Ibuprofen-Hemofarm

General characteristics. Structure:

Active agent: ibuprofen of 400 mg

Excipients: cellulose microcrystallic PH101, sodium carboxymethylstarch, silicon dioxide colloid anhydrous, stearic acid.

Structure of a film cover: copolymer of methacrylic acid and etakrilat (1:1), talc, titanium dioxide (E171), polysorbate 80.

Pharmacological properties:

Renders antiinflammatory, febrifugal, analgeziruyushchy action. Неизбирателыю blocks cyclooxygenase-1 and cyclooxygenase-2. The mechanism of action of an ibuprofen is caused by braking of synthesis of prostaglandins - mediators of pain, an inflammation and hyper thermal reaction. Weakens a pain syndrome, including joint pains at rest and at the movement; reduces morning constraint and a swelling of joints, promotes increase in volume of movements.

Pharmacokinetics. Absorption - high, absorption slightly decreases at administration of drug after food. Cmax in a blood plasma at reception is on an empty stomach reached in 45 min., at reception after food - in 1.5-2.5 h, and in synovial fluid - 2-3 h where creates big concentration, than in a blood plasma. Communication with proteins of plasma of 90%. Slowly gets into a cavity of joints, is late in synovial fabric.

Biological activity is associated with S-enantiomerom. After absorption about 60% pharmacological of an inactive R-form are slowly transformed to an active S-form. CYP2C9 isoenzyme takes part in metabolism of drug. Is exposed to presistemny and post-system metabolism in a liver. Has two-phase kinetics of elimination from T1/2 2 - 2.5 h.

It is removed by kidneys (in not changed look no more than 1%) and to a lesser extent with bile. At elderly persons pharmacokinetic parameters of an ibuprofen do not change.

Indications to use:

— inflammatory and degenerative diseases of a musculoskeletal system: rhematoid, juvenile chronic, psoriasis arthritis, osteoarthrosis, gouty arthritis, spondylarthritis ankylosing (Bekhterev's disease). Drug is intended for symptomatic therapy, reduction of pain and an inflammation at the time of use, does not influence progressing of a disease;
— pain syndrome: a mialgiya, an arthralgia, an ossalgiya, arthritis, radiculitis, migraine, head (including at a menstrual molimina) and a dentagra, neuralgia, a tendinitis, a tendovaginitis, a bursitis, the posttraumatic and postoperative pain syndrome which is followed by an inflammation at oncological diseases;
— альгодисменорея, inflammatory process in a small basin, including an adnexitis;
— a feverish syndrome at catarrhal and infectious diseases.

Route of administration and doses:

Inside, after food take also a pill sparkling (in the form of solution), and tablets, film coated.
Doses of an ibuprofen select individually so that use of the smallest possible dose to gain desirable therapeutic effect.
The sparkling tablet of the drug Ibuprofen-Hemofarm is completely dissolved in a glass (200 ml) of water, and the received solution is drunk at once. Sparkling tablets should not be swallowed, chewed and sucked in a mouth.
Sparkling tablets are appointed to children 6 years and the adult are more senior.
The adult - the single dose of an ibuprofen makes 1-2 sparkling tablets (200-400 mg); the daily dose makes 4-6 tablets sparkling (800-1200 mg), in the divided doses with an interval of 4-6 h.
Children aged from 6 up to 12 years: the single dose makes 1 sparkling tablets (200 mg); a therapeutic dose - on 1 sparkling tablet with an interval of 4-6 h, 2-4 times/days. The maximum daily dose makes 4 sparkling tablets (800 mg/days).
Children are aged more senior than 12 years: the single dose makes 1-2 sparkling tablets (200-400 mg); a therapeutic dose on 1-2 tablets with an interval of 4-6 h. The maximum daily dose makes the 5th sparkling tablets (1000 mg).
Tablets, film coated, appoint to adults and children 12 years, inside after food are more senior, it is necessary to swallow of tablets entirely, washing down with a small amount of liquid.
To adults and children 12 years - inside on 1 tablets (400 mg) are more senior. Repeated reception not earlier than in 4 h.
The adult not to take more than 3 pill for 24 h. The maximum daily dose makes 1200 mg. The maximum daily dose for children of 12-18 years makes 1000 mg.
If at administration of drug within 2-3 days symptoms are protected, it is necessary to stop treatment and to see a doctor.

Features of use:

During treatment 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 hemoglobin and a hematocrit, the analysis a calla on the occult blood is shown.
For the prevention of development of the NPVP-gastropathy it is recommended to combine with drugs of prostaglandins (мизопростол).
In need of definition of 17 ketosteroids drug should be cancelled for 48 h prior to a research.
Patients have to abstain from all types of activity requiring special attention, bystry mental and motor reaction. During treatment ethanol reception is not recommended.
For decrease in risk of development of the undesirable phenomena from a GIT it is necessary to use a minimatny effective dose minimum possible short course.

Side effects:

Co of the party of the alimentary system: The NPVP-gastropathy (abdominal pains, nausea, vomiting, heartburn, a loss of appetite, diarrhea, a meteorism, a lock, pain and discomfort in epigastric area); seldom - ulcerations of a mucous membrane of a GIT (in some cases are complicated by perforation and bleedings), irritation, dryness of a mucous membrane of an oral cavity or mouth pain, an ulceration of a mucous membrane of gums, aphthous stomatitis, pancreatitis, hepatitis.

From TsNS: headache, dizziness, sleeplessness, uneasiness, nervousness and irritability, psychomotor excitement, drowsiness, depressions, confusion of consciousness, hallucination; seldom - aseptic meningitis (is more often at patients with autoimmune diseases).

From sense bodys: decrease in hearing, ring or sonitus, reversible toxic optic neuritis, illegibility of sight or diplopia, dryness and irritation of eyes, chemosis and century (allergic genesis), scotoma.

From respiratory system: asthma, bronchospasm.

From cardiovascular system: heart failure, tachycardia, increase in the ABP.

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

Allergic reactions: skin rash (usually erythematic or small tortoiseshell), skin itch, angionevrotichssky hypostasis, anaphylactoid reactions, acute anaphylaxis, bronchospasm, fever, multiformny exudative erythema (including Stephens-Johnson's syndrome), toxic epidermal necrolysis (Lyell's disease), eosinophilia, allergic rhinitis.

From bodies of a hemopoiesis: anemia (including hemolitic, aplastic), thrombocytopenia and Werlhof's disease, agranulocytosis, leukopenia.

Others: sweating strengthening.

The risk of development of ulcerations of a mucous membrane of a GIT, bleeding (gastrointestinal, gingival, uterine, hemorrhoidal), vision disorders (disturbance of color sight, scotoma, an amblyopia) increases at prolonged use in high doses.

Interaction with other medicines:

The concomitant use of an ibuprofen with acetylsalicylic acid (ASK) and other NPVP is not recommended.

At co-administration the ibuprofen reduces antiinflammatory and antiagregantny action of ASK (increase in frequency of development of acute coronary insufficiency in the patients receiving small doses of ASK as antiagregantny means after the beginning of reception of an ibuprofen is possible).

At appointment with anticoagulating and thrombolytic medicines (alteplazy, Streptokinasa, an urokinase) the risk of development of bleedings at the same time increases.

The concomitant use with inhibitors of the return serotonin reuptake (to tsitatopra, fluoxetine, пароксетин, сертратин) increases risk of development serious a GIT of bleedings.

Tsefamandol, цефаперазон, цефотетан, valproic acid, пликамицин increase the frequency of development of a prothrombinopenia.

Cyclosporine and drugs of gold strengthen influence of an ibuprofen on synthesis of prostaglandins in kidneys that is shown by increase in nephrotoxicity. The ibuprofen increases plasma concentration of cyclosporine and probability of development of its gepatotoksichny effects. The drugs blocking canalicular secretion reduce removal and increase plasma concentration of an ibuprofen.

Inductors микросомалыюго oxidations (Phenytoinum, ethanol, barbiturates, rifampicin, phenylbutazone, tricyclic antidepressants) increase products of hydroxylated active metabolites, increasing risk of development of heavy hepatotoxic intoxications.

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

Reduces hypotensive activity of vazodilatator (including blockers of slow calcic ropes), APF inhibitors), natriuretic and diuretic - furosemide and a hydrochlorothiazide.

Reduces efficiency of uricosuric drugs, strengthens effect of indirect anticoagulants, antiagregant, fibrinolitik (increase in risk of emergence of hemorrhagic complications), strengthens ulcerogenic action with bleedings of mineralokortikosteroid and glucocorticosteroids, colchicine, estrogen, ethanol.

Strengthens effect of peroratny hypoglycemic drugs (including sulphonylurea derivatives) and insulin.

Antacids and Colestyraminum reduce absorption of an ibuprofen.

The ltitiya and a methotrexate increases concentration in blood of ditoxin, drugs.

Caffeine strengthens analgeziruyushchy effect.

Myelotoxic means strengthen manifestations of a gematotoksichnost of drug.

Contraindications:

— a full or incomplete combination of bronchial asthma, the nose recuring a polypose and okolonosovy bosoms and intolerance of ASK or other NPVP (including in the anamnesis);
— erosive and ulcer diseases of bodies of a GIT in an aggravation stage (including a peptic ulcer of a stomach and duodenum in an aggravation stage, ulcer colitis, a round ulcer, a disease Krone, NYaK), inflammatory diseases of intestines, gastrointestinal bleedings;
— disturbances of coagulability of blood (including hemophilia, hypocoagulation, lengthening of a bleeding time, tendency to bleedings, hemorrhagic diathesis);
— the period after performing aortocoronary shunting;
— intracraneal hemorrhages;
— the expressed liver failure or an active disease of a liver;
— the progressing diseases of kidneys, the expressed renal failure with clearance of creatinine less than 30 ml/min., the confirmed hyperpotassemia;
— pregnancy (III trimester);
— children's age up to 6 years (for tablets of sparkling 200 mg),
— children's age up to 12 years (for tablets, film coated 400 mg);
— hypersensitivity to any of drug components;
— hypersensitivity to acetylsalicylic acid (ASK) or other NPVP.

With care
Advanced age, chronic heart failure, arterial hypertension, coronary heart disease, cerebrovascular diseases, дислипидемия / a lipidemia, a diabetes mellitus, diseases of peripheral arteries, smoking, frequent alcohol intake, cirrhosis with portal hypertensia, a liver and/or renal failure with clearance of creatinine less than 60 ml/min., a nephrotic syndrome, a hyperbilirubinemia, a peptic ulcer of a stomach and duodenum (in the anamnesis), existence of an infection of Helicobactor pylori, gastritis, enteritis, colitis, diseases of blood of not clear etiology (a leukopenia and anemia), long use NPVP, heavy somatopathies, a concomitant use of peroral GKS (including Prednisolonum), anticoagulants (including warfarin), antiagregant (including acetylsalicylic acid, klopidogret), selective serotonin reuptake inhibitors (including to tsitalopra, fluoxetine, пароксетин, sertraline), pregnancy (I and II trimesters), lactation period.

Use of drug IBUPROFEN-HEMOFARM at pregnancy and feeding by a breast
It is contraindicated.

Use at abnormal liver functions
It is contraindicated:
— the progressing diseases of kidneys, the expressed renal failure with clearance of creatinine less than 30 ml/min., the confirmed hyperpotassemia.

Use at renal failures
It is contraindicated:
— the expressed liver failure or an active disease of a liver.

Overdose:

Symptoms: abdominal pains, nausea, vomiting, block, drowsiness, depression, headache, sonitus, metabolic acidosis, coma, acute renal failure, lowering of arterial pressure, bradycardia, tachycardia, fibrillation of auricles, apnoea.

Treatment: a gastric lavage (only during 1 h after reception), absorbent carbon, alkaline drink, an artificial diuresis, symptomatic therapy (correction of an acid-base state, arterial pressure).

Storage conditions:

Tablets, film coated and tablets sparkling store in unavailable to children, the dry place, at a temperature from 15 °C to 25 °C.

Issue conditions:

Without recipe

Packaging:

Tablets, покр. film obol., 400 mg: 10, 20, 30 or 50 pieces.