Esomeprazole/Naproxen

4
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
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