RiteMED Meloxicam Special Precautions

Cardiovascular Effects: Cardiovascular Thrombotic Events: Clinical trials using COX-2 selective and nonselective NSAIDs of up to three years duration show an increased risk of cardiovascular (CV) thrombotic events, myocardial infarction and stroke, which can be fatal. Risk for these events is greater in patients with known CV disease or risk factors for CV disease. Use the lowest effective NSAID dose for the shortest possible time to minimize the potential risk for an adverse CV event. Even in the absence of previous CV symptoms, physicians and patients should be alert for the development of such events. Inform patients about signs and/or symptoms of serious CV events and the steps to take if they occur.
There is no consistent evidence that concurrent use of Aspirin mitigates the increased risk of serious CV thrombotic events associated with NSAID use.
Clinical trials of a COX-2 selective NSAID for the treatment of pain in the first 10-14 days after CABG surgery found an increased incidence of myocardial infarction and stroke.
Hypertension: NSAIDs, including Meloxicam, can lead to the onset of new hypertension or worsening of pre-existing hypertension, either of which may contribute to the increased incidence of CV events. Use Meloxicam with caution in patients with hypertension. Impaired response to therapies such as thiazides or loop diuretics may occur in patients taking NSAIDs, including Meloxicam. Monitor blood pressure closely during initiation of NSAID treatment and throughout the course of therapy.
Congestive Heart Failure and Edema: Fluid retention and edema (including peripheral edema) have been seen in some patients taking NSAIDs. Use Meloxicam with caution in patients with fluid retention, hypertension or heart failure.
Gastrointestinal (GI) Effects: NSAIDs should be prescribed with extreme caution in those with a prior history of ulcer disease and/or gastrointestinal bleeding since such patients have a greater than 10-fold increased risk for developing a GI bleed when they use NSAIDs compared with 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. Elderly or debilitated patients, in particular, are at greater risk for serious gastrointestinal events; special care should be taken in treating this population.
The lowest effective dose should be used for the shortest possible duration to minimize the potential risk for an adverse GI event. Physicians and patients 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. This should include discontinuation of the NSAID until a serious GI adverse event is ruled out. Alternate therapies that do not involve NSAIDs should be considered especially for high-risk patients.
Renal Effects: Renal papillary necrosis and other renal injury may result from long-term administration of NSAIDs. In patients in whom renal prostaglandins have a compensatory role in the maintenance of renal perfusion, renal toxicity may occur with NSAID use because of the dose-dependent reduction in prostaglandin and renal blood flow which may precipitate overt renal decompensation. Elderly patients, those with impaired renal function, heart failure, liver dysfunction, those taking diuretics, ACE inhibitors and angiotensin II receptor antagonists are at greatest risk for this reaction. Recovery to the pretreatment state usually follows discontinuation of NSAID therapy.
Meloxicam is not recommended in patients with advanced renal disease.
Use caution when initiating Meloxicam treatment in patients with considerable dehydration. Rehydrate patients first before starting Meloxicam therapy.
Anaphylactoid Reactions: Anaphylactoid reactions may occur in patients without known prior exposure to NSAIDs. Asthmatic patients who experience rhinitis with or without nasal polyps, or who exhibit severe, potentially fatal bronchospasm after taking Aspirin or other NSAIDs are at an increased risk of this symptom complex. Seek emergency help when an anaphylactoid reaction occurs.
Skin reactions: As with other NSAIDs, Meloxicam can cause serious skin adverse events such as exfoliative dermatitis, Stevens-Johnson Syndrome (SJS), and toxic epidermal necrolysis (TEN), which can be fatal. Since these serious events may occur without warning, inform patients about the signs and symptoms of serious skin manifestations and advice them to discontinue the drug at the first appearance of skin rash or any other sign of hypersensitivity.
Hepatic Effects: Elevations of one or more liver function tests and rare cases of severe hepatic reactions including jaundice and fatal fulminant hepatitis, liver necrosis and hepatic failure, which may be fatal, have been reported with NSAID use.
Evaluate patients with signs and/or symptoms suggesting liver dysfunction or abnormal liver test for evidence of the development of more severe hepatic reaction while on Meloxicam therapy.
Discontinue Meloxicam treatment if clinical signs and symptoms consistent with liver disease develop or if systemic manifestations such as eosinophilia or rashes occur.
Hematological Effects: Anemia, which may be due to fluid retention, occult or gross gastrointestinal blood loss, or an incompletely described effect upon erythropoiesis have been seen in patients receiving NSAIDs. Periodically determine hemoglobin values in patients with initial hemoglobin values of 10 g or less who are to receive a longer duration of meloxicam therapy.
NSAIDs generally inhibit platelet aggregation and may prolong bleeding time in some patients but this effect on platelet function, compared with Aspirin, is quantitatively less, of shorter duration, and reversible. Carefully monitor patients on Meloxicam therapy who may be adversely affected by alterations in platelet function (e.g., those with coagulation disorders or patients receiving anticoagulants).
Preexisting Asthma: Asthmatic patients may have aspirin-sensitive asthma. The use of Aspirin in patients with aspirin-sensitive asthma has been associated with severe bronchospasm which can be fatal. Do not administer Meloxicam to patients with Aspirin sensitivity since cross reactivity between Aspirin and other NSAIDs have been reported. Administer Meloxicam with caution in patients with preexisting asthma.
General Precautions: Meloxicam is not a corticosteroid substitute and cannot be used to treat corticosteroid insufficiency.
The antipyretic and anti-inflammatory actions of Meloxicam may diminish the use of these diagnostic signs in detecting complications of presumed non-infectious, non-inflammatory painful conditions.
Use in Pregnancy & Lactation: See Use in Pregnancy & Lactation section for further information.
Use in Children: The safety and efficacy in children below 2 years old have not been established. The use in children 2-17 years old with juvenile rheumatoid arthritis has been established.
Use in the Elderly: As with any NSAID, exercise caution in treating the elderly (65 years and older).