Esomeprazole Magnesium Trihydrate
Incepta Pharmaceuticals Ltd.
Indications of Esonix 20 mg
Esonix 20 mg is indicated: To alleviate GERD-related symptoms such as persistent heartburn and others. In order to treat erosive esophagitis. To maintain the erosive esophagitis's ability to recover. for the eradication of Helicobacter pylori infection in individuals with duodenal ulcer disease when used in conjunction with amoxicillin and clarithromycin. Syndrome of Zollinger-Ellison. Duodenal & gastric ulcers caused by acid dyspepsia
Dosage of Esonix 20 mg
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 ErosiveEsophagitis: 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 Esonix 20 mg 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 of Esonix 20 mg
One hour before a meal, take one Esonix 20 mg pill or capsule and consumed it whole. Delayed-Release Oral Suspension use guidelines: The entire packet's contents should be placed in a little glass with 15 ml of water. After thoroughly stirring the mixer, give it two to three minutes to thicken. Within 30 minutes, stir once more and consume. Add extra water, swirl, and drink right away if any medicine is still present after consumption. If the suspension is to be taken via a nasogastric or gastric tube, 15 ml of water should be placed in the syringe. After shaking the syringe, wait two to three minutes for the suspension to thicken. Within 30 minutes, shake the syringe and administer a gastric or nasogastric injection into the stomach. Use a syringe that is the right size. Shake and ingest any leftover substances from the gastric or nasogastric tube. A gradual intravenous injection of esomeprazole IV is the recommended method of administration. 5 ml of the specified solvent (WFI) is added to the vial to create the IV injection solution. Upon reconstitution, the injection should be administered gradually over a minimum of three minutes. When kept at room temperature up to 30°C, the solution must be used within 12 hours of reconstitution. Nothing needs to be refrigerated. If there are any visible particles in the reconstituted solution, do not use them.
Interaction of Esonix 20 mg
CYP2C19 and CYP3A4 substantially metabolize esomeprazole in the liver. Studies conducted both in vivo and in vitro have demonstrated that esomeprazole is unlikely to inhibit the CYPs 1A2, 2A6, 2C9, 2D6, 2E1, and 3A4. There shouldn't be any clinically significant interactions with medications that these CYP enzymes process. According to studies on drug interactions, esomeprazole does not interact clinically with phenytoin, warfarin, quinidine, clarithromycin, or amoxicillin. The main enzyme that metabolizes esomeprazole, CYP2C19, may be affected by esomeprazole. Diazepam's clearance was reduced by 45% when Esomeprazole 30 mg and diazepam, a CYP2C19 substrate, were taken together. Diazepam plasma levels have been seen to rise 12 hours after dosage and beyond. Esomeprazole reduces the production of stomach acid. As a result, esomeprazole may hinder the absorption of medications whose bioavailability is significantly influenced by gastrointestinal pH. (e.g., ketoconazole, iron salts and digoxin). The pharmacokinetic profile of esomeprazole does not appear to be altered by the co-administration of oral contraceptives, diazepam, phenytoin, or quinidine. Esomeprazole and 14-hydroxy clarithromycin plasma levels have increased as a result of co-administration with clarithromycin, amoxicillin, and other medications.
Those with known hypersensitivity to any of the formulations should not take esomeprazole.
Side Effects of Esonix 20 mg
The side effects of Esonix 20 mg that are most frequently mentioned are headache, diarrhea, nausea, flatulence, abdominal pain, constipation, and dry mouth. When compared to short-term treatment, relevant side events occurring after maintenance therapy up to 12 months do not differ in type.
Precautions & Warnings
General: A positive symptom response to Esonix 20 mg does not rule out the possibility of stomach cancer. Patients should take esomeprazole capsules at least an hour before meals, according to the information. One spoonful of applesauce can be put into an empty bowl, the Esonix 20 mg capsules can be opened, and the pellets inside the capsule can be carefully dumped onto the applesauce for patients who have trouble swallowing capsules. After combining the pellets and applesauce, immediately ingest the mixture. Use only cold applesauce that is soft enough to be taken without chewing. You shouldn't chew or shatter the pellets. It is not advised to keep the pellet/applesauce mixture for later usage. While taking esomeprazole, antacids are acceptable.
Overdose Effects of Esonix 20 mg
Esonix 20 mg has been shown to be deadly in rats at a single oral dose of 510 mg/kg, or nearly 103 times the human dose on the basis of body surface area. The main symptoms of acute poisoning are decreased motor activity, changes in breathing frequency, tremors, ataxia, and sporadic clonic convulsions. Esomeprazole overdoses are not known to have occurred. Esomeprazole has no known particular countermeasure. Dialysis isn't expected to remove esomeprazole because of how widely it is protein bound. If an overdose occurs, symptomatic and supportive care should be provided. The possibility of ingesting numerous drugs needs to be taken into account, just like with any overdose.
Keep in a dry area at a temperature that does not go above 30°C. shield from moisture and light. Keep out of children's reach.
Mode Of Action
By specifically inhibiting the H+/K+-ATPase in the gastric parietal cell, the proton pump inhibitor esomeprazole reduces stomach acid output. The first single optical isomer of a proton pump inhibitor, esomeprazole (S-isomer of omeprazole), offers superior acid control over racemic proton pump inhibitors. Absorption: The enteric-coated pellet version of esomeprazole magnesium is what is found in esomeprazole capsules. Peak plasma levels (Cmax) after oral dosing happen about 1.5 hours later (Tmax). The area under the plasma concentration-time curve (AUC) increases by a factor of three from 20 to 40 mg, and the Cmax increases correspondingly when the dose is raised. The systemic bioavailability is about 90% at repeated once-daily dosage as opposed to 64% following a single dose. When compared to fasting settings, the AUC following a single dosage of esomeprazole is reduced by 33-53% after eating. It is recommended to take esomeprazole at least an hour before meals. Distribution: Plasma proteins are 97% bound to esomeprazole. Across the concentration range of 2–20 mmol/L, plasma protein binding remains stable. In healthy volunteers, the apparent volume of distribution at steady state is roughly 16 L. Esomeprazole is extensively processed by the cytochrome P450 (CYP) enzyme system in the liver. Esomeprazole's metabolites don't have any anti-secretory properties. The CYP2C19 isoenzyme, which produces the hydroxy and desmethyl metabolites, is essential for the majority of the metabolism of esomeprazole. The CYP3A4 enzyme, which produces the sulphone metabolite, determines the residual amount. Excretion: Esomeprazole has a plasma elimination half-life of about 1-1.5 hours. The amount of parent medication discharged in urine is less than 1%. Esomeprazole is an oral medication that is excreted in two ways: 80% of an oral dose is found in the urine as inactive metabolites, and the remaining 20% is found in the feces as inactive metabolites. Esomeprazole magnesium 40 mg once daily is administered for 7 days in combination with clarithromycin 500 mg twice daily and amoxicillin 1000 mg twice daily. Esomeprazole's average steady-state AUC and Cmax increased by 70% and 18%, respectively.
There is no sufficient and reliable research on expectant mothers. No teratogenic effects have been identified in animal investigations. Esomeprazole's excretion in milk has not been investigated. So, if the usage of esomeprazole is deemed necessary, breastfeeding should be stopped.
Pediatric Use: Pediatric patients' safety and efficacy have not been shown. Geriatric Use: There haven't been any overall variations in safety and effectiveness between elderly and younger people, and other recorded clinical experience hasn't found differences in reactions between elderly and younger patients, although it's possible that certain older people may be more sensitive. Hepatic Insufficiency: For individuals with mild to moderate hepatic insufficiency, no dosage change is advised. On the other hand, a dose of 20 mg once daily should not be exceeded in individuals with severe hepatic impairment. Renal Insufficiency: As less than 1% of esomeprazole is eliminated unaltered in the urine, it is not anticipated that the pharmacokinetics of esomeprazole in patients with a renal impairment will differ from those in healthy volunteers.
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