Amelotex: instructions for use
- Amelotex: instructions for use
Production: REPLEK PHARM, Ltd. (Macedonia)
ATX code: M01AC06 (Meloxicam)
Dosage form: tablets, 7.5 mg, 15 mg
Product: biconvex round tablets pale yellow or yellowish-greenish shade, with a slight roughness. Presence of marble is admissible.
Clinical and pharmacological group: non-steroidal anti-inflammatory drug, selective inhibitor of COX-2
Pharmacotherapeutic group: NSAIDs for oral administration of analgesic and anti-inflammatory action
Active ingredient: Meloxicam (Meloxicam)
- Microcrystalline cellulose;
- Lactose monohydrate;
- Sodium citrate;
- Magnesium stearate;
- Colloidal silicon dioxide;
The anti-inflammatory effect of meloxicam is based on the inhibition of the enzymatic activity of cyclooxygenase (COX-2), involved in the biosynthesis of prostaglandins in the inflammatory region. At COX-1, synthesizing prostaglandins, protecting the mucous membrane of the digestive tract and participating in the regulation of renal blood flow, meloxicam acts to a lesser extent. Refers to chondroitralnyh drugs, does not affect the cartilaginous tissue and does not inhibit the synthesis of proteoglycan by chondrocytes.
The drug has a good resorptive capacity (absolute bioavailability is 89%). With simultaneous intake of food, the absorption of Amelotex does not change. For internal use, the concentration is proportional to the doses (7.5 mg or 15 mg).
To achieve an equilibrium concentration, 3-5 days are required. In the case of long-term use (more than 12 months), the concentration is similar to that obtained after reaching the first equilibrium state. Penetrating through the histogematic barriers, 50% meloxicam is concentrated in the synovial fluid. Binding to plasma proteins - 99%.
The drug almost completely disintegrates in the liver to 4 inactive components. 60% of the total amount of the dose is 5'-carboxy-meloxicam, formed due to the oxidation of 5'-hydroxymethylmeloxicam, which is an intermediate metabolite. In the formation of other metabolic products, peroxidase is involved, characterized by individually varying activity.
Amelotex is excreted by the kidneys and intestines in the form of metabolites. In the unmodified state, together with feces, about 5% of the daily dose of the drug comes out, only traces are found in the urine. The half-life of meloxicam is 15-20 hours. Total plasma clearance - 8 ml / min.
Renal or liver failure of moderate severity does not significantly affect the chemical transformation of the drug substance in the human body.
Indications for use
- Osteoarthritis accompanied by pain syndrome;
- Rheumatoid arthritis ;
- Bechterew's disease (ankylosing spondylitis).
Used as a drug of symptomatic therapy, does not affect the progression of the pathological process. Take with food, without chewing and drinking with sufficient amount of water.
- Hypersensitivity to the components of the drug;
- Heart failure in the stage of decompensation;
- Rehabilitation period after aortic bypass;
- Incomplete or complete combination of nasal polyps or nasal sinuses and bronchial asthma;
- Gastric ulcer and 12p intestine;
- Crohn's disease, nonspecific ulcerative colitis and other inflammatory bowel diseases;
- Cerebrovascular or gastrointestinal bleeding;
- Liver pathology;
- Hyperkalemia and other progressive kidney diseases;
- Pregnancy and lactation;
- Lactose intolerance;
- Glucose-galactose malabsorption;
- Deficiency of lactase;
- Children up to 15 years.
- Skin allergic reactions (itching, burning, urticaria , erythematous rashes);
- Hyperemia of the skin;
- Peeling of the skin;
- Systemic anaphylactic reactions;
- Headache, dizziness;
Interaction with other medicinal products
Simultaneous reception of Amelotex with other non-steroidal anti-inflammatory drugs (including acetylsalicylic acid) can provoke the development of erosive-ulcerative lesions and gastrointestinal bleeding.
With the simultaneous use of meloxicam with lithium preparations, the concentration and toxic effects of normotimics increase.
Simultaneous use with antihypertensive drugs reduces the effectiveness of the latter.
When Amelotex interacts with Methotrexate, because of the increased side effect of cytostatics on the hematopoietic system, it is possible to develop leukopenia or anemia. In this situation, the treatment requires periodic monitoring of general clinical indicators of blood.
Simultaneous use of NSAIDs with warfarin, heparin, ticlopidine and other anticoagulants increases the risk of bleeding.
When the drug interacts with thrombolytic agents (fibrinolysin, streptokinase), periodic monitoring of the parameters of the blood coagulation system is required to avoid the development of bleeding.
Simultaneous use of meloxicam with colestyramine leads to the binding of a non-steroidal anti-inflammatory drug and to the increase of its excretion through the digestive tract.
Interaction with cyclosporine and diuretics can provoke the development of renal failure.
The use of selective serotonin reuptake inhibitors along with Amelotex increases the risk of developing gastrointestinal bleeding.
The drug is used with extreme caution in the presence of an anamnesis of peptic ulcer and 12p. Guts, and in the conduct of anticoagulant therapy (due to the high risk of development of ulcerative and erosive diseases of the digestive tract).
To people of advanced age, patients with cirrhosis of the liver, chronic heart failure, hypovolemia (decrease in the volume of circulating blood) resulting from surgical intervention, the use of the drug should constantly monitor the kidney function and, if necessary, adjust the dosage regimen.
The daily dose of Amelotex for patients on programmed hemodialysis should not exceed 7.5 mg.
With a change in the liver profile and a significant increase in the activity of transaminases, immediate withdrawal of the drug and control tests are necessary.
With simultaneous use of Amelothex and diuretics, the patient is advised to consume a sufficient amount of liquid.
With the development of various skin allergic reactions, the taking of tablets should be stopped.
As well as other non-steroidal anti-inflammatory drugs, Amelothex, used in patients suffering from infectious diseases, often erases their symptoms, creating difficulties in diagnosing.
When using a drug that has the ability to cause dizziness and drowsiness, it is recommended to abandon the driving of vehicles and the management of various mechanisms.
- Nausea, vomiting;
- Disorders of consciousness;
- Pain in the epigastric region;
- Acute kidney failure;
- Development of gastrointestinal bleeding;
- Violation of the liver, up to liver failure;
- Stop breathing.
Terms of implementation
Amelotex in the form of tablets is a drug that is prescribed by a doctor.
Keep out of reach of children, dry, protected from light, at a temperature not exceeding 25 ° C.
The drug is suitable for use for 3 years from the date of release. Use the product at the expiry date indicated on the package is prohibited.
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Prices for Amelotex tablets
Amelotex tablets 15 mg, 10 pcs. - from 80 rubles.
Amelotex tablets 15 mg, 20 pcs. - from 135 rubles.
Amelotex tablets 7.5 mg, 20 pieces - from 91 rub.