Active substanceKetoprofenKetoprofen
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  • Dosage form: & nbspfilm-coated tablets
    Composition:

    1 tablet contains:

    active substance: ketoprofen 100 mg;

    Excipients: giprolase (klozel LF) 2.4 mg, mannitol (D-mannitol) 21.0 mg, sodium croscarmellose (impellose) 5.4 mg, cellulose microcrystalline 48.4 mg, silicon dioxide colloid (aerosil) 1.0 mg, magnesium stearate monohydrate 1.8 mg;

    aboutbolo: opedraj II white (polyvinyl alcohol 4.00 mg, titanium dioxide 2.50 mg, macrogol (polyethyleneglyring) 2.02 mg, talc 1.48 mg) 10 mg.

    Description:

    Round dvukavkuklye tablets, covered with a film shell, white or almost white.

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

    M.02.A.A.10   Ketoprofen

    Pharmacodynamics:

    Non-steroidal anti-inflammatory drug. Has anti-inflammatory, analgesic and antipyretic effects associated with the suppression of cyclooxygenase 1 and cyclooxygenase 2, regulating the synthesis of Pg. By acting on the cyclooxygenase and lipoxygenase unit of arachidonic acid metabolism, it inhibits the synthesis of prostaglandins, leukotrienes and thromboxanes.

    Has a central and peripheral analgesic action, anti-bradykinin activity, stabilizes lysosomal membranes, causes significant inhibition of neutrophil activity in patients with rheumatoid arthritis.
    Has no catabolic effect on articular cartilage.
    Pharmacokinetics:

    Absorption - fast, bioavailability - more than 90%. Connection with plasma proteins up to 99%. The maximum concentration of the drug in the plasma is achieved after 0.7-1 h after ingestion. The equilibrium concentration is established 24 hours after the start of its regular intake. It penetrates well into the synovial fluid and connective tissues. In a significant amount does not penetrate the blood-brain barrier (BBB).

    It is practically completely metabolized in the liver by glucuronation with the formation of esters with glucuronic acid, has the effect of "first passage" through the liver.

    It is excreted by the kidneys (mainly) and the intestines (1%). The half-life is 1.6-1.9 hours.

    Does not possess cumulative properties.

    Indications:

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

    Pain syndrome: myalgia, ossalgia, neuralgia, tendonitis, arthralgia, bursitis, sciatica, adnexitis, otitis, headache and tooth pain in oncological diseases, post-traumatic and postoperative pain syndrome, accompanied by inflammation.

    Algodismenorea (as an analgesic and tocolytic agent).
    Contraindications:

    Hypersensitivity to ketoprofen or other components of the drug, salicylates and other NSAIDs, severe heart failure; treatment of postoperative pain during coronary artery bypass surgery; chronic dyspepsia; active peptic ulcer of the stomach or ulceration / perforation; gastrointestinal, cerebrovascular or other bleeding, patients prone to hemorrhage; severe liver or kidney dysfunction, bronchial asthma, rhinitis or urticaria in history caused by taking acetylsalicylic acid or other NSAIDs, peptic ulcer and duodenal ulcer (exacerbation), Crohn's disease, diverticulitis, hemophilia and other disorders of blood coagulation, chronic kidney failure, children's age (up to 6 years), pregnancy (III trimester), lactation.

    Carefully:

    Anemia, bronchial asthma, alcoholism, tobacco smoking, alcoholic liver cirrhosis, hyperbilirubinemia, liver failure, dehydration, sepsis, chronic heart failure, edema, arterial hypertension, blood diseases (including leukopenia), stomatitis, ischemic heart disease, cerebrovascular diseases , dyslipidemia / hyperlipidemia, diabetes mellitus, peripheral arterial disease, chronic renal failure (creatinine clearance 30-60 ml / min), ulcerative lesions of the gastrointestinal tract in the anamnesis th, the presence of infection Helicobacter pylori, long-term use of non-steroidal anti-inflammatory drugs (NSAIDs), severe somatic diseases, simultaneous administration of oral glucocorticosteroids (including prednisolone), anticoagulants (including warfarin), antiplatelet agents (including clopidogrel), selective inhibitors of inverse seizure of serotonin (including citalopram, fluoxetine, paroxetine, sertraline); old age, pregnancy (I, II trimester).

    Pregnancy and lactation:

    Application in pregnancy in the I and II trimester is possible if the expected effect of therapy exceeds the potential risk for the fetus, in the III trimester (especially after 36 weeks) - is contraindicated because of the possible influence on the tone of the uterus.

    Women planning a pregnancy should refrain from the use of ketoprofen, tk. on the background of its administration, the probability of implantation of the ovule may decrease.

    Like other substances that are excreted in breast milk, it is not recommended to use ketoprofen nursing mothers.
    Dosing and Administration:

    Inside, with food or immediately after eating, without chewing, with enough water.

    Adults appoint 1 tablet 1-2 times a day at intervals of 8 hours.

    The maximum daily dose is 200 mg.

    In order to prevent the negative effects of ketoprofen on the mucous membranes of the gastrointestinal tract, antacids can be taken at the same time.

    Side effects:

    From the digestive system: NSAID-gastropathy, abdominal pain, dyspepsia (nausea, vomiting, heartburn, flatulence, decreased appetite, diarrhea), stomatitis, impaired liver function, rarely - erosive and ulcerative lesions, bleeding and perforation of the gastrointestinal tract, taste change.

    From the nervous system: headache, dizziness, insomnia, agitation, nervousness, drowsiness, depression, asthenia, rarely - confusion or loss of consciousness, forgetfulness, memory impairment, migraine, peripheral neuropathy.

    From the sense organs: noise or ringing in the ears, blurred vision, rarely - conjunctivitis, dry eye mucosa, eye pain, conjunctival hyperemia, hearing loss, dizziness.

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

    From the respiratory system: hemoptysis, dyspnea, pharyngitis, rhinitis, bronchospasm, laryngeal edema (signs of anaphylactic reaction), rarely - asthma attacks.

    On the part of the organs of hematopoiesisI: rarely - agranulocytosis, anemia, hemolytic anemia, thrombocytopenia, leukopenia. High doses of ketoprofen can inhibit platelet aggregation, thus prolonging the bleeding time, and cause nasal bleeding and hematoma formation.

    From the urinary system: edematous syndrome, rarely - cystitis, urethritis, renal dysfunction, interstitial nephritis, nephrotic syndrome, rarely - hematuria.

    From the immune system: reactivity of the respiratory system, including bronchial asthma, its aggravation; bronchospasm or dyspnea (especially in patients with hypersensitivity to acetylsalicylic acid and other NSAIDs); very rarely - angioedema and anaphylaxis.

    Allergic reactions: skin rash (incl.erythematous, urticaria), skin itching, rhinitis, rarely exfoliative dermatitis.

    Other: increased sweating, rarely - hemoptysis, epistaxis, myalgia, muscle twitching, shortness of breath, thirst, photosensitivity, with prolonged use in large doses - vaginal bleeding.

    Laboratory indicators: very often - a deviation from the norm of liver function indicators.
    Overdose:Cases of drug overdose are not described. There is no specific antidote. Treatment is symptomatic.
    Interaction:

    With the simultaneous administration of ketoprofen and loop diuretics, the nephrotoxic effect of both drugs is enhanced.

    Reduces the effectiveness of uricosuric drugs, enhances the effect of anticoagulants, antiaggregants, fibrinolytic agents, ethanol, side effects of glucocorticosteroids and mineralocorticosteroids, estrogens, reduces the effectiveness of antihypertensive drugs and diuretics.

    Joint administration with other NSAIDs, glucocorticosteroids, ethanol, corticotropin can lead to the formation of ulcers and the development of gastrointestinal bleeding, an increased risk of kidney dysfunction.

    Simultaneous administration with oral anticoagulants, heparin, thrombolytic agents, antiaggregants, cefoperazone, cefamandol and cefotetan increases the risk of bleeding.

    Increases hypoglycemic action of insulin and oral hypoglycemic drugs (dose recalculation is necessary).

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

    Co-administration with sodium valproate reduces the aggregation of platelets.

    Increases the concentration in the plasma of verapamil and nifedipine, lithium preparations, methotrexate.

    Antacids and colestramine reduce absorption.

    Increases the hematotoxicity of myelotoxic drugs.

    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.

    Reception of ketoprofen can mask signs of an infectious disease.

    If the kidney and liver function is impaired, a dose reduction and careful monitoring is necessary.

    Effect on the ability to drive transp. cf. and fur:During the treatment period, care must be taken when driving vehicles and engaging in other potentially hazardous activities that require increased concentration and speed of psychomotor reactions.
    Form release / dosage:Tablets, film-coated, 100 mg.
    Packaging:For 20, 30, 50 tablets in a can of light-protective glass or in a polymer can, or in 2,3,5 contour squares - 10 tablets together with instructions for medical use in a pack of cardboard box.
    Storage conditions:

    Store in a dark place at a temperature not exceeding 30 FROM.

    Keep out of the reach of children.

    Shelf life:2 years.
    Do not use after the expiration date printed on the package.
    Terms of leave from pharmacies:On prescription
    Registration number:LP-001238
    Date of registration:17.11.2011
    The owner of the registration certificate:ORGANICS, JSC ORGANICS, JSC Russia
    Manufacturer: & nbsp
    Information update date: & nbsp17.11.2011
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