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Meloxicam

Class: Other Nonsteroidal Anti-inflammatory Agents
Chemical Name: 1,1-Dioxide-4-Hydroxy-2-methyl-N-(5-methyl-2-thiazolyl)-2H-1,2-benzothiazine-3-carboxamide
CAS Number: 71125-38-7
Brands: Anjeso, Mobic

Medically reviewed by Drugs.com on Oct 18, 2021. Written by ASHP.

Warning

    Cardiovascular Risk
  • Increased risk of serious (sometimes fatal) cardiovascular thrombotic events (e.g., MI, stroke). Risk may occur early in treatment and may increase with duration of use. (See Cardiovascular Thrombotic Effects under Cautions.)

  • Contraindicated in the setting of CABG surgery.

    GI Risk
  • Increased risk of serious (sometimes fatal) GI events (e.g., bleeding, ulceration, perforation of the stomach or intestine). Serious GI events can occur at any time and may not be preceded by warning signs and symptoms. Geriatric individuals and patients with history of peptic ulcer disease and/or GI bleeding are at greater risk for serious GI events. (See GI Effects under Cautions.)

Introduction

NSAIA referred to as a “preferential” rather than “selective” cyclooxygenase-2 (COX-2) inhibitor; oxicam derivative; structurally related to piroxicam.

Uses for Meloxicam

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

Used orally for symptomatic treatment of osteoarthritis. Effect comparable to that of other NSAIAs (piroxicam, diclofenac).

Rheumatoid Arthritis in Adults

Used orally for symptomatic treatment of rheumatoid arthritis in adults.

Juvenile Arthritis

Used orally for symptomatic management of pauciarticular or polyarticular course juvenile rheumatoid arthritis. Effect comparable to that of naproxen. (See Pediatric Patients under Dosage and Administration.)

Pain

Used parenterally for the relief of moderate to severe pain, either alone or in combination with non-NSAIA analgesics. Because of delayed onset of analgesia, use of parenteral meloxicam alone is not recommended when rapid onset of analgesia is required. (See Adults under Dosage and Administration.)

Meloxicam Dosage and Administration

General

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

  • Patients must be well hydrated prior to IV administration to reduce risk of renal toxicity.

Administration

Administer orally (for osteoarthritis, rheumatoid arthritis, and juvenile rheumatoid arthritis) or by IV injection (for analgesia).

Oral Administration

Administer orally once daily without regard to meals.

IV Administration

Parenteral preparation is for IV use only.

Rate of Administration

Administer by direct (“bolus”) IV injection over 15 seconds.

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.

Meloxicam capsules are not bioequivalent to other oral formulations of the drug; do not interchange at similar dosages for other oral meloxicam preparations. (See Absorption under Pharmacokinetics.)

Pediatric Patients

Juvenile Arthritis
Oral

Children ≥2 years of age: 0.125 mg/kg (maximum 7.5 mg) once daily; however, oral suspension is no longer commercially available in US, and meloxicam tablets should be used only in pediatric patients who weigh ≥60 kg. In pediatric patients weighing ≥60 kg, recommended dosage is 7.5 mg once daily (as tablets). Higher dosages not associated with additional benefit.

Adults

Osteoarthritis
Oral

7.5 mg once daily (as tablets); may increase to 15 mg once daily.

5 mg once daily (as capsules); may increase to 10 mg once daily.

Rheumatoid Arthritis
Oral

7.5 mg once daily (as tablets); may increase to 15 mg once daily.

Pain
IV

30 mg once daily.

Monitor analgesic response.

Median time to meaningful pain relief in clinical trials was 2–3 hours; some patients may require a non-NSAIA analgesic with a rapid onset of effect (e.g., upon emergence from anesthesia, upon resolution of local or regional anesthetic blocks).

Some patients may not experience adequate analgesia for the entire 24-hour dosing interval and may require a short-acting, non-NSAIA, immediate-release analgesic. (See Duration under Pharmacokinetics.)

Prescribing Limits

Pediatric Patients

Oral

Maximum 7.5 mg daily (as tablets).

Adults

Oral

Maximum 15 mg daily (as tablets).

Maximum 10 mg daily (as capsules).

Special Populations

Hepatic Impairment

Oral meloxicam: Dosage adjustment not necessary in patients with mild to moderate hepatic impairment; not adequately studied in those with severe impairment. (See Hepatic Impairment under Cautions.)

IV meloxicam: Not studied in patients with hepatic impairment.

Renal Impairment

Oral meloxicam: Dosage adjustment not necessary in patients with mild to moderate renal impairment. Use in patients with severe renal impairment not recommended. If used in patients undergoing hemodialysis, maximum recommended dosage is 5 mg once daily (as capsules) or 7.5 mg once daily (as tablets); additional doses not required following dialysis.

IV meloxicam: Not recommended in patients with moderate to severe renal impairment; contraindicated in patients with moderate to severe renal impairment who are at risk for renal failure because of hypovolemia. (See Renal Impairment under Cautions.)

Geriatric Patients

If anticipated benefits outweigh potential risks, initiate therapy at the low end of the dosage range. (See Geriatric Use under Cautions.)

CYP2C9 Poor or Intermediate Metabolizers

Manufacturer states to consider dosage reduction in known or suspected CYP2C9 poor metabolizers.

Clinical Pharmacogenetics Implementation Consortium (CPIC) guidelines recommend avoiding meloxicam use in CYP2C9 poor metabolizers.

For CYP2C9 intermediate metabolizers with a diplotype functional activity score (AS) of 1, CPIC guidelines recommend initiating meloxicam at a dosage that is 50% of the lowest recommended initial dosage and cautiously titrating to a clinically effective dosage, up to a dosage that is 50% of the maximum recommended dosage. Do not increase dosage until steady-state concentrations are attained (≥7 days after initial dose).

CPIC guidelines state that poor metabolizers should receive an alternative agent that is not metabolized by CYP2C9 or is not substantially affected by CYP2C9 genetic variants in vivo; alternatively, consider an NSAIA that is metabolized by CYP2C9 but has a shorter half-life. These alternatives also may be considered for intermediate metabolizers with an AS of 1. (See Pharmacogenomic Considerations under Cautions.)

Intermediate metabolizers with an AS of 1.5 may receive dosages recommended for normal metabolizers.

Cautions for Meloxicam

Contraindications

  • Known hypersensitivity (e.g., anaphylaxis, serious dermatologic reactions) to meloxicam or any ingredient in the formulation.

  • History of asthma, urticaria, or other sensitivity reaction precipitated by aspirin or other NSAIAs.

  • In the setting of CABG surgery.

  • Parenteral meloxicam also contraindicated in patients with moderate to severe renal impairment who are at risk for renal failure because of hypovolemia.

Warnings/Precautions

Warnings

Cardiovascular Thrombotic Effects

NSAIAs (selective COX-2 inhibitors, prototypical NSAIAs) increase the risk of serious adverse cardiovascular thrombotic events (e.g., MI, stroke) in patients with or without cardiovascular disease or risk factors for cardiovascular disease.

Findings of FDA review of observational studies, meta-analysis of randomized controlled trials, and other published information indicate that NSAIAs may increase the risk of such events by 10–50% or more, depending on the drugs and dosages studied.

Relative increase in risk appears to be similar in patients with or without known underlying cardiovascular disease or risk factors for cardiovascular disease, but the absolute incidence of serious NSAIA-associated cardiovascular thrombotic events is higher in those with cardiovascular disease or risk factors for cardiovascular disease because of their elevated baseline risk.

Increased risk may occur early (within the first weeks) following initiation of therapy and may increase with higher dosages and longer durations of use.

In controlled studies, increased risk of MI and stroke observed in patients receiving a selective COX-2 inhibitor for analgesia in first 10–14 days following CABG surgery.

In patients receiving NSAIAs following MI, increased risk of reinfarction and death observed beginning in the first week of treatment.

Increased 1-year mortality rate observed in patients receiving NSAIAs following MI; absolute mortality rate declined somewhat after the first post-MI year, but the increased relative risk of death persisted over at least the next 4 years.

Some systematic reviews of controlled observational studies and meta-analyses of randomized studies suggest naproxen may be associated with lower risk of cardiovascular thrombotic events compared with other NSAIAs. FDA states that limitations of these studies and indirect comparisons preclude definitive conclusions regarding relative risks of NSAIAs.

Use NSAIAs with caution and careful monitoring (e.g., monitor for development of cardiovascular events throughout therapy, even in those without prior cardiovascular symptoms) and at the lowest effective dosage for the shortest duration necessary.

Some clinicians suggest that it may be prudent to avoid NSAIA use, whenever possible, in patients with cardiovascular disease. Avoid use in patients with recent MI unless benefits of therapy are expected to outweigh risk of recurrent cardiovascular thrombotic events; if used, monitor for cardiac ischemia. Contraindicated in the setting of 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.)

GI Effects

Serious, sometimes fatal, GI toxicity (e.g., bleeding, ulceration, perforation of esophagus, stomach, or small or large intestine) can occur with or without warning symptoms.

Risk for GI bleeding increased more than tenfold in patients with a history of peptic ulcer disease and/or GI bleeding who are receiving NSAIAs compared with patients without these risk factors.

Other risk factors for GI bleeding include concomitant use of oral corticosteroids, antiplatelet agents (e.g., aspirin), anticoagulants, or SSRIs; longer duration of NSAIA therapy (however, short-term therapy is not without risk); smoking; alcohol use; older age; poor general health status; and advanced liver disease and/or coagulopathy.

Most spontaneous reports of fatal adverse GI effects involve geriatric or debilitated patients.

Frequency of NSAIA-associated upper GI ulcers, gross bleeding, or perforation is approximately 1% in patients receiving NSAIAs for 3–6 months and 2–4% at one year.

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

Use at lowest effective dosage for the shortest duration necessary. Avoid use of more than one NSAIA at a time. (See Specific Drugs under Interactions.)

Avoid use of NSAIAs in patients at higher risk for GI toxicity unless expected benefits outweigh increased risk of bleeding; consider alternate therapies in high-risk patients and those with active GI bleeding.

Monitor for GI ulceration and bleeding; even closer monitoring for GI bleeding recommended in those receiving concomitant low-dose aspirin for cardiac prophylaxis.

If serious adverse GI event suspected, promptly initiate evaluation and discontinue meloxicam until serious adverse GI event ruled out.

Other Warnings and Precautions

Hepatic Effects

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

Elevations of serum ALT or AST reported with NSAIAs, including meloxicam.

Discontinue if signs or symptoms of liver disease or systemic manifestations (e.g., eosinophilia, rash) occur and evaluate the patient.

Hypertension

Hypertension and worsening of preexisting hypertension reported; either event may contribute to the increased incidence of cardiovascular events. Monitor BP during initiation of meloxicam and throughout therapy.

Impaired response to ACE inhibitors, angiotensin II receptor antagonists, β-blockers, and certain diuretics may occur. (See Specific Drugs under Interactions.)

Heart Failure and Edema

Fluid retention and edema reported.

NSAIAs (selective COX-2 inhibitors, prototypical NSAIAs) may increase morbidity and mortality in patients with heart failure.

NSAIAs may diminish cardiovascular effects of diuretics, ACE inhibitors, or angiotensin II receptor antagonists used to treat heart failure or edema. (See Specific Drugs under Interactions.)

Manufacturer recommends avoiding use in patients with severe heart failure unless benefits of therapy are expected to outweigh risk of worsening heart failure; if used, monitor for worsening heart failure.

Some experts recommend avoiding use, whenever possible, in patients with reduced left ventricular ejection fraction and current or prior symptoms of heart failure.

Renal Effects

Renal papillary necrosis, renal insufficiency, acute renal failure, and other renal injury 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 dehydration or hypovolemia, in geriatric patients, and in those receiving a diuretic, ACE inhibitor, or angiotensin II receptor antagonist. (See Renal Impairment under Cautions.)

Correct fluid depletion before initiating meloxicam; monitor renal function during therapy in patients with renal or hepatic impairment, heart failure, dehydration, or hypovolemia.

Hyperkalemia

Hyperkalemia reported with NSAIAs, even in some patients without renal impairment; in such patients, effects attributed to a hyporenin-hypoaldosterone state.

Sensitivity Reactions

Anaphylactic reactions reported. Immediate medical intervention and discontinuance for anaphylaxis.

Avoid in patients with aspirin triad (aspirin sensitivity, asthma, nasal polyps); in patients with asthma but without known aspirin sensitivity, monitor for changes in manifestations of asthma.

Potentially fatal or life-threatening syndrome of multi-organ hypersensitivity (i.e., drug reaction with eosinophilia and systemic symptoms [DRESS]) reported in patients receiving NSAIAs. Clinical presentation is variable, but typically includes eosinophilia, fever, rash, lymphadenopathy, and/or facial swelling, possibly associated with other organ system involvement (e.g., hepatitis, nephritis, hematologic abnormalities, myocarditis, myositis). Symptoms may resemble those of acute viral infection. Early manifestations of hypersensitivity (e.g., fever, lymphadenopathy) may be present in the absence of rash. If signs or symptoms of DRESS develop, discontinue meloxicam and immediately evaluate the patient.

Dermatologic Reactions

Serious, potentially fatal, 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).

Hematologic Effects

Anemia reported, mainly during long-term (e.g., 6 months) therapy. May be due to occult or gross blood loss, fluid retention, or an incompletely described effect on erythropoiesis. Determine hemoglobin concentration or hematocrit if signs or symptoms of anemia occur.

Notable effects on platelets or bleeding times not observed.

NSAIAs may increase risk of bleeding. Certain coexisting conditions (e.g., coagulation disorders) or concomitant therapy (e.g., anticoagulants, antiplatelet agents, serotonin-reuptake inhibitors) may increase risk; monitor such patients for bleeding.

Pharmacogenomic Considerations

CYP2C9 poor metabolizers: Meloxicam metabolism may be decreased substantially, half-life may be prolonged, and higher plasma concentrations of the drug may increase likelihood and/or severity of adverse effects. (See Elimination: Special Populations, under Pharmacokinetics.)

CYP2C9 intermediate metabolizers: Meloxicam metabolism may be moderately or mildly reduced in those with an AS of 1 or 1.5, respectively. Higher plasma meloxicam concentrations in intermediate metabolizers with an AS of 1 may increase likelihood of adverse effects. Presence of other factors affecting meloxicam clearance (e.g., hepatic impairment, advanced age) also may increase risk of adverse effects in intermediate metabolizers.

Dosage reduction or avoidance of meloxicam may be recommended depending on CYP2C9 phenotype (see CYP2C9 Poor or Intermediate Metabolizers under Dosage and Administration); monitor for adverse effects.

Consult Clinical Pharmacogenetics Implementation Consortium Guideline (CPIC) for CYP2C9 and Nonsteroidal Anti-Inflammatory Drugs for additional information on interpretation of CYP2C9 genotype testing.

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

Use of NSAIAs during pregnancy at about ≥30 weeks’ gestation can cause premature closure of the fetal ductus arteriosus; use at about ≥20 weeks’ gestation associated with fetal renal dysfunction resulting in oligohydramnios and, in some cases, neonatal renal impairment.

Effects of NSAIAs on the human fetus during third trimester of pregnancy include prenatal constriction of the ductus arteriosus, tricuspid incompetence, and pulmonary hypertension; nonclosure of the ductus arteriosus during the postnatal period (which may be resistant to medical management); and myocardial degenerative changes, platelet dysfunction with resultant bleeding, intracranial bleeding, renal dysfunction or renal failure, renal injury or dysgenesis potentially resulting in prolonged or permanent renal failure, oligohydramnios, GI bleeding or perforation, and increased risk of necrotizing enterocolitis.

Avoid use of NSAIAs in pregnant women at about ≥30 weeks’ gestation; if use required between about 20 and 30 weeks’ gestation, use lowest effective dosage and shortest possible duration of treatment, and consider monitoring amniotic fluid volume via ultrasound examination if treatment duration >48 hours; if oligohydramnios occurs, discontinue drug and follow up according to clinical practice. (See Advice to Patients.)

Fetal renal dysfunction resulting in oligohydramnios and, in some cases, neonatal renal impairment observed, on average, following days to weeks of maternal NSAIA use; infrequently, oligohydramnios observed as early as 48 hours after initiation of NSAIAs. Oligohydramnios is often, but not always, reversible (generally within 3–6 days) following NSAIA discontinuance. Complications of prolonged oligohydramnios may include limb contracture and delayed lung maturation. In limited number of cases, neonatal renal dysfunction (sometimes irreversible) occurred without oligohydramnios. Some neonates have required invasive procedures (e.g., exchange transfusion, dialysis). Deaths associated with neonatal renal failure also reported. Limitations of available data (lack of control group; limited information regarding dosage, duration, and timing of drug exposure; concomitant use of other drugs) preclude a reliable estimate of the risk of adverse fetal and neonatal outcomes with maternal NSAIA use. Available data on neonatal outcomes generally involved preterm infants; extent to which risks can be generalized to full-term infants is uncertain.

Animal data indicate important roles for prostaglandins in kidney development and endometrial vascular permeability, blastocyst implantation, and decidualization. In animal studies, inhibitors of prostaglandin synthesis increased pre- and post-implantation losses; also impaired kidney development at clinically relevant doses.

Embryofetal deaths and increased incidence of septal heart defects observed with meloxicam in animal reproduction studies.

Effects of meloxicam on labor and delivery not known. In animal studies, NSAIAs increased incidence of dystocia, delayed parturition, and decreased pup survival.

Lactation

Distributed into milk in rats. Not known whether meloxicam distributes into milk in humans, affects milk production, or affects nursing infants.

Consider developmental and health benefits of breast-feeding along with mother's clinical need for meloxicam and any potential adverse effects on the breast-fed infant from the drug or underlying maternal condition.

Fertility

NSAIAs may be associated with reversible infertility in some women. Reversible delays in ovulation observed in limited studies in women receiving NSAIAs; animal studies indicate that inhibitors of prostaglandin synthesis can disrupt prostaglandin-mediated follicular rupture required for ovulation.

Consider withdrawal of NSAIAs in women experiencing difficulty conceiving or undergoing evaluation of infertility.

Meloxicam also may impair fertility in men. Decreased sperm count and motility and histopathologic evidence of testicular degeneration observed in animals. Not known whether these effects on fertility are reversible; clinical relevance also unknown.

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.

Manufacturers state that safety and efficacy of meloxicam capsules and parenteral meloxicam not established in pediatric patients.

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

Geriatric Use

Increased risk for serious adverse cardiovascular, GI, and renal effects.

Clinical studies of meloxicam revealed no overall differences in efficacy or safety between geriatric patients and younger individuals; however, fatal adverse GI effects with NSAIAs reported more frequently in geriatric or debilitated patients than younger adults.

Pharmacokinetics of IV meloxicam in geriatric patients with mild renal impairment are similar to those in young healthy individuals.

If anticipated benefits of meloxicam outweigh potential risks, initiate at lower end of the dosing range and monitor for adverse effects.

Hepatic Impairment

Use with caution in patients with hepatic impairment; meloxicam is extensively metabolized in the liver and may cause hepatotoxicity.

Dosage adjustment of oral meloxicam not necessary in patients with mild to moderate hepatic impairment.

Oral meloxicam not adequately studied in patients with severe hepatic impairment. If anticipated benefits outweigh potential risks in patients with severe hepatic impairment, monitor for worsening liver function.

IV meloxicam not studied in patients with hepatic impairment.

Renal Impairment

May hasten progression of renal dysfunction in patients with preexisting renal disease. Some metabolites of meloxicam are excreted by the kidneys. Monitor patients with preexisting renal disease for worsening renal function.

Dosage adjustment of oral meloxicam not necessary in patients with mild to moderate renal impairment. (See Pharmacokinetics.)

Oral meloxicam not adequately studied in patients with severe renal impairment; use not recommended. If meloxicam must be used, closely monitor renal function.

Not removed by dialysis. (See Renal Impairment under Dosage and Administration.)

Pharmacokinetics of IV meloxicam in geriatric patients with mild renal impairment are similar to those in young healthy individuals.

IV meloxicam not studied in patients with moderate or severe renal impairment; use not recommended. IV meloxicam contraindicated in patients with moderate to severe renal impairment who are at risk for renal failure because of hypovolemia.

Common Adverse Effects

Oral meloxicam: Abdominal pain or discomfort, 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).

IV meloxicam: Constipation, increased γ-glutamyl transferase (GGT, γ-glutamyltranspeptidase, GGTP) concentrations, anemia.

Interactions for Meloxicam

Metabolized by CYP isoenzymes, mainly by CYP2C9 and to a lesser extent by CYP3A4.

Drugs Affecting Hepatic Microsomal Enzymes

CYP2C9 inhibitors: Possible increased plasma concentrations of meloxicam. Consider meloxicam dosage reduction; monitor for adverse effects. Examples include, but are not limited to, amiodarone and fluconazole.

Specific Drugs

Drug

Interaction

Comments

ACE inhibitors

Reduced BP response to ACE inhibitor

Possible reversible deterioration of renal function, including acute renal failure, in geriatric patients and patients with volume depletion or renal impairment

Monitor BP

Ensure adequate hydration; assess renal function when initiating concomitant therapy and periodically thereafter

Monitor geriatric patients and patients with volume depletion or renal impairment for worsening renal function

Angiotensin II receptor antagonists

Reduced BP response to angiotensin II receptor antagonist

Possible reversible deterioration of renal function, including acute renal failure, in geriatric patients and patients with volume depletion or renal impairment

Monitor BP

Ensure adequate hydration; assess renal function when initiating concomitant therapy and periodically thereafter

Monitor geriatric patients and patients with volume depletion or renal impairment for worsening renal function

Antacids

Pharmacokinetic interaction unlikely

Administer meloxicam tablets without regard to antacids

Anticoagulants

Synergistic effects on bleeding; higher risk of serious bleeding compared with either agent alone

Warfarin: No effect on warfarin pharmacokinetics or average PT in a study in healthy individuals, but INR increased in one individual

Increased risk of major bleeding or supratherapeutic INRs in patients with reduced CYP2C9 function receiving concomitant warfarin (CYP2C9 substrate) and NSAIAs

Caution advised; monitor for bleeding

Some experts recommend avoiding concomitant use of warfarin and NSAIAs in CYP2C9 intermediate or poor metabolizers

β-Adrenergic blocking agents

Reduced BP response to β-blocker

Monitor BP

Cholestyramine

Increased meloxicam clearance and decreased AUC

Clinical importance not established

Cimetidine

Pharmacokinetics of meloxicam not altered

Cyclosporine

Possible increased cyclosporine-associated nephrotoxicity

Monitor for worsening renal function

Digoxin

No protein-binding interaction; pharmacokinetics of digoxin not altered

Diuretics (furosemide, thiazides)

Reduced natriuretic effects possible

Monitor for worsening renal function and for adequacy of diuretic and antihypertensive effects

Lithium

Decreased renal clearance and increased plasma concentrations of lithium

Monitor for lithium toxicity

Methotrexate

Possible increased risk of methotrexate toxicity (e.g., neutropenia, thrombocytopenia, renal dysfunction)

Monitor for methotrexate toxicity

NSAIAs

Concomitant NSAIAs and aspirin (analgesic dosages): Therapeutic effect not greater than that of NSAIAs alone

Concomitant NSAIAs and aspirin: Increased risk for serious adverse GI effects

Aspirin: Increased plasma meloxicam concentrations

No consistent evidence that low-dose aspirin mitigates the increased risk of serious cardiovascular events associated with NSAIAs

Aspirin: Clinical importance of pharmacokinetic interaction unknown

Concomitant use of meloxicam with other NSAIAs or with low or analgesic dosages of aspirin generally not recommended

Advise patients not to take low-dose aspirin without consulting clinician; closely monitor patients receiving concomitant antiplatelet agents (e.g., aspirin) for bleeding

Not a substitute for low-dose aspirin for cardioprophylaxis

Pemetrexed

Possible increased risk of pemetrexed-associated myelosuppression, renal toxicity, and GI toxicity

Short half-life NSAIAs (e. g., diclofenac, indomethacin): Avoid administration beginning 2 days before and continuing through 2 days after pemetrexed administration

Longer half-life NSAIAs (e.g., meloxicam, nabumetone): In the absence of data, avoid administration beginning at least 5 days before and continuing through 2 days after pemetrexed administration

Patients with Clcr 45–79 mL/minute: Monitor for myelosuppression, renal toxicity, and GI toxicity

Patients with Clcr <45 mL/minute: Concomitant use not recommended

Serotonin-reuptake inhibitors (e.g., SSRIs, SNRIs)

Possible increased risk of bleeding due to importance of serotonin release by platelets in hemostasis

Monitor for bleeding

Meloxicam Pharmacokinetics

Absorption

Bioavailability

Bioavailability is about 89% following oral administration.

Commercially available tablets and capsules are not bioequivalent. Following administration under fasting conditions, the 33% lower dose of meloxicam in the 10-mg capsules compared with the 15-mg tablets resulted in 33% lower AUC; peak plasma concentrations were comparable with the 10-mg capsules and the 15-mg tablets, but median time to peak plasma concentration was 2 hours for 5- or 10-mg capsules but 4 hours for 15-mg tablets.

Onset

Median time to meaningful pain relief is 2–3 hours after IV administration.

Duration

Adequate analgesia may not last for entire 24-hour dosing interval in some patients receiving IV meloxicam.

Food

No clinically important effect.

Special Populations

Oral meloxicam not adequately studied in patients with severe hepatic impairment. In patients with mild or moderate hepatic impairment, no important differences in plasma concentrations compared with healthy individuals.

IV meloxicam not studied in patients with hepatic impairment.

Oral meloxicam not adequately studied in patients with severe renal impairment. In patients with mild or moderate renal impairment, some pharmacokinetic values altered (total plasma concentrations decreased, free concentrations unchanged).

IV meloxicam not studied in patients with moderate or severe renal impairment. In geriatric patients with mild renal impairment, pharmacokinetics of IV meloxicam similar to those in young healthy individuals.

Systemic exposure in children 2–6 years of age lower than that in children 7–16 years of age. Systemic exposure in children 7–16 years of age similar to or slightly lower than that in adults.

Distribution

Extent

Total meloxicam concentrations in synovial fluid are 40–50% of plasma concentrations; free fraction in synovial fluid exceeds that in plasma.

Plasma Protein Binding

99.4% (principally albumin).

Special Populations

Mild to moderate hepatic impairment does not alter protein binding.

In patients with renal disease, protein binding decreases to approximately 99%. Peak plasma concentrations of unbound meloxicam are higher in patients with renal failure requiring chronic hemodialysis (free fraction 1%) than in healthy individuals (free fraction 0.3%).

Elimination

Metabolism

Extensively metabolized to inactive metabolites by CYP isoenzymes, mainly by CYP2C9 and to a lesser extent by CYP3A4.

Elimination Route

Undergoes biliary secretion and enterohepatic recirculation. Excreted to an equal extent in urine and feces as metabolites.

Half-life

Adults: Approximately 15–24 hours.

Children 2–6 years of age: 15.2 hours.

Children 7–16 years of age: 13 hours.

Special Populations

In patients with mild or moderate renal impairment, total clearance increases with degree of renal impairment, while exposure to the unbound drug is similar across all patient groups. Higher clearance may be due to increased fraction of unbound meloxicam being available for metabolism and subsequent excretion.

Not removed by dialysis.

In individuals with reduced CYP2C9 activity (e.g., CYP2C9*2 and CYP2C9*3 polymorphisms), particularly in poor metabolizers (e.g., *3/*3 diplotype), limited data indicate meloxicam exposure is increased substantially compared with normal metabolizers.

Stability

Storage

Oral

Capsules or Tablets

25°C (may be exposed to 15–30°C); protect from moisture.

Parenteral

Injection

15–25°C (may be exposed to 4–30°C); do not freeze; protect from light.

Actions

  • Inhibits COX-2 to a greater extent than COX-1; selectivity is dose dependent and is diminished at higher dosages.

  • Pharmacologic actions similar to those of other NSAIAs; exhibits anti-inflammatory, analgesic, and antipyretic activity.

Advice to Patients

  • Importance of reading the medication guide for NSAIAs that is provided each time the drug is dispensed.

  • Risk of serious cardiovascular events (e.g., MI, stroke). Importance of seeking immediate medical attention if signs and symptoms of a cardiovascular event (e.g., chest pain, dyspnea, weakness, slurred speech) occur.

  • Risk of GI bleeding and ulceration. Importance of reporting any signs or symptoms of GI ulceration or bleeding (e.g., epigastric pain, dyspepsia, melena, hematemesis). Inform patients receiving concomitant low-dose aspirin of the increased risk of GI bleeding.

  • Risk of serious skin reactions, DRESS, and anaphylactic and other sensitivity reactions. Advise patients to discontinue taking meloxicam immediately if they develop any type of rash or fever and to promptly contact their clinician. Importance of seeking immediate medical attention if an anaphylactic reaction occurs.

  • Risk of hepatotoxicity. Advise patients to discontinue taking meloxicam and immediately contact their clinician if signs or symptoms of hepatotoxicity (e.g., nausea, fatigue, lethargy, pruritus, jaundice, right upper quadrant tenderness, flu-like symptoms) occur.

  • Risk of heart failure or edema; importance of reporting dyspnea, unexplained weight gain, or edema.

  • Importance of women informing clinicians if they are or plan to become pregnant or plan to breast-feed.

  • Importance of avoiding NSAIA use beginning at 20 weeks’ gestation unless otherwise advised by a clinician; importance of avoiding NSAIAs beginning at 30 weeks’ gestation because of risk of premature closure of the fetal ductus arteriosus; monitoring for oligohydramnios may be necessary if NSAIA therapy required for >48 hours’ duration between about 20 and 30 weeks’ gestation.

  • Advise women who are trying to conceive that NSAIAs may be associated with a reversible delay in ovulation.

  • Importance of informing clinicians of existing or contemplated concomitant therapy, including prescription and OTC drugs. Advise patients that concomitant use of other NSAIAs with meloxicam provides little or no increase in efficacy but increases risk of GI toxicity, and is not recommended. Advise patients not to use concomitant low-dose aspirin without consulting their clinician. Alert patients to the presence of NSAIAs in many OTC drugs.

  • Importance of informing patients of other important precautionary information. (See Cautions.)

Preparations

Excipients in commercially available drug preparations may have clinically important effects in some individuals; consult specific product labeling for details.

Please refer to the ASHP Drug Shortages Resource Center for information on shortages of one or more of these preparations.

* available from one or more manufacturer, distributor, and/or repackager by generic (nonproprietary) name

Meloxicam

Routes

Dosage Forms

Strengths

Brand Names

Manufacturer

Oral

Capsules

5 mg*

Meloxicam Capsules

10 mg*

Meloxicam Capsules

Tablets

7.5 mg*

Meloxicam Tablets

Mobic

Boehringer Ingelheim

15 mg*

Meloxicam Tablets

Mobic

Boehringer Ingelheim

Parenteral

Injection, for IV use

30 mg/mL

Anjeso

Baudax Bio

AHFS DI Essentials™. © Copyright 2022, Selected Revisions October 18, 2021. American Society of Health-System Pharmacists, Inc., 4500 East-West Highway, Suite 900, Bethesda, Maryland 20814.

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