MOBIC
Clinical safety rating: caution
Comprehensive clinical and safety monograph for MOBIC (MOBIC).
Nonsteroidal anti-inflammatory drug (NSAID) that inhibits cyclooxygenase (COX-1 and COX-2), reducing prostaglandin synthesis, thereby decreasing inflammation, pain, and fever.
| Metabolism | Primarily hepatic metabolism via CYP2C9 (major) and CYP3A4 (minor) to inactive metabolites (4'-hydroxymeloxicam, 5'-hydroxymeloxicam, and oxalyl metabolites). |
| Excretion | Renal: ~50% as unchanged drug and metabolites; biliary/fecal: ~50% via feces; enterohepatic recirculation occurs. |
| Half-life | Terminal elimination half-life: ~20 hours (range 13–20 h); allows once-daily dosing; prolonged in elderly (25–26 h) and hepatic impairment. |
| Protein binding | ~99.4% bound to albumin; high binding may lead to drug interactions with other highly protein-bound drugs. |
| Volume of Distribution | ~0.1–0.15 L/kg (10–15 L in 70 kg adult); indicates limited tissue distribution and low Vd. |
| Bioavailability | Oral: ~89% (capsule/tablet); no significant first-pass metabolism; similar for oral suspension. |
| Onset of Action | Oral: analgesic effect within 30–60 minutes; anti-inflammatory effect within 1–2 weeks. |
| Duration of Action | Analgesic duration: ~12–24 hours; anti-inflammatory effects persist with continued dosing; steady-state reached in 3–5 days. |
| Action Class | Cell wall active agent -Extended spectrum Penicillin |
| Brand Substitutes | Nepomox 500mg Capsule, Cipmox 500 Capsule, Tidoxyl 500mg Capsule, Actimox 500mg Capsule, SB Mox 500mg Capsule |
7.5-15 mg orally once daily. Maximum 15 mg/day.
| Dosage form | TABLET |
| Renal impairment | GFR 30-60 mL/min: maximum 7.5 mg/day. GFR <30 mL/min: contraindicated. |
| Liver impairment | Child-Pugh Class B or C: maximum 7.5 mg/day. |
| Pediatric use | Children ≥2 years and ≥12 kg: 0.125 mg/kg (max 7.5 mg) orally once daily. Maximum 0.125 mg/kg or 7.5 mg, whichever is less. |
| Geriatric use | Maximum 7.5 mg/day due to increased risk of GI and renal adverse effects. |
| 1st trimester | Consult provider |
| 2nd trimester | Consult provider |
| 3rd trimester | Consult provider |
Clinical note
Comprehensive clinical and safety monograph for MOBIC (MOBIC).
| Breastfeeding | Excreted in breast milk in low amounts (M/P ratio not established). Minimal risk to infant per American Academy of Pediatrics; use caution in preterm infants or those with compromised renal function. Consider lowest effective dose and monitor infant for GI effects or bleeding. |
| Teratogenic Risk | Pregnancy Category C prior to 30 weeks gestation; Category D after 30 weeks. First trimester: Possible increased risk of cardiac defects and gastroschisis; second trimester: Associated with oligohydramnios and fetal renal dysfunction; third trimester: Risk of premature closure of ductus arteriosus, pulmonary hypertension, oligohydramnios, and neonatal renal impairment. Avoid after 30 weeks gestation. |
■ FDA Black Box Warning
Cardiovascular risk: NSAIDs may increase risk of serious cardiovascular thrombotic events, myocardial infarction, and stroke, which can be fatal. This risk may increase with duration of use. Patients with cardiovascular disease or risk factors may be at greater risk. MOBIC is contraindicated for treatment of perioperative pain in the setting of coronary artery bypass graft (CABG) surgery. Gastrointestinal risk: NSAIDs increase risk of serious gastrointestinal adverse events including bleeding, ulceration, and perforation of the stomach or intestines, which can be fatal. These events can occur at any time without warning symptoms. Elderly patients and those with a prior history of peptic ulcer disease or GI bleeding are at greater risk.
| Serious Effects |
["Known hypersensitivity to meloxicam or any component of the formulation","History of asthma, urticaria, or allergic-type reactions after taking aspirin or other NSAIDs","Perioperative pain in the setting of coronary artery bypass graft (CABG) surgery","Advanced renal disease (unless dialysis is ongoing)","Third trimester of pregnancy"]
| Precautions | ["Cardiovascular thrombotic events","Gastrointestinal bleeding, ulceration, and perforation","Hypertension and worsening of pre-existing hypertension","Heart failure and edema","Renal toxicity, including renal papillary necrosis","Anaphylactoid reactions","Serious skin reactions (e.g., Stevens-Johnson syndrome, toxic epidermal necrolysis)","Hepatic effects","Hematologic effects (anemia, prolonged bleeding time)","Masking of inflammation and fever","Use in pregnancy, especially during third trimester (risk of premature closure of ductus arteriosus and oligohydramnios)","Interaction with aspirin and other NSAIDs increasing risk of GI events"] |
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| Fetal Monitoring | Regular fetal ultrasound to assess amniotic fluid volume (oligohydramnios risk) and ductus arteriosus flow (especially after 20 weeks). Monitor maternal blood pressure, renal function, and signs of bleeding. Neonatal monitoring for bleeding, renal function, and pulmonary hypertension if used near term. |
| Fertility Effects | May impair female fertility via reversible inhibition of ovulation (NSAID-mediated luteinized unruptured follicle syndrome). Reversible upon discontinuation. No known effect on male fertility. |