VIVLODEX
Clinical safety rating: caution
Comprehensive clinical and safety monograph for VIVLODEX (VIVLODEX).
COX-2 inhibitor; reduces prostaglandin synthesis via inhibition of cyclooxygenase-2 (COX-2) with minimal COX-1 inhibition.
| Metabolism | Hepatic via CYP3A4 and CYP2C9; active metabolite meloxicam-5-carboxylic acid. |
| Excretion | VIVLODEX is a meloxicam NSAID prodrug. Following hydrolysis to meloxicam, excretion is primarily hepatic (metabolism) and renal (urine). Approximately 50% of meloxicam dose is excreted in urine as metabolites and <5% as parent drug; about 40% in feces. Biliary excretion is minor. |
| Half-life | Terminal elimination half-life of the active moiety meloxicam is approximately 20 hours (range 12-24 h), allowing once-daily dosing in chronic pain. |
| Protein binding | Meloxicam is extensively protein bound (>99%) primarily to albumin. |
| Volume of Distribution | Volume of distribution is approximately 0.1-0.2 L/kg (about 10 L in adults), indicating limited tissue distribution. |
| Bioavailability | Absolute bioavailability of oral VIVLODEX is approximately 89% (for meloxicam). |
| Onset of Action | The onset of analgesic effect is typically within 1-2 hours after oral administration, with peak plasma concentrations at 4-5 hours. |
| Duration of Action | Duration of analgesic effect is approximately 24 hours, supporting once-daily dosing. Clinical effect persists for the dosing interval. |
| Molecular Weight | 351.4 |
Once daily oral administration of 100 mg or 200 mg capsules. The recommended dose is 100 mg once daily; dose may be increased to 200 mg once daily if response is inadequate. Maximum daily dose: 200 mg.
| Dosage form | CAPSULE |
| Renal impairment | eGFR 30-89 mL/min: No adjustment needed. eGFR 15-29 mL/min: Maximum dose 100 mg once daily. eGFR <15 mL/min or ESRD: Not recommended (not studied). |
| Liver impairment | Child-Pugh Class A (mild impairment): No adjustment needed. Child-Pugh Class B (moderate impairment): Maximum dose 100 mg once daily. Child-Pugh Class C (severe impairment): Not recommended (contraindicated). |
| Pediatric use | Not approved for pediatric patients under 18 years of age; safety and efficacy have not been established. |
| Geriatric use | No specific dose adjustment required based on age alone. Use the lowest effective dose and monitor renal function due to age-related decline in GFR. For patients ≥65 years, consider maximum dose of 100 mg once daily. |
| 1st trimester | VIVLODEX (meloxicam) is contraindicated in the first trimester due to risk of cardiovascular and other malformations associated with NSAID use. |
| 2nd trimester | Use only if potential benefit justifies risk to fetus; avoid prolonged use as NSAIDs may cause oligohydramnios and fetal renal dysfunction. |
| 3rd trimester | Contraindicated in the third trimester due to risk of premature closure of the ductus arteriosus and oligohydramnios. |
Clinical note
Comprehensive clinical and safety monograph for VIVLODEX (VIVLODEX).
| Placental transfer | Meloxicam crosses the placenta; animal studies show fetal risk, and human data are limited but consistent with NSAID placental transfer. |
| Breastfeeding | Meloxicam is excreted into breast milk in low amounts; however, due to potential adverse effects in nursing infants (e.g., renal toxicity, gastrointestinal bleeding), caution is advised. Consider alternative analgesics with more safety data during breastfeeding. |
■ FDA Black Box Warning
Increased risk of cardiovascular thrombotic events, including myocardial infarction and stroke; increased risk of gastrointestinal adverse events including bleeding, ulceration, and perforation.
| Serious Effects |
Known hypersensitivity to meloxicam or any NSAIDHistory of asthma, urticaria, or allergic-type reactions after taking aspirin or other NSAIDsPerioperative pain in the setting of coronary artery bypass graft (CABG) surgeryAdvanced renal disease (creatinine clearance <30 mL/min)Active gastrointestinal bleeding or perforationHistory of recent gastrointestinal bleeding or perforation related to NSAID therapyThird trimester of pregnancy
| Precautions | Cardiovascular thrombotic events; GI bleeding; serious skin reactions (e.g., Stevens-Johnson syndrome); renal toxicity; hepatic effects; anaphylaxis; fluid retention; hypertension; asthma exacerbation. |
| Food/Dietary | No specific food interactions. May be taken with or without food. Calcium-containing antacids may reduce absorption; separate by at least 2 hours. Avoid alcohol. |
Loading safety data…
| Lactation Rating | L3 (Moderately Safe) - Limited data suggest risk; use with caution. |
| Teratogenic Risk | VIVLODEX (lornoxicam) is contraindicated in the first and third trimesters. First trimester: NSAIDs increase risk of miscarriage and cardiac defects. Third trimester: risk of premature ductus arteriosus closure and oligohydramnios. Second trimester: use only if clearly needed, lowest effective dose for shortest duration. |
| Fetal Monitoring | Monitor maternal renal function, blood pressure, and signs of gastrointestinal bleeding. In third trimester, monitor fetal ultrasound for ductus arteriosus patency and amniotic fluid volume. |
| Fertility Effects | NSAIDs may impair female fertility through reversible inhibition of ovulation and luteinized unruptured follicle syndrome. Withdrawing NSAIDs may restore normal ovulatory cycles. |
| Clinical Pearls | Vivlodex (meloxicam) is a preferential COX-2 inhibitor NSAID with a lower gastrointestinal ulcer risk than nonselective NSAIDs; however, it still carries cardiovascular and renal risks. It is rapidly absorbed with or without food, but calcium-containing antacids may reduce absorption. Use the lowest effective dose for the shortest duration. Contraindicated in patients with aspirin allergy, perioperative pain in CABG surgery, and advanced renal disease. |
| Patient Advice | Take with food or milk to reduce stomach upset. · Avoid alcohol while taking this medication to reduce GI bleeding risk. · Do not take with other NSAIDs including over-the-counter ibuprofen or naproxen. · Report signs of bruising, black/tarry stools, or vomiting blood immediately. · May cause dizziness or drowsiness; avoid driving if affected. · Stay hydrated and monitor for swelling or rapid weight gain due to fluid retention. · Consult doctor before use if you have high blood pressure, heart disease, or kidney disease. |