Butadionum
Producer: CJSC FP OBOLENSKOYE Russia
Code of automatic telephone exchange: M01AA01
Release form: Firm dosage forms. Tablets.
General characteristics. Structure:
Active ingredient: 150 mg of phenylbutazone.
Excipients: potato starch, Natrii hydrocarbonas, magnesium stearate, silicon dioxide colloid (aerosil), talc, croscarmellose sodium (primelloza).
Drug which has analgesic, febrifugal effect. Apply at neuralgia, tooth and a headache, rheumatism.
Pharmacological properties:
Pharmacodynamics. Non-steroidal anti-inflammatory drug; has the antiinflammatory, analgeziruyushchy and febrifugal effect connected with suppression of activity of cyclooxygenase 1 (TsOG1) and cyclooxygenase 2 (TsOG2), regulating synthesis of prostaglandins. Shows uricosuric action.
Pharmacokinetics. At intake absorption - high; bioavailability - 85-90%, decreases at long reception. Time of achievement of the maximum concentration (TCmax) - 1-2 h. Communication with proteins of plasma - more than 95%.
It is metabolized in a liver with formation of 2 main metabolites. An elimination half-life (T1/2) - 18-24 h. It is removed by kidneys of 70% (5% in not changed look), through digestive tract - 30% in the form of metabolites, in significant amounts are allocated with breast milk.
Indications to use:
Inflammatory and degenerative diseases of a musculoskeletal system: the rhematoid, gouty, psoriasis arthritis ankylosing a spondylitis (Bekhterev's disease), an osteoarthrosis.
Pain syndrome: a bursitis, a tendovaginitis, an arthralgia, a mialgiya, neuralgia, tooth and head (including migraine) pain, альгодисменорея, pain at injuries, burns.
It is intended for symptomatic therapy, reduction of pain and an inflammation at the time of use, does not influence progressing of a disease.
Route of administration and doses:
Inside, the adult on 150 mg in time or after food 3-4 times a day. To children since 12 years on 75 mg to 4 times a day. Duration of therapy is defined by weight of a state.
Features of use:
During treatment control of a picture of peripheral blood and a functional condition of a liver and kidneys is necessary.
In need of definition of 17 ketosteroids drug should be cancelled for 48 h prior to a research.
During treatment it is necessary to abstain from occupations potentially dangerous types of activity requiring special attention and speed of mental and motor reactions. For decrease in risk of development of the undesirable phenomena from digestive tract it is necessary to use a minimal effective dose minimum possible short course.
Side effects:
From the alimentary system: dyspepsia, NPVP-gastropathy, abdominal pain, nausea, vomiting, heartburn, diarrhea or locks; at prolonged use in high doses - an ulceration of a mucous membrane of digestive tract, aphthous stomatitis, a glossitis, an erosive esophagitis, bleeding (gastrointestinal, gingival, hemorrhoidal), an abnormal liver function.
From cardiovascular system: increase in arterial pressure, tachycardia.
From a nervous system: headache, dizziness, drowsiness, depression, excitement.
From sense bodys: decrease in hearing, sonitus.
From bodies of a hemopoiesis: agranulocytosis, leukopenia, anemia, thrombocytopenia.
Allergic reactions: skin rash, itch, small tortoiseshell, bronchospasm, edematous syndrome, Quincke's disease.
Others: sweating strengthening, uterine bleedings.
Interaction with other medicines:
Strengthens effect of indirect anticoagulants, antiagregant, fibrinolitik, side effects of glucocorticosteroids and mineralokortikoid, estrogen, morphine, p-aminosalicylic acid, penicillin, hypoglycemic effect of derivatives of sulphonylurea.
Reduces efficiency of uricosuric, hypotensive medicines and diuretics.
Increases concentration in blood of drugs of lithium, a methotrexate.
Inductors of a microsomal oxidation in a liver (Phenytoinum, ethanol, barbiturates, rifampicin, tricyclic antidepressants) increase products of hydroxylated active metabolites.
Antacids and Colestyraminum reduce absorption.
Myelotoxic medicines strengthen manifestations of a gematotoksichnost of drug.
Contraindications:
Hypersensitivity; a full or incomplete combination of bronchial asthma, the nose recuring a polypose and okolonosovy bosoms and intolerance of acetylsalicylic acid or other non-steroidal anti-inflammatory drugs (including in the anamnesis); digestive tract erosive cankers in an aggravation stage (a peptic ulcer of a stomach and a 12-perstny gut, ulcer colitis, a round ulcer), a marrow depression, dekompensirovanny chronic heart failure or a pulmonary heart, a heavy liver and/or renal failure (clearance of creatinine less than 30 ml/min.), the period after performing aortocoronary shunting; the progressing diseases of kidneys, an active disease of a liver, the confirmed hyperpotassemia, pregnancy (the III trimester), active gastrointestinal bleeding, inflammatory diseases of intestines, children's age up to 12 years.
With care: hyperbilirubinemia, bronchial asthma, chronic heart failure, hypostases, arterial hypertension, hemophilia, hypocoagulation, liver failure, chronic renal failure, decrease in hearing, pathology of a vestibular mechanism, blood disease, diabetes mellitus, system lupus erythematosus, rheumatic polimialgiya, passing arteritis, ulcerogenic diseases of digestive tract, stomatitis, coronary heart disease, cerebrovascular diseases, дислипидемия / a lipidemia, diseases of peripheral arteries, smoking, clearance of creatinine less than 60 ml/min., digestive tract cankers in the anamnesis, existence of an infection of Helicobacter pylori, advanced age, long use of non-steroidal anti-inflammatory drugs, alcoholism, heavy somatopathies, a concomitant use of peroral glucocorticosteroids (including Prednisolonum), anticoagulants (including warfarin), antiagregant (including acetylsalicylic acid, клопидогреля), selective serotonin reuptake inhibitors (including tsitaloprama, fluoxetine, paroksetin, sertraline), I-II trimester of pregnancy, lactation period.
Overdose:
Symptoms: cyanosis of finger-tips, lips, body skin, dizziness, a headache, increase or a lowering of arterial pressure, a hyperventilation of lungs, consciousness opacification, children have myoclonic spasms, nausea, vomiting, pains in a stomach, hemorrhages, an abnormal liver function and kidneys.
Treatment: a gastric lavage, administration of absorbent carbon, the symptomatic therapy directed to maintenance of the vital functions of an organism. The artificial diuresis and a hemodialysis are ineffective.
Storage conditions:
List B. In the dry, protected from light place at a temperature not above 25 °C. To store in the place, unavailable to children. A period of validity - 3 years. Not to apply after a period of validity.
Issue conditions:
According to the recipe
Packaging:
Tablets of 150 mg. On 10 or 20 tablets in a blister strip packaging from a film of the polyvinyl chloride and printing aluminum foil varnished. On 1, 2, 3, 4 or 5 blister strip packagings together with the application instruction place in a pack from a cardboard. Packs place in group packaging.