Esonix IV Injection

Indications

Esonix is prescribed for the following conditions:

• Chronic Heartburn Relief: Alleviates symptoms associated with gastroesophageal reflux disease (GERD).
• Erosive Esophagitis Treatment: Aids in the healing process of erosive esophagitis.
• Maintenance Therapy: Supports ongoing healing of erosive esophagitis.
• Helicobacter Pylori Eradication: Used alongside amoxicillin and clarithromycin to eliminate Helicobacter pylori infections in patients suffering from duodenal ulcers.
• Zollinger-Ellison Syndrome Management: Helps manage this rare condition characterized by excessive gastric acid production.
• Acid-Related Dyspepsia: Effective for treating acid-related indigestion.
• Duodenal and Gastric Ulcer Treatment: Provides relief and aids healing.

Always consult a registered healthcare professional before using this medication.

Pharmacology

Esomeprazole, a proton pump inhibitor, effectively reduces gastric acid secretion by specifically targeting the H+/K+-ATPase in gastric parietal cells. As the S-isomer of omeprazole, esomeprazole is the first single optical isomer in this class, offering superior acid control compared to traditional racemic proton pump inhibitors.

Absorption: Esonix capsules feature an enteric-coated pellet formulation of esomeprazole magnesium. Upon oral administration, peak plasma levels (Cmax) occur approximately 1.5 hours (Tmax) later. Increasing the dose leads to a proportional rise in Cmax, significantly enhancing the overall plasma concentration.

Dosage Instructions

Oral Dosage Forms:

• Erosive Esophagitis Healing: 20 mg or 40 mg once daily for 4 to 8 weeks. Most patients heal within this timeframe; if not, an additional 4 to 8 weeks may be required.
• Maintenance of Erosive Esophagitis Healing: 20 mg once daily (clinical studies did not extend beyond 6 months).
• Symptomatic GERD: 20 mg once daily for 4 weeks; consider an additional 4 weeks if symptoms persist.
• Helicobacter Pylori Eradication (Triple Therapy): 40 mg once daily for 10 days, combined with amoxicillin (1000 mg twice daily) and clarithromycin (500 mg twice daily).
• Zollinger-Ellison Syndrome: Dosage ranges from 20 mg to 80 mg once daily, adjusted as necessary based on individual response.
• Acid-Related Dyspepsia: 20-40 mg once daily for 2-4 weeks, depending on response.
• Duodenal Ulcer: 20 mg once daily for 2-4 weeks.
• Gastric Ulcer: 20-40 mg once daily for 4-8 weeks.

IV Injection or Infusion:

For Adults (≥18 years):

• GERD with Erosive Esophagitis: 20 mg or 40 mg once daily; administer IV injection over >3 minutes or IV infusion over 10-30 minutes.

For Pediatric Patients (1 to 17 years):

• Body weight <55 kg: 10 mg once daily.
• Body weight ≥55 kg: 20 mg once daily.
• Ages 1 month to <1 year: 0.5 mg/kg once daily.
• IV infusion: 10-30 minutes.

For Risk Reduction of Rebleeding from Gastric or Duodenal Ulcers in Adults:

• Administer 80 mg IV infusion over 30 minutes, followed by a continuous infusion of 8 mg/hour for a total duration of 72 hours.

Always consult a registered healthcare professional before using this medication.

Administration Guidelines

• Tablets or Capsules: Swallow whole and take one hour before meals.
• Oral Suspension: Mix the packet contents with 15 ml of water in a small glass. Stir well and let thicken for 2-3 minutes, then consume within 30 minutes. For nasogastric or gastric tube administration, use 15 ml of water and follow the same stirring and timing guidelines.
• IV Injection: Prepare the solution by adding 5 ml of 0.9% Sodium Chloride to the vial containing the dry powder. Administer IV over at least 3 minutes. Use the solution within 12 hours of preparation, stored under normal indoor lighting at a maximum of 30°C.

Always consult a registered healthcare professional before using this medication.

Drug Interactions

Esonix is primarily metabolized in the liver by CYP2C19 and CYP3A4. Studies indicate minimal risk of clinically relevant interactions with other CYP enzymes. Esonix does not significantly interact with phenytoin, warfarin, quinidine, clarithromycin, or amoxicillin. However, co-administration with diazepam may reduce its clearance by 45%, leading to increased plasma levels.

Esonix may also influence the absorption of certain medications where gastric pH is critical (e.g., ketoconazole, iron supplements, digoxin).

Contraindications

Esonix is contraindicated in individuals with known hypersensitivity to any component of the formulation.

Side Effects

Common side effects associated with Esonix may include headache, diarrhea, nausea, flatulence, abdominal discomfort, constipation, and dry mouth. No significant differences in adverse events have been observed during long-term maintenance therapy compared to short-term use.

Pregnancy and Lactation

Adequate and controlled studies in pregnant women are lacking. Animal studies have not shown teratogenic effects. The impact of esomeprazole in breast milk remains unstudied; thus, breastfeeding should be reconsidered if esomeprazole is deemed necessary.

Precautions and Warnings

• General: Symptomatic relief does not rule out the presence of gastric malignancy.
• Patient Information: Take Esonix capsules at least one hour before meals. For those who struggle with swallowing capsules, mix the contents with a tablespoon of applesauce and swallow immediately. Do not chew or crush the pellets, and do not store the mixture for later use. Antacids may be used concurrently.

Special Population Considerations

• Pediatric Use: Safety and effectiveness in children have not been established.
• Geriatric Use: No significant differences in safety or efficacy have been noted between older and younger patients, although increased sensitivity in older individuals cannot be excluded.
• Hepatic Insufficiency: No dosage adjustment is necessary for mild to moderate liver impairment, but a maximum of 20 mg daily is advised for severe hepatic insufficiency.
• Renal Insufficiency: Pharmacokinetics in patients with renal impairment are similar to those in healthy individuals, as less than 1% of Esonix is excreted unchanged in urine.

Overdose Effects

A single high oral dose of Esonix (510 mg/kg) has been lethal in animal studies. Signs of acute toxicity may include reduced motor activity, respiratory changes, tremors, ataxia, and seizures. No specific antidote exists; management should be symptomatic and supportive.

Storage Conditions

Store at temperatures not exceeding 30°C in a dry place, away from light and moisture. Keep out of reach of children.