Index of drugs

Short-term symptomatic treatment of osteoarthritis exacerbations. Long-term symptomatic treatment of rheumatoid arthritis or ankylosing spondylitis.

1 tabl contains 15 mg of meloxicam. The preparation contains lactose.

A non-steroidal anti-inflammatory drug from the oxicam group, with anti-inflammatory, analgesic and antipyretic effects. The mechanism of action is based on inhibition of prostaglandin biosynthesis. After oral administration, it is well absorbed from the gastrointestinal tract (bioavailability 89%) regardless of food intake. The maximum concentration in the blood occurs after 5-6 h; when repeated doses are administered, steady-state is achieved after 3-5 days. Long-term use of the drug does not affect the amount of blood concentration. It is 99% bound to plasma proteins. It penetrates into the synovial fluid, where it reaches about 50% of the plasma concentration. It is metabolised in the liver with the participation of CYP2C9 and small CYP3A4. Inactive metabolites are excreted in equal amounts in urine and faeces; less than 5% of the dose is excreted unchanged with faeces. T_0,5 is about 20 h. Mild to moderate renal or hepatic failure does not affect the pharmacokinetics of meloxicam; In end-stage renal failure, the volume of distribution increases significantly.

Hypersensitivity to meloxicam or other components of the preparation. Hypersensitivity to substances with a similar mechanism of action, eg NSAIDs, Acetylsalicylic acid manifested by asthma, nasal polyps, angioneurotic edema or urticaria. Active or recurrent peptic ulcer of the stomach and / or duodenum. Severe hepatic impairment. Severe un-dialyzed renal failure. Bleeding from the gastrointestinal tract, cerebrovascular bleeding or other bleeding. Severe heart failure. Severe congestive heart failure. III trimester of pregnancy, breastfeeding.

It is recommended that patients with hypertension and / or congestive heart failure with mild to moderate intensity should be observed and given appropriate advice (risk of fluid retention, sodium, potassium and edema induction). Caution should be exercised in patients with uncontrolled hypertension, congestive heart failure, stabilized ischemic heart disease, peripheral artery disease, cerebrovascular disease and prior to the initiation of long-term treatment of patients with risk factors for cardiovascular disease (eg hypertension, hyperlipidemia, diabetes, smoking) ). Patients with symptoms of the gastrointestinal tract or with a history of gastrointestinal disorders (eg, ulcerative colitis, Crohn's disease) should be monitored for gastrointestinal disorders, particularly gastrointestinal bleeding. In the event of bleeding, gastrointestinal ulceration, severe skin reactions, life-threatening hypersensitivity reactions and significant or persistent changes in laboratory tests, the drug should be discontinued. At the beginning of treatment and after increasing the dose, urine output and renal function should be carefully monitored in patients with the following risk factors: older age, concomitant therapy with ACE inhibitors, angiotensin II receptor antagonists, sartans, diuretics, hypovolemia (for whatever reason), congestive heart failure , renal failure, nephrotic syndrome, lupus nephropathy, severe hepatic impairment (serum albumin <25 g / L or ≥10 Child-Pugh). Elderly patients should be closely observed, particularly those with impaired renal, hepatic and cardiac functions (risk of worse tolerance of side effects). meloxicam, like other NSAIDs, may mask the symptoms of existing infectious diseases. Caution should be exercised in patients with active or previous bronchial asthma (risk of bronchial spasm). Due to the lactose content, the preparation should not be used in patients with galactose intolerance, Lapp lactase deficiency or malabsorption of glucose-galactose.

Meloxicam should not be used during the first and second trimesters of pregnancy unless it is absolutely necessary. If the drug is administered to women trying to get pregnant or being in the first and second trimester of pregnancy, the dose should be kept as low as possible and the treatment should last as short as possible. The use of prostaglandin synthesis inhibitors in the third trimester of pregnancy may cause pulmonary hypertension and premature closure of the ductus arteriosus, kidney damage and in the mother to suppress the uterine contractile function. The drug is contraindicated in the third trimester of pregnancy. The drug is excreted in breast milk - do not use during breastfeeding. The use of meloxicam may impair fertility in women - for women who have difficulty conceiving or are tested for fertility, discontinuation of meloxicam should be considered. It is not recommended to give the drug to women planning pregnancy.

Common: anemia, headache, headache, indigestion, nausea, vomiting, abdominal pain, constipation, bloating, diarrhea, pruritus, rash, edema (including lower limbs). Uncommon: leukocytopenia, thrombocytopenia, agranulocytosis, vertigo, tinnitus, drowsiness, palpitations, increased blood pressure, facial flushing, gastrointestinal bleeding, peptic ulcer, oral mucositis, esophagitis, urticaria, retention of sodium and water in the body, hyperkalemia, transient changes in the results of liver function tests (eg increase in transaminases or bilirubin), changes in the results of laboratory tests of renal function (eg increase in creatinine or urea). Rare: anaphylactic or anaphylactoid reactions, mood disorders, insomnia, nightmares, confusion, blurred vision (including blurred vision), asthma attacks (in patients with hypersensitivity to acetylsalicylic acid or other NSAIDs), gastrointestinal perforation, inflammation gastric mucosa, colitis, hepatitis, Stevens-Johnson syndrome, toxic epidermal necrolysis, angioneurotic edema, erythema multiforme, photosensitivity reactions, severe renal failure (at risk patients). Single cases of agranulocytosis with potential bone marrow toxicity and gastrointestinal bleeding and fatal perforations have been described. In addition, cases of myocardial insufficiency and organic kidney damage were probably reported as a result of severe renal failure: isolated cases of interstitial nephritis, acute renal tubular necrosis, nephrotic syndrome and papillary necrosis. The use of the drug may be associated with a small increase in the risk of arterial blood clots.

Orally. Adults and children over 15 years. Exacerbation of osteoarthritis - 7.5 mg per day, if necessary, the dose can be increased to 15 mg per day. Rheumatoid arthritis and ankylosing spondylitis - 15 mg per day, the dose can be reduced to 7.5 mg per day depending on the therapeutic response. The maximum daily dose is 15 mg. In elderly patients or with an increased risk of side effects, treatment should be started with a 7.5 mg daily dose. No dose adjustment is required in patients with mild to moderate renal or hepatic impairment. In dialysed patients with severe renal insufficiency - do not exceed the 7.5 mg daily dose. The tablets should be taken once a day with a meal with water.