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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 dimethyl-2-pyridinyl)methyl]sulfinyl]-1H-benzimidazole-1- 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

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