InnoGen Pharmaceuticals


InnoGen Pharmaceuticals
Full Prescribing Info
Esomeprazole magnesium trihydrate.
Each enteric-coated tablet contains: Esomeprazole (as magnesium trihydrate) equivalent to Esomeprazole 20 mg and 40 mg.
Esomeprazole is the S-isomer of omeprazole. It is a proton pump inhibitor which reduced gastric acid secretion through inhibition of H1AC1 ATPase in gastric parietal cells. By inhibiting the functioning of this enzyme, the drug prevents formation of gastric acid.
Pharmacology: Pharmacokinetics: Esomeprazole is rapidly absorbed following oral administration, with peak plasma levels occurring after approximately 1 to 2 hours. It is acid labile and an enteric-coated formulation has been developed. Bioavailability of esomeprazole increases with both dose and repeated administration to about 68% to 69% for doses of 20 and 40mg respectively. Food delays and decreases the absorption of esomeperazole, but this does not significantly change its effect on intragastric acidity. Esomeprazole is about 97% bound to plasma proteins. It is extensively metabolized in the liver by the cytochrome P450 isoenzyme CYP2C19 to hydroxyl and desmethyl metabolites, which have no effect on gastric acid secretion. The remainder is metabolized by the cytochrome P450 isoenzyme CYP34A to esomeprazole sulfone. With repeated administration, there is a decrease in first pass metabolism and systemic clearance, probably caused by an inhibition of the CYP2C19 isoenzyme. However, there is no accumulation during once daily use. The plasma elimination half-life is about 1.3 hours. Almost 80% of an oral dose is eliminated as metabolites in the urine, the remainder in the faeces.
It is used in the treatment of peptic ulcer disease (PUD), gastroesophageal reflux disease (GERD), Zollinger-Ellison syndrome and in combination with antibiotics for H. pylori eradication.
Dosage/Direction for Use
The usual dose for the treatment of peptic ulcer disease (GERD) is 20 mg to 40 mg once daily.
The usual dose for the treatment of gastroesophageal reflex disease (GERD) is 20 mg to 40 mg once daily.
The recommended initial dose for the treatment of Zollinger-Ellison syndrome is 40 mg twice daily, then adjusted as needed.
The usual dose for the eradication of H.pylori in combination with antibiotics is 40 mg once daily.
Dosage should be taken at least one hour before meals or as prescribed by the physician.
Esomeprazole is contraindicated with known hypersensitivity to drug.
Special Precautions
Before giving esomeprazole to patients with gastric ulcers the possibility of malignancy should be considered since these drugs may mask symptoms and delay diagnosis. It should be used with caution in hepatic impairment.
Adverse Reactions
Adverse effects is reported most frequently with esomeprazole have been headache, diarrhea, and skin rashes; they have sometimes been severe enough to require discontinuation of treatment. Other side effects include pruritus, dizziness, fatigue, constipation, nausea and vomiting, flatulence, abdominal pain, arthralgia and myalgia, urticartia and dry mouth, isolated cases of photosensitivity, bullous eruption, erythema multiforme, angioedema and anaphylaxis have been reported. Effects on the CNS include occasional insomnia, somnolence and vertigo; reversible confusional strains, agitation, depression and hallucinations have been occurred in severely ill patients. Raised liver enzymes and isolated cases of hepatitis, jaundice and hepatic encephalopathy have been reported. Other adverse effects reported rarely or in isolated cases include paraesthesia, blurred vision, alopacts, stomatitis, taste disturbance peripheral edema, hyponatremia, blood disorders (including agranulocytosis, leucopenia and thrombocytopenia) and interstitial nephritis.
Store at temperatures not exceeding 30°C.
ATC Classification
A02BC05 - esomeprazole ; Belongs to the class of proton pump inhibitors. Used in the treatment of peptic ulcer and gastro-oesophageal reflux disease (GERD).
EC tab 20 mg x 14's. 40 mg x 14's.
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