An anti-inflammatory and analgesic drug used in osteoarticular and muscular pain in the course of rheumatoid and degenerative diseases of the joints. Used in the short-term treatment of exacerbations of rheumatoid diseases, such as: rheumatoid arthritis, juvenile rheumatoid arthritis, ankylosing spondylitis.
Composition:
1 tabl contains 7.5 mg of meloxicam. The drug contains lactose
Action:
A drug from the group of non-steroidal anti-inflammatory drugs from the oxicam family. It exerts anti-inflammatory, analgesic and antipyretic effects by inhibiting prostaglandin cyclooxygenase. It is well absorbed from the gastrointestinal tract, bioavailability is about 89%, Cmaxoccurs within 5-6 h. After repeated administration, steady state is achieved within 3-5 days. It is very much bound to plasma proteins, mainly albumin (99%). meloxicam passes into the synovial fluid and reaches concentrations of approximately half of the concentration found in the blood. Is undergoing significant biotransformation in the liver. CYP2C9 enzymes, partly CYP3A4, are involved in the metabolism. Meloxicam is excreted mainly as metabolites in equal proportions with urine and faeces. Less than 5% of the daily dose is excreted unchanged with faeces and in the urine only in trace amounts. Medium T0,5 is about 20 hours.
Contraindications:
Hypersensitivity to meloxicam, other NSAIDs or to any of the excipients. Past hypersensitivity reactions such as bronchial asthma, nasal polyps, angioneurotic edema or urticaria due to Acetylsalicylic acid or other NSAIDs. Active or recurrent peptic ulcer of the stomach and / or duodenum. Perforation and gastrointestinal bleeding associated with NSAID therapy. Bleeding from the gastrointestinal tract, bleeding from cerebral vessels and other bleeding. Severe hepatic failure. Severe renal failure in patients not on dialysis. Severe heart failure. Children and adolescents <16 years old. Pregnancy. Period and breastfeeding.
Precautions:
Particularly cautiously use in patients who are at increased risk of ulceration and gastrointestinal bleeding. The risk of gastrointestinal bleeding, ulceration or perforation increases with increasing NSAID dosages, in patients with a history of ulceration (especially complicated hemorrhage or perforation), in the elderly and in patients taking other medicines at the same time that may increase the risk of stomach disorders and intestinal or bleeding (such as: oral corticosteroids, anticoagulants - contraindicated, selective serotonin reuptake inhibitors - SSRIs or antiplatelet agents, including low dose acetylsalicylic acid) - strict medical supervision and special caution are required in these patient groups, the lowest effective dose should be used, and combination with protective drugs (eg misoprostol or proton pump inhibitors) should be considered. Inflammation of the mucosa of the esophagus or stomach and history of a stomach ulcer require complete cure prior to using meloxicam. The concomitant use of meloxicam with other NSAIDs, including selective COX-2 inhibitors, is not recommended due to the increased risk of serious side effects. Taking meloxicam in the lowest effective dose and for the shortest time necessary to relieve symptoms reduces the risk of side effects. Carefully used in patients with ulcerative colitis, Crohn's disease (risk of exacerbation of these diseases); with reduced renal blood flow and reduced blood volume (eg in elderly patients with congestive heart failure, cirrhosis, nephrotic syndrome, renal failure or lupus nephropathy, liver failure, as well as in patients using ACE inhibitors, angiotensin receptor blockers II, diuretics or patients undergoing extensive surgery leading to hypovolaemia) - in the abovementionedpatients should not be used for more than 7 days, in case of prolonged use, it is recommended to check diuresis and other parameters of renal function; with heart failure or hypertension (risk of deterioration due to the meloxicane-induced retention of sodium, potassium and water and disruption of the natriuretic effect of diuretics, in addition, the effect of antihypertensive drugs may be impaired); with the risk of hyperkalemia (eg in patients with diabetes or those taking medicines that increase the level of potassium in the blood); with low body weight and / or weakness; in the elderly (higher risk of side effects, in addition, in these patients the function of the kidneys, liver and heart may be disturbed). 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 myocardial infarction or stroke); these data are insufficient to exclude such a risk when taking meloxicam. Meloxicam can mask the symptoms of an existing infectious disease. The use of the drug should be discontinued if: gastrointestinal symptoms, especially haemorrhage or ulceration; hypersensitivity symptoms such as: skin rash, mucosal changes; abnormal results of laboratory tests (liver, kidney function, morphology, perform appropriate control tests). Due to the lactose content, the drug should not be used in patients with inherited galactose intolerance, lactase deficiency (Lapp type) or malabsorption of glucose-galactose.
Pregnancy and lactation:
The drug is contraindicated in pregnancy. Inhibition of prostaglandin synthesis may negatively affect the course of pregnancy and / or embryo / fetal development: the risk of miscarriage and the occurrence of congenital heart defects and gastrosharing due to the use of a prostaglandin synthesis inhibitor in early pregnancy; the total risk of developing cardiovascular malformations increases from less than 1% to about 1.5%; the risk increases with the dose and duration of treatment. In the third trimester, all prostaglandin synthesis inhibitors can cause pulmonary hypertension, premature closure of the ductus arteriosus and renal dysfunction, which can be converted into renal failure with an allergy-derived hypoglycemia; in the mother - suppress the uterine contractile function; in the mother and in the fetus an anti-aggregation effect may be manifested by the prolongation of coagulation time. NSAIDs are excreted in breast milk. Use during lactation is contraindicated. Meloxicam may affect fertility in women by affecting ovulation; this effect is transient and disappears after completion of therapy.
Side effects:
Common: dizziness, headache, indigestion, nausea, vomiting, abdominal pain, constipation, bloating, diarrhea. Uncommon: anemia, dizziness, drowsiness, increased blood pressure, flushing, gastrointestinal bleeding, gastric and / or duodenal ulcer, esophagitis, oral mucositis (including ulcerative), transient disorders of liver function indicators (eg increased transaminases or bilirubin), urticaria, pruritus, rash, sodium and water retention, hyperkalemia, renal impairment (eg increased creatinine or urea), edema, including lower limb edema. Rare: leukopenia, thrombocytopenia, anaphylactic or anaphylactoid reactions, mood disorders, insomnia, nightmares, visual disturbances (including blurred vision, conjunctivitis), palpitations, heart failure, asthma attacks in some patients with hypersensitivity to acetylsalicylic acid or other NSAIDs , gastrointestinal perforation, gastritis, colitis, Stevens-Johnson syndrome, toxic epidermal necrolysis, angioneurotic edema, erythema multiforme. Very rare: agranulocytosis, hepatitis, renal failure. There have been isolated cases of interstitial nephritis, acute renal tubular necrosis, nephrotic syndrome, and renal papillary necrosis. Not known: confusion, dizziness, tinnitus, hypersensitivity to light.Clinical studies and epidemiological data suggest that the intake of certain NSAIDs (especially long-term at high doses) is associated with a small increase in the risk of arterial blockages (e.g., myocardial infarction or stroke). Nause, hypertension and heart failure have been reported in relation to NSAID treatment. Peptic ulcer of the stomach and / or duodenum, perforation or bleeding from the gastrointestinal tract may sometimes be severe, especially in elderly patients. There may also be other side effects, such as tarry stools, bloody vomiting or exacerbation of Crohn's disease.
Dosage:
Orally. Adults: 1 tabl. (7.5 mg) once a day.Special groups of patients. In elderly patients, use a dose of 7.5 mg daily. 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 dose of more than 7.5 mg per day should not be used. It is not necessary to reduce the dose in patients with mild to moderate hepatic impairment. Do not use in patients with severe hepatic impairment. Do not use in children and adolescents <16 years of age.Way of giving. The daily dose should be taken as a single dose with a meal with water.