Index of drugs

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

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

Meloxicam is a non-steroidal anti-inflammatory drug (NSAID) from the oxicam group, which has anti-inflammatory, analgesic and antipyretic effects. It inhibits the synthesis of prostaglandins, known mediators of inflammatory processes. meloxicam is well absorbed from the gastrointestinal tract. Permanent plasma concentration reaches after 3-5 days of use. It is very strongly bound to plasma proteins, mainly albumin (99%). Meloxicam passes into the synovial fluid, reaching a concentration equal to about half the concentration of the drug found in the blood plasma. Meloxicam undergoes extensive metabolic changes in the liver. In the urine, 4 different meloxicam metabolites have been identified that are pharmacodynamically inactive. CYP2C9 plays an important role in the metabolic pathway of the major metabolite, with a small share of CYP3A4 isoenzyme. The formation of the other two metabolites is probably responsible for the peroxidase activity. Meloxicam is mainly excreted in the form of metabolites, in equal proportions in urine and faeces. Less than 5% of the daily dose is excreted unchanged with faeces, whereas only trace amounts are excreted in the urine. T_0,5 is about 20 hours.

Hypersensitivity to meloxicam or other components of the drug. Hypersensitivity to substances with a similar effect, eg NSAIDs, Acetylsalicylic acid, should not be used in patients with asthma, nasal polyps, angioneurotic edema and urticaria, as a consequence of administration of Acetylsalicylic acid or other NSAIDs. Bleeding or perforation of the gastrointestinal tract due to NSAID use. Active or recurrent peptic ulcer of the stomach and / or duodenum (two or more separate episodes of confirmed ulceration or bleeding). Severe liver dysfunction. Severe renal failure in patients not on dialysis. Gastrointestinal haemorrhage, bleeding from cerebral vessels or other disorders involving a history of bleeding. Severe heart failure. Pregnancy, breastfeeding period.

Do not give this medicine to people under 15 years of age. In the event of inadequate therapeutic efficacy, the maximum recommended daily dose should not be increased or other NSAIDs should be administered at the same time (increased risk of toxicity without clear therapeutic benefits). Meloxicam should not be used together with other NSAIDs, including selective COX-2 inhibitors. Adverse reactions are often less well tolerated by elderly, small-size and weakened patients, who should therefore be carefully monitored. As with other NSAIDs, special attention should be paid to elderly patients who are often affected by renal, hepatic and cardiac function. Elderly patients have an increased incidence of adverse reactions when using NSAIDs, particularly gastrointestinal bleeding and perforation, which may result in death. meloxicam, like other NSAIDs, may mask the symptoms of concomitant infectious disease. Before starting treatment with meloxicam, make sure that any history of oesophagitis, gastric mucosa and / or peptic ulcer disease has been cured; the possibility of relapse should be considered. Following the use of all NSAIDs, there have been reports of gastrointestinal bleeding, ulceration or perforation that can be fatal. Complications can occur at any time during treatment, with prodromal signs and previous severe gastrointestinal disturbances or without them.The risk of gastrointestinal bleeding, ulceration or perforation increases with increasing dosage of NSAIDs in patients with a history of peptic ulcer disease, in particular in cases complicated by bleeding or perforation, and in the elderly; this group of patients should receive treatment at the lowest effective dosage. In these patients, as well as in patients who also require low-dose Aspirin or other medications that may increase the risk of gastro-intestinal disorders, co-administration of gastric acid-reducing medicines (eg misoprostol, proton pump inhibitors) should be considered. Patients with a history of toxicity to the gastrointestinal tract, especially those who are elderly, should report any unusual abdominal symptoms (especially bleeding from the gastrointestinal tract), especially during the initial stages of treatment. Caution is advised in patients receiving concomitant medications that may increase the risk of ulceration or bleeding, such as corticosteroids, anticoagulants such as Warfarin, SSRI, and anti-aggregation agents, i.e. acetylsalicylic acid. Caution should be exercised in patients with a history of gastrointestinal disorders (ulcerative colitis, Crohn's disease, risk of exacerbation of these diseases), hypertension (including uncontrolled hypertension), congestive heart failure, ischemic heart disease, peripheral artery disease and (or) cerebrovascular disease and prior to initiating long-term treatment of patients with risk factors for cardiovascular disease (e.g. hypertension, hyperlipidemia, diabetes, smoking). Patients with a history of hypertension or mild to moderate congestive heart failure with fluid retention and edema should be adequately controlled and given appropriate recommendations. Fluid retention and edema have been reported in association with NSAID treatment. Clinical studies and epidemiological data suggest that the intake of cyclooxygenase inhibitors (especially at high doses over a long period of time) may be associated with a small increase in the risk of thromboembolic events (e.g., myocardial infarction or stroke). These data are insufficient to exclude such a risk when taking meloxicam. Very severe skin reactions, sometimes fatal, including exfoliative epidermis, Stevens-Johnson syndrome and toxic epidermal necrolysis have been reported very rarely due to the use of NSAIDs. The highest risk of these reactions exists in the initial period of treatment, with the first symptoms in most cases occurring within the first month of treatment. Meloxicam should be discontinued after the first detection of skin rash, mucosal lesions or any other manifestation of hypersensitivity, and also in case of gastrointestinal ulceration or gastrointestinal bleeding and significant or persistent disturbances in liver and kidney function (in this case perform control tests). NSAIDs inhibit the dilatation effect of renal prostaglandins and in this way, by reducing glomerular filtration, they can induce functional renal failure; this effect is dose dependent. Administration of meloxicam to patients with impaired renal flow or reduced circulating volume may increase the symptoms of renal dysfunction. Renal function parameters return to the initial state after discontinuation of the drug. In these patients, monitoring of diuresis and other biochemical parameters of renal function is necessary during treatment with meloxicam. The highest risk of these reactions is found in the following groups of patients: old age; concomitant use of ACE inhibitors, sartans, diuretics; hypovolemia (regardless of the cause); congestive heart failure; renal failure; nephrotic syndrome; lupus nephritis; severe hepatic impairment (serum albumin <25 g / l or Child-Pugh score ≥10). In rare cases, NSAIDs may cause interstitial nephritis, glomerulonephritis, kidney spinal necrosis or nephrotic syndrome. Sodium and fluid retention may cause edema, hypertension or exacerbation of existing hypertension or heart failure.In the case of hypertension or heart failure, it is necessary to monitor the patient from the beginning of treatment. Meloxicam may weaken the hypotensive effect of the medicines used. In patients with heart failure or hypertension, non-steroidal anti-inflammatory drugs can cause sodium, potassium and fluid retention, and interfere with the diuretic effect of natriuretic agents, and may lead to exacerbation of disease symptoms. Hyperkalaemia may be promoted by diabetes and simultaneous therapy with drugs that increase the concentration of potassium in the blood. In such cases, particular attention should be paid to the monitoring of potassium in the blood. The drug contains lactose - patients with rare hereditary problems of galactose intolerance, lactase deficiency (Lapp type) or malabsorption of glucose-galactose should not use this drug.

The drug should not be used during pregnancy and while breastfeeding. Inhibition of prostaglandin synthesis may adversely affect pregnancy and / or the development of the embryo or fetus. Data from epidemiological studies suggest an increased risk of abortions and heart defects as well as abdominal cleft after the use of prostaglandin synthesis inhibitors in early pregnancy. All prostaglandin synthesis inhibitors used during the third trimester of pregnancy may cause fetus: toxic effects on the heart and lungs (with premature closure of the ductus arteriosus and pulmonary hypertension), renal dysfunction that may develop into renal failure with oligohydramnios; in the mother at the end of pregnancy and in the newborn: prolonged bleeding time, antiaggregation, which can occur even at very low doses of the drug, suppression of the uterine contraction, leading to delay or prolonged delivery. Women who have problems getting pregnant or treated for infertility should consider discontinuing meloxicam. It is not recommended to give the drug to women planning pregnancy.

Clinical studies and epidemiological data suggest that the intake of certain NSAIDs (especially long-term and high doses) is associated with a small increase in the risk of major thromboembolic events such as myocardial infarction or ischemic stroke. Edema, hypertension and heart failure have been reported in association with the use of NSAIDs. Most often, gastrointestinal side effects are observed. Peptic ulcers, perforation or gastrointestinal bleeding may occur (sometimes fatal, especially in elderly patients). Nausea, vomiting, diarrhea, bloating, constipation, dyspepsia, abdominal pain, tarry stools, bloody vomiting, ulcerative stomatitis, exacerbations of ulcerative colitis and Crohn's disease have been reported. Gastritis was less frequently observed. Side effects by frequency. Common: anemia, dizziness and dizziness, upper respiratory tract infections, flu-like symptoms, pharyngitis, indigestion, nausea, vomiting, abdominal pain, constipation, flatulence, diarrhea, rash, pruritus, edema, including swelling of the lower limbs. Uncommon: abnormal renal function parameters (organic renal failure leading to acute renal failure) have been reported following the use of other NSAIDs and may occur after administration of meloxicam, although they have not been reported so far, in particular: interstitial nephritis, acute necrosis of the coils, nephrotic syndrome and wart nodule), transient elevation of liver enzymes, hyperbilirubinemia, hyperkalemia, palpitations, thrombocytopenia (isolated cases of agranulocytosis in patients treated with meloxicam and other potentially myelotoxic agents), leukopenia, agranulocytosis, tinnitus, drowsiness, oral mucositis, esophagitis, overt or latent gastrointestinal bleeding, gastric or duodenal ulcer (ulceration or bleeding from the gastrointestinal tract may be severe, since especially in elderly patients), sodium and water retention, urticaria, increase or decrease in blood pressure, redness of the face.Rare: angina, heart failure, disorientation, confusion, conjunctivitis, blurred vision (including blurred vision), shortness of breath, acute asthma in patients with acetolsalicylic acid allergy or other NSAIDs, gastritis, gastrointestinal perforation, colitis, pancreatitis, acute inorganic renal failure with risk factors, hypersensitivity to sunlight, exceptionally cutaneous bullous lesions, erythema multiforme, Stevens-Johnson syndrome, toxic epidermal necrolysis, weight loss or increase, vasculitis, fever, weakness, heat shock, malaise, fainting, allergic reactions, anaphylactic reactions, including anaphylactic shock or anaphylactic reactions, angioneurotic edema, hepatitis, hepatic failure, jaundice, increased appetite, nervousness, anxiety, depression, insomnia, nightmares. To minimize the risk of adverse events, adopt the principle of taking the drug in the shortest possible time and in the lowest possible dose.

Orally. Adults and children> 15 years. Exacerbation of osteoarthritis: 7.5 mg / day, if necessary, the dose can be increased to 15 mg / day. Rheumatoid arthritis and ankylosing spondylitis: 15 mg daily, the dose can be reduced to 7.5 mg per day depending on the therapeutic response. The maximum daily dose is 15 mg. In patients on dialysis or with an increased risk of side effects, treatment should be started with a 7.5 mg daily dose. If there is no improvement after a few days of treatment, the clinical benefit of the treatment should be re-evaluated. The patient's condition and response to treatment should be periodically evaluated, particularly in patients with osteoarthritis. Do not exceed the 15 mg dose per day.
Table. used once a day during a meal.