Active substancePiroxicamPiroxicam
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  • Dosage form: & nbspCapsules.
    Composition:

    Composition per one capsule:

    Piroxicam (in terms of 100% substance) - 10 mg or 20 mg.

    Excipients: - microcrystalline cellulose, potato starch, talc, silicon dioxide colloid. Capsules hard gelatinous: gelatin, titanium dioxide, iron oxide yellow, indigocarmine, water.

    Description:

    Hard gelatin capsules No. 3 (for a dosage of 10 mg), a blue lid, a white body or No. 2 (for a dosage of 20 mg), a green lid, a white body. The contents of the capsules are white to light yellow powder.

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

    M.02.A.A.07   Piroxicam

    Pharmacodynamics:

    Piroxicam is a non-steroidal anti-inflammatory drug (NSAID) with anti-inflammatory, analgesic and antipyretic effects. Non-selectively inhibits the activity of cyclooxygenase 1 and cyclooxygenase 2 (COX1 and COX2), inhibits the synthesis of prostaglandins in the inflammatory focus and central nervous system, suppresses the exudative and proliferative phase of inflammation. It inhibits the aggregation of neutrophils and the formation of superoxide anions in them, the migration of polymorphonuclear cells and monocytes to the focus of inflammation. Reduces the release of lysosomal enzymes from stimulated leukocytes. Reduces the pyrogenic effect of prostaglandins on the center of thermoregulation. Reduces the severity of the pain syndrome of moderate intensity, increasing the threshold of pain sensitivity to biological amines. The analgesic effect is manifested 30 minutes after oral administration. After a single dose, the effect persists for 24 hours. With articular syndrome, it weakens or stops inflammation and pain at rest during movement, reduces morning stiffness and swelling of the joints, and increases the volume of movements.When algodismenorea (being an inhibitor of the synthesis of prostaglandins in the endometrium), it pains the pain syndrome.

    Pharmacokinetics:

    When ingested, the drug is well absorbed from the gastrointestinal tract, the maximum concentration in the plasma is proportional to the dose used. The maximum concentration in the plasma is achieved 3-5 hours after taking the drug inside. After a single dose of 20 mg Cmax - 1,5-2 mcg / ml, after a regular intake of 20 mg / day - 3-8 mcg / ml. Food slows the rate of absorption, but does not affect the amount of absorption. Bioavailability is almost 100%. The time to reach the equilibrium concentration is 7-12 days. It penetrates into the synovial fluid (40-50%), excreted in breast milk - 1-3%. Easily binds to blood plasma proteins (almost 98%).

    The half-life is 24-50 hours, with liver disease may be prolonged. The drug is metabolized in the liver by hydroxylating the side chain pyridine ring, followed by conjugation with glucuronic acid and the formation of inactive metabolites. It is excreted in the form of conjugates by the kidneys and to a lesser extent - through the intestines. In unchanged form, about 5% is deduced.

    Indications:

    Diseases of the musculoskeletal system: rheumatoid arthritis, osteoarthritis, spondylitis, sciatica, psoriatic arthropathy, gout, tendovaginitis, bursitis, Bechterew's disease (spondyloarthritis ankylosing), pain in the spine, neuralgia, myalgia, postoperative and posttraumatic pains, extra-articular rheumatic diseases, tissues. Algodismenorea. 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 to piroxicam, other non-steroidal anti-inflammatory drugs, components of the drug;
    • complete or incomplete combination of bronchial asthma, recurrent polyposis of the nasal mucosa or paranasal sinuses and intolerance to acetylsalicylic acid and other NSAIDs (including anamnesis);
    • erosive and ulcerative changes in the mucous membrane of the stomach or duodenum, active gastrointestinal bleeding; cerebrovascular or other bleeding;
    • inflammatory bowel disease (Crohn's disease, ulcerative colitis) during the exacerbation phase;
    • hemophilia and other bleeding disorders;
    • Decompensated heart failure;
    • hepatic insufficiency or any active liver disease;
    • marked renal failure (creatinine clearance less than 30 ml / min), progressive kidney disease, confirmed hyperkalemia;
    • period after aortocoronary shunting;
    • pregnancy, the period of breastfeeding;
    • children's age till 15 years.
    Carefully:

    • age over 65;
    • ischemic heart disease, cerebrovascular disease, congestive
    • heart failure;
    • dyslipidemia / hyperlipidemia;
    • arterial hypertension;
    • diabetes;
    • diseases of peripheral arteries;
    • bronchial asthma;
    • presence of hepatic porphyria;
    • clearance of creatinine from 30-60 ml / min;
    • postoperative period;
    • dehydration;
    • smoking;
    • anamnestic data on the development of gastrointestinal ulceration, the presence of Helicobacter pylori infection, prolonged use of NSAIDs, frequent alcohol consumption, severe physical illness, concomitant therapy with the following drugs:
    - anticoagulants (for example, warfarin);
    - antiaggregants (for example acetylsalicylic acid, clopidogrel);
    - oral glucocorticosteroids (for example, prednisolone);
    - selective serotonin reuptake inhibitors (eg, citalopram, fluoxetine, paroxetine, sertraline).

    Dosing and Administration:

    Adults and children over 15 years of age - inside with food.

    Diseases of the musculoskeletal system, joint diseases (rheumatoid arthritis, osteoarthritis, spondylitis), the initial and maintenance dose is 10-20 mg per day in 1 or 2 doses.

    If necessary, the dose may be temporarily increased to 30 mg per day (once or in divided doses) or reduced to 10 mg per day.

    Acute diseases of the musculoskeletal system: the first 2 days, 40 mg per day, once or several times. The maintenance dose is 20 mg per day for 1-2 weeks.

    Acute attack of gout: take 40 mg for 4-6 days.

    Postoperative and post-traumatic pain: the initial dose is 20 mg once a day.

    In some cases it is possible to increase the dose with the appointment in the first two days of 40 mg once or in divided doses.

    For algodismenosis: treatment should begin when the first symptoms appear. At an initial dose of 40 mg / day in 1 or more doses for 2 days. In the next 1-3 days - 20 mg per 1 reception.

    The maximum daily dose of the drug for adults and children over 15 years of age should not exceed 40 mg.

    Do not exceed the recommended daily dose, as this increases the risk of side effects.

    Side effects:

    The most frequently manifested by the gastrointestinal tract and digestive organs: pain in the epigastric region, belching, nausea, decreased appetite, vomiting, constipation or diarrhea, flatulence, erosive ulcerative lesions of the gastrointestinal tract, bleeding in the gastrointestinal tract, which in exceptional cases may cause anemia, perforation of the organs of the gastrointestinal tract; dry mouth, stomatitis.

    From the hepatobiliary system: impaired liver function, increased activity of "liver" transaminases; an increase in the concentration of nitrogen and creatinine in the plasma.

    From the urinary system: renal dysfunction, interstitial nephritis, papillary necrosis, nephrotic syndrome, erythrocyturia, proteinuria, hyper- or hypokalemia, glomerulonephritis, nephrosis.

    From the central nervous system: dizziness, headache, tinnitus, drowsiness, insomnia, less often - depression, irritability, hallucinations, paresthesia, inhibition, mood change.

    From the hemopoietic system and hemostasis: anemia, including aplastic and hemolytic, decreased hemoglobin, reduced hematocrit; leukopenia, eosinophilia, rarely - thrombocytopenia, bleeding, thrombocytopenic purpura (Henoch's disease); suppression of bone marrow function.

    From the cardiovascular system: increase or decrease in blood pressure, signs of heart failure, rarely - palpitation, dyspnea.

    Allergic reactions: skin rash, pruritus, erythema reaction, photosensitivity, Lyell syndrome, facial swelling, larynx, bronchospasm, malignant erythema multiforme (Stevens-Johnson syndrome), anaphylactic shock, vasculitis, serum sickness.

    Other: visual impairment, edema of the shins and feet, increased sweating, increased urea concentration; increase or decrease in body weight.

    The frequency of the above disorders increases with an increase in the daily dose of the drug.

    Overdose:

    Symptoms: abdominal pain, nausea, vomiting, drowsiness, visual impairment, when taking very large doses - loss of consciousness, coma.Treatment: gastric lavage with activated charcoal, antacids are used to slow the absorption. When severe poisoning the patient should be hospitalized. There is no specific antidote. Treatment is symptomatic.

    Interaction:

    With the simultaneous use of piroxicam and:

    • glucocorticosteroids and / or NSAIDs - there is an increased risk of side effects from the gastrointestinal tract, including bleeding;
    • phenobarbital - the level of piroxicam concentration in serum is reduced;
    • cimetidine, probenecid and sulfinpyrazone - the level of serum piroxicam concentration may increase, leading to an increased side effect of piroxicam;
    • phenytoin and / or lithium, and potassium-sparing diuretics and donators K + - can increase the level of concentration in plasma phenytoin, lithium, and potassium;
    • diuretics and antihypertensive drugs - the effect of the latter is weakened;
    • anticoagulants - the ability of platelets to aggregate decreases (risk of bleeding), it is necessary to monitor blood coagulability;
    • Acetylsalicylic acid - reduces the concentration of piroxicam in the serum,increased risk of erosive and ulcerative gastrointestinal lesions;
    • selective serotonin reuptake inhibitors (citalopram, fluoxetine, paroxetine, sertraline) the risk of development of erosive and ulcerative gastrointestinal lesions is increased;
    • methotrexate - may increase the concentration of methotrexate and increase its toxic effect.

    Special instructions:

    To prevent undesirable effects, the drug should only be used as directed by the doctor at the lowest effective dose, the minimum possible short course.

    The simultaneous use of several non-steroidal anti-inflammatory drugs increases the risk of side effects, while the therapeutic effect does not improve.

    The drug can change the properties of platelets, but does not replace the preventive effect of acetylsalicylic acid in cardiovascular diseases.

    With extreme caution, the drug should be prescribed to patients with impaired liver or kidney function, using diuretics, after extensive surgical interventions, in the elderly. Such patients need to control the cellular composition of the blood, the function of the kidneys.

    After 2 weeks of using the drug, it is necessary to monitor the parameters of liver function (transaminase).

    To reduce the risk of developing adverse events from the gastrointestinal tract, use a minimally effective dose with the minimum possible short course.

    If during treatment with the drug the patient shows signs of an ulcer in the gastrointestinal tract, then treatment must be interrupted; if the use of the drug is absolutely necessary, the treatment should be carried out under the supervision of a doctor with the simultaneous use of antacid agents.

    It is not recommended to prescribe the drug to patients with bronchial asthma, allergic rhinitis, polyps of the nasal mucosa, as well as in chronic obstructive airways diseases.

    The use of the drug may adversely affect female fertility and is not recommended for women planning pregnancy.

    During treatment with the drug, alcohol is not allowed.

    Recommendations for use in children under 15 years are currently not developed.

    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 potentiallydangerous activities that require increased concentration and speed of psychomotor reactions.

    Form release / dosage:

    Capsules of 10 or 20 mg.

    Packaging:

    10 capsules per contour cell packaging made of polyvinylchloride film and aluminum foil printed lacquered.

    2 contour squares with instructions for use in a pack of cardboard.

    Storage conditions:

    Store in a dry place, protected from light, out of reach of children, at a temperature not exceeding 25 ° C.

    Shelf life:

    2 years. Do not use after the expiry date printed on the package.

    Terms of leave from pharmacies:On prescription
    Registration number:LS-000223
    Date of registration:06.10.2009
    The owner of the registration certificate:PRODUCTION OF MEDICINES, LTD. PRODUCTION OF MEDICINES, LTD. Russia
    Manufacturer: & nbsp
    Information update date: & nbsp16.10.2015
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