Generic Name: Esomeprazole Magnesium Trihydrate 40 mg
Company Name: The IBN SINA Pharmaceutical Industry Ltd.
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Indications of Esolok 40
Esomeprazole is prescribed for the following conditions:
Esolok 40 Capsule is a medication that decreases the amount of acid produced in your stomach. It is used to treat heartburn, acid reflux, and food pipe issues. It is also employed in the prevention and treatment of stomach ulcers. You should take Esolok 40 Capsule as directed by your doctor.
Zollinger-Ellison Syndrome
Acid related Dyspepsia
Duodenal & Gastric ulcer
Pharmacology
Esomeprazole is a proton pump inhibitor that reduces stomach acid production by specifically inhibiting the H+/K+-ATPase in the gastric parietal cell. Esomeprazole (S-isomer of omeprazole) is the first proton pump inhibitor with a single optical isomer that outperforms racemic proton pump inhibitors in acid control.
For absorption, esomeprazole capsules contain an enteric-coated pellet formulation of esomeprazole magnesium. Peak plasma levels (Cmax) occur approximately 1.5 hours after oral administration (Tmax). When the dose is increased, the Cmax rises proportionally, and the area under the plasma concentration-time curve (AUC) rises three times from 20 to 40 mg. With repeated once-daily administration, systemic bioavailability is around 90%, compared to 64% with a single dose. In comparison to fasting conditions, the AUC after a single dose of esomeprazole is reduced by 33-53 percent after food ingestion. Esomeprazole should be taken at least one hour before meals.
In 97 percent of cases, esomeprazole is linked to plasma proteins. Plasma protein binding is constant over a concentration range of 2 20 mmol/L. At a steady state, the apparent volume of distribution in healthy individuals is around 16 L.
Esomeprazole is extensively metabolized in the liver by the cytochrome P450 (CYP) enzyme system. Metabolites of esomeprazole have no anti-secretory activity. The majority of esomeprazole metabolism is carried out by the CYP2C19 isoenzyme, which generates the hydroxy and desmethyl metabolites. The rest is reliant on CYP3A4, which generates the sulphone metabolite.
The plasma elimination half-life of esomeprazole is approximately 1-1.5 hours. Less than 1% of the parent medication is eliminated in the urine. Approximately 80% of an oral dose of esomeprazole is eliminated as inactive metabolites in the urine, with the remainder detected as inactive metabolites in the feces.
Antimicrobial Conjunction Therapy: For 7 days, esomeprazole magnesium 40 mg once daily is given in conjunction with clarithromycin 500 mg twice daily and amoxicillin 1000 mg twice daily. During triple combination therapy, the mean steady-state AUC and Cmax of Esomeprazole increased by 70% and 18%, respectively, when compared to treatment with Esomeprazole alone. The pharmacokinetic properties of clarithromycin and amoxicillin during triple combination treatment and when each medication is administered alone are comparable. However, when compared to treatment with clarithromycin alone, the mean AUC and Cmax for 14-hydroxy clarithromycin during triple combination therapy are increased by 19% and 22%, respectively. This increase in 14-hydroxy clarithromycin exposure is not considered clinically significant.
Dosage
Esomeprazole tablet or capsule:
Interaction
Esomeprazole is significantly metabolized in the liver by CYP2C19 and CYP3A4. According to in vitro and in vivo studies, esomeprazole is unlikely to inhibit CYPs 1A2, 2A6, 2C9, 2D6, 2E1, and 3A4. There should be no clinically significant interactions between these CYP enzymes and the medications they process. According to drug interaction studies, esomeprazole has no clinically significant interactions with phenytoin, warfarin, quinidine, clarithromycin, or amoxicillin.
Esomeprazole may interact with CYP2C19, the main Esomeprazole metabolizing enzyme. When Esomeprazole 30 mg was combined with diazepam, a CYP2C19 substrate, diazepam clearance was reduced by 45 percent. Increased diazepam plasma levels have been reported 12 hours and beyond after treatment. Esomeprazole works by preventing stomach acid production. As a result, in cases where stomach pH is a key driver of bioavailability, Esomeprazole may impair medication absorption (e.g., ketoconazole, iron salts, and digoxin).
Oral contraceptives, diazepam, phenytoin, or quinidine appear to have no effect on Esomeprazole's pharmacokinetic profile.
Clarithromycin Combination Therapy: Co-administration of esomeprazole, clarithromycin, and amoxicillin has resulted in increases in esomeprazole and 14-hydroxy clarithromycin plasma levels.
Contraindications
Esomeprazole is not recommended for those who have a history of hypersensitivity to any of the formulations.
Side Effects of Esolok 40
The most common side effects associated with Esomeprazole include headache, diarrhea, nausea, flatulence, stomach discomfort, constipation, and dry mouth. There is no difference in the types of associated adverse events seen after maintenance treatment for up to 12 months vs short-term treatment.
Pregnancy & Lactation
In pregnant women, there are no appropriate and well-controlled trials. Teratogenic effects have not been discovered in animal investigations. Esomeprazole excretion in milk has not been examined. If the use of esomeprazole is deemed necessary, breastfeeding should be stopped.
Precautions & Warnings
In general, a symptomatic response to esomeprazole treatment does not rule out stomach cancer.
According to the manufacturer's instructions, esomeprazole pills should be taken at least one hour before meals. If a patient has difficulty swallowing capsules, add one spoonful of applesauce to an empty bowl, open the Esomeprazole capsules, and carefully pour the pellets within the capsule into the applesauce. The pellets should be mixed with the applesauce and consumed quickly. The applesauce should be cold and mushy enough that it can be eaten without chewing. It is not advised to consume or crush the pellets. The pellet/applesauce mixture should not be refrigerated for future use. Antacids may be used while taking esomeprazole.
Storage Conditions
Store in a dry location at a temperature not exceeding 30°C. Keep out of direct sunlight and dampness. Keep out of children's reach.
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