Mobic Special Precautions



Boehringer Ingelheim


Full Prescribing Info
Special Precautions
As with other NSAIDs gastro-intestinal bleeding, ulceration or perforation, potentially fatal, can occur at any time during treatment, with or without warning symptoms or a previous history of serious gastro-intestinal events. The consequences of such events are generally more serious in the elderly.
Caution should be exercised when treating patients with a history of gastro-intestinal disease. Patients with gastro-intestinal symptoms should be monitored. MOBIC should be withdrawn if gastro-intestinal ulceration or bleeding occurs.
As with other NSAIDs caution should be exercised in patients receiving treatment with anticoagulants.
Serious skin reactions, some of them fatal, including exfoliative dermatitis, Stevens-Johnson syndrome, and toxic epidermal necrolysis, have been reported rarely in association with the use of MOBIC. Patients appear to be at highest risk of these reactions early in the course of therapy, the onset of the reaction occurring in the majority of cases within the first month of treatment. MOBIC should be discontinued at the first appearance of skin rash, mucosal lesions, or any other sign of hypersensitivity.
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.
NSAIDs inhibit the synthesis of renal prostaglandins, which play a supportive role in the maintenance of renal perfusion. In patients whose renal blood flow and blood volume are decreased, administration of an NSAID may precipitate overt renal decompensation which is typically followed by recovery to pre-treatment state upon discontinuation of non-steroidal anti-inflammatory therapy.
Patients at greatest risk of such a reaction are elderly individuals, dehydrated patients, those with congestive heart failure, liver cirrhosis, nephrotic syndrome and overt renal disease, those receiving a concomitant treatment with a diuretic, ACE inhibitor or angiotensin II receptor antagonist or those having undergone major surgical procedures, which led to hypovolaemia. In such patients the renal function including the volume of diuresis should be carefully monitored at the beginning of therapy.
In rare instances NSAIDs may be the cause of interstitial nephritis, glomerulonephritis, renal medullary necrosis or nephrotic syndrome.
The dose of MOBIC in patients with end-stage renal failure on haemodialysis should not exceed 7.5 mg. No dose reduction is required in patients with mild or moderate renal impairment (i.e. in patients with a creatinine clearance of greater than 25 ml/min).
As with other NSAIDs, occasional elevations of serum transaminases or other parameters of liver function have been reported. In most cases these have been small and transient increases above the normal range. If the abnormality is significant or persistent, MOBIC should be stopped and follow up tests carried out.
No dose reduction is required in patients with clinically stable liver cirrhosis.
Frail or debilitated patients may tolerate side effects less well and such patients should be carefully supervised. As with other NSAIDs, caution should be used in the treatment of elderly patients who are more likely to be suffering from impaired renal, hepatic or cardiac function.
Induction of sodium, potassium and water retention and interference with the natriuretic effects of diuretics may occur with NSAIDs. Cardiac failure or hypertension may be precipitated or exacerbated in susceptible patients as a result. For patients at risk, clinical monitoring is recommended.
Meloxicam, as any other NSAID may mask symptoms of an underlying infectious disease.
The use of meloxicam, as with any drug known to inhibit cyclooxygenase/prostaglandin synthesis, may impair fertility and is not recommended in women attempting to conceive. Therefore, in women who have difficulties conceiving, or who are undergoing investigation of infertility, withdrawal of meloxicam should be considered.
For relevant drug interactions that require particular attention, see "Interactions".
MOBIC tablets 7.5 mg contain 47 mg lactose per maximum recommended daily dose. Patients with rare hereditary conditions of galactose intolerance, e.g. galactosaemia should not take this medicine.
Effects on ability to drive and use machines: No studies on the effect on the ability to drive and use machines have been performed. However, patients should be advised that they may experience undesirable effects like visual disturbance including blurred vision, dizziness, somnolence, vertigo and other central nervous system disturbances.
Therefore, caution should be recommended when driving a car or operating a machinery. If patient experience any of these events, they should avoid potentially hazardous tasks such as driving or operating machinery.
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