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Esomeprazole/Naproxen

    Brands

    DEA Class;  Rx

    Common Brand Names; Vimovo

    Pain Management, Other

    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.

     
    For the treatment of osteoarthritis, rheumatoid arthritis, or ankylosing spondylitis in patients at risk of developing NSAID-associated gastric ulcers.
    For the treatment of juvenile rheumatoid arthritis (JRA)/juvenile idiopathic arthritis (JIA) in patients at risk of developing NSAID-associated gastric ulcers.
     

    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

    >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%)

    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; 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

    Dosage limits reflect use of the drug in this combination product.

    Adults

    1,000 mg/day PO naproxen and 40 mg/day PO esomeprazole.

    Geriatric

    1,000 mg/day PO naproxen and 40 mg/day PO esomeprazole.

    Adolescents

    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.

    Children

    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.

    esomeprazole/naproxen

    Tablet

    • 20mg/375mg
    • 20mg/500mg