Active substanceMeloksikamMeloksikam
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  • Dosage form: & nbsppills
    Composition:

    One tablet contains:

    active substance: meloxicam - 7.5 and 15 mg (in terms of 100% substance);

    Excipients: croscarmellose sodium, small dextrin, dextrin, calcium stearate monohydrate (calcium stearate 1-water) until a tablet weighing 0.1 and 0.2 g, respectively.

    Description:Round biconvex tablets from light yellow to yellow. Allowed a slight marbling.
    Pharmacotherapeutic group:Non-steroidal anti-inflammatory drug
    ATX: & nbsp

    M.01.A.C.06   Meloksikam

    M.01.A.C   Oksikamy

    Pharmacodynamics:

    Non-steroidal anti-inflammatory drug. Has anti-inflammatory, antipyretic, analgesic effect. Refers to the class of oxycomams; a derivative of enolic acid. Meloksikam suppresses the synthesis of prostaglandins in the inflammation region to a greater extent than in the gastric mucosa or kidneys, which is associated with a relatively selective inhibition of COX-2.

    When administered in high doses, prolonged use and individual characteristics of the organism, the selectivity of action against cyclooxygenase type 2 is reduced.

    Pharmacokinetics:

    Absorption from the gastrointestinal tract after ingestion - 89%. Eating does not affect absorption. Concentration in plasma is dose-dependent. The mean values ​​of Stach at reception of 15 mg of preparation Mataren® - 1,17 mkg / ml. The time to reach the maximum concentration is 4-6 hours. Equilibrium concentrations are achieved after 3-5 days.The connection with plasma proteins is 99%. Passes through the histogematic barriers, penetrates into the synovial fluid. The volume of distribution is low, an average of 11 liters.

    Concentration in the synovial fluid is 50% of the concentration in the plasma. Metabolised in the liver - to inactive metabolites. It is excreted through the intestine and kidneys (approximately in equal proportions), in unchanged form - 5% of the daily dose (through the intestine). The half-life period is 20 hours. Plasma clearance is an average of 8 ml / min (decreases in old age).

    Indications:Rheumatoid arthritis; osteoarthritis; ankylosing spondylitis (Bechterew's disease) and other inflammatory and degenerative joint diseases accompanied by pain syndrome.
    Contraindications:

    Hypersensitivity to any component of the drug, as well as to non-steroidal anti-inflammatory drugs of other groups;

    Presence in an anamnesis of attacks of a bronchial asthma, a urticaria or an acute rhinitis provoked by reception of an acetylsalicylic acid or other NSAIDs;

    Exacerbation of peptic ulcer of stomach and duodenum;

    Severe hepatic impairment;

    Severe heart failure;

    Chronic renal failure in patients not undergoing hemodialysis; Gastrointestinal, cerebrovascular or other bleeding.

    Children's age (up to 12 years), pregnancy, lactation.

    Carefully:The drug should be used with caution in elderly patients, in patients with an erosive-ulcerative lesion of the gastrointestinal tract in an anamnesis.
    Pregnancy and lactation:

    The use during pregnancy is contraindicated.

    During the lactation period, when the drug is used, the question of stopping breastfeeding should be addressed.

    Dosing and Administration:

    Inside, with food, once a day.

    With rheumatoid arthritis and Bechterew's disease (ankylosing spondylitis) at 15 mg / day, when a positive therapeutic effect is achieved, the dose can be reduced to 7.5 mg / day.

    For osteoarthritis, 7.5 mg / day, if necessary, increase the dose to 15 mg / day. The maximum daily dose is 15 mg.

    The initial dose in patients with an increased risk of side effects is 7.5 mg / day.

    In patients with severe renal impairment on hemodialysis, the maximum daily dose of 7.5 mg.When slight or moderate decrease in renal function (creatinine clearance of more than 25 ml / min) as well as in liver cirrhosis in a stable clinical condition - correction dose is not required.

    Side effects:

    From the digestive system: more than 1% - dyspepsia, incl. nausea, vomiting, abdominal pain, constipation, flatulence, diarrhea; 0.1-1% - a transient increase in the activity of "liver" transaminases, hyperbilirubinemia, belching, esophagitis, gastroduodenal ulcer, bleeding from the gastrointestinal tract (including latent), stomatitis; less than 0.1% - perforation of the gastrointestinal tract, colitis, hepatitis, gastritis.

    On the part of the organs of hematopoiesis: more than 1% - anemia; 0.1-1% change in the blood formula, incl. leukopenia, tamocytopenia.

    From the skin: more than 1% - itching, skin rash; 0,1-1% - urticaria; less than 0.1% - photosensitivity, bullous eruptions, erythema multiforme, incl. Stevens-Johnson syndrome, toxic epidermal necrolysis.

    From the respiratory system: less than 0.1% - bronchospasm.

    From the nervous system: more than 1% - dizziness, headache; 0,1-1% - vertigo, tinnitus, drowsiness; less than 0,1% - confusion, disorientation, emotional lability.

    From the side of the cardiovascular system: more than 1% - peripheral edema; 0.1-1% - increased blood pressure, palpitations, "tides" of blood to the skin of the face.

    From the side of the urinary system: 0.1-1% - hypercreatininaemia and / or elevated urea in the blood serum; less than 0.1% - acute renal failure; connection with the reception of meloxicam is not established - interstitial nephritis, albuminuria, hematuria.

    From the sense organs: less than 0.1% - conjunctivitis, visual impairment, incl. blurred vision.

    Allergic reactions: less than 0.1% - angioedema, anaphylactoid / anaphylactic reactions.

    Overdose:

    If the recommended dose is not observed when taken orally, an overdose of the drug may occur, manifested in an increase in side effects.

    Treatment: gastric lavage and symptomatic therapy. There are no specific antidotes and antagonists.

    Interaction:

    With the simultaneous administration of other non-steroidal anti-inflammatory drugs, the risk of ulcerative lesions of the gastrointestinal tract and gastrointestinal hemorrhage increases.

    Meloksikam increases the concentration of lithium (Li +) in plasma.

    Reduces the effectiveness of intrauterine contraceptives, hypotensive drugs.

    Indirect anticoagulants, ticlopidine, heparin, thrombolytics increase the risk of bleeding. Methotrexate enhances myelodepressant effect, it is not recommended to share methotrexate in a dose of more than 15 mg per week.

    Diuretics increase the risk of kidney dysfunction.

    Cyclosporine increases nephrotoxicity.

    Kolestyramin accelerates excretion.

    Myelotoxic drugs increase the manifestation of hematotoxicity of the drug.

    Special instructions:

    In the event of peptic ulcers or gastrointestinal bleeding, the development of side effects from the skin and mucous membranes, the drug should be discarded.

    In patients with reduced circulating blood volume and reduced glomerular filtration (dehydration, chronic heart failure, cirrhosis, nephrotic syndrome, clinically pronounced kidney disease, diuretics, dehydration after large surgical operations), there may be a clinically pronounced chronic renal failure,which is completely reversible after drug withdrawal (in such patients at the beginning of treatment should monitor daily diuresis and kidney function). With a persistent and significant increase in transaminases and changes in other indicators of liver function, the drug should be withdrawn and control tests carried out.

    In patients with an increased risk of side effects, treatment starts with a dose of 7.5 mg. In the terminal stage of chronic renal failure in patients on hemodialysis, the dose should not exceed 7.5 mg / day.

    Effect on the ability to drive transp. cf. and fur:During the period of treatment, care must be taken (when dizziness and drowsiness occur) when driving vehicles and taking other potentially dangerous activities that require an increased concentration of attention and speed of psychomotor reactions.
    Form release / dosage:Tablets of 7.5 and 15 mg.
    Packaging:For 10 tablets in a planar cell package. 1 or 2 contoured cell packs together with instructions for medical use of the drug in a cardboard pack.
    Storage conditions:

    List B.

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

    Shelf life:

    2 years.

    Do not use the drug after the expiration date.

    Terms of leave from pharmacies:On prescription
    Registration number:LSR-000071
    Date of registration:22.05.2007 / 10.12.2009
    Expiration Date:Unlimited
    The owner of the registration certificate:NIZHFARM, JSC NIZHFARM, JSC Russia
    Representation: & nbspNizhpharm, JSCNizhpharm, JSCRussia
    Information update date: & nbsp26.03.2018
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