Atrophic gastritis has been noted occasionally in gastric
corpus biopsies from patients treated long-term withomeprazole, of which esomeprazole is an enantiomer.
Patients undergoing on-demand treatment should beinstructed to contact their physician if their symptomschange in charachter.
When prescribing esomeprazole for on-demand therapy,
the implications for interactions with otherpharmaceuticals, due to fluctuating plasma
concentrations of esomeprazole should be considered.
Zoom capsules are an enteric-coated pellet formulation of
When prescribing esomeprazole for eradication of
esomeprazole magnesium due to its acid labile nature.
helicobacter pylori infection possible drug interactions
Esomeprazole is the S-isomer of omeprazole, which inhibits
for other components in the triple therapy should be
gastric acid secretion more effectively than Omeprazole.
Chemically it is bis(5-methoxy-2-[(S)-[4-methoxy-3, 5-
Patients with rare hereditary problems of fructose
intolerance, glucose-galactose malabsorption or sucrase-
isomaltase insufficiency should not take this medicine.
Safety and effectiveness in pediatric patients have not
Esomeprazole works by binding irreversibly to the H+/K+
ATPase in the proton pump. Because the proton pump isthe final pathway for secretion of hydrochloric acid by the
parietal cells in the stomach, its inhibition dramatically
There are no adequate and well-controlled studies in
decreases the secretion of hydrochloric acid into the
pregnant women. Esomeprazole should be used during
Because esomeprazole is likely to be excreted in human
After oral administration peak plasma levels (Cmax) occur
milk, a decision should be made whether to discontinue
at approximately 1.5 hours (Tmax). The Cmax increases
nursing or to discontinue the drug, taking into account
proportionally when the dose is increased, and there is a
importance of the drug to the mother due to the potential
three-fold increase in the area under the plasma
for serious adverse reactions in nursing infants from
concentration-time curve (AUC) from 20 to 40mg.
At repeated once-daily dosing with 40mg, the systemicbioavailability is approximately 90% compared to 64% after
Protect from sunlight & moisture.
The expiration date refers to the product correctly stored
The AUC after administration of a single 40mg dose of
esomeprazole is decreased by 43-53% after food intakecompared to fasting conditions. Esomeprazole should be
taken at least one hour before meal. Food delays anddecreases the absorption of esomeprazole, but this does
not significantly change its effect on the intragastric acidity.
* Zoom (Esomeprazole) 20mg capsule is available in
Distribution:Esomeprazole is 97% bound to plasma proteins. Plasma
* Zoom (Esomeprazole) 40mg capsule is available in
protein binding is constant over the concentration range
of 2-20µmol/L. The apparent volume of distribution at steadystate in healthy volunteers is approximately 16L.
Metabolism:Esomeprazole is extensively metabolized in the liver bythe cytochrome P450 (CYP) enzyme system. The
Manufactured by: Opal Laboratories (Pvt.) Ltd.
metabolites of esomeprazole lack antisecretory activity.
The major part of esomeprazole’s metabolism is dependentupon the CYP2C19 isoenzyme, which forms the hydroxy
and desmethyl metabolites. The remaining part is dependenton CYP3A4 which forms the sulphone metabolite.
Total plasma clearance is about 17L/h after a single dose
and about 9L/h after repeated administration. The plasmaelimination half-life of esomeprazole is approximately 1-1.5 hours. Less than 1% of the parent drug is excreted inthe urine. Approximately 80% of an oral dose ofesomeprazole is excreted as inactive metabolites in theurine, and the remainder is found as inactive metabolitesin the feces.
SPECIAL POPULATIONS:Geriatric:The AUC and Cmax values were slightly higher (25% and18%, respectively) in the elderly as compared to youngersubjects at steady state. Dose adjustment based on ageis not necessary.
The pharmacokinetics of esomeprazole have not been
The following adverse drug reactions have been reported
studied in patients <18 years of age.
during therapy of esomeprazole. None found to be dose-related.
Gender:The AUC and Cmax values were slightly higher (13%) in
Common: Headache, abdominal pain, diarrhoea, flatulence,
females than in males at steady state. Dose adjustment
Uncommon: Dermatitis, pruritus, urticaria, dizziness, dry
In patients with mild and moderate hepatic insufficiency,the AUCs were within the range that could be expected in
Rare: Hypersensitivity reactions e.g. angioedema,
patients with normal liver function. In patients with severe
hepatic insufficiency the AUCs were 2 to 3 times higherthan in the patients with normal liver function. No dose
The following adverse drug reactions have been observed
adjustment is recommended for patients with mild to
for the racemate omeprazole and may occur with
moderate hepatic insufficiency (Child Pugh Classes A and
B). However, in patients with severe hepatic insufficiency(Child Pugh Class C) a dose of 20mg once daily should
Central and peripheral nervous system: Paraesthesia,
somnolence, insomnia, vertigo, reversible mental confusion,agitation, aggression, depression and hallucinations,
predominantly in severely ill patients.
The pharmacokinetics of esomeparazole in patients withrenal impairment are not expected to be altered relative to
healthy volunteers, as less than 1% of esomeprazole isexcreted unchanged in urine.
Gastrointestinal: Stomatitis and gastrointestinal candidiasis.
Haematological: Leukopenia, thrombocytopenia,
1. Gastroesophageal Reflux Disease (GERD):
Hepatic: Increased liver enzymes, encephalopathy in
patients with pre-existing severe liver disease; hepatitis
Long term management of patients with healed
with or without jaundice, hepatic failure.
Symptomatic treatment of gastroesophageal reflux
Skin: Rash, photosensitivity, erythema multiforme, Stevens-
Johnson syndrome, toxic epidermal necrolysis (TEN),
2. As a triple therapy (Esomeprazole plus amoxicillinand clarithromycin) for the eradication of helicobacter
Other: Malaise, hypersensitivity reactions e.g. fever,
bronchospasm, Interstitial nephritis, increased sweating,
Healing of duodenal ulcer associated with helicobacter
peripheral edema, blurred vision, taste disturbance and
Prevention of relapse of peptic ulcers in patients withhelicobacter pylori associated ulcers.
Note: In patients who failed the therapy, susceptibility testing
Zoom (Esomeprazole) is contraindicated in patients with
should be done. If resistance to clarithromycin is
known hypersensitivity to drug or any component of the
demonstrated or susceptibility testing is not possible,
formulation or to substituted benzimidazoles.
alternative antimicrobial therapy should be instituted.
In common with the use of other inhibitors of acid
The recommended adult dosages are outlined in the table
secretion or antacids, the absorption of ketoconazole and
itraconazole can decrease during treatment with
Zoom (Esomeprazole) capsules should be swallowed whole
esomeprazole due to decreased intragastric acidity during
and taken at least one hour before meal.
esomeprazole metabolising enzyme. Thus, when
esomeprazole is combined with drugs metabolised by
CYP2C19, such as diazepam, citalopram, imipramine,clomipramine, phenytoin etc., the plasma concentrations
of these drugs may be increased and a dose reduction
In the presence of any alarming symptoms (e.g.significantunintentional weight loss, recurrent vomiting, dysphagia,
haematemesis or melaena) and when gastric ulcer is
suspected or present, malignancy should be excluded,
as treatment with esomeprazole may alleviate symptoms
and delay diagnosis. Patients on long-term treatment
(particularly those treated for more than a year) should
be kept under regular surveillance since the symptomatic
response to therapy with esomeprazole does not
Volume 3, Issue 1 (January 2013) ISSN: 2249-7382 EVALUATION OF VARIOUS TECHNIQUES USED BY THE PUBLIC SECTOR BANKS FOR THE MANAGEMENT OF NON PERFORMING ASSETS ( NPAs) ABSTRACT The banks and financial institutions in India have made significant contributions to almost all the sectors of the Indian economy such as agriculture, industries of all categories and sizes, tra
MOAA: Military Officers Association of AmericaMOAA Legislative Up. http://www.moaa.org/lac/lac_issues/lac_issues_update/lac_issues_updat. MOAA Legislative Update: Roth TSP/SBP Allowance Bill Passes April 03, 2009 USPHS/NOAA Corps to Get Post-9/11 GI Bill In a much-welcome surprise, the VA announcedthis week that USPHS and NOAA Commissioned Corps officers will be entitled to educational