Microsoft word - pc esomeprazole 40mg.doc

PC - ESOMEPRAZOLE 40mg
Composition
Each enteric coated tablet contains: Esomeprazole 40mg
Description
Esomeprazole magnesium is bis(5-methoxy-2-[(S)-[(4-methoxy-3,5-dimethyl-2-pyridinyl)methyl] sulfinyl]-1H-benzimidazole-1-yl) magnesium
trihydrate, a compound that inhibits gastric acid secretion. Esomeprazole is the S-isomer of omeprazole, which is a mixture of the S- and R-
isomers. The stability of esomeprazole magnesium is a function of pH; it rapidly degrades in acidic media, but it has acceptable stability under
alkaline conditions.
Each 40mg film coated tablet contains 44.4 mg of esomeprazole magnesium, which is equivalent to 40mg of esomeprazole, and the following inactive ingredients: microcrystalline cellulose, maize starch, croscarmellose sodium, calcium stearate, talc, colloidal anhydrous silica, poly vinyl pyrrolidone K-30, sodium propyl hydroxyl benzoate, sodium methyl hydroxyl benzoate, iso propyl alcohol. The enteric coating consists of cellulose acetate phthalate, macrogol 6000, titanium dioxide, talc, ethyl cellulose, colour sunset yellow lake, iso propyl alcohol, and acetone. Pharmacological Action
Esomeprazole is a proton pump inhibitor that suppresses gastric acid secretion by specific inhibition of H+/K+-ATPase in the gastric parietal cell.
By acting specifically on the proton pump, esomeprazole blocks the final step in acid production, thus reducing gastric acidity. This effect is dose-
related up to a daily dose of 20 to 40 mg and leads to inhibition of gastric acid secretion.
Indications
Esomeprazole is used for the treatment of symptomatic gastroesophageal reflux disease (GERD), short-term treatment of erosive esophagitis,
and maintenance of erosive esophagitis healing. It is also approved for use with antibiotics for the treatment of Helicobacter pylori-associated
duodenal ulcers.
Contraindications
Hypersensitivity to any component of the formulation of esomeprazole, omeprazole, or to substituted benzimidazoles , and hepatic function
impairment.
Drug Interaction
Some medicines or medical conditions may interact with esomeprazole. When any drug is prescribed, the possibility of drug interactions should
always be considered. Tell your doctor or pharmacist of all the prescription and nonprescription drugs that you are taking, especially:
Digoxin, Diazepam, Ketoconazole, Itraconazole, Sucralfate, Iron supplements, Vitamins with iron, Cilostazol Warning
Pregnancy: The safety of esomeprazole in pregnancy has not been established. Esomeprazole should not be administered to pregnant women
unless the expected benefits outweigh the potential risks.
Lactation: It has not been investigated whether or not esomeprazole is excreted in human breast milk. No studies in lactating women have been
performed. Therefore, esomeprazole should not be given to nursing mothers unless its use is considered essential.
Children: The safety and effectiveness of esomeprazole in children have not yet been established.
Precautions
Symptomatic response to therapy with esomeprazole does not preclude the presence of gastric malignancy.
Atrophic gastritis has been noted occasionally in gastric corpus biopsies from patients treated long-term with omeprazole, of which esomeprazole is an enantiomer. Adverse Effects
The adverse events associated with esomeprazole therapy are generally similar to those seen with the placebo and omeprazole therapy. The
most common adverse events reported in the clinical trials were diarrhoea, abdominal pain, flatulence, gastritis, nausea, and headache.
Overdose
Symptoms of an esomeprazole overdose include confusion, headache, drowsiness, blurred vision, fast heartbeat, nausea, dry mouth, sweating,
flushing, shortness of breath, tremor, loss of coordination, or seizure (convulsions).
Dosage
For GERD, 20 or 40 mg of esomeprazole is given once daily for 4-8 weeks.
For the treatment of H. pylori, 40 mg is administered once daily in combination with amoxicillin and clarithromycin for 10 days. Esomeprazole should be administered one hour before meals, swallowed whole and should not be crushed or chewed. Storage
Store in a dry place, protected from light. Keep out of reach of children. Store in original packaging.
Presentation
PC - Esomeprazole 40mg is supplied as a yellow, round biconvex, enteric coated tablet of esomeprazole magnesium. Blister packages are
supplied as 3 x 10 tablets.
Willemstad, Curacao, Netherlands Antilles

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