esomeprazole/naproxen (Rx)Brand and Other Names:Vimovo

 
 
 

Dosing & Uses

AdultPediatric

Dosage Forms & Strengths

esomeprazole/naproxen

tablet

  • 20mg/375mg
  • 20mg/500mg
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Rheumatoid Arthritis

1 tablet PO twice daily at least 30 min before meal

Osteoarthritis

1 tablet PO twice daily at least 30 min before meal

Ankylosing Spondylitis

1 tablet PO twice daily at least 30 min before meal

Renal Impairment

CrCl <30 mL/min: Use not recommended

Dose Modification

If a dose of omeprazole needs to be < 40 mg/day consider alternate treatment

Administration

Tablet consists of immediate-release esomeprazole layer and enteric-coated naproxen core; swallow whole, do not chew, crush, dissolve, or split

Safety and efficacy not established

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Interactions

Interaction Checker

esomeprazole/naproxen and

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     activity indicator 
    No Interactions Found
    Interactions Found

    Contraindicated

      Serious - Use Alternative

        Significant - Monitor Closely

          Minor

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            Adverse Effects

            >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%)

            <1%

            GERD

            Duodenal ulcer

            Erosive esophagitis

            Postmarketing reports

            Gait disturbance

            Abdominal distension

            Gastroesophageal reflux

            Hematochezia

            Contusion

            Fall

            Joint swelling

            Muscle spasms

            Renal tubular necrosis

            Naproxen

            • Body as a Whole: Angioneurotic edema, menstrual disorders
            • Cardiovascular: Congestive heart failure, vasculitis, pulmonary edema
            • Gastrointestinal: Inflammation, bleeding (sometimes fatal, particularly in the elderly), ulceration, and obstruction of the upper or lower gastrointestinal tract, esophagitis, stomatitis, hematemesis, colitis, exacerbation of inflammatory bowel disease (ulcerative colitis, Crohn’s disease)
            • Hepatobiliary: Hepatitis (some cases have been fatal)
            • Hemic and Lymphatic: Eosinophilia, hemolytic anemia, aplastic anemia
            • Metabolic and Nutritional: Hyperglycemia, hypoglycemia
            • Nervous System: Depression, dream abnormalities, insomnia, malaise, myalgia, muscle weakness, aseptic meningitis, cognitive dysfunction, convulsions
            • Respiratory: Eosinophilic pneumonitis
            • Dermatologic: Alopecia, urticaria, toxic epidermal necrolysis, erythema multiforme, erythema nodosum, fixed drug eruption, lichen planus, pustular reaction, systemic lupus erythematoses, bullous reactions, including Stevens-Johnson syndrome, photosensitive dermatitis, photosensitivity reactions, including rare cases resembling porphyria cutanea tarda (pseudoporphyria) or epidermolysis bullosa.
            • Special Senses: Hearing impairment, corneal opacity, papillitis, retrobulbar optic neuritis, papilledema
            • Urogenital: Glomerular nephritis, hematuria, hyperkalemia, interstitial nephritis, nephrotic syndrome, renal disease, renal failure, renal papillary necrosis, raised serum creatinine
            • Reproduction (female): Infertility

            Esomeprazole

            • Blood and Lymphatic: Agranulocytosis
            • Eye: Blurred vision
            • Gastrointestinal: Pancreatitis, microscopic colitis
            • Hepatobiliary: Hepatic failure, hepatitis with or without jaundice
            • Immune System: Anaphylactic reaction/shock
            • Infections and Infestations: GI candidiasis, Clostridium difficile associated diarrhea
            • Metabolism and Nutritional Disorders: Hypomagnesemia, with or without hypocalcemia and/or hypokalemia
            • Musculoskeletal and Connective Tissue: Muscular weakness, myalgia, bone fracture
            • Nervous System: Hepatic encephalopathy
            • Psychiatric: Aggression, agitation, hallucination
            • Renal and Urinary: Interstitial nephritis
            • Reproductive System and Breast: Gynecomastia
            • Respiratory, Thoracic, and Mediastinal: Bronchospasm
            • Skin and Subcutaneous Tissue: Alopecia, erythema multiforme, photosensitivity, Stevens-Johnson syndrome, toxic epidermal necrolysis (some fatal)
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            Warnings

            Black Box Warnings

            Cardiovascular Risk

            • NSAIDs may increase risk of serious cardiovascular thrombotic events, myocardial infarction (MI), and stroke, which can be fatal
            • Risk may increase with duration of use
            • Patients with risk factors for or existing cardiovascular disease may be at greater risk
            • NSAIDs are contraindicated for perioperative pain in the setting of coronary artery bypass graft (CABG) surgery (increased risk of MI and stroke)

            Gastrointestinal Risk

            • NSAIDs increase risk of serious GI adverse events including bleeding, ulceration, and perforation of the stomach or intestines, which can be fatal
            • GI adverse events may occur at any time during use and without warning symptoms
            • Elderly patients are at greater risk for serious GI events

            Contraindications

            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

            Cautions

            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

            Hypomagnesemia may occur with prolonged use (ie, >1 year); adverse effects may result and include tetany, arrhythmias, or seizures; in 25% of cases reviewed, magnesium supplementation alone did not improve low serum magnesium levels and the PPI had to be discontinued

            PPIs possibly associated with increased incidence of Clostridium difficile-associated diarrhea (CDAD); consider diagnosis of CDAD for patients taking PPIs with diarrhea that does not improve

            PPIs decreased gastric acidity increases serum chromogranin A (CgA) levels and may cause false-positive diagnostic results for neuroendocrine tumors; temporarily discontinue PPIs before assessing CgA levels

            Acute interstitial nephritis reported in patients taking PPIs; may occur at any point during PPI therapy and is generally attributed to idiopathic hypersensitivity reaction; discontinue VIMOVO if acute interstitial nephritis develops

            Daily treatment with any acid-suppressing medications over a long period of time (e.g., longer than 3 years) may lead to malabsorption of cyanocobalamin (vitamin B12) caused by hypo-or achlorhydria; rare reports of cyanocobalamin deficiency occurring with acid-suppressing therapy reported

            Patients with advanced renal disease should be adequately hydrated

            If skin fragility, blistering or other symptoms suggestive of pseudoporphyria occur, discontinue treatment and monitor patient

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            Pregnancy & Lactation

            Pregnancy Category: C <30 wk gestation; D ≥30 wk gestation

            Lactation: Naproxen is distributed in breast milk, not recommended

            Pregnancy Categories

            A:Generally acceptable. Controlled studies in pregnant women show no evidence of fetal risk.

            B:May be acceptable. Either animal studies show no risk but human studies not available or animal studies showed minor risks and human studies done and showed no risk.

            C:Use with caution if benefits outweigh risks. Animal studies show risk and human studies not available or neither animal nor human studies done.

            D:Use in LIFE-THREATENING emergencies when no safer drug available. Positive evidence of human fetal risk.

            X:Do not use in pregnancy. Risks involved outweigh potential benefits. Safer alternatives exist.

            NA:Information not available.

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            Pharmacology

            Mechanism of Action

            Naproxen: NSAID that inhibits inflammatory reactions and pain by decreasing activity of cyclo-oxygenase, which is responsible for prostaglandin synthesis; has antipyretic and analgesic effects

            Esomeprazole: S-isomer of omeprazole, a proton pump inhibitor; inhibits gastric acid secretion by inhibiting H+/K+-ATPase enzyme system at secretory surface of gastric parietal cells

            Naproxen

            Half-Life: 13-15 hr

            Bioavailability: 95%

            Duration: 4-7 hr

            Onset: 1 hr

            Distribution: 0.16 L/kg

            Peak Serum Time: 1.5-3 hr; high fat meal prolongs Tmax by 10 hr

            Peak Plasma Concentration: 62-96 mcg/mL Vd: 0.16 L/kg

            Protein Bound: >99% albumin

            Metabolism: hepatic via CYP2C9, CYP1A2; also undergoes hepatic conjugation

            Clearance: 0.13 L/min/kg

            Excretion: feces < 3%, urine 95%

            Esomeprazole

            Half-Life: 1.2-1.5 hr

            Bioavailability: 90%, food decreases AUC by 33-53%

            Duration: 17 hr gastric acid inhibition at steady state

            Onset: 1-2 hr

            Peak Plasma Time: 1-1.6 hr

            Vd: 16 L

            Protein Bound: 97%

            Clearance: 9-16 L/hr

            Excretion: Feces 20%, urine 80%

            Metabolism

            • Extensively by hepatic P450 enzyme: major metabolic pathway is via CYP2C19, the rest is via CYP3A4
            • Slow metabolizers (3% of Caucasians and African-Americans) are deficient in CPY2C19 enzyme system, plasma concentration can be higher than those with the enzyme present
            • CYP2C19 inhibitor
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            Formulary

            FormularyPatient Discounts

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            The above information is provided for general informational and educational purposes only. Individual plans may vary and formulary information changes. Contact the applicable plan provider for the most current information.

            Tier Description
            1 This drug is available at the lowest co-pay. Most commonly, these are generic drugs.
            2 This drug is available at a middle level co-pay. Most commonly, these are "preferred" (on formulary) brand drugs.
            3 This drug is available at a higher level co-pay. Most commonly, these are "non-preferred" brand drugs.
            4 This drug is available at a higher level co-pay. Most commonly, these are "non-preferred" brand drugs or specialty prescription products.
            5 This drug is available at a higher level co-pay. Most commonly, these are "non-preferred" brand drugs or specialty prescription products.
            6 This drug is available at a higher level co-pay. Most commonly, these are "non-preferred" brand drugs or specialty prescription products.
            NC NOT COVERED – Drugs that are not covered by the plan.
            Code Definition
            PA Prior Authorization
            Drugs that require prior authorization. This restriction requires that specific clinical criteria be met prior to the approval of the prescription.
            QL Quantity Limits
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            ST Step Therapy
            Drugs that have step therapy associated with each prescription. This restriction typically requires that certain criteria be met prior to approval for the prescription.
            OR Other Restrictions
            Drugs that have restrictions other than prior authorization, quantity limits, and step therapy associated with each prescription.
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