Indications of Nexum 20 Capsule

• 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

Pharmacology of Nexum 20 Capsule

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 & Administration of Nexum 20 Capsule

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.

Use Delayed-Release Oral Suspension as directed: Fill a small glass with 15 mL of water with the entire contents of the packet. Stir vigorously in the mixer and set aside for 2 to 3 minutes to thicken. Stir once more, then consume within 30 minutes. If any medicine remains after drinking, dilute it with extra water, swirl it well, and drink it right away. The volume of water in the syringe should be 15 ml if the suspension is to be supplied through a nasogastric or gastric tube.

Esomeprazole IV Injection: Esomeprazole IV should be administered slowly through the veins. 5 mL of the specified solvent (WFI) is added to the vial to make the IV injection solution. The injection should be given carefully over a period of at least 3 minutes after reconstitution. When stored at room temperature up to 30°C, the solution should be used within 12 hours of reconstitution. There is no need for refrigeration. If there are visible particulates in the reconstituted solution, it should not be used.

Interaction of Nexum 20 Capsule

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 Nexum 20 Capsule

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.

Pharmaceutical Name of Nexum 20 Capsule

Square Pharmaceuticals Ltd

Generic of Nexum 20 Capsule

Esomeprazole Magnesium Trihydrate