Active substanceIndomethacinIndomethacin
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  • Dosage form: & nbspointment for external use
    Composition:

    In 100 grams of ointment contains:

    active substance: indomethacin 10 g;

    auxiliary substances: polyethylene oxide-1500 (macrogol) 40 g, polyethylene oxide-400 (macrogol) 35.65 g, dimime (dimethylsulfoxide) 10 g, trolamine (triethanolamine thermostable) 0.25 g, nipagine (methyl parahydroxybenzoate) 0.1 g, purified water 4 g .

    Description:

    Ointment from light yellow to yellow with a greenish shade of color, with a weak specific odor.

    Pharmacotherapeutic group:NSAIDs
    ATX: & nbsp

    C.01.E.B.03   Indomethacin

    S.01.B.C.01   Indomethacin

    M.02.A.A.23   Indomethacin

    Pharmacodynamics:

    Indomethacin has a local anesthetic, anti-inflammatory and anti-edematic effect.

    With external application removes pain, reduces edema and erythema, helps reduce morning stiffness and swelling of the joints, contributes to an increase in the volume of movements.

    Indications:

    - Inflammatory and degenerative diseases of the musculoskeletal system (articular syndrome with exacerbation of gout, rheumatoid arthritis, psoriatic arthritis, ankylosing spondylitis, osteochondrosis with radicular syndrome, sciatica,inflammatory lesions of ligaments and tendons, bursitis, sciatica, lumbago), with the exception of degenerative diseases of the hip and small intervertebral joints;

    - muscular pain of rheumatic and non-rheumatic origin;

    - post-traumatic inflammation of soft tissues and the musculoskeletal system (injuries and ruptures of ligaments, bruises).

    Contraindications:

    Hypersensitivity to indomethacin, other non-steroidal anti-inflammatory drugs or other components of the dosage form, pregnancy and lactation period, children's age (up to 6 years), violation of the integrity of the skin at the site of the intended application, a complete or incomplete combination of bronchial asthma, recurrent polyposis of the nasal mucosa or paranasal sinuses and intolerance to acetylsalicylic acid or other NSAIDs (including in the anamnesis ).

    Carefully:

    Simultaneous use with other non-steroidal anti-inflammatory drugs, hepatic porphyria (exacerbation), erosive-ulcerative lesions of the gastrointestinal tract, severe violations of liver and kidney function, chronic heart failure, bronchial asthma, advanced age, hypocoagulation.

    Dosing and Administration:

    Outwardly. The total amount of ointment for adults per day should not exceed 15 cm, squeezed out of the tuba, for children from 12 years old - 7.5 cm.

    Adults and children from the age of 12 ointment is applied a thin layer on the skin of painful areas of the body 2-3 times a day for 2-3 cm (1-1.5 g).

    Children from 6 to 12 years old use no more than 1 cm of the drug no more than 2 times a day.

    Children are not recommended to use occlusive dressings.

    The duration of therapy without a doctor's consultation is no more than 2 weeks.

    A warning. The drug should be applied only to undamaged skin. Avoid getting ointment in the eyes, mucous membranes and open wounds. With prolonged treatment (more than 10 days), check the blood picture (number of white blood cells and platelets).

    Side effects:

    Possible development local side effects: dry skin, rash, allergic reactions, itching and flushing of the skin, burning.

    The possibility of development is not ruled out systemic side effects: angioedema, asthma, photosensitization reactions.

    In isolated cases - exacerbation of psoriasis.

    Overdose:

    Extremely low systemic absorption of active components of the drug with external application makesan overdose is almost impossible.

    However, with the accidental use of large amounts of ointment, undesirable reactions: nausea, vomiting, severe headache, dizziness, memory impairment and disorientation. In more severe cases, there are paresthesias, numbness of limbs and convulsions.

    When accidentally ingesting large amounts of the drug, systemic side effects may develop.

    Treatment includes rapid removal of the drug from the body and the use of appropriate symptomatic agents. Indomethacin can not be removed from the body by hemodialysis.

    Interaction:

    Ointment can enhance the effect of drugs that cause photosensitivity.

    Clinically significant interaction with other drugs is not described.

    Special instructions:

    Ointment should be applied only on undamaged skin areas, avoid contact with eyes or mucous membranes.

    Form release / dosage:

    Ointment for external use, 10%.

    Packaging:

    30 g in aluminum tubes or in polymer tubes.

    Each tube together with the instruction for use is placed in a pack of cardboard.

    Storage conditions:

    In dry, dark place at a temperature of no higher than 25 ° C.

    Keep out of the reach of children.

    Shelf life:

    2 years.

    Do not use after the expiration date.

    Terms of leave from pharmacies:On prescription
    Registration number:P N001072 / 01
    Date of registration:29.09.2010
    Expiration Date:Unlimited
    The owner of the registration certificate:BIOSINTEZ, PAO BIOSINTEZ, PAO Russia
    Manufacturer: & nbsp
    Representation: & nbspBIOSINTEZ JSC BIOSINTEZ JSC Russia
    Information update date: & nbsp31.10.2017
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