• Naproxen provides symptomatic management of osteoarthritis, rheumatoid arthritis, or ankylosing spondylitis; addition of esomeprazole decreases the risk of gastric ulcers in patients at risk of NSAID-associated gastric ulcers.
• Not indicated for acute pain due to delayed absorption of naproxen.

Contraindicated in:

• Hypersensitivity to either naproxen or esomeprazole
• History of allergic reactions (including asthma or urticaria) to aspirin or other NSAIDs
• Severe hepatic impairment
• Moderate to severe renal impairment
• Coronary artery bypass graft (CABG) surgery
• OB: Avoid use of NSAIDs after 30 wk gestation
• Lactation: Lactation.

Use Cautiously in:

• Cardiovascular disease or risk factors for cardiovascular disease (may ↑ risk of serious cardiovascular thrombotic events, myocardial infarction, and stroke, especially with prolonged use or use of higher doses); avoid use in patients with recent MI or HF
• History of GI bleeding/ulcer disease (↑ risk of GI bleeding)
• History of HF or fluid retention (may worsen)
• Renal impairment, hypovolemia, salt depletion, HF, liver dysfunction (↑ risk of adverse renal reactions)
• OB: Use at or after 20 wk gestation may cause fetal or neonatal renal impairment; if treatment is necessary between 20 wk and 30 wk gestation, limit use to the lowest effective dose and shortest duration possible
• Pedi: Safety and effectiveness not established in children
• Geri: ↑risk of GI bleeding, adverse cardiovascular or renal reactions in older adults; consider age, hepatic/renal function, ↓ body mass, concurrent chronic illnesses and drug therapy.

CNS: dizziness, drowsiness, headache.

CV: HF, MYOCARDIAL INFARCTION, STROKE, edema, hypertension, palpitations.

Derm: DRUG REACTION WITH EOSINOPHILIA AND SYSTEMIC SYMPTOMS (DRESS), STEVENS-JOHNSON SYNDROME, TOXIC EPIDERMAL NECROLYSIS, photosensitivity, rash, sweating.

EENT: tinnitus, visual disturbances.

F and E: hyperkalemia.

GI: DRUG-INDUCED HEPATITIS, GI BLEEDING, constipation, dyspepsia, nausea, abdominal pain, anorexia, diarrhea, dry mouth, flatulence, vomiting.

GU: cystitis, hematuria, renal failure.

Hemat: blood dyscrasias, prolonged bleeding time.

MS: bone fracture.

Resp: dyspnea.

Misc: HYPERSENSITIVITY REACTIONS (INCLUDING ANAPHYLAXIS) .

Drug-Drug:

• Naproxen may limit cardioprotective (antiplatelet) effects ofaspirin.
• Naproxen may ↑ risk of bleeding with anticoagulants, aspirin, clopidogrel, ticagrelor, prasugrel, corticosteroids, fibrinolytics, SNRIs, or SSRIs.
• Naproxen has additive adverse GI side effects with aspirin, corticosteroids, alcohol, SSRIs, oral potassium supplements and other NSAIDs.
• Probenecid may ↑ naproxen levels and risk of toxicity.
• Naproxen may ↑ risk of toxicity from methotrexate, antineoplastics, or radiation therapy.
• Naproxen may ↑ levels and risk of toxicity from lithium.
• Cyclosporine, ACE inhibitors, angiotensin II receptor blockers, or chronic use of acetaminophen may ↑ naproxen's adverse renal effects.
• Naproxen may ↓ response to antihypertensives or diuretics.
• Naproxen may ↑ risk of hypoglycemia with insulin or oral hypoglycemic agents.Esomeprazole may ↓ absorption and effectiveness of digoxin, iron salts, and ketoconazole.

(Generic available)

• Delayed–release tablets: naproxen 375 mg/esomeprazole 20 mg; naproxen 500 mg/esomeprazole 20 mg;

• PO (Adults): One tablet (naproxen 375 mg/esomeprazole 20 mg or naproxen 500 mg/esomeprazole 20 mg) twice daily; use lowest effective dose.

Vimovo

• Naproxen — Inhibits prostaglandin synthesis.
• Esomeprazole — binds to an enzyme on gastric parietal cells in the presence of acidic gastric pH, preventing the final transport of hydrogen ions into the gastric lumen.

• Decreased pain/swelling with improved mobility and decreased risk of gastric ulcer in high risk patients.

Therapeutic Classification: antirheumatics, nonopioid analgesics, antiulcer agents

Pharmacologic Classification: benzimidazoles, nonsteroidal anti-inflammatory drugs (NSAIDs), proton pump inhibitors

Naproxen

Absorption: Completely absorbed from the GI tract.

Distribution: Crosses the placenta; enters breast milk in low concentrations.

Protein Binding: >99%.

Metabolism/Excretion: Mostly metabolized by the liver.

Half-life: 10–20 hr.

Esomeprazole

Absorption: 90% absorbed following oral administration; food ↓ absorption.

Distribution: Unknown.

Protein Binding: 97%.

Metabolism/Excretion: Extensively metabolized by the liver (primarily by the CYP2C19 isoenzyme, but also the CYP3A4 isoenzyme) (the CYP2C19 enzyme system exhibits genetic polymorphism; 15–20% of Asian patients and 3–5% of Caucasian and Black patients may be poor metabolizers and may have significantly ↑ esomeprazole concentrations and an ↑ risk of adverse effects); <1% excreted unchanged in urine.

Half-life: 1.0–1.5 hr.

• Instruct patient to take medication as directed. Take missed doses as soon as remembered but not if almost time for the next dose. Do not double doses. Advise patient to read the Medication Guide before starting therapy and with each Rx refill in case of changes.
• May cause drowsiness or dizziness. Advise patient to avoid driving or other activities requiring alertness until response to the medication is known.
• Advise patient to inform health care professional of medication regimen before treatment or surgery.
• Caution patient to avoid the concurrent use of alcohol, aspirin, acetaminophen, or other NSAIDs or OTC medications without consulting health care professional. Use of naproxen with 3 or more glasses of alcohol per day may increase risk of GI bleeding.
• Advise patient to notify health care professional promptly if rash, GI pain or bleeding, chest pain, shortness of breath, weakness, slurring of speech, unexplained weight gain, edema, or signs and symptoms of hepatotoxicity (nausea, fatigue, lethargy, pruritus, jaundice, upper right quadrant tenderness, flu-like symptoms) or anaphylaxis (difficulty breathing, swelling of face or throat) occur.
• Rep: May cause fetal harm. Advise females of reproductive potential to notify health care professional if pregnancy is planned or suspected or if breastfeeding. Advise women to avoid naproxen in the 3rd trimester of pregnancy (after 29 wk), may cause premature closure of the fetal ductus arteriosus. Use of naproxen after 20 wk may cause fetal renal dysfunction leading to oligohydramnios. May cause reversible infertility in women attempting to conceive; may consider discontinuing naproxen.

na-PROX-en/es-o-MEP-ra-zole