Detailed Precautions
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Mobic Information
Detailed Precautions
General
Mobic cannot be expected to substitute for corticosteroids or to treat corticosteroid insufficiency. Abrupt discontinuation of corticosteroids may lead to disease exacerbation. Patients on prolonged corticosteroid therapy should have their therapy tapered slowly if a decision is made to discontinue corticosteroids.
The pharmacological activity of Mobic in reducing inflammation and possibly fever may diminish the utility of these diagnostic signs in detecting complications of presumed noninfectious, painful conditions.
Hepatic Effects
Borderline elevations of one or more liver tests may occur in up to 15% of patients taking Anti-Inflammatory Drugs">NSAIDs, including Mobic. These laboratory abnormalities may progress, may remain unchanged, or may be transient with continuing therapy. Notable elevations of ALT or AST (approximately three or more times the upper limit of normal) have been reported in approximately 1% of patients in clinical trials with Anti-Inflammatory Drugs">NSAIDs. In addition, rare cases of severe hepatic reactions, including jaundice and fatal fulminant hepatitis, liver necrosis and hepatic failure, some of them with fatal outcomes, have been reported with Anti-Inflammatory Drugs">NSAIDs. Patients with signs and/or symptoms suggesting liver dysfunction, or in whom an abnormal liver test has occurred, should be evaluated for evidence of the development of a more severe hepatic reaction while on therapy with Mobic. If clinical signs and symptoms consistent with liver disease develop, or if systemic manifestations occur (e.g., eosinophilia, rash, etc.), Mobic should be discontinued.
Renal Effects
Caution should be used when initiating treatment with Mobic in patients with considerable dehydration. It is advisable to rehydrate patients first and then start therapy with Mobic. Caution is also recommended in patients with pre-existing kidney disease (see WARNINGS, Advanced Renal Disease).
Long-term administration of Anti-Inflammatory Drugs">NSAIDs has resulted in renal papillary necrosis and other renal medullary changes. Renal toxicity has also been seen in patients in whom renal prostaglandins have a compensatory role in the maintenance of renal perfusion. In these patients, administration of Anti-Inflammatory Drugs">NSAIDs may cause dosedependent reduction in prostaglandin formation and, secondarily, in renal blood flow, which may precipitate overt renal decompensation. Patients at greatest risk of this reaction are those with impaired renal function, heart failure, liver dysfunction, those taking diuretics and ACE inhibitors, and the elderly. Discontinuation of Anti-Inflammatory Drugs">NSAID therapy is usually followed by recovery to the pretreatment state.
The extent to which metabolites may accumulate in patients with renal failure has not been studied with Mobic. Because some Mobic metabolites are excreted by the kidney, patients with significantly impaired renal function should be more closely monitored.
Hematological Effects
Anemia is sometimes seen in patients receiving Anti-Inflammatory Drugs">NSAIDs, including Mobic. This may be due to fluid retention, GI blood loss, or an incompletely described effect upon erythropoiesis. Patients on long-term treatment with Anti-Inflammatory Drugs">NSAIDs, including Mobic, should have their hemoglobin or hematocrit checked if they exhibit any signs or symptoms of anemia.
Drugs which inhibit the biosynthesis of prostaglandins may interfere to some extent with platelet function and vascular responses to bleeding.
Anti-Inflammatory Drugs">NSAIDs inhibit platelet aggregation and have been shown to prolong bleeding time in some patients.
Unlike aspirin their effect on platelet function is quantitatively less, or of shorter duration, and reversible. Mobic does not generally affect platelet counts, prothrombin time (PT), or partial thromboplastin time (PTT). Patients receiving Mobic who may be adversely affected by alterations in platelet function, such as those with coagulation disorders or patients receiving anticoagulants, should be carefully monitored.
Fluid Retention and Edema
Fluid retention and edema have been observed in some patients taking Anti-Inflammatory Drugs">NSAIDs, including Mobic.
Therefore, as with other Anti-Inflammatory Drugs">NSAIDs, Mobic should be used with caution in patients with fluid retention, hypertension, or heart failure.
Pre-existing Asthma
Patients with asthma may have aspirin-sensitive asthma. The use of aspirin in patients with aspirinsensitive asthma has been associated with severe bronchospasm which can be fatal. Since cross reactivity, including bronchospasm, between aspirin and other nonsteroidal anti-inflammatory drugs has been reported in such aspirin-sensitive patients, Mobic should not be administered to patients with this form of aspirin sensitivity and should be used with caution in patients with pre-existing asthma.
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