Adult Dose
Intravenous
Gastro-oesophageal reflux disease
Adult: 20 or 40 mg by inj over at least 3 min or infusion over 10-30 min once daily for <10 days. Convert to oral therapy as soon as possible.
NSAID-associated ulceration
Adult: 20 mg/day by inj over at least 3 min or infusion over 10-30 min. Convert to oral therapy as soon as possible.
Gastric and duodenal ulcers
Adult: 80 mg infusion over 30 min followed by continuous infusion of 8 mg/hr over 72 hr, then convert to oral therapy given as 40 mg once daily for 4 wk.
Elderly: No dosage adjustment needed.
Hepatic impairment: Severe (Child-Pugh class C): <20 mg/day.
Child Dose
Short-term Treatment of GERD
IV
Short-term treatment of GERD with erosive esophagitis when oral therapy is not possible or appropriate
<1 month: Safety and efficacy not established
1 month to 1 year: 0.5 mg/kg IV qDay
>1 year (<55 kg): 10 mg IV qDay
>1 year (?55 kg): 20 mg IV qDay
Increased risk of digoxin-induced cardiotoxic effects. Increased risk of hypomagnesaemia w/ diuretics. May increase INR and prothrombin time w/ warfarin. May increase serum concentration of tacrolimus, saquinavir, methotrexate. May interfere the elimination of drugs metabolised by CYP2C19 (e.g. diazepam). May decrease the bioavailability of ketoconazole, erlotinib and Fe salts.
Potentially Fatal: May decrease serum concentration and pharmacological effects of rilpivirine, atazanavir and nelfinavir. May decrease the antiplatelet effects of clopidogrel.
Esomeprazole is contraindicated in patients with known hypersensitivity to any component of the formulation or to substituted Benzimidazoles.
>10%
Headache (2-11%)
1-10%
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%)
<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)
Paediatric; pregnancy, lactation. Malignancy and hepatic impairment. Increased risk of developing certain infections such as community-acquired pneumonia. For patients with severe liver impairment, a dose of 20 mg should not be exceeded.
Lactation: Unknown whether esomeprazole is distributed into breast milk; discontinue drug or do not nurse
Esomeprazole is a PPI that suppresses gastric acid secretion by inhibiting H+/K+ ATPase in the gastric parietal cell. It is the S-isomer of omeprazole.
Pregnancy
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; reproduction studies in rats and rabbits resulted in dose-dependent embryo-lethality at omeprazole doses that were approximately 3.4 to 34 times an oral human dose of 40 mg (based on a body surface area for a 60 kg person)
Lactation
Esomeprazole is the S-isomer of omeprazole and limited data suggest that omeprazole may be present in human milk; there are no clinical data on effects of esomeprazole on breastfed infant or on milk production; developmental and health benefits of breastfeeding should be considered along with mother’s clinical need for therapy and any potential adverse effects on breastfed infant from treatment or from underlying maternal condition
