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Meloxicam

Pronunciation

Pronunciation: mell-ox-ih-kam
Class: NSAID

Trade Names

Mobic
- Tablets 7.5 mg
- Tablets 15 mg
- Oral suspension 7.5 mg per 5 mL

Apo-Meloxicam (Canada)
CO Meloxicam (Canada)
Gen-Meloxicam (Canada)
Mobicox (Canada)
Novo-Meloxicam (Canada)
PMS-Meloxicam (Canada)
ratio-Meloxicam (Canada)

Pharmacology

Decreases inflammation, pain, and fever, probably through inhibition of cyclooxygenase activity and prostaglandin synthesis.

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Pharmacokinetics

Absorption

Bioavailability is 89%. T max is 4 to 5 h. Steady state reached by day 5 with multiple dosing.

Distribution

Vd is approximately 10 L; protein binding is approximately 99.4% (primarily albumin).

Metabolism

Meloxicam is almost completely metabolized to 4 inactive metabolites by peroxidase and CYP-450 2C9 and 3A4.

Elimination

Meloxicam is equally excreted in the urine and feces, mainly in the form of metabolites. Mean t ½ is 15 to 20 h; Cl is 7 to 9 mL/min.

Special Populations

Renal Function Impairment

Meloxicam plasma concentration is decreased and Cl increased in patients with renal function impairment.

Indications and Usage

Relief of signs and symptoms of osteoarthritis and rheumatoid arthritis. Relief of the signs and symptoms of pauciarticular or polyarticular course juvenile rheumatoid arthritis (JRA) in patients 2 yr of age and older.

Unlabeled Uses

Treatment of ankylosing spondylitis, pain, and acute shoulder pain.

Contraindications

Patients who have experienced asthma, urticaria, or allergic-type reactions after taking aspirin or other NSAIDs; hypersensitivity to any component of product; treatment of perioperative pain in the setting of coronary artery bypass graft (CABG) surgery.

Dosage and Administration

Osteoarthritis and Rheumatoid Arthritis
Adults

PO 7.5 to 15 mg once daily (max, 15 mg/day).

Pauciarticular and Polyarticular Course JRA
Children 2 yr of age and older

PO 0.125 mg/kg once daily (max, 7.5 mg/day).

General Advice

  • Meloxicam suspension and tablets are interchangeable on a mg to mg basis.
  • Administer without regard to meals or antacids. Administer with food if GI upset occurs.
  • Shake suspension gently before measuring dose. Use dosing syringe, dosing spoon, or dosing cup to measure and administer prescribed dose of suspension.

Storage/Stability

Store at controlled room temperature (59° to 86°F). Protect tablets from moisture. Keep suspension tightly closed.

Drug Interactions

Angiotensin-converting enzyme (ACE) inhibitors (eg, captopril)

Antihypertensive effects may be decreased.

Aspirin

Additive GI toxicity.

Cholestyramine

Plasma levels of meloxicam may be reduced.

Lithium

May increase lithium levels.

Loop diuretics (eg, furosemide), thiazide diuretics (eg, chlorothiazide)

Diuretic effects may be decreased.

Methotrexate

Risk of methotrexate toxicity may be increased.

Warfarin

May increase risk of gastric erosion and bleeding.

Laboratory Test Interactions

None well documented.

Adverse Reactions

Cardiovascular

Angina pectoris, arrhythmia, cardiac failure, hypertension, hypotension, MI, palpitation, tachycardia, vasculitis (less than 2%).

CNS

Headache (8%); dizziness, insomnia (4%); abnormal dreaming, anxiety, confusion, convulsions, depression, fatigue, increased appetite, nervousness, paresthesia, somnolence, tremor, vertigo, (less than 2%).

Dermatologic

Rash (3%); pruritus (2%); alopecia, angioedema, bullous eruption, increased sweating, photosensitivity reaction, urticaria (less than 2%); erythema multiforme, exfoliative dermatitis, Stevens-Johnson syndrome, toxic epidermal necrolysis (postmarketing).

EENT

Pharyngitis (3%); abnormal vision, conjunctivitis, taste perversion, tinnitus (less than 2%).

GI

Dyspepsia (10%); diarrhea (8%); nausea (7%); dyspeptic signs and symptoms (6%); abdominal pain (5%); constipation, flatulence, vomiting (3%); colitis, dry mouth, duodenal ulcer, eructation, esophagitis, gastric ulcer, gastritis, gastroesophageal reflux, GI hemorrhage, hematemesis, hemorrhagic duodenal ulcer, hemorrhagic gastric ulcer, intestinal perforation, melena, pancreatitis, perforated duodenal ulcer, perforated gastric ulcer, ulcerative stomatitis (less than 2%).

Genitourinary

UTI (7%); micturition frequency (2%); albuminuria, increased BUN and creatinine, hematuria, renal failure (less than 2%); interstitial nephritis (postmarketing).

Hematologic-Lymphatic

Anemia (4%); leukopenia, purpura, thrombocytopenia (less than 2%); agranulocytosis (postmarketing).

Hepatic

Increased ALT and AST, bilirubinemia, hepatitis, increased gamma-glutamyl-transferase (less than 2%); jaundice, liver failure (postmarketing).

Metabolic-Nutritional

Dehydration, weight decrease or increase (less than 2%).

Musculoskeletal

Arthralgia (5%); back pain (3%); joint-related signs and symptoms (2%).

Respiratory

Upper respiratory tract infection (8%); coughing (2%); asthma, bronchospasm, dyspnea (less than 2%).

Miscellaneous

Influenza-like symptoms (6%); edema, household accidents, pain (5%); fall (3%); allergic reaction, face edema, fever, hot flushes, malaise, syncope (less than 2%); anaphylactic reactions, including shock (postmarketing).

Precautions

Warnings

CV risk

NSAIDs may cause an increased risk of serious CV thrombotic events, MI, and stroke that can be fatal. Risk may be increased with duration of use and in patients with CV disease, or risk factors for CV disease. Use lowest effective dose for shortest duration possible. Meloxicam is contraindicated for treatment of perioperative pain in the setting of CABG surgery.

GI risk

NSAIDs cause an increased risk of serious GI adverse reactions, including bleeding, ulceration, and perforation of the stomach or intestines that can be fatal. These events can occur at any time during use and without warning symptoms. Elderly patients are at greater risk for serious GI events.


Monitor

Monitor for signs and symptoms of bleeding. Monitor BP closely during initiation of treatment and throughout course of therapy. Patients on long-term use should have their CBC and chemistry profile checked periodically. Evaluate renal and hepatic function prior to starting, and periodically thereafter, during long-term treatment.


Pregnancy

Category C . Avoid use during pregnancy, particularly in late pregnancy, because of known effects of NSAIDs on the fetal CV system (eg, closure of ductus arteriosus).

Lactation

Undetermined.

Children

Safety and efficacy not established for JRA patients younger than 2 yr of age.

Elderly

Use with caution in patients 65 yr of age and older.

Renal Function

Not recommended in patients with advanced renal disease. Use with caution in patients with preexisting kidney disease.

Hepatic Function

Use with caution; discontinue use if clinical signs and/or symptoms of liver disease develop.

Anaphylactoid reactions

May occur. Do not give to patients with the aspirin triad.

Corticosteroid therapy

Meloxicam is not a substitute for corticosteroids and cannot be used to treat corticosteroid insufficiency.

Dehydration

Use with caution. Rehydrate patient before starting therapy.

Discontinuation

Discontinue use if clinical signs and symptoms consistent with liver or renal disease develop, systemic manifestations occur (eg, eosinophilia, rash), or if abnormal liver tests persist or worsen.

Fluid retention

May cause fluid retention and edema; use with caution in patients with fluid retention, hypertension, or heart failure.

GI effects

Use with extreme caution, or use alternative therapies not involving NSAIDs, in patients with prior history of ulcer disease or GI bleeding, or with concurrent risk factors for GI bleeding (eg, concomitant use of oral corticosteroid or anticoagulants, smoking, alcohol use, elderly or debilitated patient).

Hematologic effects

May cause anemia. May inhibit platelet aggregation and prolong bleeding time. Carefully monitor patients who may be adversely affected by alterations in platelet function (eg, coagulation disorders, concurrent anticoagulation therapy).

Hypertension

May lead to onset of new hypertension or worsening of preexisting hypertension. Use with caution in patients with hypertension.

Preexisting asthma

Patients with asthma may have aspirin-sensitive asthma, which has been associated with severe, sometimes fatal, bronchospasm. Use with caution in patients with asthma; do not administer to patients with aspirin-sensitive asthma.

Renal effects

Long-term use of NSAIDs has resulted in renal papillary necrosis and other renal injury. Overt renal decompensation has occurred in patients in whom renal prostaglandins have a compensatory role in maintenance of renal perfusion.

Skin reactions

May cause serious adverse skin reactions, including exfoliative dermatitis, Stevens-Johnson syndrome, and toxic epidermal necrolysis that can be fatal.

Overdosage

Symptoms

Acute renal failure, cardiac arrest, coma, convulsions, CV collapse, drowsiness, epigastric pain, GI bleeding, hepatic function impairment, hypertension, lethargy, nausea, respiratory depression, vomiting.

Patient Information

  • Advise patient or caregiver to read Medication Guide for Non-Steroidal Anti-Inflammatory Drugs (NSAIDs) before starting therapy and to read and check for new information each time the medication is refilled.
  • Advise patient that dose is individualized based upon severity of symptoms and response to therapy.
  • Instruct patient to take prescribed dose once daily without regard to meals. Advise patient to take with food if stomach upset occurs.
  • Advise patient or caregiver using suspension to shake suspension gently before measuring dose and to use dosing spoon, syringe, or cup to measure and administer dose.
  • Caution patient not to change the dose or stop taking unless advised by health care provider. Advise patient to notify health care provider if medication does not adequately control arthritis symptoms.
  • Caution patient to avoid smoking, alcohol, and self-administration of aspirin-containing medications while taking meloxicam.
  • Advise patient that if a dose is missed, to take it as soon as possible, but if close to the next dose, to skip that dose and take the next dose at the regularly scheduled time. Caution patient not to double the dose to catch up.
  • Advise patient to discontinue drug and notify health care provider if any of the following occur: persistent or recurrent indigestion or stomach pain, chest pain, unexplained shortness of breath, sudden weakness, visual changes, slurring of speech, skin rash, itching, black or bloody stools, rapid weight gain or swelling, changes in urine patterns, joint pain, fever, bleeding or unusual bruising, persistent nausea, fatigue, yellowing of the skin or eyes.

Copyright © 2009 Wolters Kluwer Health.

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