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Uses

Consider potential benefits and risks of meloxicam therapy as well as alternative therapies before initiating therapy with the drug. Use lowest effective dosage and shortest duration of therapy consistent with the patient's treatment goals.

Osteoarthritis

Symptomatic treatment of osteoarthritis. Effect comparable to that of other NSAIAs (piroxicam, diclofenac).

Rheumatoid Arthritis in Adults

Symptomatic treatment of rheumatoid arthritis in adults.

Juvenile Arthritis

Symptomatic management of pauciarticular or polyarticular course juvenile rheumatoid arthritis in children ≥2 years of age. Effect comparable to that of naproxen.

Cardiovascular Risk Reduction

Not a substitute for aspirin in the prevention of adverse cardiovascular events (MI).

Dosage and Administration

General

• Consider potential benefits and risks of meloxicam therapy as well as alternative therapies before initiating therapy with the drug.

Administration

Oral Administration

Administer orally once daily without regard to meals.

Agitate the suspension well prior to administration of each dose.

Formulation Considerations

Meloxicam oral suspension is the preferred dosage form for children weighing <60 kg because of suitability for providing the calculated dosage.

Dosage

To minimize the potential risk of adverse cardiovascular and/or GI events, use lowest effective dosage and shortest duration of therapy consistent with the patient's treatment goals. Adjust dosage based on individual requirements and response; attempt to titrate to the lowest effective dosage.

Pediatric Patients

Juvenile Arthritis

Oral

Children ≥2 years of age: 0.125 mg/kg (maximum 7.5 mg) once daily. Higher dosages not associated with additional benefit.

Adults

Osteoarthritis

Oral

7.5 mg once daily; may increase to 15 mg once daily.

Rheumatoid Arthritis

Oral

7.5 mg once daily; may increase to 15 mg once daily.

Prescribing Limits

Pediatric Patients

Oral

Maximum 7.5 mg daily.

Adults

Oral

Maximum 15 mg daily.

Special Populations

Dosage in Hepatic Impairment

Dosage adjustment not necessary in patients with mild to moderate hepatic impairment; not studied in those with severe impairment.

Dosage in Renal Impairment

Dosage adjustment not necessary in patients with mild to moderate renal impairment (Cl_cr >15 mL/minute); not recommended in those with severe impairment.

Cautions

Contraindications

• Known hypersensitivity to meloxicam or any ingredient in the formulation.
• History of asthma, urticaria, or other sensitivity reaction precipitated by aspirin or other NSAIAs.
• Treatment of perioperative pain in the setting of CABG surgery.

Warnings/Precautions

Warnings

Cardiovascular Effects

Selective COX-2 inhibitors have been associated with an increased risk of serious adverse cardiovascular thrombotic events in certain situations. Several prototypical NSAIAs also have been associated with an increased risk of cardiovascular events. Current evidence suggests that use of meloxicam might be associated with increased cardiovascular risk.

Use NSAIAs with caution and careful monitoring (e.g., monitor for development of cardiovascular events), and at the lowest effective dosage for the shortest duration necessary.

Short-term use to relieve acute pain, especially at low dosages, does not appear to be associated with increased risk of serious cardiovascular events (except immediately following CABG surgery).

No consistent evidence that concomitant use of low-dose aspirin mitigates the increased risk of serious adverse cardiovascular events associated with NSAIAs. (See Specific Drugs under Interactions.)

Hypertension and worsening of preexisting hypertension reported; either event may contribute to the increased incidence of cardiovascular events. Use with caution in patients with hypertension; monitor BP. Impaired response to certain diuretics may occur. (See Specific Drugs under Interactions.)

Fluid retention and edema reported. Caution in patients with fluid retention or heart failure.

GI Effects

Serious GI toxicity (e.g., bleeding, ulceration, perforation) can occur with or without warning symptoms; increased risk in those with a history of GI bleeding or ulceration, geriatric patients, smokers, those with alcohol dependence, and those in poor general health.

Lower incidence of adverse GI effects compared with other prototypical NSAIAs (e.g., diclofenac, naproxen, piroxicam) in some studies.

Renal Effects

Direct renal injury, including renal papillary necrosis, reported in patients receiving long-term NSAIA therapy.

Potential for overt renal decompensation. Increased risk of renal toxicity in patients with renal or hepatic impairment or heart failure, in patients with volume depletion, in geriatric patients, and in those receiving a diuretic, ACE inhibitor, or angiotensin II receptor antagonist. (See Renal Impairment under Cautions.)

Correct dehydration before initiating meloxicam therapy.

Sensitivity Reactions

Hypersensitivity Reactions

Anaphylactoid reactions reported.

Immediate medical intervention and discontinuance for anaphylaxis.

Avoid in patients with aspirin triad (aspirin sensitivity, asthma, nasal polyps); caution in patients with asthma.

Dermatologic Reactions

Serious skin reactions (e.g., exfoliative dermatitis, Stevens-Johnson syndrome, toxic epidermal necrolysis) reported; can occur without warning. Discontinue at first appearance of rash or any other sign of hypersensitivity (e.g., blisters, fever, pruritus).

General Precautions

Hepatic Effects

Severe reactions including jaundice, fatal fulminant hepatitis, liver necrosis, and hepatic failure (sometimes fatal) reported rarely with NSAIAs.

Elevations of serum ALT or AST reported.

Monitor for symptoms and/or signs suggesting liver dysfunction; monitor abnormal liver function test results. Discontinue if signs or symptoms of liver disease or systemic manifestations (e.g., eosinophilia, rash) occur or if liver function test abnormalities persist or worsen.

Hematologic Effects

Anemia reported rarely. Determine hemoglobin concentration or hematocrit in patients receiving long-term therapy if signs or symptoms of anemia occur.

Notable effects on platelets or bleeding times not observed.

Other Precautions

Not a substitute for corticosteroid therapy; not effective in the management of adrenal insufficiency.

May mask certain signs of infection.

Obtain CBC and chemistry profile periodically during long-term use.

Specific Populations

Pregnancy

Category C. Avoid use in third trimester because of possible premature closure of the ductus arteriosus.

Lactation

Distributed into milk in rats; not known whether distributed into milk in humans. Discontinue nursing or the drug.

Pediatric Use

Safety and efficacy not established in children <2 years of age.

Safety and efficacy in pediatric patients 2–17 years of age with juvenile rheumatoid arthritis supported by evidence from controlled studies.

Abdominal pain, vomiting, diarrhea, headache, and pyrexia reported more frequently in children than adults.

Geriatric Use

Caution advised. Fatal adverse GI effects reported more frequently in geriatric patients than younger adults.

Hepatic Impairment

Not studied in patients with severe hepatic impairment (Child-Pugh class III).

Renal Impairment

Use with caution in renal disease. Use not recommended in patients with advanced renal disease; close monitoring of renal function advised if used.

Common Adverse Effects

Abdominal pain, diarrhea, dizziness, dyspepsia, edema, flatulence, headache, nausea, rash, upper respiratory tract infection, influenza-like illness, musculoskeletal and connective tissue signs and symptoms (back pain, muscle spasms, musculoskeletal pain).