Befron

General characteristics. Structure:

Active ingredient: 100 mg of an ibuprofen.

Excipients: citric acid monohydrate, citrate sodium a dihydrate, Natrium benzoicum, potassium to atsesulfa, sorbitol of 70%, gum xanthane, polysorbate 80 (Twin 80), silicon dioxide colloid anhydrous (Aerosil 200), sugar the refined (sucrose), grape fragrance, water cleared.

Pharmacological properties:

Pharmacodynamics. Befron - non-steroidal anti-inflammatory drug. Has anesthetic, febrifugal and antiinflammatory effect. The mechanism of action of an ibuprofen is caused by braking of synthesis of inflammatory prostaglandins due to cyclooxygenase enzyme blocking.

Action of Befrona® for children can continue till 8 o'clock.

Pharmacokinetics. It is quickly soaked up from digestive tract. The maximum concentration in plasma is defined in 1-2 hours. Communication with proteins of a blood plasma – 90%. Elimination half-life about 2 hours. Is exposed to metabolism in a liver. It is removed by kidneys (in an invariable look no more than 1%) and to a lesser extent, with bile.

Indications to use:

Befron apply at children from 3 months of life to 12 years as febrifugal and anesthetic at:

-  acute respiratory viral infections;

- flu;

- post-inoculative reactions;

- the infectious and inflammatory diseases which are followed by fervescence;

- head and dentagra;

- migraines;

- neuralgia;

- ear pains and in a throat;

- pains at stretchings and other types of pain.

Route of administration and doses:

Drug is accepted inside. Before the use contents of a bottle should be shaken up well. Drug is accepted after food, with a large amount of liquid. The measured spoon (capacity of 2,5 and 5 ml) enclosed in packaging allows to dose correctly and rationally drug. The dose is established depending on age and the body weight of the child.

The diseases which are followed by fervescence and pain. The dosage for children depends on age and the body weight of the child. The single dose makes 5-10 mg/kg of body weight of the child 3-4 times a day. Maximum daily dose of 25-30 mg/kg of body weight of the child.

To children aged:

• 3-6 months: on 2,5 ml 3 times within 24 hours, no more than 150 mg a day.
• 6-12 months: on 2,5 ml 3-4 times within 24 hours, no more than 200 mg a day.
• 1-3 years: on 5,0 ml 3 times within 24 hours, no more than 300 mg a day.
• 4-6 years: on 7,5 ml 3 times within 24 hours, no more than 450 mg a day.
• 7-9 years: on 10 ml 3 times within 24 hours, no more than 600 mg a day.
• 10-12 years: on 15 ml 3 times within 24 hours, no more than 900 mg a day.

Do not exceed the specified dose!

Fervescence after inoculations. One measured spoon on 2,5 ml to children aged till 1 year, after 1 year, if necessary, one more measured spoon on 2,5 ml in 6 hours.

Do not apply more than 5 ml within 24 hours!

Treatment duration:

- No more than 3 days as febrifugal.

- No more than 5 days as anesthetic.

Features of use:

It is necessary to estimate estimated advantage and possible risk before to give to the child of BEFRON if the child aged from 3 up to 6 months.

During treatment control of a picture of peripheral blood and a functional condition of a liver and kidneys is necessary.

Considering a possibility of emergence of frustration from the alimentary system, it is necessary to avoid a concomitant use of BEFRONA

with the substances or medicines having ulcerogenic effect (including acetylsalicylic acid, corticosteroids).

Side effects:

Usually drug is well transferred.

Infrequently:

- allergic reactions: urticaria, skin itch, various skin rashes;

- feeling of discomfort in a stomach, an abdominal pain, nausea, dyspepsia.

Seldom:

- vomiting, meteorism, diarrhea, lock;

- headache, dizziness, excitement, sleeplessness, drowsiness, depression, confusion of consciousness, hallucination, sonitus.

Very seldom:

- heavy hypersensitivity reactions: face edema, language and throat, short wind, tachycardia, arterial hypotension (anaphylaxis, Quincke's edema or heavy shock);

- exacerbation of bronchial asthma and bronchospasm;

- a round ulcer, a perforation of the ulcer or gastrointestinal bleeding, a melena, vomiting blood (sometimes with a lethal outcome, especially at elderly patients) a stomacace, gastritis, an exacerbation of ulcer colitis and disease Krone;

- an acute renal failure, папиллонекроз (especially at long reception), the urea associated with increase in serum and hypostases;

- hemopoiesis disturbances (anemia, leukopenia, thrombocytopenia, pancytopenia, agranulocytosis). The first symptoms are: fever, a pharyngalgia, superficial ulcers in oral cavities, grippopodobny symptoms, the expressed weakness, inexplicable bleeding and emergence of bruises;

- abnormal liver functions;

- development of severe forms of skin reactions, such as violent reactions, including a mnogoformny erythema, a toxic epidermal necrolysis, Stephens-Johnson's syndrome is possible.

Isolated cases:

- at patients with the preexisting autoimmune disorders (a system lupus erythematosus, the mixed disease of connecting fabric) during treatment by an ibuprofen observed symptoms of aseptic meningitis, such as stiff neck, headache, nausea, vomiting, fever or disturbance of orientation;

- violent dermatosis;

- stomach ulcer or gastric bleeding.

Due to the treatment of NPVS it was reported about development of hypostases, arterial hypertension and heart failure.

At emergence of side effects it is necessary to stop drug use.

Interaction with other medicines:

Simultaneous use of BEFRONA with anticoagulants can lead to strengthening of their action.

BEFRON increases concentration of digoxin, Phenytoinum, methotrexate, lithium in a blood plasma at simultaneous use with these drugs. Use of BEFRONA together with diuretics and anti-hypertensive means reduces their efficiency.

Strengthens side effects of mineralokortikosteroid and glucocorticosteroids.

Contraindications:

- hypersensitivity to an ibuprofen, acetylsalicylic acid or other non-steroidal anti-inflammatory drugs (NPVP), and also to other components of drug;

- the bronchial asthma, a small tortoiseshell, rhinitis provoked by reception of acetylsalicylic acid (salicylates) or other NPVP (nonsteroid antiinflammatory drugs);

- digestive tract canker (peptic ulcer of a stomach and duodenum, ulcer colitis);

- gastrointestinal bleeding;

- blood diseases: hypocoagulation, leukopenia, hemophilia, hemorrhagic vasculitis;

- renal and/or liver failure;

- decrease in hearing;

- children's age up to 3 months;

- pregnancy and period of a lactation.

Overdose:

Symptoms: abdominal pains, nausea, vomiting, headache, sonitus, metabolic acidosis, coma, acute renal failure, lowering of arterial pressure, bradycardia, tachycardia.

Treatment: a gastric lavage (only within an hour after reception), absorbent carbon, alkaline drink, an artificial diuresis, symptomatic therapy.

Storage conditions:

To store at  a temperature not above 25 °C, in the dry, protected from light place. To store in the place, unavailable to children! Period of storage 2 years. Not to apply after a period of storage. A period of storage after the first opening of a bottle 1 month.

Issue conditions:

Without recipe

Packaging:

100 ml of drug place in a glass dark bottle with the screwing-up cover with control of the first opening. On a bottle paste the self-adhesive label. 1 bottle together with a measured spoon and the instruction on a medical use in the state and Russian languages is placed in a cardboard pack.