VIMOVO
Clinical safety rating: caution
Comprehensive clinical and safety monograph for VIMOVO (VIMOVO).
VIMOVO (esomeprazole and naproxen) is a fixed-dose combination. Naproxen is a nonsteroidal anti-inflammatory drug (NSAID) that inhibits cyclooxygenase (COX-1 and COX-2), decreasing prostaglandin synthesis, thereby reducing inflammation, pain, and fever. Esomeprazole is a proton pump inhibitor (PPI) that suppresses gastric acid secretion by inhibiting the H+/K+ ATPase in gastric parietal cells. The combination is intended to reduce the risk of NSAID-associated gastric ulcers.
| Metabolism | Esomeprazole is extensively metabolized in the liver primarily by CYP2C19 and CYP3A4. Naproxen is metabolized in the liver primarily by CYP2C9. |
| Excretion | Renal 50% as naproxen metabolites, <1% unchanged naproxen; less than 1% excreted unchanged in feces as esomeprazole; esomeprazole metabolites excreted in urine 80% and feces 20%. |
| Half-life | Naproxen: 12-17 hours (prolonged in elderly and renal impairment; dosing interval typically 12 hours). Esomeprazole: 1-1.5 hours (metabolized by CYP2C19 and CYP3A4; no accumulation after repeated dosing). |
| Protein binding | Naproxen: >99% bound to albumin; esomeprazole: 97% bound to plasma proteins (mainly albumin). |
| Volume of Distribution | Naproxen: 0.16 L/kg (indicates distribution mainly in plasma and extracellular fluid); esomeprazole: 0.22 L/kg (distribution slightly larger, but still limited). |
| Bioavailability | VIMOVO: fixed-dose combination; naproxen bioavailability ~95% (oral); esomeprazole ~64% after oral administration (first-pass metabolism; food delays absorption but does not affect AUC). |
| Onset of Action | Naproxen: 1 hour (analgesic effect); esomeprazole: 3-5 days for maximal acid suppression (single dose effect within 1 hour). |
| Duration of Action | Naproxen: up to 12 hours (sustained release formulation); esomeprazole: up to 24 hours for acid suppression (once daily dosing). |
One tablet (naproxen 500 mg/esomeprazole 20 mg) orally twice daily.
| Dosage form | TABLET, DELAYED RELEASE |
| Renal impairment | GFR 30-89 mL/min: no adjustment; GFR <30 mL/min: contraindicated. |
| Liver impairment | Child-Pugh A: no adjustment; Child-Pugh B: maximum daily dose naproxen 500 mg; Child-Pugh C: contraindicated. |
| Pediatric use | Not recommended for use in pediatric patients. |
| Geriatric use | Start at lowest effective dose; avoid use in elderly with high bleeding risk; monitor renal function. |
| 1st trimester | Consult provider |
| 2nd trimester | Consult provider |
| 3rd trimester | Consult provider |
Clinical note
Comprehensive clinical and safety monograph for VIMOVO (VIMOVO).
| Breastfeeding | Limited data. Esomeprazole is excreted in human milk in low concentrations (M/P ratio unknown; estimated relative infant dose <1% of maternal weight-adjusted dose). Naproxen enters breast milk in minimal amounts (M/P ratio ~0.01). Due to potential for adverse effects in infants (GI bleeding, renal impairment), use with caution and monitor infant for drowsiness, poor feeding, and rash. |
| Teratogenic Risk | Pregnancy Category C (first and second trimesters) and Category D (third trimester). First trimester: NSAIDs are associated with increased risk of miscarriage and cardiac defects; esomeprazole has no consistent evidence of major malformations. Second trimester: NSAIDs may cause fetal renal dysfunction and oligohydramnios; esomeprazole risk remains low. Third trimester: NSAIDs cause premature closure of ductus arteriosus and potential persistent pulmonary hypertension; esomeprazole risks are minimal. |
■ FDA Black Box Warning
Naproxen: Nonsteroidal anti-inflammatory drugs (NSAIDs) cause an increased risk of serious cardiovascular thrombotic events, including myocardial infarction and stroke, which can be fatal. This risk may increase with duration of use. Patients with cardiovascular disease or risk factors for cardiovascular disease may be at greater risk. Naproxen is contraindicated for the treatment of perioperative pain in the setting of coronary artery bypass graft (CABG) surgery. NSAIDs cause an increased 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 during use and without warning symptoms. Elderly patients and patients with a prior history of peptic ulcer disease and/or GI bleeding are at greater risk.
| Serious Effects |
["Hypersensitivity to esomeprazole, naproxen, or any component of the formulation","History of asthma, urticaria, or allergic-type reactions after taking aspirin or other NSAIDs","History of gastrointestinal bleeding or perforation related to previous NSAID therapy","Active peptic ulcer disease or active gastrointestinal bleeding","Severe heart failure","Advanced renal disease (unless undergoing dialysis)","In the setting of coronary artery bypass graft (CABG) surgery","Known deficiency of CYP2C19 (for esomeprazole)"]
| Precautions |
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| Fetal Monitoring | Monitor for oligohydramnios (ultrasound if NSAID use >48 hours), fetal ductus arteriosus constriction (echocardiogram if third-trimester use), maternal blood pressure, renal function, and signs of GI bleeding. In long-term use, assess for fetal growth restriction. |
| Fertility Effects | NSAIDs (naproxen) may impair female fertility by inhibiting prostaglandin synthesis, leading to luteinized unruptured follicle syndrome and reversible infertility. Discontinuation often restores fertility. Esomeprazole has no known effect on fertility. |
| ["Cardiovascular thrombotic events","Gastrointestinal bleeding, ulceration, and perforation","Acute interstitial nephritis","Hepatotoxicity","Hypertension","Heart failure and edema","Renal toxicity","Anaphylactic reactions","Skin reactions (e.g., Stevens-Johnson syndrome)","Hematologic toxicity","Exacerbation of asthma","Masking of signs of infection","Cyanocobalamin (vitamin B12) deficiency","Hypomagnesemia","Interaction with methotrexate","Interaction with clopidogrel","Fractures with PPIs"] |