Dosing and uses of Mobic, Vivlodex (meloxicam)
Adult dosage forms and strengths
tablet (Mobic)
- 7.5mg
- 15mg
capsule (Vivlodex)
- 5mg
- 10mg
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
Pediatric dosage forms and strengths
tablet (Mobic)
- 7.5mg
- 15mg
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
Mobic, Vivlodex (meloxicam) adverse (side) 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
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
Pregnancy and 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.
Pharmacology of Mobic, Vivlodex (meloxicam)
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
