The Texman (Texamen)

Composition Pharmacodynamics Indications Carefully Contraindications Dosing and Administration Side effects Form release / dosage
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Active substanceTenoxicamTenoxicam
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  • Artoxane
    lyophilizate w / m in / in 
    Rotafarm Limited     United Kingdom
  • The Texman
    lyophilizate w / m in / in 
    Mustafa Nevzat Ilach Sanai A.Sh.     Turkey
  • The Texman
    pills inwards 
    Mustafa Nevzat Ilach Sanai A.Sh.     Turkey
    • Dosage form: & nbsplyophilizate for the preparation of solution for intravenous and intramuscular administration
    Composition:

    In 1 Bottle contains:

    Active substance:

    Tenoxicam

    20.00 mg

    Heb.

    Auxiliary components:

    Mannitol

    57.33 mg

    Heb.

    Sodium hydroxide

    3.28 mg

    Heb.

    Trometamol

    3.00 mg

    Heb.

    Sodium metabisulfite

    2.00 mg

    Heb.

    Disodium Edetate

    0.20 mg

    Heb.

    Description:Lyophilized yellow powder with a greenish shade of color.
    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 period 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 prolonged use, there is no accumulation of Tenoxicam; 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, reduction of 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), gastritis of severe course; complete or incomplete combination of bronchial asthma, recurrent nasal polyposis and paranasal sinuses and ASA intolerance or other NSAIDs (including in history); hemophilia, hypocoagulation, hepatic and / or renal failure (QC less than 30 ml / min), inflammatory diseases of the digestive tract, progressive kidney disease, active liver disease, condition after CABG; confirmed hyperkalemia, hearing loss, pathology of the vestibular apparatus, deficiency of glucose-6-phosphate dehydrogenase; blood diseases, pregnancy, lactation.

    Carefully:

    Chronic obstructive pulmonary disease, edema, arterial hypertension, diabetes mellitus, coronary artery disease, cerebrovascular diseases, dyslipidemia / hyperlipidemia, peripheral arterial disease, smoking, CRF (KK 30-60 ml / min), infection N. pylori, long-term use of NSAIDs, alcoholism, severe somatic diseases, simultaneous administration of oral GCS (including prednisolone), anticoagulants (including warfarin), antiplatelet agents (including acetylsalicylic acid, clopidogrel), selective inhibitors of reuptake serotonin (including citalopram, fluoxetine, paroxetine, sertraline), elderly age.

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

    Intramuscularly, intravenously. Injections Texamen appointed for short-term treatment - 20 mg per day, with long-term treatment - 20 mg per day, with long-term use - 10 mg per day. With gouty arthritis 1-2 days 40 mg per day is prescribed, and the next 3-5 days -20 mg per day. The prescribed dose should be applied in one dose.

    Side effects:

    The undesirable phenomena that can occur when using Texamen in coated tablets include the following:

    Disturbances from the digestive system (1.4% of cases):

    A burning sensation in the stomach, stomach pain, vomiting, nausea, diarrhea, constipation, flatulence, etc. NSAIDs-gastropathy, abdominal pain, stomatitis, anorexia, liver dysfunction. With prolonged use in large doses - ulceration of the mucous membrane of the gastrointestinal tract 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.

    Disorders from the central nervous system (2.6% of cases):

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

    Disturbances from the skin and subcutaneous tissue (2.5% of cases):

    Rashes, itching, erythema and urticaria. Photodermatitis, Stevens-Johnson syndrome, Lyell's syndrome were extremely rare.

    Disorders from the urinary system (1-2%):

    Increase of urea nitrogen and creatinine in the blood.

    Violations from hand hematopoiesis P-2%):

    Agranulocytosis, leukopenia, rarely anemia, thrombocytopenia.

    Disorders from the hepatobiliary system (1-2%):

    Increased ALT activity, ACT, gamma-HT and serum bilirubin levels.

    Laboratory indicators:

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

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

    On the background of treatment, there may be mental disorders (1.7%) and metabolic disorders (1%).

    Overdose:In case of an overdose of the drug, symptomatic treatment is necessary.
    Interaction:

    Reduces the effectiveness of uricosuric drugs, increases the effect of anticoagulants, antiaggregants, fibrinolytics, side effects of MCH and GCS, estrogens; reduces the effectiveness of antihypertensive drugs and diuretics; enhances the hypoglycemic effect of sulfonylurea derivatives. 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.

    Dr. NSAIDs are a risk of side effects, especially from the digestive tract. Myelotoxic drugs increase the manifestation of hematotoxicity of the drug.

    Special instructions:

    During treatment, it is necessary to monitor the pattern of peripheral blood and the functional state of the liver and kidneys, the prothrombin index

    the background of indirect anticoagulants), the concentration of glucose in the blood (against the background of oral hypoglycemic drugs). If it is necessary to determine 17-ketosteroids, the drug should be discontinued 48 hours before the test.

    A few days before 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 CHF.

    To reduce the risk of developing adverse events on the part of 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: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.
    Form release / dosage:

    Primary packaging

    The lyophilized powder containing 20 mg of the active ingredient is placed in a colorless glass type 3 bottle sealed with a bromobutyl rubber stopper, crimped with an aluminum ring or an aluminum cap "flip off" with plastic disc or plastic lid, over aluminum.

    Solvent (water for injection): 2 ml per ampoule of colorless glass. Secondary packaging:

    1 bottle with the drug and 1 ampoule with the solvent is placed in a cassette made of polyvinyl chloride; 1 cassette along with the instructions for use are placed in a cardboard box.

    1 bottle with the drug and 1 ampoule with a solvent, along with instructions for use, are placed in a cardboard box.

    50 bottles of the drug are placed in a cardboard box (for hospitals): with instructions for use; 50 ampoules of solvent are placed in a separate cardboard box (for hospitals).

    Packaging:

    (50) - vial, ampoule (1) / instructions for medical use / - a pallet of PVC, a pack of cardboard

    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-000295
    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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