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Esomeprazole

    Brands

    DEA Class; Rx, OTC

    Common Brand Names; Nexium, Nexium 24HR

    • Proton Pump Inhibitors

    Proton pump inhibitor; S-isomer of omeprazole
    Used for GERD, NSAID-induced ulcer healing and prevention, erosive esophagitis, H. pylori eradication, upper GI rebleeding prophylaxis after therapeutic endoscopy, and hypersecretory conditions; available OTC for short-term treatment of heartburn
    Avoid concomitant use with clopidogrel; consider using a PPI with less CYP2C19 inhibitory activity

     Indicated for

    • GERD Without Erosive Esophagitis
    • GERD With Erosive Esophagitis
    • Helicobacter Pylori Eradication
    • Risk Reduction of NSAID-Associated Gastric Ulcer
    • NSAID-Induced Gastric Ulcer
    • Zollinger-Ellison Syndrome
    • Gastric or Duodenal Ulcers Following Therapeutic Endoscopy
    • Frequent Heartburn

    Hypersensitivity to esomeprazole or other proton pump inhibitors (PPIs)

    Patients receiving rilpivirine- containing products

    • Headache (2-11%)
    • Flatulence (10%)
    • Indigestion (6%)
    • Nausea (6%)
    • Abdominal pain (1-6%)
    • Diarrhea (2-4%)
    • Xerostomia (3-4%)
    • Dizziness (2-3%)
    • Constipation (2-3%)
    • Somnolence (1-2%)
    • Pruritus (1%)
    • Blood and lymphatic system disorders: Agranulocytosis, pancytopenia
    • Blurred vision
    • GI disorders: Pancreatitis, stomatitis, microscopic colitis
    • Hepatobiliary disorders: Hepatic failure, hepatitis with or without jaundice
    • Anaphylactic reaction/shock
    • GI candidiasis
    • Hypomagnesemia
    • Musculoskeletal disorders: Muscular weakness, myalgia, bone fracture
    • Nervous system disorders: Hepatic encephalopathy, taste disturbance
    • Psychiatric disorders: Aggression, agitation, depression, hallucination
    • Interstitial nephritis
    • Gynecomastia
    • Bronchospasm
    • Skin and subcutaneous tissue disorders: Alopecia, erythema multiforme, hyperhidrosis, photosensitivity, Stevens-Johnson syndrome, toxic epidermal necrolysis (sometimes fatal fatal)

    Do not use if allergic to the drug; may cause severe skin reactions; symptoms may include, skin reddening, blisters, rash; if allergic reaction occurs, discontinue use and seek medical help immediately

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

    PPIs may decrease the efficacy of clopidogrel by reducing the formation of the active metabolite

    Severe hepatic impairment

    Cutaneous lupus erythematosus (CLE) and systemic lupus erythematosus (SLE) reported with PPIs; avoid using for longer than medically indicated; discontinue if signs or symptoms consistent with CLE or SLE are observed and refer patient to specialist; most patients improve with discontinuation of PPI alone in 4-12 weeks; serological testing (e.g. ANA) may be positive and elevated serological test results may take longer to resolve than clinical manifestations

    Severe cutaneous adverse reactions, including Stevens-Johnson syndrome (SJS) and toxic epidermal necrolysis (TEN), drug reaction with eosinophilia and systemic symptoms (DRESS), and acute generalized exanthematous pustulosis (AGEP) reported in association with use of PPIs; discontinue therapy at first signs or symptoms of severe cutaneous adverse reactions or other signs of hypersensitivity and consider further evaluation

    Relief of symptoms does not eliminate the possibility of a gastric malignancy; consider additional follow-up and diagnostic testing in adult patients who have suboptimal response or early symptomatic relapse after completing treatment with a PPI

    Therapy increases risk of Salmonella, Campylobacter, and other infections

    Contains enteric coated granules (acid labile); do not chew or crush; take 1 hr before meals

    Published observational studies suggest that PPI therapy may be associated with an increased risk for osteoporosis-related fractures of the hip, wrist, or spine; particularly with prolonged (>1 yr), high-dose therapy

    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

    There are no adequate and well-controlled studies in pregnant women; esomeprazole is the S-isomer of omeprazole; available epidemiologic data fail to demonstrate an increased risk of major congenital malformations or other adverse pregnancy outcomes with first trimester omeprazole use

    Esomeprazole is the S-isomer of omeprazole and limited data suggest that omeprazole may be present in human milk

    Adults

    20 mg/day PO for heartburn (OTC); 40 mg/day PO is FDA-approved maximum; however, up to 80 mg/day is used off-label for H. pylori eradication; 40 mg/day IV for GERD; 80 mg IV for 1 dose, then 8 mg/hour for upper GI rebleeding prophylaxis after therapeutic endoscopy; up to 240 mg/day PO for Zollinger-Ellison syndrome.

    Geriatric

    20 mg/day PO for heartburn (OTC); 40 mg/day PO is FDA-approved maximum; however, up to 80 mg/day is used off-label for H. pylori eradication; 40 mg/day IV for GERD; 80 mg IV for 1 dose, then 8 mg/hour for upper GI rebleeding prophylaxis after therapeutic endoscopy; up to 240 mg/day PO for Zollinger-Ellison syndrome.

    Adolescents

    weight 55 kg or more: 40 mg/day PO is FDA-approved maximum; however, up to 80 mg/day has been used off-label; 20 mg/day IV.
    weight less than 55 kg: 40 mg/day PO is FDA-approved maximum; however, up to 80 mg/day has been used off-label; 10 mg/day IV.

    Children

    12 years and weight 55 kg or more: 40 mg/day PO is FDA-approved maximum; however, up to 80 mg/day has been used off-label; 20 mg/day IV.
    12 years and weight less than 55 kg: 40 mg/day PO is FDA-approved maximum; however, up to 80 mg/day has been used off-label; 10 mg/day IV.
    1 to 11 years and weight 55 kg or more: 20 mg/day PO and 20 mg/day IV are FDA-approved; however, up to 3.3 mg/kg/day PO (Max: 80 mg/day PO) has been used off-label.
    1 to 11 years and weight 20 to 54 kg: 20 mg/day PO and 10 mg/day IV are FDA-approved; however, up to 3.3 mg/kg/day PO (Max: 80 mg/day PO) has been used off-label.
    1 to 11 years and weight less than 20 kg: 10 mg/day PO and 10 mg/day IV are FDA-approved; however, up to 3.3 mg/kg/day PO (Max: 40 mg/day) has been used off-label.

    Infants

    In general for infants, maximum doses are 1.33 mg/kg/day PO and 0.5 mg/kg/day IV.
    weight 7.6 to 12 kg: 10 mg/day PO; 0.5 mg/kg/day IV.
    weight 5.1 to 7.5 kg: 5 mg/day PO; 0.5 mg/kg/day IV.
    weight 3 to 5 kg: 2.5 mg/day PO; 0.5 mg/kg/day IV.

    Neonates

    Safety and efficacy have not been established; however, 0.5 mg/kg/day PO/IV has been used off-label.

    Esomeprazole

    capsule, delayed-release (as magnesium)

    • 20mg (Rx/OTC)
    • 40mg
    • 24.65mg (strontium salt)
    • 49.3mg (strontium salt)

    tablet delayed release (as magnesium)

    • 20 mg

    injection, powder for reconstitution

    • 20mg/vial
    • 40mg/vial

    packets for oral suspension

    • 10mg
    • 20mg
    • 40mg