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ETC / RX - Non steroid anti-inflammatory - Melic 7.5mg

COMPOSITION:

Meloxicam 7.5 mg; 15 mg

Per each film coated tablet.


INDICATIONS:

Acute and chronic symptomatic treatment of osteoarthritis and rheumatoid arthritis.


ADMINISTRATION AND DOSAGE:

Rheumatoid arthritis: Meloxicam is given 15mg orally once daily. According to the therapeutic response, the dose may be reduced to 7.5mg/day.
Osteoarthritis: Meloxicam can be given 7.5mg – 15mg once daily.
Dosage for children under 15 years old has not been established.
The maximum recommended daily dose of meloxicam is 15mg. For patients with renal insufficiency undergoing dialysis, the maximum recommended daily dose is 7.5mg.


CONTRAINDICATIONS:

  • Perioperative treatment of pain in patients undergoing coronary artery bypass graft surgery (CABG)
  • Known hypersensitivity to Meloxicam, Aspirin, or NSAIDs, including signs/symptoms of asthma, nasal polyps, angioedema or urticaria, following administration of aspirin or other NSAIDs
  • Active gastrointestinal bleeding, ulceration
  • Active inflammatory bowel disease (Crohn’s disease or ulcerative colitis).
  • Severe hepatic insufficiency or non-dialysed severe renal insufficiency
  • Severe heart failure
  • Pregnant or breast – feeding women
  • Children under 15 years of age.
  • Concomitant administration of drugs known to inhibit CYP2C9 (eg. Sulfaphenazole, sulfinpyrazone, sulfamethoxazole and fluconazole)
  • The use of meloxicam tablets is contraindicated in patients with rare hereditary galactose intolerance, due to the lactose content of the formulations.
  • As with all NSAIDs, meloxicam is contraindicated in patients with recent cerebrovascular bleeding or established systemic bleeding disorders.

WARNINGS AND PRECAUTIONS:

  • Use with caution in patients with history of gastrointestinal bleeding, impaired cardiac function, hypertension, volume depleted patients, mild to moderate renal impairment, and in patients receiving anticoagulants.
  • Make sure you know how you react to meloxicam before driving a car, operating machinery, or anything else that could be dangerous if you are not alert.
  • Cardiovascular Risk
  • NSAIDs may increase the risk of serious cardiovascular thrombotic events, myocardial infarction, and stroke, which can be fatal. This risk may increase with duration of use. Patients with cardiovascular disease or risk factors for cardiovascular disease may be at greater risk.
  • Gastrointestinal (GI) Effects
  • Serious GI toxicity such as bleeding, ulceration and perforation of the stomach, small intestine or large intestine, which may be potentially fatal, can occur at any time, with or without warning symptoms, in patients treated with NSAIDs.
  • Studies have shown that patients with prior history of ulcer disease and/or GI bleeding and who use NSAIDs have a greater than tenfold higher risk of developing a GI bleed than patients with neither of these factors.
  • Caution is advised in patients most at risk of developing a GI complication with NSAIDs: the elderly, patients using other NSAIDs or aspirin concomitantly or patients with a prior history of or recent GI disease such as ulceration and GI bleeding.
  • For high risk patients, alternate therapies that do not involve NSAIDs should be considered.

SIDE EFFECTS:

Nausea, abdominal pain, dyspepsia, diarrhea, skin rash and pruritus. Other side effects such as haematemesis, duodenal or gastric ulcer, fluid retention, anemia and elevated liver enzymes have also been reported.
As with other NSAID medicines, meloxicam may cause dizziness, drowsiness or blurred vision in some people.


INTERACTIONS:

  • No relevant pharmacokinetic drug-drug interactions were detected with respect to the concomitant administration of antacid, cimetidine, digoxin and furosemide.
  • Other Prostaglandin Synthetase Inhibitors (PSI) including glucocorticoids and salicylates: Co-administration of PSIs may increase the risk of gastrointestinal ulcers and bleeding via a synergistic effect and is not recommended. The concomitant use of meloxicam with other NSAIDs is not recommended. Concomitant administration of aspirin (1000mg tid) to healthy volunteers tended to increase the AUC (10%) and Cmax (24%) of meloxicam. The clinical significance of this interaction is not known.
  • Oral anticoagulants, antiplatelet drugs, systemically administered heparin, thrombolytics and Selective Seretonin Reuptake Inhibitors (SSRIs): increased risk of bleeding via inhibition of platelet function. If such co-prescribing cannot be avoided, close monitoring is required.
  • Lithium: NSAIDs have been reported to increase lithium plasma levels.
  • Methotrexate: NSAIDs can reduce the tubular secretion of methotrexate thereby increasing the plasma concentrations of methotrexate.
  • Contraception: A decrease of the efficacy of intrauterine devices by NSAIDs has been previously reported but needs further confirmation.
  • Diuretics: Treatment with NSAIDs is associated with the potential for acute renal insufficiency in patients who are dehydrated. Patients receiving meloxicam and diuretics should be adequately hydrated and be monitored for renal function prior to initiating treatment.
  • Antihypertensives (e.g. beta-blockers, ACE-inhibitors, vasodilators, diuretics): A reduced effect of the antihypertensive drug by inhibition of vasodilating prostaglandins has been reported during treatment with NSAIDs.
  • NSAIDs and angiotensin-II receptor antagonists as well as ACE inhibitors exert a synergistic effect on the decrease of glomerular filtration. In patients with pre-existing renal impairment this may lead to acute renal failure.
  • Cholestyramine binds meloxicam in the gastrointestinal tract leading to a faster elimination of meloxicam.
  • Nephrotoxicity of cyclosporin may be enhanced by NSAID’s via renal prostaglandin mediated effects. During combined treatment renal function is to be measured.
  • Interactions with oral antidiabetics cannot be excluded.

PRESENTATION:

  • Box of 4 blisters x 7 coated tablets.
  • Box of 2 blisters x 10 coated tablets.