Index of drugs

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

1 tabl disintegrating in the mouth contains 7.5 mg or 15 mg of meloxicam. The product contains mannitol, sorbitol and aspartame.

A non-steroidal anti-inflammatory drug from the oxicam group with 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, bioavailability is about 89% (capsules). It has been shown that tablets, oral suspension and capsules are bioequivalent. After administration of the single dose formulation, the mean maximum plasma concentration is reached after 5-6 h. After repeated administration, steady state was achieved after 3-5 days. The maximum concentration of meloxicam in plasma at steady-state occurs 5-6 hours after administration. Meloxicam binds strongly to plasma proteins, mainly albumin (99%). It penetrates into synovial fluid, reaching concentrations approximately equal to half the concentrations found in the plasma. Meloxicam undergoes extensive biotransformation in the liver. In the urine, 4 pharmacodynamically inactive meloxicam metabolites were identified. CYP2C9 and to a lesser extent CYP3A4 play an important role in metabolism. Meloxicam is mainly eliminated in the form of metabolites, equally with urine and faeces. Less than 5% of the daily dose is excreted unchanged in the faeces, whereas only trace amounts of the parent compound are excreted in the urine. Medium T_0,5 in the elimination phase, it is about 20 hours.

Hypersensitivity to meloxicam or any of the excipients, as well as hypersensitivity to substances with similar effects, eg NSAIDs, acetylsalicylic acid. Meloxicam should not be used in patients with symptoms of asthma, nasal polyps, angioneurotic edema or urticaria that have occurred following Acetylsalicylic acid or other NSAIDs. History of gastrointestinal bleeding or perforation associated with prior treatment with NSAIDs. Third trimester of pregnancy. Children and youth under 16 years. Active or recurrent peptic ulcer of the stomach and / or duodenum or gastrointestinal bleeding (i.e., at least 2 distinct episodes of confirmed ulceration or bleeding) in a history. Active inflammatory bowel disease (Crohn's disease, ulcerative colitis). Severe hepatic impairment. Severe renal impairment in patients not on dialysis. Bleeding from the gastrointestinal tract, bleeding from cerebral vessels or other disorders leading to bleeding. Severe heart failure. Meloxicam is contraindicated in the treatment of perioperative pain following coronary artery bypass grafting (CABG).

Avoid using the product concomitantly with other NSAIDs, including selective COX-2 inhibitors. The preparation should not be used to treat patients who need to relieve acute pain. Before using meloxicam, make sure that all history of oesophagitis, gastritis and / or stomach ulcers have been completely cured - patients who have these disorders are at risk of relapse during treatment with meloxicam. During therapy, there is a risk of bleeding from the gastrointestinal tract, ulceration or perforation. This risk is greater when using high doses of NSAIDs, in patients with a history of peptic ulcer disease, especially if there are complications in the form of haemorrhage or perforation, and in elderly patients. Treatment in these patients should be started with the lowest effective doses. In these patients, as well as in patients requiring simultaneous use of low-dose acetylsalicylic acid or other drugs that may increase the risk of gastrointestinal disorders, combination therapy with protective drugs (eg misoprostol or proton pump inhibitors) should be considered.Patients, especially the elderly, who have a previous history of gastrointestinal toxicity should report any abdominal symptoms (especially bleeding from the gastrointestinal tract), especially during the initial treatment period. Caution is advised in patients taking concomitant medications that may increase the risk of ulceration or bleeding, such as Heparin used therapeutically or in geriatrics, anticoagulants such as Warfarin, or other NSAIDs, including acetylsalicylic acid in anti-inflammatory doses (≥ 1g in a single dose or in a daily dose of ≥3 g). In case of bleeding from the gastrointestinal tract or ulcer, treatment with the preparation should be discontinued. Patients with a history of hypertension and / or mild to moderate congestive heart failure with fluid retention and edema should be adequately controlled. In patients at risk, it is recommended to monitor blood pressure before treatment and especially during the initial period of treatment. Taking some NSAIDs (especially at high doses and prolonged) may be associated with a small increase in the risk of arterial blockages (eg, myocardial infarction or stroke). Caution should be exercised in patients with uncontrolled hypertension, congestive heart failure, stable ischemic heart disease, peripheral arterial disease and / or cerebrovascular disease, and caution should be exercised before initiating long-term treatment of patients with risk factors for cardiovascular disease ( e.g. hypertension, hyperlipidemia, diabetes, smoking). Meloxicam should be discontinued after the first occurrence of skin rash, mucosal damage or any other signs of hypersensitivity. In the event of significant or sustained changes in liver or kidney function, meloxicam should be discontinued and appropriate studies performed. NSAIDs, by inhibiting the effects of vasodilating prostaglandins in the kidneys, may induce functional renal failure due to decreased glomerular filtration; this side effect is dose-dependent. Close monitoring of diuresis and renal function is recommended at the beginning of treatment or after increasing the dose in patients with the following risk factors: older age; concomitant treatment with ACE inhibitors, angiotensin II receptor antagonists, sartans, diuretics; hypovolemia (regardless of the reasons); congestive heart failure; renal failure; nephrotic syndrome; lupus nephritis; severe hepatic insufficiency (serum albumin less than 25 g / l or Child-Pugh score 10). The use of NSAIDs may lead to the retention of sodium, potassium and water and interfere with the natriuretic effect of diuretics. It can also reduce the hypotensive effects of drugs used in hypertension. In susceptible patients this may result in or exacerbate edema, heart failure or hypertension. For these reasons, clinical monitoring of patients at risk is necessary. In patients with diabetes or those taking concomitant medications that increase the level of potassium in the blood, hyperkalaemia may occur - regular monitoring of potassium levels. Elderly patients, small-size or weakened patients often have worse tolerance of side effects and should therefore be carefully monitored. Special care should be taken in elderly patients who often have problems with their kidneys, liver and heart. Elderly patients are more likely to experience side effects caused by NSAIDs, particularly gastrointestinal bleeding and perforation, which may result in death. Treatment with the preparation may mask the symptoms of a simultaneous infection. The tablets contain aspartame, which is a source of phenylalanine and may be harmful for patients with phenylketonuria. Sorbitol tablets - do not use this medicine in patients with rare hereditary fructose intolerance.

Inhibition of prostaglandin synthesis may adversely affect the course of pregnancy and / or the development of the embryo or fetus.Data from epidemiological studies indicate an increased risk of abortions as well as heart defects and gastroschisis in newborns due to the use of drugs inhibiting prostaglandin synthesis in early pregnancy. In the first and second trimester of pregnancy, meloxicam should only be used in cases of absolute necessity. If meloxicam is used in women planning pregnancy or during the first or second trimester of pregnancy, the lowest possible dose and the shortest treatment period should be used. In the third trimester of pregnancy, all prostaglandin synthesis inhibitors may expose the fetus to: toxic effects on the heart and lungs (premature closure of patent ductus arteriosus and pulmonary hypertension); kidney problems that may lead to renal failure with reduced amount of amniotic fluid; and maternal and neonatal exposures in the final stages of pregnancy: prolonged bleeding time as a result of inhibition of platelet aggregation, which may occur even at very low doses; inhibition of uterine contractions and prolonging labor. Therefore, the use of meloxicam is contraindicated in the third trimester of pregnancy. The use of the preparation may reduce fertility and is not recommended in women planning pregnancy. In women who have difficulty conceiving or who are diagnosing infertility, discontinuation of meloxicam should be considered. NSAIDs are excreted in breast milk, but there are no data on meloxicam. For safety reasons, the drug is not recommended in breast-feeding women.

Very common: indigestion, nausea, vomiting, abdominal pain, constipation, flatulence, diarrhea. Common: headache. Uncommon: hypersensitivity, allergic reactions other than anaphylactic or anaphylactoid reactions, dizziness, drowsiness, balance disorders, increased blood pressure, flushing, latent or macroscopic gastrointestinal haemorrhage, oral mucositis, gastritis, belching with regurgitation, liver dysfunction (eg transaminase elevation or bilirubin), angioneurotic edema, pruritus, rash, sodium and water retention, hyperkalemia, impairment of renal function parameters (increase in serum creatinine and / or urea), swelling, including swelling of the lower limbs. Rare: morphological imaging of the blood (including the percentage of individual types of white blood cells), leukopenia, thrombocytopenia, mood changes, nightmares, blurred vision, including blurred vision, conjunctivitis, tinnitus, palpitations, asthma attacks in patients with allergies for acetylsalicylic acid or other NSAIDs, colitis, gastric and duodenal ulcer, esophagitis, Stevens-Johnson syndrome, toxic epidermal necrolysis, urticaria. Very rare: agranulocytosis, gastrointestinal perforation, hepatitis, bullous skin inflammation, erythema multiforme, acute renal failure, particularly in at-risk patients. Not known: anaphylactic reactions, anaphylactoid reactions, confusion, disorientation, hypersensitivity to light.
The use of some NSAIDs (especially at high doses and prolonged) may be associated with a small increase in the risk of arterial blockages (eg, cardiac infarction or stroke). In the context of NSAID treatment, the occurrence of edema, hypertension and heart failure has been reported. In the context of NSAID treatment, very rare cases of interstitial nephritis, acute tubular necrosis, nephrotic syndrome and renal papillary necrosis have been reported.

Orally. Exacerbation of osteoarthritis: 7.5 mg once a day; if necessary, in the absence of improvement, the dose can be increased to 15 mg once a day. Rheumatoid arthritis, ankylosing spondylitis: 15 mg once a day. Depending on the clinical response, the dose may be reduced to 7.5 mg once a day (one 7.5 mg tablet). During treatment, the patient should be checked periodically to determine whether the symptoms have gone away and what is the response to the treatment, especially in patients with osteoarthritis. Do not exceed the daily dose of 15 mg. The recommended dose for long-term treatment of elderly patients with rheumatoid arthritis or ankylosing spondylitis is 7.5 mg / day.In patients with an increased risk of side effects, treatment should start with a 7.5 mg daily dose. In patients on dialysis with severe renal impairment, a daily dose of 7.5 mg should not be exceeded. No dose reduction is required in patients with mild to moderate renal impairment (ie with a creatinine clearance greater than 25 ml / min). No dose reduction is required in patients with mild to moderate hepatic impairment.
The tablet should be placed on the tongue and allowed to dissolve slowly within 5 min (do not chew or swallow undissolved tablet), and then drink 240 ml of water. In patients with dry mouth, water can be used to wet the mucous membrane of the cheeks.