Active substanceMeloksikamMeloksikam
Similar drugsTo uncover
  • Ameloteks®
    pills inwards 
  • Ameloteks®
    suppositories rect. 
  • Arthrosan®
    pills inwards 
  • Arthrosan®
    solution w / m 
  • Bi-ksikam
    solution w / m 
    VEROPHARM SA     Russia
  • Bi-ksikam
    pills inwards 
    VEROPHARM SA     Russia
  • Genitron®
    pills inwards 
    FARMAK, PAO     Ukraine
  • Genitron®
    solution w / m 
    FARMAK, PAO     Ukraine
  • M-Kam®
    pills inwards 
  • Matarin®
    pills inwards 
    NIZHFARM, JSC     Russia
  • Medsikam®
    pills inwards 
    FARMAKTIV, LLC     Russia
  • MELBEK®
    pills inwards 
  • Melbeck® forte
    pills inwards 
  • Meloks®
    pills inwards 
    Medocemi Co., Ltd.     Cyprus
  • Meloksikam
    pills inwards 
  • Meloksikam
    pills inwards 
  • Meloksikam
    solution w / m 
  • Meloksikam
    pills inwards 
    ALSI Pharma, ZAO     Russia
  • Meloksikam
    pills inwards 
    OZONE, LLC     Russia
  • Meloksikam
    pills inwards 
    ALTAYVITAMINS, CJSC     Russia
  • Meloksikam
    pills inwards 
    VERTEKS, AO     Russia
  • Meloksikam
    solution w / m 
    ATOLL, LLC     Russia
  • Meloksikam
    suppositories rect. 
    DALHIMFARM, OJSC     Russia
  • Meloksikam
    solution w / m 
    ALVILS, LTD.     Russia
  • Meloksikam
    pills inwards 
  • Meloksikam
    solution w / m 
    BIOSINTEZ, PAO     Russia
  • Meloxicam Velpharm
    pills inwards 
    VELFARM, LLC     Republic of San Marino
  • Meloxicam Velpharm
    solution w / m 
    VELFARM, LLC     Republic of San Marino
  • Meloksikam DS
    solution w / m 
  • Meloksikam STADA
    pills inwards 
    NIZHFARM, JSC     Russia
  • Meloksikam-OBL
    pills inwards 
  • Meloksikam-Prana
    pills inwards 
    PRANAFARM, LLC     Russia
  • Meloksikam-SZ
    pills inwards 
    NORTH STAR, CJSC     Russia
  • Meloxicam-SOLOFARM
    solution w / m 
    GROTEKS, LLC     Russia
  • Meloksikam-Teva
    pills inwards 
  • Meloflam®
    pills inwards 
  • Meloflex Rompharm
    solution w / m 
  • Mesipol®
    solution w / m 
  • MIXOL-OD
    pills inwards 
  • Mirlox®
    pills inwards 
  • Movageyn® Express
    pills inwards 
  • Movalis®
    suspension inwards 
  • Movalis®
    solution w / m 
  • Movalis®
    pills inwards 
  • Movalis®
    suppositories rect. 
  • Movasin®
    solution w / m 
    BIOKOM, CJSC     Russia
  • Movasin®
    pills inwards 
    BIOKOM TECHNOLOGY, LLC     Republic of Belarus
  • Movix®
    pills inwards 
    Unifarm JSC     Bulgaria
  • Oxycamox®
    pills inwards 
    Sandoz d.     Slovenia
  • Flexibon
    pills inwards 
  • Exen-Sanovel
    pills inwards 
  • Dosage form: & nbsp

    pills

    Composition:

    Each tablet contains:

    Active substance:

    Meloksikam - 7.5 mg, 15 mg.

    Excipients:

    Sodium citrate dihydrate is 13.50 mg, 27.00 mg.

    Lactose monohydrate is 18.75 mg, 37.50 mg.

    Cellulose microcrystalline - 85.00 mg, 170.00 mg.

    Povidone - 8.25 mg, 16.50 mg.

    Crospovidone - 12.50 mg, 25.00 mg.

    Silicon dioxide colloid - 3,00 mg, 6,00 mg.

    Magnesium stearate - 1.50 mg, 3.00 mg

    Description:Light yellow round, flat tablets with separating risk on one side. Insignificant marbles, inclusions and roughness of the surface are permissible.
    Pharmacotherapeutic group:Non-steroidal anti-inflammatory drug
    ATX: & nbsp

    M.01.A.C.06   Meloksikam

    M.01.A.C   Oksikamy

    Pharmacodynamics:Meloksikam - non-steroidal anti-inflammatory drug (NSAID), which has anti-inflammatory, analgesic and antipyretic effects. Anti-inflammatory effect is associated with inhibition of the enzymatic activity of cyclooxygenase-2 (COX-2), involved in the biosynthesis of prostaglandins in the inflammatory region. Less meloxicam acts on cyclooxygenase-1 (COX-1), involved in the synthesis of prostaglandin, which protects the mucous membrane of the gastrointestinal tract (GIT) and takes part in the regulation of blood flow in the kidneys.
    Pharmacokinetics:

    After oral administration meloxicam is well absorbed from the digestive tract. Bioavailability is about 90%. Simultaneous food intake does not change the intake. When using the drug inside at doses of 7.5 and 15 mg, its concentrations are proportional to the doses.The maximum concentration in the blood plasma (about 1000 μg / l for a dose of 7.5 mg) after a single dose is achieved after approximately 4-6 hours. Equilibrium concentrations are achieved within 3-5 days. With long-term use of the drug (more than 1 year), the concentrations are similar to those that occur after the first achievement of a steady state of pharmacokinetics. Binding to plasma proteins is more than 99%. The range of differences between the maximum and basal concentrations of the drug after its administration once a day is relatively small and amounts to using a dose of 7.5 mg 0.4-1.0 μg / ml, and when a dose of 15 mg is 0.8-2, 0 μg / ml (respectively, the values ​​of Cmin and Cmax). Meloksikam penetrates through the histohematological barriers. The concentration of the drug in the synovial fluid reaches 40-50% of the maximum concentration of the drug in the blood plasma.

    Almost completely metabolized in the liver with the formation of four pharmacologically inactive derivatives. The main metabolite, 5-carboxy- meloxicam (60% of the dose) is formed by oxidation of the intermediate metabolite of 5-hydroxymethylmeloxicam, which is also excreted, but to a lesser degree (9% of the dose).In vitro studies have shown that in this metabolic transformation an important role is played by CYP 3A4. In the formation of the other two metabolites (constituting 16% and 4% of the dose, respectively), peroxidase takes part, the activity of which probably varies individually. The drug is excreted equally with feces and urine, mainly in the form of metabolites. In the unchanged form, less than 5% of the daily dose is output, and in the urine in unchanged form meloxicam is found only in trace amounts. The half-life of meloxicam is 15-20 hours. The average plasma clearance is 8 ml / min. In elderly people, the clearance of the drug is reduced.

    The volume of distribution is low and averages 11 liters.

    The drug is not excreted by dialysis.

    Moderate dysfunction of the liver and / or kidneys does not have a significant effect on the pharmacokinetics of meloxicam.

    Indications:

    - Symptomatic treatment of rheumatoid arthritis;

    - Symptomatic treatment of osteoarthritis;

    - Symptomatic treatment of ankylosing spondylitis (Bekhterev's disease).

    Contraindications:

    - Hypersensitivity to meloxicam or other component of the drug, including anamnestic information;

    - a combination of bronchial asthma, recurrent nasal polyposis and paranasal sinuses and intolerance to acetylsalicylic acid and drugs of pyrazolone series;

    - Stomach ulcer and duodenal ulcer (in the phase of exacerbation);

    - inflammatory bowel disease (in the phase of exacerbation);

    - cerebrovascular or other bleeding;

    severe hepatic insufficiency or active liver disease;

    - chronic renal failure in patients not undergoing dialysis (creatinine clearance less than 30 ml / min), progressive kidney disease, confirmed hyperkalemia;

    - active gastrointestinal hemorrhage;

    severe uncontrolled heart failure;

    - conditions after aortocoronary shunting;

    - Congenital lactase deficiency, lactose intolerance, glucose-galactose malabsorption;

    - children under the age of 15;

    - Pregnancy;

    - the period of breastfeeding.

    Carefully:Elderly age, ischemic heart disease, chronic heart failure, cerebrovascular disease, dyslipidemia / hyperlipidemia, diabetes mellitus, peripheral arterial disease,chronic renal failure (creatinine clearance 30-60 ml / min), ulcerative gastrointestinal lesions in history, the presence of Helicobacter pylori infection, prolonged use of NSAIDs, alcoholism, smoking, severe somatic diseases, simultaneous intake of oral glucocorticosteroids (including prednisolone), anticoagulants (including warfarin), antiaggregants (including clopidogrel), selective serotonin reuptake inhibitors (including citalopram, fluoxetine, paroxetine, sertraline).
    Pregnancy and lactation:Meloks® is contraindicated during pregnancy. For the duration of treatment, breastfeeding should be discontinued.
    Dosing and Administration:

    The drug is taken once a day, with food.

    Rheumatoid arthritis: 15 mg / day. If the therapeutic effect is sufficient, the dose can be reduced to 7.5 mg / day.

    Osteoarthritis: 7.5 mg / day. If necessary, it is possible to increase the dose to 15 mg / day.

    Ankylosing spondylitis: 15 mg / day.

    The maximum daily dose is 15 mg. In patients with an increased risk of developing unwanted effects, as well as in patients with severe renal failure who are on hemodialysis, the daily dose should not exceed 7.5 mg.

    Side effects:

    Undesirable reactions are listed according to the following gradation: often (≥1%, <10%); infrequently (> 0.1%, <1%); rarely (> 0.01%, <0.1%); very rarely (<0.01 including individual messages.

    Meloks® is usually well tolerated. However, the following side effects may occur:

    From the digestive system: often - dyspepsia, nausea, vomiting, abdominal pain, constipation, flatulence, diarrhea; infrequently - stomatitis, transient changes in liver function indicators (for example, an increase in the level of transaminases or bilirubin), belching, esophagitis, gastroduodenal ulcer, bleeding from the gastrointestinal tract (including latent); rarely - perforation of the gastrointestinal tract, colitis, hepatitis, gastritis.

    From the respiratory system: rarely - an attack of bronchial asthma.

    From the central nervous system: often - headache; infrequently - dizziness, vertigo, noise in the ears, drowsiness; rarely confusion, disorientation, emotional lability.

    From the sense organs: rarely - conjunctivitis, impaired vision.

    From the cardiovascular system: often - peripheral edema; infrequently - increased blood pressure, palpitations, "tides" of blood to the face.

    From the hematopoiesis: often - anemia; infrequently - a change in the blood formula, incl. leukopenia, thrombocytopenia.

    From the genitourinary system: infrequently - changes in renal function (increase in the level of creatinine and / or urea blood); rarely acute renal failure; connection with the reception of meloxicam is not established - interstitial nephritis, albuminuria, hematuria.

    From the skin and mucous membranes: often - itching, skin rash; infrequently - hives; rarely - photosensitivity, bullous eruptions, erythema multiforme, incl. Stevens-Johnson syndrome, toxic epidermal necrolysis.

    Allergic Reagents: rarely - angioedema, immediate type hypersensitivity reactions, including anaphylactoid / anaphylactic.

    Others: fever.

    Overdose:

    Symptoms: impaired consciousness, nausea, vomiting, epigastric pain, gastrointestinal bleeding, acute renal failure, hepatic insufficiency, respiratory arrest, asystole.

    Treatment: there is no specific antidote. In case of overdosage, gastric lavage should be performed, activated charcoal intake should be prescribed (within the next hour) and symptomatic therapy.

    To accelerate the excretion of meloxicam can be applied colestramine.

    Hemodialysis, forced diuresis and alkalinization of urine are not effective because of the high connection of the drug with blood proteins.

    Interaction:

    Joint application of Melox with:

    - other NSAIDs, including salicylates in high doses: simultaneous administration of more than one drug from the NSAID group may increase the risk of erosive ulcerative lesions and bleeding of the gastrointestinal tract;

    - anticoagulants (ticlopidine, heparin, warfarin, as well as thrombolytic drugs (streptokinase, fibrinolysin): increased risk of bleeding. It is necessary to periodically monitor the coagulability of blood;

    - selective serotonin reuptake inhibitors the risk of developing gastrointestinal bleeding increases.

    - lithium preparations: it is possible to develop cumulation of lithium and increase its toxic effect (it is recommended to monitor the concentration of lithium in blood plasma);

    - methotrexate: may increase the side effects of methotrexate on the hematopoietic system (the risk of anemia and leukopenia). In such cases, periodic monitoring of the general blood test is necessary;

    - contraceptive means: possible decrease in the effectiveness of intrauterine contraceptives;

    - diuretics and cyclosporine: there is a potential for the development of renal failure.

    - antihypertensive agents (for example, beta-blockers, ACE inhibitors, vasodilators, diuretics): a possible decrease in the effectiveness of antihypertensive drugs;

    - colestyramine: as a result of the binding of meloxicam, the excretion of the drug through the gastrointestinal tract is enhanced.

    Special instructions:

    Like other NSAIDs, Melox® should be used with caution in patients who have a history of peptic ulcer and duodenal ulcer, as well as patients who are on anticoagulation therapy. In such patients, the risk of ulcerative-erosive gastrointestinal diseases is increased.

    Maintain caution and monitor renal function in elderly patients, in patients with chronic heart failure with circulatory failure, with cirrhosis, hypovolemia as a result of surgical interventions.

    In patients with renal insufficiency, if the creatinine clearance is more than 25 ml / min, dosage adjustment is not required.

    In patients on dialysis, the dosage of the drug should not exceed 7.5 mg per day.

    At the same time taking meloxicam and diuretics should take a sufficient amount of fluid.

    The use of meloxicam, like other NSAIDs, can mask the symptoms of infectious diseases.

    The use of meloxicam, as well as other drugs that block the synthesis of prostaglandins, can affect fertility, which should be warned by women planning pregnancy (reduces the likelihood of pregnancy).

    Effect on the ability to drive transp. cf. and fur:Taking the drug may cause undesirable side effects such as headache, dizziness and drowsiness. Therefore, when taking meloxicam, it is desirable to abandon the management of vehicles and work with moving mechanisms.
    Form release / dosage:Tablets of 7.5 mg and 15 mg.
    Packaging:

    For 10 tablets in a blister of PVC / PVDC / aluminum foil.

    2 blisters together with instructions for use in a cardboard box.

    Storage conditions:Store in a dry, dark 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 expiration date printed on the package.

    Terms of leave from pharmacies:On prescription
    Registration number:П N013541 / 01
    Date of registration:26.03.2012
    Expiration Date:Unlimited
    The owner of the registration certificate:Medocemi Co., Ltd.Medocemi Co., Ltd. Cyprus
    Representation: & nbspMEDOKEMI LTD. MEDOKEMI LTD. Cyprus
    Information update date: & nbsp21.04.2018
    Illustrated instructions
      Instructions
      Up