Revmalgyn (meloxicam) tablets 15 mg. №10

Description

Revmalgyn (meloxicam) tablets 15 mg. №10

Composition

active ingredient: meloxicam (meloxicam);

1 tablet contains meloxicam 7.5 mg or 15 mg;

excipients: sodium citrate, lactose monohydrate, microcrystalline cellulose, povidone, anhydrous colloidal silicon dioxide, crospovidone, magnesium stearate.

Dosage form

Tablets.

Basic physical and chemical properties:

• for a dosage of 7.5 mg: tablets of light yellow color, round shape, with a biconvex surface;
• for a dosage of 15 mg: tablets of light yellow color, round shape, with a dividing risk, with a biconvex surface.

Pharmacotherapeutic group

Non-steroidal anti-inflammatory drugs and antirheumatic drugs.
ATX code M01A C06.

Pharmacological properties

Meloxicam is a non-steroidal anti-inflammatory drug (NSAID) of the enolic acid class with anti-inflammatory, analgesic and antipyretic effects. Meloxicam showed high anti-inflammatory activity in all standard models of inflammation. As with other NSAIDs, its exact mechanism of action remains unknown. However, there is a common mechanism of action for all NSAIDs (including meloxicam): inhibition of the biosynthesis of prostaglandins, which are inflammatory mediators.

Indications

Revmalgyn tablets 15 mg are used for the symptomatic treatment of pain syndrome with:

• ankylosing spondylitis;
• arthrosis;
• osteoarthritis;
• degenerative joint diseases;
• rheumatoid arthritis.

Contraindications:

• Hypersensitivity to meloxicam or other constituents of the drug, or to active substances with a similar effect, such as NSAIDs, aspirin. Revmalgyn tablets 15 mg should not be given to patients who develop asthma symptoms, nasal polyps, angioedema, or urticaria after taking aspirin or other NSAIDs;
• III trimester of pregnancy;
• children up to age 16;
• a history of gastrointestinal bleeding or perforation associated with previous NSAID therapy;
• a history of active or recurrent peptic ulcer / bleeding (two or more separate confirmed cases of ulcer or bleeding);
• severe liver failure;
• severe renal failure without dialysis;
• gastrointestinal bleeding, history of cerebrovascular bleeding, or other bleeding disorders;
• severe heart failure;
• treatment of perioperative pain in coronary artery bypass grafting (CABG).

Method of administration and dosage

Apply orally.

The daily amount of the drug should be taken as a single dose with water or other liquid during meals.

Adverse reactions can be minimized by using the lowest effective dose for the shortest duration of treatment necessary to control symptoms. The patient’s need for symptomatic relief and response to treatment should be periodically assessed.

• Exacerbation of osteoarthritis: 7.5 mg / day (1 tablet of 7.5 mg or half a tablet of 15 mg). If necessary, the dose can be increased to 15 mg/day (1 tablet 15 mg or 2 tablets 7.5 mg).
• Rheumatoid arthritis, ankylosing spondylitis: 15 mg/day (1 tablet 15 mg or 2 tablets 7.5 mg).

Depending on the therapeutic effect, the dose can be reduced to 7.5 mg / day (1 tablet 7.5 mg or half a tablet 15 mg).

DO NOT EXCEED 15 mg/day.

Children

Revmalgyn tablets 7.5 mg and 15 mg, is contraindicated in children under 16 years of age.

Overdose

Symptoms of acute NSAID overdose are usually limited to lethargy, drowsiness, nausea, vomiting and epigastric pain, which are generally reversible with maintenance therapy. Gastrointestinal bleeding may occur. Severe poisoning can lead to hypertension, acute renal failure, liver dysfunction, respiratory depression, coma, seizures, cardiovascular failure, and cardiac arrest. Anaphylactoid reaction has been reported with the therapeutic use of NSAIDs, which can also occur with overdose.
In case of an overdose of NSAIDs, patients are recommended symptomatic and supportive measures. Studies have shown an acceleration of the elimination of meloxicam by taking four oral doses of cholestyramine 3 times a day.

Side effects:

• On the part of the blood and lymphatic system:
• infrequently – anemia, deviations of blood test parameters from the norm (including changes in the number of leukocytes), leukopenia, thrombocytopenia;
• From the immune system: allergic reactions, except for anaphylactic and anaphylactoid;
• Mental disorders: mood changes, nightmares;
• From the nervous system: headache, dizziness, drowsiness;
• From the side of the organs of vision: disturbances in the function of vision, including blurred vision, conjunctivitis;
• On the part of the hearing organs and vestibular apparatus: dizziness, ringing in the ears;
• Cardiac disorders: palpitations;
• Vascular disorders: increased blood pressure, hot flashes;
• From the respiratory system, chest and mediastinal organs: asthma in patients allergic to aspirin and other NSAIDs;
• From the digestive tract: disorders of the digestive system: dyspepsia, nausea, vomiting, abdominal pain, constipation, flatulence, diarrhea, latent or macroscopic gastrointestinal bleeding, stomatitis, gastritis, belching, colitis, gastroduodenal ulcer, esophagitis;
• From the hepatobiliary system: impaired liver function indicators (for example, increased transaminases or bilirubin), hepatitis;
• On the part of the skin and subcutaneous tissue: angioedema, itching, rashes, Stevens-Johnson syndrome, toxic epidermal necrolysis, urticaria;
• From the urinary system: sodium and water retention, hyperkalemia, changes in renal function indicators (increased serum creatinine and / or urea), acute renal failure, in particular in patients with risk factors, urinary tract infections, urinary frequency disorders.
• General disorders and disorders at the injection site: edema, including edema of the lower extremities, flu-like symptoms.
• From the musculoskeletal system: arthralgia, back pain, symptoms associated with joints.