Butadione-OBL (Butadion-OBL)

Composition Pharmacodynamics Indications Carefully Contraindications Dosing and Administration Side effects Form release / dosage
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Active substancePhenylbutazonePhenylbutazone
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    pills inwards 
    OBOLENSKOE PHARMACEUTICAL ENTERPRISE, CJSC     Russia
    • Dosage form: & nbsppills
    Composition:

    1 tablet contains:

    active substance: phenylbutazone 150 mg;

    auxiliary substances: potato starch, sodium bicarbonate, magnesium stearate, silicon dioxide colloid (aerosil), talc, croscarmellose sodium (impellosis)

    Description:

    Tablets are white or white with a yellowish hue of a flat-cylindrical shape with a risk and a facet. At the break of white or white with a yellowish tint of color.

    Pharmacotherapeutic group:NSAIDs
    ATX: & nbsp

    M.02.A.A.01   Phenylbutazone

    M.01.A.A.01   Phenylbutazone

    Pharmacodynamics:

    Non-steroidal anti-inflammatory drug; renders anti-inflammatory, analyrAn antipyretic and antipyretic effect associated with inhibition of cyclooxygenase 1 (COX1) and cyclooxygenase 2 (COX2) activity regulating the synthesis of prostaglandins.

    Has a uricosuric effect.

    Pharmacokinetics:

    At intake absorption - high; bioavailability - 85-90%, decreases with long-term admission. Time to reach the maximum concentration (TCmax) - 1-2 hours Link with plasma proteins - more than 95%.

    Metabolized in the liver with education 2 major metabolites. The half-life (T1/2) - 18-24 hours Kidney 70% (5% unchanged), through the gastrointestinal tract - 30% in the form of metabolites, in significant quantities excreted in breast milk.

    Indications:

    Inflammatory and degenerative diseases of the musculoskeletal system: rheumatoid, gouty, psoriatic arthritis, ankylosing spondylitis (Bechterew's disease), osteoarthrosis.

    Pain syndrome: bursitis, tendovaginitis, arthralgia, myalgia, neuralgia, dental and head (including migraine) pain, algodismenorea, pain with injuries, burns.

    It is intended for symptomatic therapy, reducing pain and inflammation at the time of use, the progression of the disease is not affected.

    Contraindications:

    Hypersensitivity; complete or incomplete combination of bronchial asthma, recurrent nasal polyposis and paranasal sinuses and intolerance to acetylsalicylic acid or other non-steroidal anti-inflammatory drugs (including in anamnesis); erosive and ulcerative lesions of the gastrointestinal tract in the stage of exacerbation (peptic ulcer of stomach and duodenum,ulcerative colitis, peptic ulcer), bone marrow depression, decompensated chronic heart failure or pulmonary heart failure, severe hepatic and / or renal insufficiency (creatinine clearance less than 30 ml / min), period after coronary artery bypass grafting; progressive kidney disease, active liver disease, confirmed hyperkalemia, pregnancy (III trimester), active gastrointestinal bleeding, inflammatory bowel disease, children under 12 years.

    Carefully:

    Hyperbilirubinemia, bronchial asthma, chronic heart failure, edema, arterial hypertension, hemophilia, hypocoagulation, hepatic insufficiency, chronic renal failure, hearing loss, vestibular apparatus pathology, blood diseases, diabetes mellitus, systemic lupus erythematosus, rheumatic polymyalgia, transient arteritis, ulcerogenic diseases gastrointestinal tract, stomatitis, ischemic heart disease, cerebrovascular diseases, dyslipidemia / hyperlipidemia, diseases erifericheskih arteries, smoking and creatinine clearance less than 60 mL / minulcerative lesions of the gastrointestinal tract in an anamnesis, the presence of infection Helicobacter pylori, Advanced age, long-term use of non-steroidal anti-inflammatory drugs, alcoholism, severe somatic disorders, simultaneous reception of oral corticosteroids (including prednisone), anticoagulants (including warfarin), antiplatelet agents (including acetylsalicylic acid, clopidogrel ), selective serotonin reuptake inhibitors (including citalopram, fluoxetine, paroxetine, sertraline), I-II trimester of pregnancy, lactation.

    Dosing and Administration:

    Inside, adults 150 mg during or after meals 3-4 times a day.

    Children from 12 years old 75 mg to 4 times a day.

    The duration of therapy is determined by the severity of the condition.

    Side effects:

    From the digestive system: dyspepsia, NSAID-gastropathy, abdominal pain, nausea, vomiting, heartburn, diarrhea, or constipation; with prolonged use in large doses - ulceration of the mucous membrane of the gastrointestinal tract, aphthous stomatitis, glossitis, erosive esophagitis, bleeding (gastrointestinal, gingival, hemorrhoidal), impaired liver function.

    From the side of the cardiovascular system: increased blood pressure, tachycardia.

    From the nervous system: headache, dizziness, drowsiness, depression, agitation.

    From the sense organs: hearing loss, tinnitus.

    From the hematopoiesis: agranulocytosis, leukopenia, anemia, thrombocytopenia.

    Allergic reactions: skin rash, itching, urticaria, bronchospasm, edematous syndrome, angioedema.

    Other: increased sweating, uterine bleeding.

    Overdose:

    Symptoms: cyanosis of the coccyx fingers, lips, skin, dizziness, headache, increase or decrease in blood pressure, hyperventilation of the lungs, confusion, in children - myoclonic cramps, nausea, vomiting, abdominal pain, hemorrhage, impaired liver and kidney function.

    Treatment: gastric lavage, administration of activated carbon, symptomatic therapy aimed at maintaining vital body functions. Forced diuresis and hemodialysis are ineffective.

    Interaction:

    Strengthens the effect of indirect anticoagulants, antiaggregants, fibrinolytics,side effects of glucocorticosteroids and mineralocorticoids, estrogens, morphine, paraaminosalicylic acid, penicillin, hypoglycemic effect of sulfonylurea derivatives.

    Reduces the effectiveness of uricosuric, hypotensive drugs and diuretics.

    Increases the concentration in the blood of lithium preparations, methotrexate.

    Inductors of microsomal oxidation in the liver (phenytoin, ethanol, barbiturates, rifampicin, tricyclic antidepressants) increase the production of hydroxylated active metabolites.

    Antacids and colestramine reduce absorption.

    Myelotoxic drugs increase the manifestation of hematotoxicity of the drug.

    Special instructions:

    During treatment, it is necessary to monitor the picture of peripheral blood and the functional state of the liver and kidneys.

    If it is necessary to determine 17-ketosteroids, the drug should be discontinued 48 hours before the test.

    To reduce the risk of developing adverse events from the gastrointestinal tract, a minimum effective dose should be used with the minimum possible short course.

    Effect on the ability to drive transp. cf. and fur:

    During treatment, one should refrain from engaging in potentially dangerous activities that require increased attention and speed of mental and motor reactions.

    Form release / dosage:

    Tablets, 150 mg.

    Packaging:

    For 10 or 20 tablets in a contour mesh box made of polyvinylchloride film and aluminum foil printed lacquered.

    For 1, 2, 3, 4 or 5 contour squares, together with the instructions for use, are placed in a pack of cardboard. The packets are placed in a group package.

    Storage conditions:

    In a dry, protected from light place at a temperature of no higher than 25 ° C. Keep out of the reach of children.

    Shelf life:3 years.
    Do not use after the expiration date.
    Terms of leave from pharmacies:On prescription
    Registration number:P N002725 / 01
    Date of registration:17.07.2008 / 11.05.2012
    Expiration Date:Unlimited
    The owner of the registration certificate:OBOLENSKOE PHARMACEUTICAL ENTERPRISE, CJSC OBOLENSKOE PHARMACEUTICAL ENTERPRISE, CJSC Russia
    Manufacturer: & nbsp
    Representation: & nbspOBOLENSKOE PHARMACEUTICAL ENTERPRISE, CJSCOBOLENSKOE PHARMACEUTICAL ENTERPRISE, CJSCRussia
    Information update date: & nbsp13.03.2017
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