Active substanceKetoprofenKetoprofen
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  • Dosage form: & nbspgel for external use
    Composition:

    100 g of gel contains:

    active substanceso: ketoprofen 2.5 g;

    Excipients: Carbomer (carbopol) 1, 5 g, ethanol (ethyl alcohol) 32.0 g, trolamine (triethanolamine) 2.8 g, lavender oil 0.1 g, water purified to 100 g.

    Description:

    Colorless, transparent or opalescent gel.

    Pharmacotherapeutic group:non-steroidal anti-inflammatory drug (NSAID)
    ATX: & nbsp

    M.02.A.A.10   Ketoprofen

    Pharmacodynamics:

    Ketoprofen is a non-steroidal anti-inflammatory drug (NSAID), has anti-inflammatory, analgesic and antipyretic effects associated with inhibition of cyclooxygenase-1 (COX-1) and cyclooxygenase-2 (COX-2) activity regulating the synthesis of prostaglandinsPg). With articular syndrome, weakening of arthralgia at rest and during movement, a decrease in "morning stiffness" and swelling of the joints. Ketoprofen does not have a catabolic effect on articular cartilage.

    Pharmacokinetics:

    With external application, it is absorbed extremely slowly and practically does not accumulate in the body. Bioavailability of ketoprofen is about 5%.After external use in a dose of 50-150 mg concentration in the plasma after 5-8 hours - 0.08-0.15 μg / ml.

    Indications:

    Acute and chronic inflammatory diseases of the musculoskeletal system (articular syndrome with exacerbation of gout, rheumatoid arthritis, psoriatic arthritis, ankylosing spondylitis, osteoarthritis, osteochondrosis with radicular syndrome, sciatica, inflammatory defeat of ligaments and tendons, bursitis, sciatica, lumbago).

    Muscular pain of rheumatic and non-rheumatic origin.

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

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

    Hypersensitivity to ketoprofen or other non-steroidal anti-inflammatory drugs, complete or incomplete combination of bronchial asthma, recurrent nasal polyposis and paranasal sinuses and intolerance to acetylsalicylic acid or other NSAIDs (including anamnesis), damage to the skin (wet dermatoses, eczema, infected abrasions,wounds) at the site of the intended application, pregnancy III trimester and lactation period, children's age (up to 6 years).

    Carefully:

    Erosive-ulcerative lesions of the gastrointestinal tract, pronounced impaired renal and hepatic function, chronic heart failure, bronchial asthma, pregnancy I-II trimester, hepatic porphyria, old age, children under 12 years old.

    Pregnancy and lactation:

    The use of the drug in the third trimester of pregnancy is contraindicated.

    The use of the drug in the I and II trimester is possible only after consulting a doctor if the intended benefit to the mother exceeds the potential risk to the fetus.

    Application in the lactation period is not recommended.

    Dosing and Administration:

    Outwardly.

    Adults and children from the age of 12 apply a small amount of gel (3-5 cm) 2-3 times a day with a thin layer, followed by a long and careful rubbing into the inflamed or painful parts of the body.

    Children from 6 to 12 years old Do not apply more than 1-2 cm of the drug no more often than 2 times a day. The duration of the course of treatment should not exceed 14 days without consulting a doctor. Can be used in phonophoresis.

    Side effects:

    Local Reactions: allergic dermatitis, eczema, skin hyperemia, photodermatitis, boule dermatitis, exanthema, purpura.

    Systemic reactions: urticaria, generalized skin rash, swelling, photosensitivity, stomatitis.

    Overdose:

    Very low systemic absorption of the active ingredient of the drug when applied externally makes practically impossible overdose.

    Interaction:

    With external application of ketoprofen, interaction with other drugs has not been established.

    Special instructions:The drug should be applied only to undamaged skin areas, avoiding contact with open wounds, eyes and mucous membranes.
    After applying the drug, you should wash your hands.
    Do not use with occlusive dressings.

    Before using the gel for patients with impaired liver and / or kidney function, gastrointestinal diseases in history, bronchial asthma, heart failure, it is necessary to consult a doctor.

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

    No data.

    Form release / dosage:

    Gel for external use 2.5%.

    Packaging:

    For 30 g in aluminum tubes or in tubes laminated.

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

    Storage conditions:

    In the dark place at a temperature of no higher than 25 ° C. Do not freeze.

    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:LP-000139
    Date of registration:12.01.2011
    The owner of the registration certificate:SYNTHESIS, JSC Joint-stock Kurgan Society of Medical Preparations and Products SYNTHESIS, JSC Joint-stock Kurgan Society of Medical Preparations and Products Russia
    Manufacturer: & nbsp
    Representation: & nbspSYNTHESIS JSC Joint-Stock Kurgan Society of Medical Preparations and Products SYNTHESIS JSC Joint-Stock Kurgan Society of Medical Preparations and Products Russia
    Information update date: & nbsp12.01.2011
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