of decrease in body temperature begins in 30 min. after drug use, and its maximum action is shown in 3 h.
Febrifugal and soothing action is shown earlier and in lower doses, than antiinflammatory.
Soft gelatin capsules Ibufenum the Junior contain an ibuprofen in the liquid state. The gelatin capsule provides high precision of dosing of the substances which are contained in them. The cover of the capsule provides protection of active ingredient against light, air and moisture, and also masks unpleasant taste and a smell of drug at reception. The capsule is dissolved in a GIT quicker, than the dragee and tablets, and its liquid contents is quicker and easier absorbed in a human body, providing high bioavailability of an ibuprofen.
After oral administration more than 80% of an ibuprofen are soaked up in a digestive tract. 90% of drug contact proteins of a blood plasma (generally with albumine).
The period of achievement of Cmax in a blood plasma at reception on an empty stomach makes 45 min., at reception after food — 1,5–2,5 h; in synovial fluid — 2–3 h where higher concentration, than in a blood plasma are reached.
Drug does not kumulirut in an organism.
The ibuprofen mainly in a liver is metabolized. Is exposed to presistemny and post-system metabolism. After absorption about 60% pharmacological of an inactive R-form of an ibuprofen are slowly transformed to an active S-form.
60–90% of drug are allocated with kidneys in the form of metabolites and products of their linkng with glucuronic acid, to a lesser extent — with bile, and in not changed look no more than 1% are allocated. T½ makes about 2 h, patients with diseases of a liver and kidneys have 1,8–3,5 h. After reception of a single dose drug is completely removed during 24 h.

Indications to use:

Symptomatic treatment of fever and pain of various origin (including fever after immunization, a SARS, flu, pain at a teething, pain after an odontectomy and other types of pain, including inflammatory genesis).
Ibufenum is Forte not intended for a symptomatic treatment of fever after immunization.

Route of administration and doses:

Ibufenum Forte
When determining a dose of an ibuprofen consider the body weight and age of the patient.
The ibuprofen dose, as a rule, makes 5–10 mg/kg of body weight. The maximum daily dose — 30 mg/kg of body weight.
For exact dosing in packaging the measured cap is applied.
Before suspension use the bottle needs to be shaken up.
The following doses should be accepted not earlier than in 6 h after the previous reception.
It is impossible to exceed the maximum daily dose.

Body weight (age of the patient)	Single dose	Maskimalny daily dose
10–15 kg (1–3 years)	2,5 ml (there correspond 100 mg of an ibuprofen)	7,5 ml (there correspond 300 mg of an ibuprofen)
16–19 kg (4–6 years)	4 ml (there correspond 160 mg of an ibuprofen)	12 ml (there correspond 480 mg of an ibuprofen)
20–19 kg (7–9 years)	5 ml (there correspond 200 mg of an ibuprofen)	15 ml (there correspond 600 mg of an ibuprofen)
30–39 kg (10–12 years)	7,5 ml (there correspond 300 mg of an ibuprofen)	22,5 ml (there correspond 900 mg of an ibuprofen)
> 40 kg (12 years and adults are more senior)	5–10 ml (there correspond 200–400 mg of an ibuprofen)	30 ml (there correspond 1200 mg of an ibuprofen)

Without consultation of the doctor it is impossible to apply suspension more than 3 days.
If symptoms remain or amplify or appear new, the patient should see a doctor.

Features of use:

Before an initiation of treatment it is necessary to consult with the doctor.
It is necessary to be careful to patients with:

• system lupus erythematosus and general diseases of connecting fabric;
• gastrointestinal diseases, chronic inflammatory diseases of intestines (ulcer colitis, Lesnevsky's disease — Krone);
• renal failure;
• abnormal liver function;
• inborn disturbance of metabolism of porphyrine;
• AG and/or heart failure;
• directly after operations.
Use of drug in a minimal effective dose in the shortest possible time reduces risk of development of side effects (see Influence on a GIT and cardiovascular system).
At patients of advanced age the risk of emergence of side effects as a result of reception of medicine is higher, than at young patients.
At persons with OH and other allergic diseases, active or in the anamnesis, use of drug can cause a bronchospasm.
There is a risk of developing of bleeding from a GIT, an ulcer or perforation with a lethal outcome. In case of bleeding from a GIT or an ulcer it is necessary to stop medicine reception immediately. Patients with gastrointestinal diseases in the anamnesis, especially elderly people, it is necessary to inform on need to stop treatment and to see behind consultation a doctor at emergence of any unusual symptoms from a GIT (in particular bleedings). At emergence of symptoms of a gastropathy the careful control including carrying out an ezofagogastroduodenoskopiya, the general blood test (hemoglobin definition), the analysis a calla on the occult blood is shown.
In need of definition of 17 ketosteroids drug should be cancelled for 48 h prior to a research.
It is necessary to consider carrying out a combination therapy protective drugs, for example mizoprostoly or inhibitors of a proton pomp, especially at the patients needing prolonged use of acetylsalicylic acid in low doses or other medicines which can cause side effects from a GIT.
At prolonged use of anesthetics in high doses there can be a headache which it is impossible to treat by increase in a dose of drug.
With care it is necessary to use drug at patients who accept at the same time other medicines increasing risk of disturbances from a GIT or bleeding, for example GKS and antitrombotichesky drugs, such as warfarin or antiagregant, such as acetylsalicylic acid.
Reception of an ibuprofen, especially in high doses (2400 mg/days) for a long time, can cause slight increase of risk of an embolism of arteries (for example a heart attack or a stroke). In general, epidemiological researches do not show that use of an ibuprofen in low doses (for example ≤1200 mg/days) is connected with increase in risk of a heart attack.
Simultaneous prolonged use of various analgeziruyushchy medicines can lead to damage of kidneys and a renal failure (a post-analgetic nephropathy).
Heavy skin reactions, including with a lethal outcome, including exfoliative dermatitis, Stephens's syndrome — Johnson and a toxic epidermal necrolysis, in connection with use of medicines of the NPVP group were noted extremely seldom. The highest risk of heavy reactions arises at the beginning of therapy, in most cases in the 1st month of use of drug. At emergence of the first symptoms of skin rash, injury of a mucous membrane or other symptoms of hypersensitivity administration of drug should be stopped.
It is proved that medicines which brake TsOG (synthesis of prostaglandins) can cause disturbance of reproductive function in women, influencing an ovulation. Such action has temporality and stops after completion of therapy.
At use of an ibuprofen noted separate cases of a toxic amblyopia therefore it is necessary to inform the doctor on any vision disorder.
Drug contains Natrium benzoicum therefore with extra care patients should appoint with hypersensitivity, especially to children with atopic changes, OH.
Drug does not contain sugar therefore it can be applied at persons with a diabetes mellitus.
Patients cannot appoint drug with rare hereditary intolerance of fructose.
Use during pregnancy and feeding by a breast. Inhibitors of synthesis of prostaglandins can negatively influence the course of pregnancy and/or development of an embryo/fruit. Data of epidemiological researches indicate increase in risk of abortion, and also development of heart diseases after use of inhibitors of synthesis of prostaglandin on early durations of gestation. The risk as it is considered, increases at increase in a dose and duration of treatment.
In the I-II trimester of pregnancy the ibuprofen should be applied only when, according to the doctor, the advantage for mother considerably exceeds potential risk for a fruit. If to apply an ibuprofen at women in attempts of fertilization or in I and II trimesters of pregnancy, the dose has to be as low as possible, and treatment duration — as it is possible well.
The ibuprofen is contraindicated in the III trimester of pregnancy.
The ibuprofen and its metabolites can get in low concentration into breast milk. It is still unknown of harmful effects on children of chest age therefore, as a rule, at short-term treatment of pain and fever drug in the recommended doses there is no need to stop feeding by a breast.

Ibufenum Forte. In this dosage form drug is intended for use for children aged from 1 year (with body weight> 10 kg). Do not apply to treatment of fever after immunization.

Ability to influence speed of response at control of vehicles or work with other mechanisms. At short-term use Ibufenum Fort/Ibufenum the Junior do not influence or slightly influence ability to control of vehicles and work with mechanisms, but at long reception there can be such side effects as increased fatigue and dizziness.

Side effects:

Usually drug is well transferred, however its use for some persons can cause side reactions.
At use of drug within 2–3 days of side reactions practically do not note. In case of prolonged use emergence of stated below side reactions is possible.
Side effects are distributed on emergence frequency: very often (≥1/10); often (≥1/100, <1/10); infrequently (≥1/1000, <1/100); seldom (≥1/10 000, <1/1000); very seldom (<1/10 000).
General disturbances: infrequently — hypersensitivity in the form of urticaria and an itch, increase in sweating; very seldom — heavy hypersensitivity reactions with a face edema, language and a throat, short wind, tachycardia, decrease in the ABP, anaphylactoid reactions (an anaphylaxis, a Quincke's edema up to shock); aggravation OH and bronchospasm or диспноэ, allergic rhinitis, eosinophilia.
From sense bodys: seldom — a hearing disorder (decrease in hearing, a ring or a sonitus); infrequently — a vision disorder (toxic damage of an optic nerve, an illegibility of sight or doubling, scotoma, dryness and irritation of eyes, a chemosis and a century of allergic genesis).
From the alimentary system: often — diarrhea (because of existence in drug of a maltitol and a glitserol); infrequently — dyspepsia, an abdominal pain, nausea; seldom — swelling, locks, vomiting, gastritis; very seldom — a degtepodobny chair, vomiting with blood impurity, a stomacace, an exacerbation of colitis and disease Krone. The aggravation of a peptic ulcer of a stomach and/or duodenum with bleeding or without, sometimes with a lethal outcome, especially at elderly people, and also perforation is possible.
From a nervous system: infrequently — a headache; seldom — dizziness, sleeplessness, excitability, irritability and feeling of fatigue; in some cases — a depression, psychotic reactions and a sonitus.
From kidneys and urinary tract: seldom — hypostases; very seldom — reduction of excretion of urea, OPN, increase in concentration of sodium in a blood plasma (a sodium delay), allergic nephrite, a glomerulonephritis, an oliguria, cystitis, a hamaturia; папиллонекроз, especially at prolonged use; increase in level of urea in a blood plasma.
From a liver and biliary tract: very seldom — an abnormal liver function, especially at prolonged use; hepatitis, pancreatitis, duodenitis, esophagitis.
From blood and lymphatic system: very seldom — anemia, a leukopenia, thrombocytopenia, a pancytopenia, an agranulocytosis. The first symptoms are fever, a pharyngalgia, a superficial ulcer of a mucous membrane of an oral cavity, grippopodobny symptoms, fatigue, bleeding (for example bruises, dot hemorrhages, a purpura, nasal bleeding).
From skin: very seldom — a polymorphic erythema, Stephens's syndrome — Johnson, a toxic epidermal necrolysis (Lyell's disease).
From immune system: infrequently at patients with the existing autoimmune diseases (a system lupus erythematosus, general diseases of connecting fabric) at treatment of an ibuprofen noted separate cases of development of the symptoms arising at aseptic meningitis such as stiff neck, headache, nausea, vomiting, high temperature of a body, disorientation. Allergic reactions in the form of an enanthesis, an itch, an attack OH, decrease in the ABP.
From cardiovascular system: very seldom — heart failure, tachycardia, increase in the ABP. There are data that reception of an ibuprofen, especially for a long time in high doses, can be connected with increase in risk of developing of a thrombembolia of arteries.

Interaction with other medicines:

The ibuprofen (as well as other medicines of the NPVP group) should not be applied at the same time with the following medicines:

• acetylsalicylic acid or other NPVP (the risk of emergence of side reactions from a GIT increases);
• anti-hypertensive means and diuretics (medicines of the NPVP group can lead to decrease in efficiency of action of these means);
• digoxin (level of both drugs in a blood plasma increases);
• anticoagulants (it was reported that NPVP can strengthen effect of the medicines reducing coagulability of blood);
• lithium and a methotrexate (NPVP can cause increase in concentration in plasma both lithium, and a methotrexate);
• a zidovudine (it was reported about increase in a bleeding time at the patients accepting at the same time an ibuprofen and a zidovudine);
• cyclosporine and takrolimusy (the risk of emergence of nephrotoxicity increases);
• antibiotics of group of hinolon (there can be a risk of development of spasms);
• mineralokortikoidam, GKS (expressiveness of side reactions increases);
• sulphonylurea derivatives (the hypoglycemic effect amplifies);
• antacids and Colestyraminum (reduce absorption);
• caffeine (strengthens analgeziruyushchy effect);
• antitrombotichesky means and the selection inhibitors of serotonin: the risk of developing of gastrointestinal bleeding increases;
• kaliysberegayushchy diuretics (can lead to a hyperpotassemia, recommend control of level of potassium in a blood plasma).

Contraindications:

Hypersensitivity to an ibuprofen or any of drug components, and also to other NPVP; an allergy in the anamnesis in the form of rhinitis, a small tortoiseshell or OH in response to acetylsalicylic acid or other NPVP; acute or chronic stomach ulcer and/or a duodenum with a perforation or bleeding, including such which resulted from therapy of NPVP; heavy liver failure, heavy renal failure or heavy heart failure; the persons who are at the same time receiving other NPVP, including TsOG-2 inhibitors (the increased risk of side effect); disturbances of a hemopoiesis of the obscure etiology; cerebrovascular or other acute bleedings, disturbances of coagulability of blood; blood diseases: hemophilia, hypocoagulation, hemorrhagic diathesis; dehydration caused by vomiting, diarrhea or the insufficient use of liquid; The III trimester of pregnancy, children aged up to 3 months.

Overdose:

 Children have an exceeding of a dose> 400 mg/kg of body weight can cause overdose (acute intoxication). For adults the dose capable to cause such symptoms is definitely not defined. Т½ at overdose makes 1,5–3 h. In case of acute overdose symptoms depend on amount of the accepted medicine, and also time which passed from the moment of administration of drug.
Symptoms
At most of patients who accepted orally clinically significant quantity of NPVP dizziness, a headache, a nystagmus, a vision disorder, a sonitus, decrease in the ABP, a loss of consciousness, nausea, vomiting, pain develop in epigastriums or diarrhea. Also perhaps gastrointestinal bleeding. At a serious poisoning note toxicity signs from TsNS which is shown in the form of drowsiness, sometimes excitement and a disorientation or a coma. Sometimes at patients reveal spasms. At serious poisoning the metabolic acidosis is noted, and also prothrombin time / the international normalized relation is extended. OPN and damage of a liver can develop. At patients attacks are OH possible.
Treatment
If after acute overdose there passed no more than 1 h, it is recommended to cause vomiting, to wash out a stomach or to accept absorbent carbon. At frequent convulsive attacks with the increasing duration it is necessary in/in to enter diazepam or lorazepam.
At пациентв with OH it is necessary to use the medicines expanding bronchial tubes.
The hemodialysis can be shown at treatment of patients with a complication in the form of OPN which arose owing to overdose of NPVP.
In cases of overdose of an ibuprofen there is no antidote and specific treatment.
The symptomatic treatment is based on monitoring of the vital functions with measurement of the ABP, control of indicators of an ECG, and also interpretation of the symptoms indicating possible bleeding from a GIT, emergence of a metabolic acidosis and disturbances from TsNS.

Storage conditions:

In original packaging at a temperature not above 25 °C to store a bottle densely closed. A suspension period of validity after opening of a bottle — 6 months.

Issue conditions:

Without recipe

Packaging:

Susp. оральн. 200 mg / 5 ml фл. 100 ml, No. 1.