Dosage and administration	Dosage Adults – Rheumatoid arthritis and ankylosing spondylitis: Initial dose is ½ tablet (7.5mg) once a day. the dose may be increased to a maximum dose of one tablet (15 mg) once a day. – For long-term treatment, particularly in elderly patients or patients with increased risks for adverse reactions, the recommended dose is ½ tablet (7.5mg) once a day. – Do not exceed the dose of 15 mg (1 tablet) per day. – Exacerbations of osteoarthritis: ½ tablet (7.5mg) once a day. If necessary (in the absence of improvement) the dose may be increased to 1 tablet (15 mg) once a day. Elderly patients: The recommended dose is ½ tablet (7.5mg) once a day. Hepatic impairment, renal impairment: Mild and moderate: It is unnecessary to adjust the dosage. In case of severe impairment, meloxicam is contraindicated. In dialysis patients with severe renal failure: The dose should not exceed ½ tablet (7.5 mg) per day. Children: The safety and efficacy have not been determined. Administration: Agimesi 15 tablets may be taken once a day without regard to meals or timing of antacids.
Contraindications	– Hypersensitivity to meloxicam or to any of the excipients, a history of hypersensitivity to aspirin or other nonsteroidal anti-inflammatory drugs. – Meloxicam should not be given to patients who have developed symptoms of asthma, nasal polyps, angioneurotic edema or Quincke’s edema. – Progressive gastric and duodenal ulcers. – Gastrointestinal, cerebral hemorrhage. – Severe hepatic failure, severe renal failure without hemodialysis. – Pregnant women and breast-feeding mothers.
Warnings and precautions for use	Meloxicam should be carefully indicated to patients with a history of gastric and duodenal ulcers, or patients concomitantly taking anticoagulants because meloxicam can cause gastric and duodenal ulcers or hemorrhage. Meloxicam must be discontinued immediately if there are abnormal signs of the skin and mucous membranes or symptoms of gastrointestinal ulcers or bleeding. Meloxicam inhibits the synthesis of renal prostaglandins leading to the reduction in renal blood flow. In patients with decreased renal blood flow or hypovolemia such as heart failure, nephrotic syndrome, liver cirrhosis, severe renal disease; those receiving a diuretic drug or undergoing major surgical procedures volume of diuresis and renal function should be carefully monitored before starting meloxicam therapy. Meloxicam may cause slight and transient increase in transaminase levels or other liver function parameters. When these parameters exceed normal limits significantly or persistently, meloxicam should be stopped, and follow-up tests should be carried out. Elderly patients: Meloxicam should not be used in the elderly with impaired liver, kidney and heart function. Risk of cardiovascular thrombotic events Non-steroidal anti-inflammatory drugs (NSAIDs), non-aspirin, with systemic effects may cause an increased risk of cardiovascular thrombotic events, including heart attack and stroke which can be fatal. This risk may occur early in the first few weeks of treatment and increase with duration of use. CV thrombotic risk has been observed most consistently at higher doses. The occurrence of cardiovascular events should be periodically evaluated, even in the absence of previous CV symptoms. Patients should be warned about the symptoms of a serious cardiovascular events and should meet the doctor as soon as these symptoms occur. Agimesi 15 tablet should be used at the lowest effective daily dose for the shortest possible duration to minimize the risk for adverse cardiovascular events.
Recommendation for pregnancy and breastfeeding	Pregnancy Experimental studies did not show evidence of teratogenic effect of meloxicam. However, meloxicam is not recommended during pregnancy, at least the third trimester, because of the risk of premature closure of the ductus arteriosus or other adverse reactions to the fetus. Lactation Meloxicam should not be used during breastfeeding. If meloxicam treatment is required, the mother should stop breastfeeding.
Effects on ability to drive and use machines	Meloxicam has no influence on the ability to drive and use machine. However, vertigo, drowsiness may occur in some cases. If affected, patients should be advised not to drive or operate machinery.
Interactions, incompatibilities of medicine	Meloxicam has an increased synergistic effect on the inhibition of cyclo-oxygenase with other nonsteroidal anti-inflammatory drugs at high doses, this may increase the risk of gastrointestinal ulcers and bleeding. The concomitant use of meloxicam with other NSAIDs is not recommended. Oral anticoagulants, ticlopidine, heparin, thrombolytics: Meloxicam increases the risk of bleeding; thus, the combination should be avoided. Anticoagulant effect should be monitored closely during the treatment. Lithium: NSAIDSMeloxicam may increase blood lithium levels (via decreased renal excretion of lithium), which may reach toxic values. Therefore, blood lithium concentration should be monitored if the combination of these drugs is required. Methotrexate: Meloxicam may increase the hematological toxicity of methotrexate. In the case of combination treatment, blood cell count should be performed periodically. IUD (Intra-Uterine Device): Meloxicam decreases the efficacy of intrauterine devices. Diuretics: Meloxicam may increase the risk of acute renal insufficiency in patients who are dehydrated. If the combination is required, patients should be adequately hydrated and renal function should be closely monitored. Antihypertensive agents (e.g. Alpha-adrenergic blockers, angiotensin converting enzyme inhibitors, vasodilators): Due to its effect on the inhibition of prostaglandin synthesis, meloxicam reduces vasodilatory and hypotensive effect of combined medicines. Cholestyramine: Cholestyramine binds meloxicam in the gastrointestinal tract leading to reduction of absorption and faster elimination of meloxicam. Cyclosporine: Meloxicam increases nephrotoxicity of cyclosporine, therefore, when combined, renal function should be monitored carefully. Warfarin: Meloxicam may enhance the effect of blood thinners, thus, bleeding time should be monitored if the combination treatment is required. Furosemide and thiazides: Meloxicam reduces diuretic effect of furosemide, thiazide diuretics.
Undesirable effects (ADRs)	Like other nonsteroidal anti-inflammatory drugs, meloxicam may cause unwanted effects in many organs of the body especially the gastrointestinal tract, blood, kidneys and skin. Attention should be paid to the risk of cardiovascular thrombotic events (see Warning and precautions). Common, ADR >1/100 – Digestive disorders, nausea, vomiting, abdominal pain, constipation, flatulence, diarrhea, anemia, pruritus, rash. – Headache, oedema Uncommon 1/100 > ADR >1/1000 – Slightly raised transaminases, bilirubin, eructation, esophagitis, gastric and duodenal ulcers, latent gastrointestinal hemorrhage. – Leukopenia, thrombocytopenia. – Stomatitis, urticaria. – Increased blood pressure, palpitations, flushes. – Increased serum creatinine and blood urea concentration. – Dizziness, tinnitus and drowsiness. Rare ADR < 1/1000 – Colitis, gastrointestinal perforation, gastritis, hepatitis. – Increased photosensitivity reactions, erythema multiforme, Stevens-Johnson syndrome, Lyell syndrome, bronchial asthma. – Angioneurotic edema, anaphylactic shock. Guidelines for ADR management: To minimize undesirable effects on the digestive tract of meloxicam, meloxicam should be used immediately after eating or accompanied by antacids and gastric mucosal protective agent.
Overdose and management	There is no specific antidote of meloxicam. Patients should be managed with symptomatic and supportive care following meloxicam overdose. Measures used to accelerate the removal and reduce the absorption of meloxicam should also be useful, such as gastric lavage, oral cholestyramine.
Pharmacodynamic properties	Meloxicam is a non-steroidal anti-inflammatory drug (NSAID), a derivative of oxicam, with anti-inflammatory, analgesic and antipyretic properties. As with other NSAIDs, meloxicam inhibits the synthesis of prostaglandins, which are mediators playing an important role in pathogenic mechanisms of inflammation, fever, pain process. Based on in vitro studies meloxicam is previously considered as selective inhibitors of COX-2. But in vivo, effects of meloxicam demonstrate that it inhibits selectively the action of COX-2 approximately tenfold higher than that COX-1 and its partial inhibition of platelet cyclooxygenase-1 blocks production of thromboxane with both doses of 7.5 mg / day and 15 mg / day. In clinical trials, meloxicam has less gastrointestinal adverse effects than the nonselective COX inhibitors do. The degree of COX-1 inhibition depends on meloxicam dose (dose of 7.5 mg/day causes less adverse reactions than dose of 15 mg/day do) and individual patients. Clinical monitoring is required to assess exactly the degree of selective COX-2 inhibition of meloxicam.
Pharmacokinetic properties	– Absorption: Meloxicam is well absorbed from the gastrointestinal tract, which is reflected by a high absolute bioavailability of 89% following oral administration compared to intravenous injection, food has negligible influence on the absorption. – Distribution: Meloxicam is extensively bound to plasma proteins (>99%), mainly to albumin. Meloxicam diffuses well into synovial fluid of which the concentrations are approximately half of those in plasma. However, the concentration of free meloxicam in synovial fluid is 2.5 times higher than that in the plasma. This is because protein concentration in synovial fluid is lower than in plasma. – Metabolism: Meloxicam is almost completely metabolized in the liver primarily by cytochrome P450 CYP2C9 and to a minor extent by CYP3A4. – Elimination: Inactive metabolites are predominantly excreted in urine and feces. A small amount of unchanged parent compound is excreted in urine (0.2%) and feces (1.6%). The mean elimination half-life is about 20 hours. In patients with mild or moderate renal or hepatic impairment (creatinine clearance > 20 ml/min) there is no need for dose adjustment.
Storage conditions, shelf-life, quality specification of the medicine	Storage conditions: Protect from humidity and light, below 30 degrees C. Shelf – life: 36 months from the manufacture date. Quality specification: In house specification.

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