meloxicam (Rx)

Brand and Other Names:Mobic, Vivlodex, more...Anjeso, Qmiiz
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Dosing & Uses

AdultPediatric

Dosage Forms & Strengths

tablet (Mobic)

  • 7.5mg
  • 15mg

tablet, oral distintegrating (Qmiiz)

  • 7.5mg
  • 15mg

capsule (Vivlodex)

  • 5mg
  • 10mg

injection, IV aqueous dispersion (Anjeso)

  • 30mg/mL single-dose vial

Osteoarthritis

Indicated to relieve signs and symptoms of osteoarthritis

Mobic or Qmiiz: 7.5-15 mg PO qDay; not to exceed 15 mg/day

Vivlodex: Start with 5 mg PO qDay; if needed, may increase to 10 mg/day

Use the lowest effective dose for shortest duration consistent with individual patient treatment goals

Rheumatoid Arthritis

Indicated to relieve signs and symptoms of rheumatoid arthritis

Mobic or Qmiiz: 7.5-15 mg PO qDay; not to exceed 15 mg/day

Moderate-to-Severe Pain

Indicated for management of moderate-to-severe pain, alone or in combination with non-NSAID analgesics

Anjeso: 30 mg IV qDay

Dosage Modifications

Hepatic impairment

  • Mild-to-moderate: No dosage adjustment required
  • Severe: Not studied

Renal impairment

  • Mild-to-moderate: No dosage adjustment required
  • Severe
    • Anjeso: : Not recommended; contraindicated in patients with moderate-to-severe renal insufficiency who are at risk for renal failure due to volume depletion
    • Mobic or Qmiiz: Not recommended
  • Hemodialysis
    • Mobic or Qmiiz: Not to exceed 7.5 mg/day
    • Vivlodex: Not to exceed 5 mg/day

Dosing Considerations

Vivlodex capsules and Qmizz ODT are not interchangeable with other formulations of oral meloxicam even if the mg strength is the same

Anjeso alone is not recommended for situations when rapid onset of analgesia required owing to the drug’s delayed onset of analgesia (mean onset 2-3 hr)

Dosage Forms & Strengths

tablet (Mobic)

  • 7.5mg
  • 15mg

tablet, oral distintegrating (Qmiiz)

  • 7.5mg
  • 15mg

Juvenile Idiopathic Arthritis

Indicated for relief of signs and symptoms of pauciarticular or polyarticular course juvenile rheumatoid arthritis in patients who weigh ≥60 kg

60 kg or greater

  • Mobic tablet: 0.125 mg/kg PO qDay; not to exceed 7.5 mg/day  
  • Qmiiz ODT: 7.5 mg PO qDay
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Interactions

Interaction Checker

and meloxicam

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            Adverse Effects

            1-10%

            Indigestion (3.8-9.5%)

            Upper respiratory infection (≤8.3%)

            Headache (2.4-8.3%)

            Diarrhea (1.9-7.8%)

            Nausea (2.4-7.2%)

            Abdominal pain (1.9-4.7%)

            Edema (0.6-4.5%)

            Anemia (≤4.1%)

            Dizziness (1.1-3.8%)

            Constipation (0.8-2.6%)

            Angina (<2%)

            Congestive heart failure (<2%)

            Decreased platelet aggregation, purpuric disorder (<2%)

            Gastrointestinal (GI) hemorrhage (<2%)

            GI perforation, GI ulcer (<2%)

            Hepatitis (<2%)

            Hypertension (<2%)

            Inflammatory disorder of digestive tract (<2%)

            Myocardial infarction (<2%)

            Vomiting (<3%)

            IV

            • Constipation (7.6%)
            • GGT increased (2.8%)
            • Anemia (2.4%)

            <1%

            Anaphylactoid reaction

            Angioedema

            Fever

            Asthma, bronchospasm

            Cerebrovascular accident

            Erythema multiforme, erythroderma

            Immune hypersensitivity reaction

            Interstitial nephritis, renal failure

            Jaundice, liver failure

            Stevens-Johnson syndrome

            Tinnitus, hearing loss

            Toxic epidermal necrolysis

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            Warnings

            Black Box Warnings

            Cardiovascular risk

            • Nonsteroidal anti-inflammatory drugs (NSAIDs) may increase risk of serious cardiovascular thrombotic events, myocardial infarction (MI), and stroke, which can be fatal
            • Risk may increase with duration of use
            • Patients with existing cardiovascular disease or risk factors for such disease may be at greater risk
            • NSAIDs are contraindicated for perioperative pain in setting of coronary artery bypass graft (CABG) surgery

            Gastrointestinal risk

            • NSAIDs increase risk of serious GI adverse events, including bleeding, ulceration, and gastric or intestinal perforation, which can be fatal
            • GI adverse events may occur at any time during use and without warning symptoms
            • Elderly patients are at greater risk for serious GI events

            Contraindications

            Known hypersensitivity (eg, anaphylactic or serious skin reactions)

            History of asthma, urticaria, or other allergic-type reactions after taking aspirin or other NSAIDs

            Perioperative pain management in the setting of coronary artery bypass graft (CABG) surgery

            Anjeso: Moderate-to-severe renal insufficiency in patients at risk for renal failure owing to volume depletion

            Qmiiz: Phenylketonuria

            Cautions

            Cardiovascular thrombotic events

            • Increased risk of serious cardiovascular (CV) thrombotic events, including myocardial infarction (MI) and stroke, which can be fatal
            • Based on available data, it is unclear that the risk for CV thrombotic events is similar for all NSAIDs
            • The relative increase in serious CV thrombotic events over baseline conferred by NSAID use appears to be similar in those with and without known CV disease or risk factors for CV disease; however, patients with known CV disease or risk factors had a higher absolute incidence of excess serious CV thrombotic events
            • Increased CV thrombotic risk has been observed most consistently at higher doses
            • Minimize potential risk by using lowest effective dose for the shortest duration possibleCABG
              • 2 large, controlled clinical trials of a COX-2 selective NSAID for pain in the first 10-14 days following CABG surgery found an increased incidence of MI and stroke
              • NSAIDs are contraindicated in the setting of CABG
            • Post-MI
              • Observational studies conducted in the Danish National Registry have demonstrated that patients treated with NSAIDs post-MI were at increased risk of reinfarction, CV-related death, and all-cause mortality beginning in the first week of treatment
              • Avoid in patients with recent MI unless benefits outweigh risk of recurrent CV thrombotic events; if used, monitor for cardiac ischemia

            GI effects

            • NSAIDs can cause serious GI adverse events including inflammation, bleeding, ulceration, and perforation of the esophagus, stomach, small intestine, or large intestine, which can be fatal
            • Patients with a prior history of PUD and/or GI bleeding who used NSAIDs have >10-fold increased risk for developing a GI bleed compared with patients without these risk factors
            • Other risk factors include longer duration of NSAID therapy; concomitant use of oral corticosteroids, aspirin, anticoagulants, or SSRIs; smoking; use of alcohol; advanced liver disease and /or coagulopathy; older age; and poor general health status

            Heart failure and edema

            • The Coxib and traditional NSAID Trialists’ Collaboration meta-analysis of randomized controlled trials demonstrated an ~2-fold increase in hospitalizations for heart failure in COX-2 selective-treated patients and nonselective NSAID-treated patients compared with placebo-treated patients
            • Fluid retention and edema observed in some patients treated with NSAIDs
            • Meloxicam may blunt the CV effects of several therapeutic agents used to treat these medical conditions (eg, diuretics, ACE inhibitors, ARBs)

            Renal toxicity and hyperkalemia

            • Long-term administration of NSAIDs has resulted in renal papillary necrosis, renal insufficiency, acute renal failure, and other renal injury
            • NSAIDs are not recommended with moderate to severe renal insufficiency and are contraindicated in patients with moderate to severe renal insufficiency at risk for renal failure due to volume depletion
            • Increased serum potassium concentration, including hyperkalemia, reported with NSAIDs, even in some patients without renal impairment

            Asthma exacerbation

            • A subpopulation of patients with asthma may have aspirin-sensitive asthma which may include chronic rhinosinusitis complicated by nasal polyps; severe, potentially fatal bronchospasm; and/or intolerance to aspirin and other NSAIDs
            • Contraindicated in aspirin-sensitive asthma owing to cross-reactivity
            • Caution in patients with asthma without known aspirin sensivitiy

            Additional cautions

            • Hepatotoxicity: May increase ALT or AST
            • Hypertension: Can lead to new onset of hypertension or worsening of pre-existing hypertension, either of which may contribute to the increased incidence of CV events
            • Anaphylactic reactions reported in patients with and without known hypersensitivity to meloxicam and in patients with aspirin-sensitive asthma
            • Serious skin reactions reported, including exfoliative dermatitis, Stevens-Johnson syndrome, toxic epidermal necrolysis, which can be fatal
            • Premature closure of fetal ductus arteriosus: Avoid NSAIDs in pregnant women starting at 30 weeks of gestation (third trimester)
            • Hematologic toxicity: Anemia reported; causes vary including blood loss, fluid retention, or effect on erythropoiesis
            • Masking of inflammation and fever: Reducing inflammation, and possibly fever, may diminish the utility of diagnostic signs in detecting infections
            • Monitoring: Consider monitoring patients on long-term PO NSAID treatment with a CBC and a chemistry profile periodically to detect GI bleeding, hepatotoxicity, or renal injury
            • IV meloxicam not indicated for long-term treatment
            • Qmiiz ODT contains phenylalanine; contraindicated in patients with phenylketonuria

            Drug interaction overview

            • CYP2C9 inhibitors
              • Meloxicam is a CYP2C9 substrate
              • Coadministration with CYP2C9 inhibitors (eg, amiodarone, fluconazole) may increase meloxicam plasma levels owing to reduced metabolic clearance
              • Consider meloxicam dose reduction
            • Drugs that interfere with hemostasis
              • Monitor if coadministered with anticoagulants (eg, warfarin), antiplatelet agents (eg, aspirin), selective serotonin reuptake inhibitors (SSRIs), and serotonin norepinephrine reuptake inhibitors (SNRIs) for signs of bleeding
              • Coadministration with analgesic doses of aspirin is not recommended owing to increased risk of bleeding
              • If coadministration with low-dose aspirin for cardiac prophylaxis, monitor closely for evidence of GI bleeding
            • ACE inhibitors, ARBs, or beta blockers
              • NSAIDs may diminish antihypertensive effect of ACE inhibitors, angiotensin receptor blockers (ARBs), or beta blockers
              • In patients who are elderly, volume-depleted (including those on diuretic therapy), or have renal impairment, coadministration of an NSAID with ACE inhibitors or ARBs may result in deterioration of renal function, including possible acute renal failure; these effects are usually reversible
              • If coadministered, patients should be well hydrated; monitor for signs of worsening renal function
            • Diuretics
              • NSAIDs may reduce the natriuretic effect of loop and thiazide diuretics
              • This effect is attributed to the NSAID inhibition of renal prostaglandin synthesis
              • However, studies with furosemide and meloxicam have not demonstrated a reduced natriuretic effect
            • Lithium
              • NSAIDs elevate plasma lithium levels and reduce renal lithium clearance
              • Mean minimum lithium concentration increased 15%; renal clearance decreased by ~20%
              • Effect attributed to NSAID inhibition of renal prostaglandin synthesis
              • Monitor for lithium toxicity
            • Methotrexate
              • Coadministration of NSAIDs and methotrexate may increase risk for methotrexate toxicity (eg, neutropenia, thrombocytopenia, renal dysfunction)
            • Cyclosporine
              • Coadministration may increase nephrotoxicity
              • If coadministered, monitor for worsening renal function
            • NSAIDs or salicylates
              • Coadministration with other NSAIDs or salicylates increases risk of GI toxicity, with little or no increase in efficacy
              • Concomitant use no recommended
            • Pemetrexed
              • Coadministration may increase risk of pemetrexed-associated myelosuppression, renal, and GI toxicity
              • CrCl 45-79 mL/min: Interrupt meloxicam dosing for at least 5 days before, the day of, and 2 days after pemetrexed administration
              • CrCl <45 mL/min: Concomitant administration of meloxicam with pemetrexed is not recommended
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            Pregnancy & Lactation

            Pregnancy

            NSAID use during third trimester of pregnancy increases the risk of premature closure of the fetal ductus arteriosus

            Avoid use in pregnant women starting at 30 weeks of gestation (third trimester)

            Teratogenicity: Data from observational studies regarding potential embryofetal risks of NSAID use in women in the first or second trimesters of pregnancy are inconclusive

            Animal studies

            • Based on animal data, prostaglandins have been shown to have an important role in endometrial vascular permeability, blastocyst implantation, and decidualization
            • In animal studies, administration of prostaglandin synthesis inhibitors, such as meloxicam, resulted in increased pre- and post-implantation loss

            Clinical considerations

            • Human data are not available on the effects during labor or deliveryIn animal studies, NSAIDs inhibit prostaglandin synthesis, cause delayed parturition, and increase the incidence of stillbirth

            Infertility

            • Females
              • Based on the mechanism of action, prostaglandin-mediated NSAIDs may delay or prevent rupture of ovarian follicles, which has been associated with reversible infertility in some women
            • Males
              • May compromise fertility in males of reproductive potential
              • Oral administration of meloxicam to male rats for 35 days resulted in decreased sperm count and motility and histopathological evidence of testicular degeneration at 0.3-times the MRHD based on BSA comparison
              • The clinical relevance of these findings is unknown

            Lactation

            Human data are not available on whether meloxicam is present in human milk, or on the effects on breastfed infants, or on milk production

            Animal data: Present in milk of lactating rats at concentrations higher than those in plasma

            Pregnancy Categories

            A: Generally acceptable. Controlled studies in pregnant women show no evidence of fetal risk.

            B: May be acceptable. Either animal studies show no risk but human studies not available or animal studies showed minor risks and human studies done and showed no risk.

            C: Use with caution if benefits outweigh risks. Animal studies show risk and human studies not available or neither animal nor human studies done.

            D: Use in LIFE-THREATENING emergencies when no safer drug available. Positive evidence of human fetal risk.

            X: Do not use in pregnancy. Risks involved outweigh potential benefits. Safer alternatives exist.

            NA: Information not available.

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            Pharmacology

            Mechanism of Action

            Member of oxicam class; inhibits synthesis of prostaglandins in body tissues by inhibiting at least 2 cyclo-oxygenase (COX) isoenzymes, COX-1 and COX-2; COX-2 may be inhibited to a greater extent than COX-1 is

            Absorption

            Bioavailability: 89%

            Peak plasma time

            • Mobic tab: 6.57 hr
            • Vivlodex cap: 2 hr (fasting); 5 hr (fed)
            • Anjeso IV: 0.12 hr

            Peak plasma concentration

            • Mobic tab: 1221.9 ng/mL
            • Anjeso IV: 5642.9 ng/mL

            AUC

            • Mobic tab: 53,988.8 ng⋅hr/mL
            • Anjeso IV: 107,508.7 ng⋅hr/mL

            Distribution

            Protein bound: 99.4%; primarily to albumin

            Vd: ~10 L

            Metabolism

            Metabolized in liver by CYP2C9 (major) and CYP3A4 (minor)

            Metabolites (inactive): 5'-Carboxy meloxicam, 5'-hydroxymethyl meloxicam

            Enzymes inhibited: COX-1, COX-2

            Elimination

            Half-life: 15-20 hr (PO); 24 hr (IV)

            Plasma clearance: 7-9 mL/min

            Dialyzable: No

            Excretion: Equally excreted in urine and feces, mostly as metabolites

            Pharmacogenomics

            Poor CYP2C9 metabolizers

            • Consider dose meloxicam reduction
            • Abnormally high plasma levels owing to reduced metabolic clearance may occur
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            Administration

            Oral Administration

            Tablet, capsule, or ODT: May take with or without meals

            Oral disintegrating tablet (ODT)

            • Leave ODT in original package until the time of administration
            • Use dry hands when handling ODT
            • Open carton and peel back foil on the blister; do not push the tablet through the foil as this could damage the tablet
            • Gently remove tablet from the blister and immediately place in mouth or onto tongue
            • Tablet will disintegrate quickly in saliva and can be easily swallowed with or without drinking liquid

            IV Administration

            Anjeso: IV bolus injected over 15 seconds

            Hydrate before administering to reduce risk of renal toxicity

            Storage

            Capsule or tablet

            • Store at 25ºC (77ºF); excursions permitted to 15-30ºC (59-86ºF)
            • Store in original container and keep the bottle tightly closed to protect from moisture
            • Dispense in a tight container if package is subdivided

            Oral disintegrating tablet

            • Store at 20-25ºC (68-77ºF); excursions permitted to 15-30ºC (59-86ºF)
            • Avoid high humidity and excessive heat above 40ºC (104ºF)

            IV

            • Store at 15-25ºC (59-77ºF); excursions permitted to 4-30ºC (40-86ºF)
            • Do not freeze
            • Protect from light
            • Latex-free
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            Images

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            Formulary

            FormularyPatient Discounts

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            Tier Description
            1 This drug is available at the lowest co-pay. Most commonly, these are generic drugs.
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