Butadione (Butadion)

Composition Pharmacodynamics Indications Carefully Contraindications Dosing and Administration Side effects Form release / dosage
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Active substancePhenylbutazonePhenylbutazone
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  • Butadione
    ointment externally 
    ATOLL, LLC     Russia
  • Butadione
    ointment externally 
    GEDEON RICHTER, OJSC     Hungary
  • Butadione-OBL
    pills inwards 
    OBOLENSKOE PHARMACEUTICAL ENTERPRISE, CJSC     Russia
    • Dosage form: & nbspointment for external use
    Composition:

    Each tube (20 g of ointment) contains:

    active substance: phenylbutazone 1 g;

    Excipients: methyl parahydroxybenzoate 0.04 g, carmellose sodium 0.13 g, silicon dioxide colloid 0.89 g, polysorbate 60 1.00 g, glycerol (85%) 1.40 g, propylene glycol 2.40 g, paraffin liquid 6.00 g, water 7.14 g

    Description:

    A white homogeneous ointment with a weak specific odor.

    Pharmacotherapeutic group:NSAIDs
    ATX: & nbsp

    M.02.A.A.01   Phenylbutazone

    M.01.A.A.01   Phenylbutazone

    Pharmacodynamics:

    Nonsteroidal anti-inflammatory drug, has anti-inflammatory and analgesic effect. Indiscriminately inhibits the activity of cyclooxygenase (COX-1 and COX-2) and inhibits the synthesis of prostaglandins. Phenylbutazone inhibits the synthesis of ATP-dependent mucopolysaccharides.

    Butadion is used to eliminate the pain syndrome and reduce the swelling associated with the inflammatory process. When topical application causes weakening or disappearance of pain in joints at rest and during movement. Reduces the morning stiffness and swelling of the joints, contributes to an increase in the volume of movements.

    Pharmacokinetics:

    At application system absorption does not exceed 5%.

    Phenylbutazone is metabolized in the liver, excreted in the form of metabolites mainly by the kidneys and around 1/4 through the intestines. Elimination time from blood plasma is long (an average of 70 hours, in elderly people up to 105 hours).

    Indications:

    Post-traumatic inflammation of soft tissues and joints, for example, as a result of stretching, overstrain and bruises.

    Rheumatic diseases of soft tissues (tendovaginitis, bursitis, lesion of periarticular tissues).

    Muscular pain of rheumatic and non-rheumatic origin.

    Pain and puffiness associated with diseases of the muscles and joints.

    Rheumatoid arthritis, osteoarthritis, sciatica, lumbago, sciatica.

    Contraindications:

    - Hypersensitivity to phenylbutazone or other components of the drug, to acetylsalicylic acid or other non-steroidal anti-inflammatory drugs (NSAIDs);

    - anamnestic data on an attack of bronchial obstruction, allergic rhinitis, hives after taking acetylsalicylic acid or other NSAIDs;

    - Pregnancy (I and III trimester), lactation period;

    - violation of the integrity of the skin at the site of the intended application;

    - children's age till 14 years;

    - joint use with other drugs containing phenylbutazone.

    Pregnancy and lactation:

    The drug is contraindicated in the I and III trimester of pregnancy because of the possibility of impaired development of the fetus. In the II trimester of pregnancy, Butadione is used only if the intended benefit to the mother exceeds the potential risk to the fetus.

    If it is necessary to use the drug during lactation, it is recommended to stop breastfeeding.

    Dosing and Administration:

    Outwardly.

    Adults and children over 14 years of age: the drug is applied in a thin layer, a strip 2-3 cm above the focus of inflammation without rubbing 2-3 times a day. The course of treatment is 7-10 days. After 10 days of use, consult a physician.

    Elderly patients: there is no need for a special mode of use.

    Side effects:

    Local Reactions: eczema, photosensitivity, contact dermatitis (itching, redness, swelling of the treated area of ​​the skin; papules, vesicles, peeling).

    Allergic reactions: urticaria, angioedema, bronchospasm, generalized skin rash.

    Overdose:

    Extremely low absorption of active components of the drug with external application makes an overdose almost impossible.

    In case of accidental ingestion of large amounts of ointment (more than 20 g), systemic undesirable reactions characteristic of NSAIDs are possible. It is necessary to wash the stomach, taking activated charcoal.

    Interaction:

    Clinically significant interaction with other drugs has not been described.

    It should avoid the combined use of Butadione with other non-steroidal anti-inflammatory drugs.

    The drug may enhance the effect of drugs that cause photosensitivity.
    Special instructions:

    If skin reddening occurs, therapy should be discontinued.

    Ointment should be applied only to intact skin, avoiding getting on open wounds.

    After applying, do not apply an occlusive dressing.

    Do not allow the drug to enter the eyes and mucous membranes.

    The drug should not be used to treat deep vein thrombophlebitis of the extremities.

    To prevent photosensitivity, protect the skin from direct sunlight.

    When combined with other dosage forms of Butadione, the maximum daily dose of this drug should be taken into account.

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

    There is no information about the influence of Butadion on the ability to drive and engage in other activities that require concentration and speed of psychomotor reactions.

    Form release / dosage:Ointment for external use, 5%.
    Packaging:

    20 g of an ointment in an aluminum tube with a white polyethylene cap having a perforating tip.

    One tube in a cardboard box with instructions for medical use.

    Storage conditions:

    Store at a temperature of 8 to 15 ° C.

    Keep out of the reach of children.

    Shelf life:

    5 years.

    Do not use after the expiration date printed on the package.

    Terms of leave from pharmacies:Without recipe
    Registration number:П N011429 / 01
    Date of registration:26.05.2009 / 07.02.2013
    Expiration Date:Unlimited
    The owner of the registration certificate:GEDEON RICHTER, OJSC GEDEON RICHTER, OJSC Hungary
    Manufacturer: & nbsp
    Representation: & nbspGEDEON RICHTER OJSC GEDEON RICHTER OJSC Hungary
    Information update date: & nbsp13.03.2017
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