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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

Form release: biconvex round tablets of pale yellow or yellowish-greenish tint, with a slight roughness. The presence of marbling is allowed.

Clinico-pharmacological group: nonsteroidal anti-inflammatory drug, selective COX-2 inhibitor

Pharmacotherapeutic group: NSAIDs for oral analgesic and anti-inflammatory action

Composition

Active ingredient: Meloxicam (Meloxicam)

Excipients:

  • microcrystalline cellulose;
  • lactose monohydrate;
  • Povidone;
  • sodium citrate;
  • magnesium stearate;
  • colloidal silicon dioxide;
  • crospovidone.

Pharmacodynamics

The anti-inflammatory effect of meloxicam is based on the inhibition of the enzymatic activity of cyclooxygenase (COX-2), which is involved in the biosynthesis of prostaglandins in the area of ​​inflammation. On COX-1, a synthesizing prostaglandin that protects the mucous membrane of the digestive tract and is involved in the regulation of renal blood flow, meloxicam acts to a lesser extent. It belongs to chondron-neutral drugs, does not affect cartilage tissue and does not suppress the synthesis of proteoglycan by chondrocytes.

Pharmacokinetics

The drug has good resorptive capacity (absolute biosity is 89%). With simultaneous ingestion of food, absorption of Amelotex does not change. For internal use, the concentration is proportional to the dose (7.5 mg or 15 mg).

It takes 3-5 days to achieve an equilibrium concentration. In case of a long-term administration of the drug (more than 12 months), the concentration is similar to that obtained after reaching the first equilibrium state. Penetrating through histohematogenous barriers, 50% of meloxicam is concentrated in the synovial fluid. Plasma protein binding - 99%.

The drug is almost completely disintegrated in the liver to 4 inactive components. 60% of the total dose is 5'-carboxy-meloxicam, resulting from the oxidation of 5'-hydroxymethyl meloxicam, which is an intermediate metabolite. Peroxidase, characterized by individually varying activity, is involved in the formation of other metabolic products.

Amelotex is excreted by the kidneys and intestines in the form of metabolites. In an unchanged condition, along with the feces, about 5% of the daily dose of the drug is released, only traces are found in the urine. The half-life of meloxicam is 15-20 hours. Total plasma clearance - 8 ml / min.

Medium renal or hepatic failure does not significantly affect the chemical transformations of the drug in the human body.

Indications for use

  • Osteoarthritis, accompanied by pain;
  • Rheumatoid arthritis ;
  • Ankylosing spondylitis (ankylosing spondylitis).

Used as a drug of symptomatic therapy, does not affect the progression of the pathological process. To accept during food, without chewing and washing down with enough water.


Contraindications

  • Hypersensitivity to the drug;
  • Heart failure in the stage of decompensation;
  • The period of rehabilitation after aortic shunting;
  • An incomplete or complete combination of nasal polyps or nasal sinuses and bronchial asthma;
  • Gastric ulcer and 12p intestine;
  • Crohn's disease, ulcerative colitis and other inflammatory bowel diseases;
  • Cerebrovascular or gastrointestinal bleeding;
  • Liver pathology;
  • Hyperkalemia and other advanced kidney diseases;
  • Pregnancy and lactation;
  • Lactose intolerance;
  • Glucose-galactose malabsorption;
  • Lactase deficiency;
  • Children's age up to 15 years.

Side effects

  • Skin allergic reactions (itching, burning, urticaria , erythematous rash);
  • Hyperemia of the skin;
  • Photosensitization;
  • Skin peeling;
  • Systemic anaphylactic reactions;
  • Headache, dizziness;
  • Drowsiness.

Interaction with other drugs

Simultaneous use of Amelotex with other nonsteroidal anti-inflammatory drugs (including acetylsalicylic acid) can trigger the development of erosive and ulcerative lesions and gastrointestinal bleeding.

With the simultaneous use of meloxicam with lithium preparations, the concentration and toxic effect of mood stabilizers increases.

The simultaneous use of antihypertensive drugs reduces the effectiveness of the latter.

In the interaction of Amelotex with Methotrexate, due to increased side effects of cytostatic on the hematopoietic system, leukopenia or anemia may develop. In this situation, the treatment requires periodic monitoring of general blood counts.

The 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), in order to avoid the development of bleeding, periodic monitoring of blood coagulation parameters is required.

The simultaneous use of meloxicam with Kolestiramine leads to the binding of non-steroidal anti-inflammatory drug and enhance its excretion through the digestive tract.

Interaction with cyclosporine and diuretics can trigger the development of renal failure.

The use of selective serotonin reuptake inhibitors together with Amelotex increases the risk of gastrointestinal bleeding.


special instructions

The drug is used with extreme caution in the presence of a history of gastric ulcer and 12p. intestine, and when conducting anticoagulant therapy (due to the high risk of developing ulcerative-erosive diseases of the digestive tract).

Older people, patients with cirrhosis of the liver, chronic heart failure, hypovolemia (decrease in circulating blood volume) resulting from surgical intervention, when using the drug, you should constantly monitor 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.

When the liver profile changes and a significant increase in transaminase activity, immediate withdrawal of the drug and control tests are required.

With the simultaneous use of Amelotex and diuretics, it is recommended that the patient consume a sufficient amount of fluid.

With the development of various skin allergic reactions taking pills should be discontinued.

Just like other non-steroidal anti-inflammatory drugs, Amelotex, used in patients with infectious diseases, often erases their symptoms, making it difficult to make a diagnosis.

When using a drug that has the ability to cause dizziness and drowsiness, it is recommended to refuse to drive vehicles and control various mechanisms.

Overdose

  • Nausea, vomiting;
  • Disorders of consciousness;
  • Epigastric pain;
  • Acute renal failure;
  • Development of gastrointestinal bleeding;
  • Liver dysfunction, up to liver failure;
  • Asystole;
  • Stop breathing.

Terms of implementation

Amelotex tablet form is a prescription drug.

Storage conditions

Keep out of reach of children, dry, protected from light, at a temperature not exceeding 25 C.

Shelf life

The drug is usable for 3 years from the date of issue. Use of the product after the expiration date indicated on the package is prohibited.

Analogs Amelotex

  • Movalis pills
  • Artrozan tablet
  • Meloxicam tablets
  • Lem pills
  • Bi-xikam tablets
  • Mesipol tablets
  • Movasin tablets
  • Matarin pills
  • Melox tablets
  • Melbec pills
  • Movix Tablets
  • Actamelox tablets

Amelotex tablet prices

Amelotex tablets 15 mg, 10 pcs. - from 80 rubles.

Amelotex tablets 15 mg, 20 pcs. - from 135 rubles.

Amelotex tablets 7.5 mg, 20 pcs.- from 91r rub.

Rate Amelotex on a 5-point scale:
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