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

    one tablet contains:

    Name of components

    Amount, mg

    Tenoxicam

    20

    Lactose Monohydrate

    90,0

    Corn starch

    70,0

    Pregelatinized starch

    16,0

    Talc

    3,0

    Magnesium stearate

    1,0

    Opadry OY-S 22989 yellow

    5,6

    Hepromellosis

    2,9

    Titanium dioxide

    1,8

    Macragol-400 (polyethylene glycol 400)

    0,3

    Iron oxide yellow

    0,6

    Description:

    Yellow with a brown shade of color is oval, biconvex tablets covered with a film membrane with a risk on one side. On the cross section, the core is bright yellow.

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

    M.01.A.C.02   Tenoxicam

    Pharmacodynamics:

    Tenoxicam, which is a thienothiazine oxycam derivative, is a non-steroidal anti-inflammatory drug. In addition to anti-inflammatory, analgesic and antipyretic effects, the drug also interferes with the aggregation of platelets. Tenoxicam exerts its anti-inflammatory effect by suppressing the activity of cyclooxygenase isoenzymes involved in the metabolism of arachidonic acid, and thus suppresses the synthesis of prostaglandins. Tenoxicam does not affect the activity of lipoxygenases. Besides tenoxicam suppresses certain functions of leukocytes, including phagocytosis, histamine release and reduces the content of active radicals in the inflammatory focus.

    Pharmacokinetics:

    The drug is rapidly absorbed from the gastrointestinal tract in an unchanged form. Stach is reached 2 hours after taking the drug. When taking the drug after a meal or together with antacids, the speed decreases, but not the degree of its absorption. The average half-life is 70 hours. Tenoxicam it is absorbed completely, its bioavailability is 100%. In the blood, the drug binds to proteins by 99%. The drug penetrates well into the synovial fluid, is characterized by low systemic clearance and a long half-life, which allows you to take tenoxicam once a day. Two-thirds of the accepted dose of the drug is excreted in the urine, 1/3 - with feces. With long-term use, no accumulation of tenocsicam is observed; the serum content of the preparation is 10-15 μg / ml.

    Indications:

    Rheumatoid arthritis, osteoarthritis, ankylosing spondylitis, articular syndrome with exacerbation of gout, bursitis,tenosynovitis; pain syndrome (weak and moderate intensity): arthralgia, myalgia, neuralgia, migraine, dental and headache, algodismenorea; pain with injuries, burns.

    With inflammatory and degenerative diseases of the musculoskeletal system accompanied by pain syndrome such as, sciatica, lumbago, epicondylitis. 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, erosive-ulcerative lesions of the gastrointestinal tract (including in the anamnesis), gastrointestinal bleeding (including in the anamnesis), severe gastritis; complete or incomplete combination of bronchial asthma, recurrent nasal polyposis and eyesinus sinuses and intolerance to aminosalicylic acid or other non-steroidal anti-inflammatory drugs (including in the anamnesis); hemophilia, hypocoagulation, hepatic and / or renal failure (correlation coefficient less than 30 ml / min), inflammatory diseases of the gastrointestinal tract, progressive kidney disease, active liver disease,condition after aorto-coronary bypass surgery; confirmed hyperkalemia, hearing loss, pathology of the vestibular apparatus, deficiency of glucose-6-phosphate dehydrogenase; blood diseases, pregnancy, lactation.

    Carefully:

    Chronic heart failure, edema, arterial hypertension, diabetes mellitus, coronary heart disease, cerebrovascular disease, dyslipidemia / hyperlipidemia, peripheral arterial disease, smoking, chronic renal failure (KK 30-60 ml / min), infection N. pylori, long-term use of non-steroidal anti-inflammatory drugs, alcoholism, severe somatic diseases, simultaneous administration of oral glucocorticosteroids (including prednisolone), anticoagulants (including warfarin), antiplatelet agents (including acetylsalicylic acid, clopidogrel), selective inhibitors re-uptake of serotonin (including citalopram, fluoxetine, paroxetine, sertraline), elderly age.

    Pregnancy and lactation:Tenoxicam is contraindicated in pregnancy and lactation.
    Dosing and Administration:

    Inside.For 20 mg (1 tablet) 1 time per day, after meals (preferably at the same time, with prolonged use - 10 mg per day.

    In acute attacks of gout - 40 mg once a day for the first 2 days, then go to 20 mg once a day for 5 days.

    Elderly patients are prescribed at a dose of 20 mg / day.

    Side effects:

    The following undesirable phenomena were observed during treatment with the use of texamen at the following frequency:

    Very often (> 1/10); often (> 1/100 - <1/10); not often (> 1/1000 - <1/100); rarely (> 1/10000 - <1/1000); very rarely (<1/10000), the frequency is unknown (the frequency can not be determined based on the available data).

    The undesirable phenomena that can be observed against the use of teksamena in coated tablets include the following:

    Not often (> 1/1000 - <1/100)

    From the digestive system:

    A burning sensation in the stomach, stomach pain, vomiting, nausea, diarrhea, constipation, flatulence and gastropathy, abdominal pain, stomatitis, anorexia, and liver dysfunction. With prolonged use in large doses - ulceration of the mucous membrane of the gastrointestinal tract), bleeding (gastrointestinal, gingival, uterine, hemorrhoidal), perforation of intestinal walls.

    From the side of the cardiovascular system:

    heart failure, tachycardia, increased blood pressure.

    Rarely (> 1/10000 - <1/1000)

    Allergic Reagents:

    Rashes, itching, erythema and urticaria. Photodermatitis.

    From the nervous system:

    Headache, dizziness, drowsiness, depression, agitation, hearing loss, tinnitus, eye irritation, blurred vision.

    From the genitourinary system:

    Increase of urea nitrogen and creatinine in the blood.

    From the hematopoiesis:

    Agranulocytosis, leukopenia, rarely anemia, thrombocytopenia.

    Co side of the hepatobiliary system:

    Increase in activity of alanine transaminase, aspartate aminotransferase and gamma-glutamyltransferase and serum bilirubin level.

    Laboratory indicators:

    Hypercreatininaemia, hyperbilirubinemia, increased urea nitrogen concentration and activity of hepatic transaminases, prolonged bleeding time.

    On the background of treatment, there may be mental disorders and metabolic disorders.

    Very rarely (<1/10000): Stevens-Johnson syndrome, Lyell syndrome.

    The undesirable phenomena observed on the part of the hemopoiesis system include a decrease in the level of hemoglobin and granulocytopenia.

    Overdose:When an overdose of the drug requires symptomatic treatment
    Interaction:

    Reduces the effectiveness of uricosuric medicines, enhances the effect of anticoagulants, antiplatelet agents, fibrinolytics, side effects of adrenal cortex hormone and glucocorticosteroids and estrogens; reduces the effectiveness of antihypertensive drugs and diuretics; enhances the hypoglycemic effect of derivatives of sulfonyl urea.

    Increases concentration in blood preparations Li+, methotrexate.

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

    Antacids and colestramine reduce absorption.

    Other non-steroidal anti-inflammatory drugs are the risk of side effects, especially from the gastrointestinal tract.

    Myelotoxic drugs increase the manifestation of hematotoxicity of the drug.

    Special instructions:

    During the treatment, it is necessary to control the picture of peripheral blood and the functional state of the liver and kidneys, the prothrombin index (against the background of indirect anticoagulants),concentration of glucose in the blood (against the background of oral hypoglycemic medicinal means). If it is necessary to determine the 17-ketosteroids, the drug should be discontinued 48 hours before the test. A few days before the surgery, the drug is canceled. The possibility of delay Na+ and water in the body when administered with diuretics to patients with arterial hypertension and chronic heart failure.

    During the treatment period, care must be taken when driving vehicles and engaging in other potentially dangerous activities that require an increased concentration of attention and speed of psychomotor reactions.

    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:

    Impact on the ability to drive vehicles and manage mechanisms

    One of the undesirable effects of the drug is dizziness, this should be taken into account in situations requiring close attention of the patient,for example when driving a vehicle or complex technical devices.
    Form release / dosage:

    For 10 tablets in a blister of PVC / Al. One blister along with the instructions for use are placed in a cardboard box.

    Packaging:blisters (1) / instructions for medical use /
    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 expiry date printed on the package.
    Terms of leave from pharmacies:On prescription
    Registration number:LS-000294
    Date of registration:04.03.2010
    The owner of the registration certificate:Mustafa Nevzat Ilach Sanai A.Sh.Mustafa Nevzat Ilach Sanai A.Sh. Turkey
    Manufacturer: & nbsp
    Representation: & nbspASFARMA-ROS LLCASFARMA-ROS LLCRussia
    Information update date: & nbsp16.09.2015
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