Classes
DEA Class; Rx
Common Brand Names; Vimovo
Pain Management, Other
Description
Fixed-dose combination of an immediate release proton pump inhibitor and an enteric coated NSAID within single tablet; as with all NSAIDs may increase CV events; used to reduce risk of adverse GI effects in treatment of OA, RA, and ankylosing spondylitis.
Indications
Contraindications
Hypersensitivity, including angioedema and anaphylactic reaction/shock has been reported with esomeprazole
Asthma, urticaria, or allergic-type reactions after taking aspirin or other NSAIDs
NSAIDs are contraindicated in late stage pregnancy (risk for closure of ductus arteriosus)
NSAIDs are contraindicated for perioperative pain in setting of CABG surgery
Perioperative pain in the setting of coronary artery bypass graft surgery
Concomitant administration with rilpivirine-containing products
Adverse Effects
>10%
Gastric erosion (19%); compared with 38% for equal naproxen dose without PPI
Dyspepsia (18%); compared with 27% for equal naproxen dose without PPI
Gastritis (17%)
1-10%
Diarrhea (6%)
Abdominal pain (6%)
Nausea (5%)
Hiatal hernia (4%)
Abdominal distension (4%)
Flatulence (4%)
Esophagitis (4%)
Constipation (3%)
Headache (3%)
Dysgeusia (2%)
Erosive duodenitis (2%)
Hemorrhagic gastritis (1%)
Warnings
NSAIDs increase risk for thrombotic events (eg, MI, stroke); consistent evidence does not exist that concurrent use of aspirin mitigates the increased risk of serious CV thrombotic events
NSAIDs increase risk for hypertension (or worsening hypertension), CHF, and edema
NSAIDs increase risk of GI ulceration, bleeding, and perforation
Caution with history of inflammatory bowel disease or GI bleeding
Long-term NSAID use may cause renal papillary necrosis or 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 inhibitors, or angiotensin-receptor blockers
Caution with pre-existing asthma
Inhibits platelet aggregation
PPIs may increase risk of osteoporosis-related fractures
Pregnancy and Lactation
Pregnancy; Avoid use of NSAIDs in pregnant women at about 30 weeks gestation and later; NSAIDs increase risk of premature closure of fetal ductus arteriosus at approximately this gestational age
Lactation: Naproxen is distributed in breast milk, not recommended
Maximum Dosage
Dosage limits reflect use of the drug in this combination product.
1,000 mg/day PO naproxen and 40 mg/day PO esomeprazole.
1,000 mg/day PO naproxen and 40 mg/day PO esomeprazole.
Weighing 50 kg or more: 1,000 mg/day PO naproxen and 40 mg/day PO esomeprazole.
Weighing 38 to 49 kg: 750 mg/day PO naproxen and 40 mg/day PO esomeprazole.
12 years weighing 50 kg or more: 1,000 mg/day PO naproxen and 40 mg/day PO esomeprazole.
12 years weighing 38 to 49 kg: 750 mg/day PO naproxen and 40 mg/day PO esomeprazole.
1 to 11 years: Safety and efficacy have not been established.
How supplied
esomeprazole/naproxen
Tablet
- 20mg/375mg
- 20mg/500mg
