Esolok 20 Capsule (Delayed Release)
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Indication
Esomeprazole is indicated:
- Treatment of Gastroesophageal Reflux Disease (GERD)
- Healing of Erosive Esophagitis
- Maintenance of Healing of Erosive Esophagitis
- Symptomatic Gastroesophageal Reflux Disease
- H. pylori Eradication to Reduce the Risk of Duodenal Ulcer Recurrence
- Zollinger-Ellison Syndrome
- Acid Related Dyspepsia
- Duodenal and Gastric Ulcer
Pharmacology
Esomeprazole exerts its stomach acid-suppressing effects by preventing the final step in gastric acid production by covalently binding to sulfhydryl groups of cysteines found on the H+/K+-ATPase enzyme at the secretory surface of gastric parietal cells. This effect leads to inhibition of both basal and stimulated gastric acid secretion, irrespective of the stimulus. As the binding of esomeprazole to the H+/K+-ATPase enzyme is irreversible and new enzyme needs to be expressed in order to resume acid secretion, esomeprazole's duration of antisecretory effect that persists longer than 24 hours
Dosage
Healing of Erosive Esophagitis: 20 mg or 40 mg Once Daily for 4-8 Weeks. The majority of patients are healed within 4 to 8 weeks. For patients who don't heal after 4-8 weeks, an additional 4-8 weeks of treatment may be considered. Maintenance of Healing of Erosive
Esophagitis: 20 mg Once Daily (Clinical studies did not extend 6 months).
Symptomatic GERD: 20 mg Once Daily for 4 Weeks. If symptoms do not resolve completely after 4 weeks, an additional 4 weeks of treatment may be considered.
Helicobacter Pylori eradication: Triple Therapy to reduce the risk of Duodenal Ulcer recurrence-Esomeprazole 40 mg Once Daily for 10 days, Amoxicillin 1000 mg Twice Daily for 10 days, Clarithromycin 500 mg Twice Daily for 10 days.
Zollinger-Ellison Syndrome: The dose is 20-80 mg once daily. The dosage should be adjusted individually and treatment continued as long as clinically indicated.
Acid-related Dyspepsia: 20-40 mg once daily for 2-4 weeks according to the response.
Duodenal ulcer: 20 mg once daily for 2-4 weeks. Gastric ulcer: 20-40 mg once daily for 4-8 weeks.
Injection: The recommended adult dose is 40 mg Esomeprazole given once daily by intravenous injection (not less than 3 minutes) or intravenous infusion (10 to 30 minutes). Esomeprazole IV injection should not be administered concomitantly with any other medications through the same intravenous site. Treatment with Esomeprazole IV injection should be discontinued as soon as the patient is able to resume treatment with Esomeprazole delayed-release capsules. Safety and effectiveness in paediatric patients have not been established.
Administration
Direction for use of Delayed-Release Oral Suspension: Whole contents of the packet should be taken into a small glass containing 15 ml. of water. The mixer should be stirred well and leave 2 to 3 minutes to thicken. Stir again and drink within 30 minutes. If any medicine remains after drinking, add more water, stir, and drink immediately. If the suspension is to be administered through a nasogastric or gastric tube, the volume of water in the syringe should be 15 ml. & immediately shake the syringe and leave 2 to 3 minutes to thicken. Shake the syringe and inject it through the nasogastric or gastric tube into the stomach within 30 minutes. An appropriately sized syringe should be used. Shake and flush any remaining contents from the nasogastric or gastric tube into the stomach.
Esomeprazole IV Injection: Esomeprazole IV should be given as a slow intravenous injection. The solution for IV injection is obtained by adding to the vial 5 ml of the solvent (WFI) provided. After reconstitution, the injection should be given slowly over a period of at least 3 minutes. The solution should be used within 12 hours of reconstitution when stored at room temperature up to 30°C. No refrigeration is required. The reconstituted solution should not be used if it contains visible particulate.
injection (no less than 3 minutes) or intravenous infusion (10 to 30 minutes).?ÿ
Interaction
Esomeprazole appears to be a selective inhibitor of the cytochrome P450 mono-oxygenase system, there may be an effect on hepatic clearance, but there have been no reports to date of clinically relevant interactions. There is some uncertainty over the effect of Esomeprazole on the oral combined contraceptive pill. Physiological changes similar to those found with omeprazole are likely to take place because of the reduction in gastric acid which is likely to influence the bacterial colonization of the stomach and duodenum and also vitamin B12 absorption.
Contradiction
Esomeprazole is contraindicated in those patients who have known hypersensitivity to any other components of the formulation.
Side Effect
Side effects reported with Esomeprazole include headache, diarrhea and abdominal pain.
Pregnancy
US FDA pregnancy category of Esomeprazole is C. So, Esomeprazole should be avoided in pregnancy and lactation unless the potential benefits to the other outweigh the possible risks to the fetus.
Precaution
Exclude the possibility of malignancy when gastric ulcer is suspected and before treatment for dyspepsia. When using in combination with antibiotic, refer to the prescribing information of the respective antibiotics.
Overdose
Storage
Keep in dry place and away from light and heat. Keep out of the reach of children.
| Size/Weight | 20 mg |
|---|---|
| Generic Name | Esomeprazole Magnesium Trihydrate |
| Formation | Capsule |
| Manufactured By | Ibn-Sina Pharmaceuticals Ltd. |
| Country of Manufacture | Bangladesh |
| Prescription Required | No |
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