Vimovo

Generic name:

naproxen / esomeprazole magnesium

Drug class:

Nonsteroidal anti-inflammatory drug (NSAID) and proton pump inhibitor (PPI) combination

Dosage form:

Delayed-release/extended-release tablets

Root of administration:

Oral

Dose:

• 375 mg naproxen / 20 mg esomeprazole once daily
• 500 mg naproxen / 20 mg esomeprazole once daily
• Taken in the morning on an empty stomach, at least 60 minutes before food

Mechanism of action:

Naproxen inhibits cyclooxygenase-1 and cyclooxygenase-2, reducing prostaglandin synthesis for anti-inflammatory, analgesic, and antipyretic effects. Esomeprazole irreversibly inhibits the H+/K+-ATPase in gastric parietal cells, suppressing gastric acid secretion to protect the gastrointestinal mucosa.

Drug usage cases:

• Osteoarthritis
• Rheumatoid arthritis
• Ankylosing spondylitis
• Reduction of risk of NSAID-associated gastric ulcers in at-risk patients
• Off-label: Gout flares
• Off-label: Tendonitis and bursitis
• Off-label: Juvenile idiopathic arthritis

Drug contra indications:

• Hypersensitivity to naproxen, esomeprazole, aspirin, other NSAIDs, or benzimidazole agents
• History of asthma, urticaria, or allergic-type reactions after taking aspirin or other NSAIDs
• Active or suspected gastrointestinal bleeding or peptic ulcer disease
• Severe hepatic impairment (Child-Pugh C)
• Severe renal impairment (CrCl < 30 mL/min)
• Concurrent use of rilpivirine-containing products
• Patients in whom naproxen or esomeprazole are otherwise contraindicated

Side effects:

• Gastrointestinal: dyspepsia, abdominal pain, nausea, diarrhea, constipation, flatulence, GI ulceration, bleeding, perforation
• Central nervous system: headache, dizziness, somnolence
• Cardiovascular: hypertension, edema, palpitations
• Renal: increased BUN, increased serum creatinine, renal impairment
• Hepatic: elevated liver enzymes (AST/ALT), hepatitis
• Dermatologic: rash, pruritus, Stevens-Johnson syndrome, toxic epidermal necrolysis
• Hematologic: anemia, bleeding, thrombocytopenia, leukopenia
• Respiratory: dyspnea
• PPI-specific: hypomagnesemia, vitamin B12 deficiency, flatulence, abdominal pain, headache
• Other: weight gain, arthralgia, back pain

Warnings:

• Cardiovascular risk: increased risk of serious CV thrombotic events, myocardial infarction, and stroke
• Gastrointestinal risk: serious GI adverse events including bleeding, ulceration, and perforation
• Renal toxicity: risk of renal impairment, interstitial nephritis, acute renal failure
• Hepatic effects: risk of hepatic dysfunction and elevated liver enzymes
• Anaphylactic reactions: possible in patients with or without known NSAID allergy
• Serious skin reactions: exfoliative dermatitis, Stevens-Johnson syndrome, toxic epidermal necrolysis
• Masking of inflammation and fever: may diminish signs of infection
• PPI-related: Clostridium difficile-associated diarrhea, bone fracture risk, hypomagnesemia, fundic gland polyps, vitamin B12 deficiency
• Use in elderly: greater risk for GI bleeding, cardiovascular and renal adverse events

Use during pregnancy or breastfeeding:

Naproxen is pregnancy category C in the first and second trimesters and category D in the third trimester (risk of premature closure of the ductus arteriosus). Esomeprazole is pregnancy category C; use only if the potential benefit justifies the risk. Both agents are excreted in breast milk; use with caution during breastfeeding or consider alternative therapies.