meloxicam (Rx)

Brand and Other Names:Mobic, Vivlodex
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Dosing & Uses

AdultPediatric

Dosage Forms & Strengths

tablet (Mobic)

  • 7.5mg
  • 15mg

capsule (Vivlodex)

  • 5mg
  • 10mg
more...

Osteoarthritis

Mobic: 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

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

Dosage Modifications

Hepatic impairment

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

Renal impairment

  • Mild-to-moderate: No dosage adjustment required
  • Severe: Not studied
  • Hemodialysis
    • Mobic: Hemodialysis did not lower the drug plasma concentration, therefore, additional doses are not necessary after hemodialysis
    • Vivlodex: Not to exceed 5 mg/day

Dosing Considerations

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

Dosage Forms & Strengths

tablet (Mobic)

  • 7.5mg
  • 15mg
more...

Pauciarticular/Polyarticular Course Juvenile Idiopathic Arthritis

<2 years: Safety and efficacy not established

>2 years (≥60 kg): 0.125 mg/kg PO once daily; not to exceed 7.5 mg/day 

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Interactions

Interaction Checker

and meloxicam

No Results

     activity indicator 
    No Interactions Found
    Interactions Found

    Contraindicated

      Serious - Use Alternative

        Significant - Monitor Closely

          Minor

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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%)

            <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

            Absolute

            • Salicylate allergy
            • Perioperative pain in setting of coronary artery bypass graft (CABG) surgery
            • History of asthma, urticaria, or other allergic-type reactions after taking aspirin or other NSAIDs

            Relative

            • Bleeding disorders
            • Systemic lupus erythematosus
            • Ulcerative colitis
            • Late pregnancy (may cause premature closure of ductus arteriosus)
            • Gastritis
            • GI hemorrhage
            • GI ulcer
            • Predisposition to GI hemorrhage
            • Severe hepatic impairment

            Cautions

            Use caution in asthma (bronchial), congestive heart failure, hypertension, fluid retention, renal impairment, stomatitis, history of GI ulcers

            Fluid retention and edema observed in some patients treated with NSAIDs; use of meloxicam may blunt cardiovascular effects of several therapeutic agents used to treat these medical conditions (e.g., diuretics, ACE inhibitors, or angiotensin receptor blockers)

            Avoid use in patients with severe heart failure unless benefits expected to outweigh risk of worsening heart failure; if meloxicam used in patients with severe heart failure, monitor patients for signs of worsening heart failure

            Increased risk of potentially fatal thrombotic events (eg, MI and stroke); further increased with longer duration of drug use and presence of preexisting cardiovascular disease; to minimize potential risk for adverse cardiovascular event in NSAID-treated patients, use lowest effective dose for shortest duration possible; physicians and patients should remain alert for of such events, throughout entire treatment course, even in absence of previous cardiovascular symptoms; patients should be informed about symptoms of serious cardiovascular events and steps to take if they occur

            Risk of hyperkalemia increases with use

            Increased risk of GI ulcers with prolonged use

            NSAID use may compromise existing renal function; rehydrate patient before initiating therapy; monitor renal function closely; long-term administration of NSAIDs may result in renal papillary necrosis and other renal injury; patients at greatest risk include elderly individuals; those with impaired renal function, hypovolemia, heart failure, liver dysfunction, or salt depletion; and those taking diuretics, angiotensin-converting enzyme (ACE) inhibitors, or angiotensin receptor blockers

            Risk of new-onset hypertension or exacerbation of preexisting hypertension

            May cause severe skin reactions including exfoliative dermatitis, Stevent-Johnson syndrome, and toxic epidermal necrolysis; discontinue at first sign of skin reactions

            Concomitant aspirin may not mitigate thrombotic risk but increases GI ulcer risk

            May cause drowsiness, blurred vision, dizziness, and other CNS effects

            May decrease platelet adhesion and aggregation

            Avoid use of meloxicam in patients with recent myocardial infarction unless benefits outweigh risk of recurrent cardiovascular thrombotic events; if used in patients with recent myocardial infarction, monitor patients for signs of cardiac ischemia

            Anaphylactoid reactions may occur in patients that have never been exposed to the drug; not for use in patients who experience bronchospasm, asthma, rhinitis, or urticaria with NSAID or aspirin therapy; seek emergency help if an anaphylactic reaction occurs

            Use with caution in patients with hepatic impairment; closely monitor patients with any abnormal LFT; discontinue therapy if signs or symptoms of liver disease develop or if systemic manifestation occur

            Monitor hemoglobin or hematocrit in patients with any signs or symptoms of anemia

            Heart Failure(HF) risk

            • NSAIDS have the potential to trigger HF by prostaglandin inhibition that leads to sodium and water retention, increased systemic vascular resistance, and blunted response to diuretics
            • NSAIDS should be avoided or withdrawn whenever possible
            • AHA/ACC Heart Failure Guidelines; Circulation. 2016; 134
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            Pregnancy & Lactation

            Pregnancy category: C; D in third trimester of pregnancy; drug should be avoided in late pregnancy

            Quebec Pregnancy Registry identified 4705 women who had spontaneous abortions by 20 weeks' gestation; each case was matched to 10 control subjects (n=47,050) who had not had spontaneous abortions; exposure to nonaspirin NSAIDs during pregnancy was documented in approximately 7.5% of cases of spontaneous abortions and approximately 2.6% of controls

            Lactation: Unknown whether drug is excreted in breast milk; effect on infant unknown; not recommended

            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: 4-5 hr (initial); 12-14 hr (secondary peak)

            Distribution

            Protein bound: 99.4%

            Vd: 10 L

            Metabolism

            Metabolized in liver by CYP3A4

            Metabolites: 5'-Carboxy meloxicam, 5'-hydroxymethyl meloxicam

            Enzymes inhibited: COX-1, COX-2

            Elimination

            Half-life: 15-20 hr

            Dialyzable: No

            Excretion: Urine, feces

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            Formulary

            FormularyPatient Discounts

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            The above information is provided for general informational and educational purposes only. Individual plans may vary and formulary information changes. Contact the applicable plan provider for the most current information.

            Tier Description
            1 This drug is available at the lowest co-pay. Most commonly, these are generic drugs.
            2 This drug is available at a middle level co-pay. Most commonly, these are "preferred" (on formulary) brand drugs.
            3 This drug is available at a higher level co-pay. Most commonly, these are "non-preferred" brand drugs.
            4 This drug is available at a higher level co-pay. Most commonly, these are "non-preferred" brand drugs or specialty prescription products.
            5 This drug is available at a higher level co-pay. Most commonly, these are "non-preferred" brand drugs or specialty prescription products.
            6 This drug is available at a higher level co-pay. Most commonly, these are "non-preferred" brand drugs or specialty prescription products.
            NC NOT COVERED – Drugs that are not covered by the plan.
            Code Definition
            PA Prior Authorization
            Drugs that require prior authorization. This restriction requires that specific clinical criteria be met prior to the approval of the prescription.
            QL Quantity Limits
            Drugs that have quantity limits associated with each prescription. This restriction typically limits the quantity of the drug that will be covered.
            ST Step Therapy
            Drugs that have step therapy associated with each prescription. This restriction typically requires that certain criteria be met prior to approval for the prescription.
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