Composition:Each enteric coated tablet contains:
Esomeprazole magnesium trihydrate equivalent to Esomeprazole. . . . . . . . . . . . .40 mg
Alu-Alu blister containing 10 tablets, 3 blisters in a box.
Adults: Esoragim 40 is used for the treatment of:
Gastric and duodenal ulcers.
Severe gastroesophageal reflux disease (erosive esophagitis, ulcers or narrowing (stricture) of the esophagus determined by endoscopy).
Prevention of gastric and duodenal ulcers associated with NSAID therapy.
In combination with appropriate antibacterial therapeutic regimens for the eradication of Helicobacter pylori
Pathological hypersecretory conditions including Zollinger-Ellison Syndrome
Children from 12 years of age and over:
This medicine is indicated for the treatment of gastroesophageal reflux disease with esophagitis.
|Dosage and administration||
Hypersensitivity to esomeprazole, other proton pump inhibitors or any excipient of this medicine.
|Warnings and precautions for use||
Before starting esomeprazole therapy, the doctor must rule out the possibility of gastric cancer because the medicine can mask the symptoms, and so delay the diagnosis of cancer.
|Recommendation for pregnancy and breastfeeding||
|Effects on ability to drive and use machines||
There is no evidence to prove esomeprazole has influence on the ability to drive or use machines. However, it should be noted that the medicine can cause headache, dizziness, drowsiness, visual disturbances.
|Interactions, incompatibilities of medicine||
Effects of esomeprazole on the pharmacokinetics of other medicinal products: Protease inhibitors: Omeprazole has been reported to interact with some protease inhibitors. The clinical importance and the mechanisms behind these reported interactions are not always known. Increased gastric pH during omeprazole treatment may change the absorption of the protease inhibitors. Other possible interaction mechanisms are via inhibition of CYP 2C19.
|Undesirable effects (ADRs)||
In general, esomeprazole is well tolerated when used for both short and long time.
|Overdose and management||
– Overdose: There have been no report on the overdose of esomeprazole in human.
Esomeprazole is the S-isomer of omeprazole, and similar to omeprazole it is used in the treatment of gastric and duodenal ulcers, gastroesophageal reflux disease and Zollinger – Ellison syndrome.
After oral administration esomeprazole is rapidly absorbed, with peak plasma levels occurring approximately 1-2 hours after dosing. The bioavailability of esomeprazole increases proportionally when the dose is increased and used repeatedly, 68% with dose of 20mg and 89% with dose of 40mg. Absorption of esomeprazole is decreased and delayed if taken with food. After administration of a single 40mg dose of esomeprazole with meal the AUC is decreased by 33% to 53% compared to fasting conditions. Therefore, esomeprazole should be taken at least one hour before meals. Esomeprazole is bound to plasma proteins by about 97%. The apparent volume of distribution at steady state in healthy volunteers is approximately 16 liters.
|Storage conditions, shelf-life, quality specification of the medicine||
Storage conditions: Protect from humidity and light, below 30 degrees C.