Antipyretic drugs / Cold and Flu / Painkillers / Painkillers and Antispasmodics

Bofen 100 mg / 5 ml 100 ml suspension for oral administration

Brands: Borshchahivskiy CPP/BCPP (Ukraine)

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Bofen 100 mg / 5 ml 100 ml suspension for oral administration quantity

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Brands:: Borshchahivskiy CPP/BCPP (Ukraine)

Description

The instruction

for medical use

of BOFEN medicine

A trade name

Bofen

Mezhdunarodnoye the unlicensed

name Ibuprofen Dosage Form Suspension of oral, 100 mg / 5 ml

Structure

of 1 ml of suspension contains

active agent an ibuprofen (in recalculation for 100% dry matter) 20 mg,

excipients: Natrium benzoicum (E 211), glycerin, maltit liquid, saccharin of sodium, sodium citrate, citric acid monohydrate, sodium chloride, polysorbate 80, xanthane gum, fragrance orange, the water purified.

The description

of White or almost white color suspension with a characteristic smell of orange.

Pharmacotherapeutic group

Nonsteroid anti-inflammatory and antirheumatic drugs. Derivatives of propionic acid. Ibuprofen.

The ATX M01A E01 code

The pharmacological

Pharmacokinetics Later properties of intake an ibuprofen is absorbed in a digestive tract and begins to have effect through an insignificant period. Effect of drug lasts till 8 o’clock.

The pharmacodynamics

Drug has febrifugal, anti-inflammatory and analgeziruyushchy effect. The mechanism of action consists in inhibition of synthesis of prostaglandins of mediators of temperature reaction, inflammation and pain.

Indications

– symptomatic treatment of fever of various origin to children of 3 months (with body weight not less than 5 kg) up to 12 years, including fever after immunization, acute respiratory viral infections, flu

– head, a toothache, a sore throat, at a teething, after odontectomy, in sprain and other types of pain, including inflammatory genesis.

A route of administration and doses

For short-term oral administration.

Before each use suspension should be shaken up.

The dose depends on age and the body weight of the child. The daily dose makes 20-30 mg/kg of body weight of the child. The single dose has to make 5-10 mg/kg of body weight.

The maximum daily dose should not exceed 30 mg/kg of body weight.

In fever and pain to apply:

children are from 3 to 6 months old on 2.5 ml of suspension (50 mg) each 8 hours, but no more than 3 times a day, the daily dose makes 7.5 ml (150 mg),

from 6 to 12 months on 2.5 ml of suspension (50 mg) each 6-8 hours, but no more than 4 times a day, the daily dose makes 10 ml (200 mg),

from 1 year to 3 years on 5 ml of suspension (100 mg) each 8 hours, but no more than 3 times a day, the daily dose makes 15 ml (300 mg),

from 4 to 6 years on 7.5 ml of suspension (150 mg) each 8 hours, but no more than 3 times a day, a daily dose no more than 22.5 ml (450 mg),

from 7 to 9 years on 10 ml of suspension (200 mg) 3 times a day (600 mg a day),

from 10 to 12 years on 15 ml of suspension (300 mg) 3 times a day (900 mg a day).

In fever after immunization to apply:

to children at the age of 3-6 months of 2.5 ml (50 mg), in need of 2.5 more ml (50 mg) in 6 hours, but no more than 5 ml (100 mg) within 24 hours.

For children aged from 3 up to 6 months if the available symptoms amplify or remain after administration of drug within 24 hours from the beginning of a disease, it is necessary to see a doctor immediately.

For children aged from 6 months duration of treatment depends on a course of the disease and usually is 3 days if fever does not pass within 3 days or symptoms worsen, it is necessary to see a doctor.

To use drug only to children from 3 months and with body weight not less than 5 kg. To children up to 7 years to use drug only under observation of the doctor.

Side effects

Undesirable effects can be minimized, using the lowest effective dose during the shortest term necessary for control of symptoms.

Infrequently (from  1/1000 to  1/100)

– reactions of hypersensitivity, including various skin rashes (including. makulopapulezny), urticaria and an itching

– nausea, sensation of discomfort or pain in epigastriums, dyspepsia

Seldom (from  1/10000 to  1/1000)

– vomiting, a meteorism, diarrhea, a constipation, changes of appetite (including anorexia), dryness in a mouth, heartburn, a glossitis, an esophagitis, gastritis, a duodenitis

– a headache, dizziness, insomnia, drowsiness, emotional lability, irritability, nervousness, uneasiness, an indisposition, fatigue

– a ring in ears

It is very rare (& gt, 1/10,000)

– anaphylactoid/anaphylactic reactions, including edema of face, language, throats, a Quincke’s edema with short wind, tachycardia, arterial hypotension, an acute anaphylaxis

– bronchial asthma, aggravation of symptoms of bronchial asthma, a bronchospasm

– exfoliative and bullous dermatitis (including Stephens-Johnson’s syndrome, a polymorphic erythema and a toxic epidermal necrolysis)

– psychomotor excitement

– a hearing disorder, a hearing loss, vertigo

– conjunctivitis, dryness of mucous membranes of eyes

– aseptic meningitis with stiff neck, a headache, nausea, vomiting, fever, a disorientation usually at patients with the existing autoimmune diseases (such as system lupus erythematosus, diffusion diseases of connective tissue)

– digestive tract erosive cankers (including a stomacace, stomach ulcer), perforation or gastrointestinal bleedings (including rectal bleeding), a melena, a hematemesis, sometimes with the lethal investigation, exacerbation of ulcer colitis and Crohn’s disease

– an abnormal liver function, especially at prolonged use, in the form of hepatitis, jaundice, a hepato-renal syndrome, a gepatonekroz, a liver failure

– pancreatitis

– cystitis, a dysuria, are possible renal failures with development of a hyperpotassemia, hyperuricemia, azotemia, decrease in clearance of creatinine, an oliguria/polyuria, hypostases, an acute renal failure (especially at patients with already existing considerable renal failures), tubular necrosis, papillary necrosis (especially at prolonged use, associated with increase in level of urea in blood serum), a toxic nephropathy in various forms, including interstitial nephrite, a glomerulonephritis, a nephritic syndrome, a nephrotic syndrome, a hamaturia, a proteinuria

– hemopoiesis disturbance (anemia, including hemolytic, aplastic anemia, decrease in a hematocrit and level of hemoglobin, a leukopenia, thrombocytopenia with/without purpura, purple, a pancytopenia, a neutropenia, an agranulocytosis, an eosinophilia), bruises, reversible aggregation of thrombocytes, a pulmonary eosinophilia. The first signs: fever, a sore throat, erosion of a mucous membrane of an oral cavity, grippopodobny symptoms, feeling of increased fatigue, bleeding, including from a nose, ecchymomas, menorrhagias. At long therapy by an ibuprofen it is necessary to control a blood pattern.

Frequency is unknown (it cannot be estimated on the available data)

– nonspecific allergic reactions

– a photosensitization, an alopecia, peeling of skin, increase in perspiration

– a toxic optic neuritis, illegibility of sight, decrease in sight, scotoma, a toxic amblyopia, a diplopia, change of color perception

– a depression, confusion of consciousness, a hallucination

– a spasm, paresthesia, cerebrovascular complications, a coma

– heavy skin infections and complications from soft tissues during a course of chicken pox

– a liquid delay, hypostases, arterial hypotension / hypertensia, heartbeat, arrhythmias (including sinus tachycardia / bradycardia), heart failure, usually at patients with disturbances of warm function. Clinical trials and epidemiological data indicate that use of an ibuprofen, especially in high doses (2400 mg a day) and at long-term therapy can be connected with slight increase of risk of arterial thrombosis and its consequences (for example, a myocardial infarction or a stroke).

– changes in an endocrine system and metabolism, respiratory depression, apnoea, not cardiogenic fluid lungs, pneumonia, alveolitis, rhinitis.

Bofen’s reception should be stopped at emergence of any side reaction and to see immediately a doctor.

Contraindications

– hypersensitivity to an ibuprofen or to other components of drug

– hypersensitivity to acetylsalicylic acid or to other non-steroidal anti-inflammatory drugs

– simultaneous use with other NPVS, including with selection inhibitors of cyclooxygenase-2

– a peptic ulcer stomach/bleeding in an active form or a recurrence in the anamnesis (two and more expressed episodes of a peptic ulcer or bleeding)

– reactions of hypersensitivity (for example, asthma, rhinitis, a Quincke’s disease or a small tortoiseshell) which were observed after use of an ibuprofen, acetylsalicylic acid (aspirin) or other NPVS earlier

– disturbances of a hemopoiesis or fibrillation

– cerebrovascular or other bleedings

– the gastrointestinal bleedings / perforation in the anamnesis connected with the previous therapy of NPVS

– a heavy abnormal liver function, kidneys, heart failure,

decrease in hearing

– hereditary intolerance of fructose

– the III trimester of pregnancy

– children’s age up to 3 months

Medicinal interactions

the Ibuprofen, as well as other NPVS, it is not necessary to apply in a combination with:

aspirin: as it can increase risk of emergence of side reactions, except cases when aspirin (the dose is not higher than 75 mg a day) was appointed by the doctor.

Drugs of sulphonylurea and Phenytoinum: strengthening of effect is possible.

Anticoagulants: NPVS can increase medical effect of such anticoagulants as warfarin.

Lithium: increase in their level in blood plasma because of decrease in renal excretion of these drugs is possible.

Methotrexate: reduction of canalicular secretion of a methotrexate is possible, thereby increase its concentration in blood and a gematotoksichnost.

Cyclosporine: the increased risk of nephrotoxicity.

Antihypertensive drugs (APF inhibitors and antagonists of angiotensin II) and diuretics: easing of their effect is possible. At some patients with a renal failure (for example, with dehydration or at elderly patients with the weakened function of kidneys) simultaneous use of APF inhibitors or the antagonist of angiotensin II and drugs inhibiting cyclooxygenase can lead to further deterioration in function of kidneys, including a possible acute renal failure that usually has reversible character. Therefore it is necessary to appoint such combinations with care, especially to patients of advanced age. In need of long-term treatment it is necessary to carry out adequate hydration of the patient and to consider a question of carrying out monitoring of function of kidneys at the beginning of the combined treatment and also with a certain frequency further. Diuretics can increase risk of nephrotoxic action of NPVS.

Corticosteroids (including glucocorticoids): can increase risk of emergence of side reactions, especially formation of gastrointestinal ulcers and bleedings.

Cardiac glycosides (including digoxin): can aggravate heart failure, reduce glomerular filtration rate and increase the level of glycosides in blood plasma.

Antithrombocytic means and selection inhibitors of serotonin: the risk of developing of gastrointestinal bleeding can increase.

Inhibitors of a kaltsinevrin (cyclosporine, takrolimusy): NPVS increase nephrotoxicity of these drugs through influence on renal prostaglandins.

Mifepristone: it is not necessary to accept NPVS within 8-12 days after mifepristone use, it can lead to reduction of effect of action of the last.

Zidovudine: increase in risk of a hemarthrosis and hematomas at HIV-positive patients who perform the accompanying treatment by a zidovudine and an ibuprofen.

Hinolonovy antibiotics: increase in risk of developing of spasms is possible.

Probenetsid, Sulfinpyrazonum: simultaneous use with an ibuprofen can cause a delay of a conclusion of the last of an organism.

Aminoglycosides: NPVS can reduce removal of aminoglycosides.

Holestiramin: at co-administration the reduction of absorption of an ibuprofen in digestive tract is possible. The clinical importance is unknown.

Antidepressants, klopidogrely, prasugrely, heparin, pentoksifilliny, herbal extracts (for example, Ginkgo of a bilob): increase in risk of bleedings at use with NPVS, including an ibuprofen is possible.

CYP2C9 inhibitors: possibility of pharmacokinetic interaction: increase in time of influence (exposure) in an ibuprofen (substrate CYP2C9). It is necessary to consider reduction of a dose of an ibuprofen at simultaneous use with powerful CYP2C9 inhibitors (such as vorikonazol, flukonazol), especially at high doses of an ibuprofen.

Aliskiren, – adrenoblockers, – adrenoblockers, blockers of calcium channels, a clonidine, metildopy, nitrates: NPVS counteract their hypotensive effect.

Special instructions

before use of drug it is necessary to consult to the doctor!

It is necessary to apply the smallest effective dose during the minimum term necessary for elimination of symptoms of a disease to reduction of risk of side reactions.

The ibuprofen can mask symptoms of an infection.

It is recommended to avoid use of an ibuprofen at the available chicken pox because of a possibility of crushing infectious damages of skin and complications from soft tissues.

Use of NPVS, including ibuprofen, can provoke a bronchospasm, asthma attacks, a rhinedema at the patients having bronchial asthma, chronic obstructive respiratory diseases, allergic diseases or have background of these diseases. Heavy acute reactions of hypersensitivity, including an acute anaphylaxis, were observed seldom. At the first signs of reactions of hypersensitivity the use of the drug Bofen should be stopped.

The care at use of an ibuprofen is necessary for persons:

with a system lupus erythematosus and other diffusion diseases of connective tissue because of the increased risk of developing aseptic meningitis as manifestations of reactions of hypersensitivity. Aseptic meningitis was observed also at patients who had no these chronic diseases,

with the burdened allergological anamnesis because of the increased risk of emergence of reactions of hypersensitivity,

with hepatic dysfunction the increase in arterial blood pressure and/or heart failure in an abnormal liver function can progress and/or there can be a liquid delay in an organism.

Patients with arterial hypertension and/or moderate, or average degree stagnant heart failure in the anamnesis should begin with care long-term treatment (consultation of the doctor is necessary) as at therapy by an ibuprofen, as well as other NPVS, it was reported about cases of a delay of liquid, arterial hypertension and hypostases.

To patients with uncontrollable arterial hypertension, stagnant heart failure, stable coronary heart disease, diseases of peripheral arteries and/or cerebrovascular pathology an ibuprofen appoint advantage/risk only after the careful analysis of a ratio.

Use of an ibuprofen, especially in high doses (2400 mg a day) and also long-term treatment can be led to slight increase of risk of arterial trombotichesky complications (for example, a myocardial infarction or a stroke). Patients with the significant risk factors of cardiovascular complications (such as arterial hypertension, a lipidemia, diabetes, smoking) should appoint long-term treatment of NPVS only after careful considering.

The risk of gastrointestinal bleeding, perforation, ulcer increases at increase in doses of NPVS at patients with an ulcer in the anamnesis, especially, if it is complicated by bleeding or perforation, and at elderly patients. These patients have to begin treatment with the minimum doses. It is necessary to be careful at treatment of the patients receiving the accompanying drugs which can increase risk of a gastrotoksichnost or bleeding, such as oral corticosteroids or anticoagulants (for example, warfarin) or antithrombocytic means (for example, aspirin). At long-term treatment for these patients and also for the patients needing the accompanying use of low doses of acetylsalicylic acid (aspirin) or other medicines which can increase risk for digestive tract it is necessary to consider appointment of combination therapy as the doctor mizoprostoly or inhibitors of a proton pomp. To patients with the available gastrointestinal disorders in the anamnesis, first of all to patients of advanced age, it is necessary to report about any unusual symptoms from digestive tract (mainly bleeding), especially about gastrointestinal bleeding in an initiation of treatment. In gastrointestinal bleeding or an ulcer at patients who receive an ibuprofen the treatment should be stopped immediately.

The ibuprofen, as well as other NPVS, can influence aggregation of thrombocytes and extend a bleeding time at healthy people.

Carefully patients should apply an ibuprofen with considerable degree of dehydration as there is a risk of a renal failure and development of a renal failure.

Reception of NPVS can result in nephrotoxicity, to dose-dependent decrease in synthesis of prostaglandins and provoke development of a renal failure because of disturbance of renal blood circulation. Such patients need to control function of kidneys. After the termination of therapy of NPVS the function of kidneys is usually restored.

It was very seldom reported about serious skin reactions, including exfoliative dermatitis, Stephens-Johnson’s syndrome, a toxic epidermal necrolysis, at use of NPVS, some with a lethal outcome. In most cases these reactions arose at patients in the first month of treatment. Bofen’s reception needs to be stopped at the first manifestations of skin rash, damage of mucous membranes or any other signs of hypersensitivity.

It is not necessary to exceed the recommended doses.

Pregnancy and the period of a lactation

to use Drug only to children of 3 months with body weight not less than 5 kg to 12 years.

Oppression of synthesis of prostaglandins at use of NPVS, including ibuprofen, can have negative effect on a course of pregnancy and/or development of an embryo/fruit. Data of epidemiological researches indicate the increased risk of an abortion, congenital malformations of a cardiovascular system and gastroshizis at use of inhibitors of synthesis of prostaglandins in the early stages of pregnancy. The absolute risk of anomalies of a cardiovascular system increases with less than 1% up to 1.5%. It is considered that the risk increases with increase in a dose and duration of therapy. Use of drug in the I and II trimesters of pregnancy or is during childbirth possible only if the expected advantage for mother considerably exceeds potential risk for a fruit.

At use of any inhibitors of synthesis of prostaglandins during the III trimester of pregnancy the following impacts on a fruit are possible:

– cardiopulmonary toxicity (with premature closing of an arterial channel of a fruit and pulmonary hypertensia),

– a renal failure which can progress to a renal failure with development of an oligogidroamnioz.

Also use of an ibuprofen at the end of pregnancy can cause:

– lengthening of a bleeding time, anti-aggregation effect that can arise even at very low doses, with increase in risk of bleedings at mother and the child,

– oppression of sokratitelny function of a uterus that can lead to a delay or increase in a duration of delivery.

Thus, use of an ibuprofen in the III trimester of pregnancy is contraindicated.

By results of limited researches it is revealed that the insignificant quantity of an ibuprofen gets into breast milk. Drug is not recommended to be used during feeding by a breast.

Features of influence of medicine on ability to run the vehicle or potentially dangerous mechanisms

to use Drug only to children up to 12 years.

The overdose

Use to children more than 400 mg/kg of body weight can cause emergence of symptoms of intoxication. Elimination half-life at overdose makes 1.5-3 hours.

Symptoms: depend on amount of the taken drug and time which passed after reception, but it is impossible to exclude individual reactions. In most cases abdominal pain, nausea, vomiting, diarrhea. The slackness, drowsiness, a headache and gastrointestinal bleedings are possible also a ring in ears.

In more serious poisonings such symptoms of neurotoxicity as dizziness, block, oppression a breath/apnoea, cyanosis, short wind, a nystagmus, a disorder of vision, sometimes excitement, spasms, a disorientation, a loss of consciousness, a coma are observed.

In a serious poisoning considerable arterial hypotension, bradycardia/tachycardia, fibrillation of auricles, a hyperpotassemia, a metabolic acidosis, lengthening of a prothrombin time, an acute renal failure, injuries of a liver is possible. At patients with bronchial asthma the aggravation of symptoms of asthma is possible.

Treatment: has to be symptomatic and supporting, and also to include ensuring passability of airways. Gastric lavage (only within 1 hour after reception), activated carbon, alkaline drink, an artificial diuresis is recommended. At frequent or long spasms of muscles the treatment should be carried out by administration of diazepam or lorazepam. In bronchial asthma it is necessary to apply bronchodilators. Monitoring of indicators of warm activity and key indicators of activity is necessary for stabilization of a condition of the patient. The hemodialysis is inefficient.

A form of release and packing

On 100 ml of drug in bank polymeric or in a bottle polymeric complete with a cover with control of the first opening. On bank or a bottle paste the label produced by a printing method of the press. To bank or a bottle together with the instruction for medical use of drug in the state and Russian languages and a spoon dosing place in a pack from cardboard.

On 100 ml of drug in a bottle
to Develop

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