Meloxicam: Package Insert and Label Information (Page 2 of 4)
5.12 Hematologic Toxicity
Anemia has occurred in NSAID-treated patients. This may be due to occult or gross blood loss, fluid retention, or an incompletely described effect upon erythropoiesis. If a patient treated with meloxicam capsules have any signs or symptoms of anemia, monitor hemoglobin or hematocrit.
NSAIDs, including meloxicam, may increase the risk of bleeding events. Concomitant use of warfarin and other anticoagulants, antiplatelet agents (e.g., aspirin), and serotonin reuptake inhibitors (SSRIs) and serotonin norepinephrine reuptake inhibitors (SNRIs) may increase this risk. Monitor these patients for signs of bleeding [see Drug Interactions (7) ].
5.13 Masking of Inflammation and Fever
The pharmacological activity of meloxicam capsules in reducing inflammation, and possibly fever, may diminish the utility of diagnostic signs in detecting infections.
5.14 Laboratory Monitoring
Because serious GI bleeding, hepatotoxicity, and renal injury can occur without warning symptoms or signs, consider monitoring patients on long-term NSAID treatment with a CBC and a chemistry profile periodically [see Warnings and Precautions (5.2, 5.3, 5.6)].
6 ADVERSE REACTIONS
The following adverse reactions are discussed in greater detail in other sections of the labeling:
• Cardiovascular Thrombotic Events [see Warnings and Precautions (5.1) ]
• GI Bleeding, Ulceration and Perforation [see Warnings and Precautions (5.2) ]
• Hepatotoxicity [see Warnings and Precautions (5.3) ]
• Hypertension [see Warnings and Precautions (5.4) ]
• Heart Failure and Edema [see Warnings and Precautions (5.5) ]
• Renal Toxicity and Hyperkalemia [see Warnings and Precautions (5.6) ]
• Anaphylactic Reactions [see Warnings and Precautions (5.7) ]
• Serious Skin Reactions [see Warnings and Precautions (5.9) ]
• Hematologic Toxicity [see Warnings and Precautions (5.11) ]
6.1 Clinical Trials Experience
Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in practice.
Adverse Reactions in Patients with Osteoarthritis Pain
Eight hundred sixty-eight (868) patients with osteoarthritis pain, ranging in age from 40 to 87 years, were enrolled in two Phase 3 clinical trials and received meloxicam capsules 5 mg or 10 mg once daily. Fifty percent (50%) of patients were aged 61 years or older.
Two hundred sixty-nine (269) patients received meloxicam capsules 5 mg or 10 mg once daily in the 12-week, double-blind, placebo-controlled, clinical trial of osteoarthritis pain of the knee or hip. The most frequent adverse reactions in this study are summarized in Table 1.
|Adverse Reactions||Meloxicam Capsules 5 mg or 10 mg N=269||Placebo N=133|
Six hundred (600) patients received meloxicam capsules 10 mg once daily in a 52-week, open-label, clinical trial in osteoarthritis pain of the knee or hip. Of these, 390 (65%) patients completed the trial. The most frequent adverse reactions in this study are summarized in Table 2.
|Adverse Reactions||Meloxicam Capsules 10 mg N=600|
|Urinary Tract Infection||6%|
|Upper Respiratory Tract Infection||4%|
|Pain in Extremity||2%|
|Additional adverse reactions reported for meloxicam:|
|Body as a Whole||allergic reaction, face edema, fatigue, fever, hot flushes, malaise, syncope, weight decrease, weight increase|
|Cardiovascular||angina pectoris, cardiac failure, hypertension, hypotension, myocardial infarction, vasculitis|
|Central and Peripheral Nervous System||convulsions, paresthesia, tremor, vertigo|
|Gastrointestinal||colitis, dry mouth, duodenal ulcer, eructation, esophagitis, gastric ulcer, gastritis, gastroesophageal reflux, gastrointestinal hemorrhage, hematemesis, hemorrhagic duodenal ulcer, hemorrhagic gastric ulcer, intestinal perforation, melena, pancreatitis, perforated duodenal ulcer, perforated gastric ulcer, stomatitis ulcerative|
|Heart Rate and Rhythm||arrhythmia, palpitation, tachycardia|
|Hematologic||agranulocytosis, leukopenia, purpura, thrombocytopenia|
|Immune System||anaphylactoid reactions (including shock)|
|Liver and Biliary System||ALT increased, AST increased, bilirubinemia, GGT increased, hepatitis, jaundice, liver failure|
|Metabolic and Nutritional||dehydration|
|Psychiatric||abnormal dreaming, alterations in mood (such as mood elevation), anxiety, appetite increased, confusion, depression, nervousness, somnolence,|
|Respiratory||asthma, bronchospasm, dyspnea|
|Skin and Appendages||alopecia, angioedema, bullous eruption, erythema multiforme, exfoliative dermatitis, photosensitivity reaction, pruritus, Stevens-Johnson Syndrome, toxic epidermal necrolysis, sweating increased, urticaria|
|Special Senses||abnormal vision, conjunctivitis, taste perversion, tinnitus|
|Urinary System||albuminuria, acute urinary retention, BUN increased, creatinine increased, hematuria, interstitial nephritis, renal failure,|
7 DRUG INTERACTIONS
See Table 3 for clinically significant drug interactions with meloxicam.
|Drugs That Interfere with Hemostasis|
|Clinical Impact|| |
|Intervention:||Monitor patients with concomitant use of meloxicam with anticoagulants (e.g., warfarin), antiplatelet agents (e.g., aspirin), selective serotonin reuptake inhibitors (SSRIs), and serotonin norepinephrine reuptake inhibitors (SNRIs) for signs of bleeding [see Warnings and Precautions (5.11)].|
|Clinical Impact:||Controlled clinical studies showed that the concomitant use of NSAIDs and analgesic doses of aspirin does not produce any greater therapeutic effect than the use of NSAIDs alone. In a clinical study, the concomitant use of an NSAID and aspirin was associated with a significantly increased incidence of GI adverse reactions as compared to use of the NSAID alone [see Warnings and Precautions (5.2)]. Meloxicam is not a substitute for aspirin for cardiovascular prophylaxis.|
|Intervention:||Concomitant use of meloxicam and analgesic doses of aspirin is not generally recommended because of the increased risk of bleeding [see Warnings and Precautions (5.11)].|
|ACE Inhibitors, Angiotensin Receptor Blockers, and Beta-blockers|
|Clinical Impact:|| |
|Clinical Impact:||Clinical studies, as well as post-marketing observations, showed that NSAIDs reduced the natriuretic effect of loop diuretics (e.g., furosemide) and thiazide diuretics in some patients. This effect has been attributed to the NSAID inhibition of renal prostaglandin synthesis.|
|Intervention:||Clinical studies, as well as post-marketing observations, showed that NSAIDs reduced the natriuretic effect of loop diuretics (e.g., furosemide) and thiazide diuretics in some patients. This effect has been attributed to the NSAID inhibition of renal prostaglandin synthesis.|
|Clinical Impact||The concomitant use of meloxicam with digoxin has been reported to increase the serum concentration and prolong the half-life of digoxin.|
|Intervention||During concomitant use of meloxicam and digoxin, monitor serum digoxin levels|
|Clinical Impact||Concomitant use of NSAIDs and methotrexate may increase the risk for methotrexate toxicity (e.g., neutropenia, thrombocytopenia, renal dysfunction).|
|Intervention||During concomitant use of meloxicam and methotrexate, monitor patients for methotrexate toxicity.|
|Clinical Impact||Concomitant use of meloxicam and cyclosporine may increase cyclosporine’s nephrotoxicity.|
|Intervention||During concomitant use of meloxicam and cyclosporine, monitor patients for signs of worsening renal function.|
|NSAIDs and Salicylates|
|Clinical Impact:||Concomitant use of meloxicam with other NSAIDs or salicylates (e.g., diflunisal, salsalate) increases the risk of GI toxicity, with little or no increase in efficacy [see Warnings and Precautions (5.2)].|
|Intervention:||The concomitant use of meloxicam with other NSAIDs or salicylates is not recommended.|
|Clinical Impact:||Concomitant use of meloxicam and pemetrexed may increase the risk of pemetrexed-associated myelosuppression, renal, and GI toxicity (see the pemetrexed prescribing information).|
|Intervention||During concomitant use of meloxicam and pemetrexed, in patients with renal impairment whose creatinine clearance ranges from 45 to 79 mL/min, monitor for myelosuppression, renal and GI toxicity. NSAIDs with short elimination half-lives (e.g., diclofenac, indomethacin) should be avoided for a period of two days before, the day of, and two days following administration of pemetrexed. In the absence of data regarding potential interaction between pemetrexed and NSAIDs with longer half-lives (e.g., meloxicam, nabumetone), patients taking these NSAIDs should interrupt dosing for at least five days before, the day of, and two days following pemetrexed administration.|
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