COMPOSITIONS :
Mevilox® Tablet 7.5 mg, each tablet contains : Meloxicam 7.5 mg.
DECRIPTIONS :
Mevilox® with Meloxicam as active ingredient is available in tablet 7.5 mg and 15 mg.
INDICATIONS :
Mevilox® is indicated for :
- Short term symptomatic treatment of acute exacerbation osteoarthritis.
- Long term symptomatic treatment of rheumatoid arthritis (chronic polyarthritis).
DOSAGE AND ADMINISTRATIONS :
- Rheumatoid arthritis : 15 mg/day. According to therapeutic response, the dose may be reduced to 7.5 mg/day.
- Osteoarthritis : 7.5 mg/day. If necessary, the dose may be increased to 15 mg/day.
- In patients with increased risks of adverse reactions : Start treatment at the dose of 7.5 mg/day.
- In dialysis patients with severe renal failure : The dose should not exceed 7.5 mg/day.
- The maximum recommended daily dose of Meloxicam is 15 mg.
- As a dosage for use in children has yet to be established, usage should be restricted to adults.
- Tablet should be swallowed with water or other fluid in conjuction with food.
CONTRAINDICATIONS :
- Known hypersensitivity to Meloxicam or any excipients of the drug. There is a potential for cross sensitivity to Acetosal and other non-steroidal anti-inflammatory drugs (NSAIDs).
- Meloxicam should not be given to patients who have developed signs of asthma, nasal polyps, angio-oedema or urticaria following the administration of Acetosal or other NSAIDs.
- Active peptic ulceration, severe hepatic insufficiency, nondialysed severe renal insufficiency.
- Children and adolescents aged less than 15 years, pregnancy or breastfeeding.
- Gastrointestinal bleeding, cerebrovascular bleeding or other bleeding disorders.
WARNINGS AND PRECAUTIONS :
CARDIOVASCULAR EFFECTS
- Cardiovascular thrombotic events
Clinical trials of several COX-2 selective and nonselective NSAIDs of up to three years duration have shown an increase risk of serious cardiovascular (CV) thrombotic events, myocardial infarction and stroke, which can be fatal. All NSAIDs, both COX-2 selective and nonselective, may have a similar risk. Patients with known cardiovascular disease or risk factors for cardiovascular disease may be at greater risk. To minimize the potential risk for an adverse cardiovascular event in patients treated with an NSAID, the lowest effective dose should be used for the shortest duration possible. Physicians and patients should remain alert for the development of such events, even in the absence of previous cardiovascular symptoms. Patients should be informed about the sign and/or symptomps of serious cardiovascular events and the steps to take if they occur.
There is no consistent evidence that concurrents use of Acetosal mitigates the increased risk of serious cardiovascular thrombotic events associated with NSAID use. The concurrent use of Acetosal and an NSAID does increase the risk of serious GI events (see WARNINGS, gastrointestinal (GI) effects – risk of GI ulceration, bleeding and perforation).
Two large, controlled, clinical trials of a COX-2 selective NSAID for the treatment of pain the first 10 – 14 days following coronary artery bypass graft (CABG) surgery found an increased incidence of myocardial infarction and stroke (see CONTRAINDICATIONS).
- Hypertension
NSAIDs, including Mevilox® can lead to onset of new hypertension or worsening of pre-existing hypertension, either of which may contribute to the increased incidence of cardiovascular events. Patients taking Thiazide or loop diuretics may have impaired response to these therapies when taking NSAIDs. NSAIDs, including Mevilox®, should be used with caution in patients with hypertension. Blood pressure (BP) should be monitored closely during the initiation of NSAID treatment and throughout the course of therapy.
- Congestive heart failure and edema
Fluid retention and edema have been observed in some patients taking NSAIDs. Mevilox® should be used with caution in patients with fluid retention or hearts failure.
Gastrointestinal (GI) Effects
- Risk of GI ulceration, bleeding and perforation
NSAIDs, including Mevilox®, can cause serious gastrointestinal adverse events including inflammation, bleeding, ulceration and perforation of the stomach, small intestine or large intestine or large intestine, which can be fatal. These serious adverse events can occur at any time, with or without warning symptoms, in patients treated with NSAIDs. Only one in five patients, who develop a serious upper GI adverse events of NSAID therapy, is symptomatic. Upper GI ulcers, gross bleeding or perforation caused by NSAIDs occur in approximately 1% of patients treated for 3 – 6 months and in about 2 – 4% of patients treated for one year. These trends continue with longer duration of use, increasing the likehood of developing a serious GI event at some time, during the course of therapy. However, even short-term therapy is not without risk.
NSAIDs should be prescribed with extreme caution in those with prior history of ulcer disease or gastrointestinal bleeding. Patients with prior history of peptic ulcer disease and/or gastrointestinal bleeding and who use NSAIDs, have a greater than 10-fold higher risk for developing a GI bleed compared to patients with neither of these risk factors. Other factors that increase the risk for GI bleeding in patients treated with NSAIDs include concomitant use of oral corticosteroids or anticoagulants, longer duration of NSAID therapy, smoking, use of alcohol, older age and poor general health status. Most spontaneous reports of fatal GI events are in the elderly or debilitated patients and therefore, special care should be taken in treating this population.
To minimize the potential risk for an adverse GI event, in patients treated with NSAIDs, the lowest effective dose should be used for the shortest possible duration. Patients and physicians should remain alert for signs and symptoms of GI ulceration and bleeding during NSAID therapy and promptly initiate additional evaluation and treatment if a serious GI adverse event is suspected. For high-risk patients, alternate therapies that do not involve NSAIDs should be considered.
OTHERS
- The over dose causation anaphylactiod reaction and renal disease.
- Should be used long term causation anemia.
- Should be used with caution in patient fluid retention, hypertension, hepatic failure.
- NSAIDs inhibit the syntheis of renal prostaglandin’s which play a supportive role in the maintenance of renal perfusion. In patients whose volume and renal blood flow are decreased, administration of an NSAID can cause renal failure but can be recovered upon discontinuation of nonsteroidal antiinflammatory therapy. Patients at greatest risk of such a reaction are dehydrated patients, those with congestive heart failure, liver cirrhosis, nephrotic syndrome and renal disease, those receiving a diuretic or those having undergone major surgical procedures which led to hypovolaemia.
DRUG INTERACTIONS :
- Other NSAIDs including salicylates in high doses : Concomitant administration of more than one NSAID may increasae the risk of gastrointestinal ulceration and bleeding through synergistic action.
- Oral anticoagulants, Ticlopidine, systemically administered heparin, thrombolytics : Increased risk of bleeding. If such co-prescribing cannot be avoided, close monitoring of the effects of anticoagulants is required.
- Lithium : NSAIDs have been reported to increase lithium plasma levels. It is recommended that plasma lithium levels be motnitored when initiating, adjusting and discontinuing Meloxicam.
- Methotrexate : As other NSAIDs Meloxicam may increase the haematologic toxicity of Methotrexate. In this situation, strict monitoring of blood cell count is recommended.
- Contraception : NSAIDs have been reported to decrease the efficacy of intrauterine devices.
- 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 affect of the antihypertensive drug by inhibition of vasodilating prostaglandins has been reported during treatment with NSAIDs.
- Cholestyramine binds Meloxicam in the gastrointestinal tract leading to a faster elimination of Meloxicam.
- Nephrotoxicity of Cyclosporine may be enhanced by NSAIDs via renal prostaglandin mediated effects. During combined treatment renal function is to be measured.
ADVERSE REACTIONS :
The following adverse events (more frequent than 1%) which may be causally related with the administration of Meloxicam have been reported.
- Gastrointestinal : Dyspepsia, nausea, vomiting, abdominal pain, constipation, flatulence, diarrhea, collitis, dry mouth, duodenal ulcer, esophagitis, gastric ulcer, gastritis, gastroesophageal reflux, gastrointestinal hemorrhage, stomatitis ulcerative.
- Hematological : Anemia.
- Cutaneo-mucosal reactions : Pruritis, skin rash, urticaria, stomatitis, esophagitis.
- Central nervous system : Lightheadedness, headache.vertigo, tinnitus, drowsiness.
- Cardiovascular : Palpitasi, flushes, oedem of the lower limbs, angina pectoris, cardiac failure, hypertension, hypotension, myocardial infarction, vasculitis.
- Liver function : Raised transaminases or bilirubin.
- Allergic reactions, anaphylactoid reactions, face edema, fatigue, fever, weight decrease, weight increase.
- In respiratory system can happen asthma, bronchospasm, dyspnea.
PRESENTATIONS :
Mevilox® Tablet 7.5 mg Box, 3 blisters @ 10 tablets Reg. No. DKL0402336310A2
STORAGE :
STORE BELOW 30°C, PROTECT FROM LIGHT
ON MEDICAL PRESCRIPTION ONLY
Manufactured by :
BERNOFARM
Sidoarjo – Indonesia
