Short- term symptomatic treatment of acute attacks of rheumatoid arthritis and ankylosing spondylitis, when oral and rectal routes of administration can not be applied.
active substance: meloxicam;
1 tablet contains 15 mg of meloxicam;
excipients: sodium citrate, lactose monohydrate, microcrystalline cellulose, povidone, colloidal anhydrous silicon dioxide, crospovidone, magnesium stearate.
Dosage form. Tablets.
Pharmacological properties Revmalgyn
Meloxicam is a non-steroidal anti-inflammatory drug (NSAID) of the enolic acid class, which has anti-inflammatory, analgesic and antipyretic effects. Meloxicam exhibited 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 mediators of inflammation.
Short-term symptomatic treatment of exacerbation of osteoarthritis.
Long-term symptomatic treatment of rheumatoid arthritis and ankylosing spondylitis.
- Hypersensitivity to meloxicam or other constituents of the drug, or to active substances with a similar effect, such as NSAIDs, aspirin. Meloxicam 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
The daily amount of the drug should be used once, washed down with water or other liquid, during meals.
Adverse reactions can be minimized by using the minimum effective dose for the shortest period 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 7.5 mg or half a tablet 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 the dose 15 mg / day.
Special categories of patients.
Elderly patients and patients with an increased risk of developing adverse reactions.
The recommended dose for long-term treatment of rheumatoid arthritis and ankylosing spondylitis for elderly patients is 7.5 mg per day. Patients with an increased risk of adverse reactions should start treatment with 7.5 mg per day.
For patients with severe renal insufficiency on dialysis, the dose should not exceed 7.5 mg per day. Patients with mild to moderate renal impairment (namely, patients with creatinine clearance above 25 ml / min) do not require dose reduction (relative to patients with severe renal impairment without dialysis.
Patients with mild to moderate hepatic impairment do not need dose reduction (for patients with severe hepatic impairment, see the section “Contraindications”).
Revmalgyn, 7.5 mg and 15 mg tablets, is contraindicated in children under 16 years of age.
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.
- 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.
Store in its original packaging at a temperature not exceeding 25 ° C. Keep out of the reach of children.