Description
Indications of Epizol 40
- Esomeprazole is prescribed to treat chronic heartburn and other GERD symptoms.
- In order to treat erosive esophagitis,
- For the maintenance of erosive esophagitis healing
- In patients with duodenal ulcer illness, in conjunction with amoxicillin and clarithromycin, for the elimination of Helicobacter pylori infection.
- Syndrome of Zollinger-Ellison
- Duodenal and gastric ulcers due to acid dyspepsia
Pharmaceutical Name of Epizol 40
Pharmacology
Esomeprazole is a proton pump inhibitor that inhibits the H+/K+-ATPase in the gastric parietal cell, suppressing gastric acid output. The first single optical isomer of a proton pump inhibitor, esomeprazole (S-isomer of omeprazole), provides superior acid control than racemic proton pump inhibitors.
Nexum 20 capsules contain an enteric-coated pellet version of esomeprazole magnesium for improved absorption. Peak plasma levels (Cmax) occur roughly 1.5 hours after oral dosing (Tmax). When the dose is increased, the Cmax increases correspondingly, and the area under the plasma concentration-time curve (AUC) increases thrice from 20 to 40 mg. The systemic bioavailability with repeated once-daily doses is around 90%, compared to 64% after a single dose.
Nexum 20 binds to plasma proteins 97 percent of the time. Over a concentration range of 2 20 mmol/L, plasma protein binding remains constant. In healthy volunteers, the apparent volume of distribution at steady state is around 16 L.
Esomeprazole is extensively processed by the cytochrome P450 (CYP) enzyme system in the liver. Esomeprazole’s metabolites have no anti-secretory properties. The CYP2C19 isoenzyme, which creates the hydroxy and desmethyl metabolites, is responsible for the majority of esomeprazole metabolism. The sulphone metabolite is formed by CYP3A4, which is responsible for the remaining proportion.
Nexum 20 has a plasma elimination half-life of approximately 1–1.5 hours. In the urine, less than 1% of the parent medication is eliminated. Approximately 80% of an oral dose of esomeprazole is eliminated in the urine as inactive metabolites, with the remainder detected in the feces as inactive metabolites.
Antimicrobial Combination Therapy: Esomeprazole magnesium 40 mg once day is administered for 7 days in combination with clarithromycin 500 mg twice daily and amoxicillin 1000 mg twice daily. When compared to treatment with Esomeprazole alone, the mean steady-state AUC and Cmax of Esomeprazole increased by 70% and 18%, respectively, during triple combination therapy. During triple combination therapy and single-drug administration, the pharmacokinetic characteristics for clarithromycin and amoxicillin are similar.
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
Esomeprazole tablet or capsule: should be swallowed whole and taken one hour before a meal.
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.
Interaction of Epizol 40
CYP2C19 and CYP3A4 substantially metabolize esomeprazole in the liver. Esomeprazole does not appear to inhibit CYPs 1A2, 2A6, 2C9, 2D6, 2E1, or 3A4 in vitro or in vivo investigations. There should be no clinically significant interactions with medicines processed by these CYP enzymes. Esomeprazole has no clinically significant interactions with phenytoin, warfarin, quinidine, clarithromycin, or amoxicillin, according to drug interaction studies.
The principal Esomeprazole metabolizing enzyme, CYP2C19, may be harmed by Esomeprazole. When Esomeprazole 30 mg and diazepam, a CYP2C19 substrate, were given together, diazepam clearance was reduced by 45 percent. Increased diazepam plasma levels have been seen up to 12 hours following dosage. Gastric acid secretion is inhibited by esomeprazole. As a result, Esomeprazole may interfere with the absorption of medications whose bioavailability is influenced by gastrointestinal pH. (e.g., ketoconazole, iron salts and digoxin).
Contraindications
In patients who have a history of hypersensitivity to any of the formulations, esomeprazole is not recommended.
Side Effect of Epizol 40
Headache, diarrhoea, nausea, flatulence, abdominal pain, constipation, and dry mouth are the most common side effects reported with Nexum 20. When compared to short-term treatment, there is no difference in the categories of linked adverse events noticed with maintenance treatment up to 12 months.
Pregnancy & Lactation
In pregnant women, there are no sufficient and well-controlled trials. No teratogenic effects have been found in animal investigations. Nexum 20 excretion in milk has not been studied. If the use of esomeprazole is thought necessary, breastfeeding should be terminated.
Precautions & Warnings
General: A symptomatic response to Nexum 20 medication does not rule out the possibility of gastric cancer.
Esomeprazole pills should be taken at least one hour before meals, according to the manufacturer’s instructions. One tablespoon of applesauce can be put to an empty bowl for patients who have trouble swallowing capsules, and the Esomeprazole capsules can be opened and the pellets carefully spilled into the applesauce. The pellets should be combined with applesauce and quickly eaten.
Therapeutic Class
Proton Pump Inhibitor
Storage Conditions
Store in a dry location at a temperature of not more than 30°C. Light and dampness should be avoided. Keep out of children’s reach.
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