Pack: Strip of 10 tablets.
COMPOSITION : Each Tablet contains :
Esomeprazole 40 mg
M.O.A: Esomeprazole belongs to class of medications called proton pump inhibitors. It blocks the activity of the proton pumps in the stomach wall that produce acid, thereby reducing the amount of acid produced in the stomach.
Esomeprazole is acid labile and is administered orally as gastro-resistant granules. In vivo conversion to the R-isomer is negligible. Absorption of esomeprazole is rapid, with peak plasma levels occurring approximately 1-2 hours after dose. The absolute bioavailability is 64% after a single dose of 40 mg and increases to 89% after repeated once-daily administration. For 20 mg esomeprazole the corresponding values are 50% and 68% respectively. Food intake both delays and decreases the absorption of esomeprazole although this has no significant influence on the effect of esomeprazole on intragastric acidity.
The apparent volume of distribution at steady state in healthy subjects is approximately 0.22 l/kg body weight. Esomeprazole is 97% plasma protein bound.
Esomeprazole is completely metabolised by the cytochrome P450 system (CYP). The major part of the metabolism of esomeprazole is dependent on the polymorphic CYP2C19, responsible for the formation of the hydroxy- and desmethyl metabolites of esomeprazole. The remaining part is dependent on another specific isoform, CYP3A4, responsible for the formation of esomeprazole sulphone, the main metabolite in plasma.
The parameters below reflect mainly the pharmacokinetics in individuals with a functional CYP2C19 enzyme, extensive metabolisers.
Total plasma clearance is about 17 l/h after a single dose and about 9 l/h after repeated administration.
The plasma elimination half-life is about 1.3 hours after repeated once-daily dosing. Esomeprazole is completely eliminated from plasma between doses with no tendency for accumulation during once-daily administration.
The major metabolites of esomeprazole have no effect on gastric acid secretion. Almost 80 % of an oral dose of esomeprazole is excreted as metabolites in the urine, the remainder in the faeces. Less than 1 % of the parent drug is found in urine.
INDICATION: Erosive oesophagitis.
DOSAGE: As directed by the physician
SIDE EFFECTS : Headache, Sinus inflammation, Nasal congestion, Abdominal cramping, Diarrhea, Dizziness, Increase in bowel movements, Dry mouth.
4SomprazSun Pharma Lab62/105EsomacCIPLA99.5/10
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