Manufacturer:

AstraZeneca Pharmaceuticals

Pharmacological Class:

NSAID + proton pump inhibitor

Active Ingredient(s):

Naproxen 375mg + esomeprazole (as magnesium trihydrate) 20mg; naproxen 500mg + esomeprazole (as magnesium trihydrate) 20mg; delayed-release tablets.

Indication(s):

Osteoarthritis, rheumatoid arthritis, ankylosing spondylitis: to improve symptoms and reduce risk of gastric ulcers in patients at risk of developing NSAID-associated gastric ulcers.

Pharmacology:

Vimovo is a delayed-release formulation of an NSAID plus a proton pump inhibitor. The tablets combine an enteric-coated core containing naproxen surrounded by an immediate-release coating of esomeprazole magnesium. Upon oral administration, esomeprazole is released first in the stomach, and the naproxen is released later in the small intestine. With twice-daily dosing, naproxen levels reach steady-state in about 4–5 days.

Clinical Trials:

Two randomized, double-blind studies were conducted to compare the incidence of gastric ulcer in patients taking this product or enteric-coated naproxen. Subjects had conditions that were expected to require daily NSAID therapy for at least 6 months and, if they were under age 50, had a history of GI or duodenal ulcer within the past 5 years. These studies showed that Vimovo 500/20 twice daily significantly reduced the 6-month cumulative incidence of gastric ulcers, compared to enteric-coated naproxen 500mg twice daily.

Other studies were conducted that established the efficacy of Vimovo in treating the signs/symptoms of osteoarthritis of the knee.

Legal Classification:

Rx

Adults:

Swallow whole. Take at least 30min before meals. >18 years: One 375/20 or 500/20 tab twice daily. Use lowest effective dose for the shortest duration. Consider dose reduction in mild to moderate hepatic impairment.

Children:

<18 years: not recommended.

Contraindication(s):

Aspirin allergy/triad. Coronary artery bypass surgery. Late pregnancy (≥30 weeks gestation).

Warnings/Precautions:

Increased risk of serious cardiovascular thrombotic events, MI, stroke, gastrointestinal adverse events (bleeding, ulceration, perforation); may be fatal. Moderate to severe renal impairment (CrCl <30mL/min) or severe hepatic impairment: not recommended. History of ulcer disease, GI bleeding, or inflammatory bowel disease (eg, ulcerative colitis, Crohn’s disease). Hypertension; monitor BP. CHF. Edema. Bleeding disorders. Pre-existing asthma. Impaired renal or hepatic function. Monitor blood, liver, and renal function in chronic use. Discontinue if liver or renal dysfunction, or serious rash occurs. Increased risk of osteoporosis-related fractures with high-doses or on long-term therapy. Elderly. Debilitated. Pregnancy (Cat.C <30 weeks gestation, Cat.D ≥30 weeks gestation). Labor & delivery, nursing mothers: not recommended.

Interaction(s):

Concomitant atazanavir, nelfinavir: not recommended. May potentiate saquinavir (monitor; consider reducing saquinavir dose), protein-bound drugs (eg, hydantoins, sulfonamides, sulfonylureas). Increases lithium levels. Methotrexate excretion reduced. May antagonize diuretics, beta-blockers (eg, propranolol), ACE inhibitors. Increased renal toxicity with ACE inhibitors. Increased risk of GI bleed with oral corticosteroids, smoking, alcohol, SSRIs. Monitor aspirin and oral anticoagulants. May affect CYP2C19 substrates (eg, diazepam, cilostazol). May affect absorption of pH-dependent drugs (eg, ketoconazole, digoxin, iron salts). Probenecid increases plasma levels and delays elimination.

Adverse Reaction(s):

Erosive gastritis, dyspepsia, gastritis, diarrhea, gastric ulcer, upper abdominal pain, nausea; renal papillary necrosis; see literature re: risk of cardiovascular events, serious gastrointestinal events.

How Supplied:

Tabs—60, 500