Xeldrin 40

Indications

Xeldrin is commonly prescribed for the treatment of:

• Gastric and duodenal ulcers
• NSAID-induced gastric and duodenal ulcers
• Preventative care in patients with a history of NSAID-induced ulcers
• Gastroesophageal reflux disease (GERD)
• Long-term management of acid reflux
• Acid-related dyspepsia (indigestion)
• Severe ulcerating reflux esophagitis
• Prevention of acid aspiration during general anesthesia
• Zollinger-Ellison syndrome
• Peptic ulcers caused by Helicobacter pylori

Always use as per the guidance of a registered healthcare provider.

Pharmacology

Omeprazole, a benzimidazole derivative, effectively inhibits gastric acid production. By blocking the hydrogen-potassium-adenosine triphosphatase (H+/K+ ATPase) enzyme system in the parietal cells of the stomach, it prevents acid secretion. The therapeutic effects begin within an hour of oral administration, reaching peak activity in two hours, with effects lasting up to 72 hours. After discontinuation, normal acid secretion gradually resumes over 3 to 5 days.

Dosage

Oral Dosage:

• Gastric and Duodenal Ulcers:
  • 20 mg daily for 4 weeks for duodenal ulcers, 8 weeks for gastric ulcers. In severe or recurrent cases, the dose may increase to 40 mg daily. Maintenance doses can be 20 mg daily.
  • For relapse prevention in duodenal ulcers: 10–20 mg daily.
• NSAID-Associated Ulcers:
  • 20 mg once daily for 4 weeks, with an additional 4 weeks if healing is not complete. Prophylaxis: 20 mg daily for patients with a history of NSAID-induced ulcers.
• Gastroesophageal Reflux Disease (GERD):
  • 20 mg daily for 4 weeks, extendable to 4–8 weeks if healing is incomplete. For treatment-resistant GERD, 40 mg daily for up to 8 weeks. Maintenance dose: 20 mg daily.
• Long-term Acid Reflux Management:
  • 10–20 mg daily.
• Acid-Related Dyspepsia:
  • 10–20 mg daily for 2–4 weeks.
• Acid Aspiration Prophylaxis:
  • 40 mg on the evening before surgery and 40 mg 2–6 hours prior to surgery.
• Zollinger-Ellison Syndrome:
  • Starting dose of 60 mg daily, typically ranging from 20–120 mg. Doses above 80 mg should be split into two daily doses.
• Helicobacter pylori Eradication for Peptic Ulcer:
  • 20 mg twice daily combined with:
    • Amoxicillin 500 mg and Metronidazole 400 mg, three times a day for one week, or
    • Clarithromycin 250 mg and Metronidazole 400 mg, twice a day for one week, or
    • Amoxicillin 1 g and Clarithromycin 500 mg, twice a day for one week.
• Pediatric Use (Severe Reflux Esophagitis, Age >1 year):
  • For children weighing 10-20 kg: 10–20 mg daily for 4–12 weeks.
  • For children >20 kg: 20–40 mg daily for 4–12 weeks.

Intravenous (IV) Injection:

• Acid Aspiration Prophylaxis:
  • Administer 40 mg slowly (over 5 minutes) one hour before surgery.
• Duodenal Ulcer, Gastric Ulcer, or Reflux Esophagitis:
  • For patients unable to take oral medication, 40 mg once daily via IV.
• Zollinger-Ellison Syndrome:
  • Initial IV dose of 60 mg daily, potentially increased based on patient response.

Use as directed by your healthcare provider.

Administration

For IV Injection:

• Omeprazole powder (lyophilized) should be reconstituted with 10 mL water for injection. Administer the solution slowly over 2 to 5 minutes at a maximum rate of 4 mL/min. Use the freshly prepared solution within 4 hours of reconstitution.

For IV Infusion:

• Dilute the vial in 100 mL saline or 5% dextrose and infuse over 20–30 minutes or longer. Use within 12 hours for saline or 6 hours for dextrose solutions.

Always consult a healthcare provider before use.

Drug Interactions

• Reduced absorption of ketoconazole may occur with Xeldrin, as with other acid secretion inhibitors.
• Xeldrin may slow the metabolism of diazepam, phenytoin, and warfarin. Regular monitoring is advised for patients using these medications.
• Xeldrin can increase blood levels of clarithromycin when co-administered.
• No significant interactions have been observed with phenacetin, caffeine, theophylline, propranolol, metoprolol, cyclosporine, or antacids.

The absorption of Xeldrin is unaffected by food or alcohol. No significant interaction with NSAIDs like piroxicam, diclofenac, or naproxen is noted, making it suitable for concurrent use with these drugs.

Contraindications

Xeldrin should not be used by individuals with known hypersensitivity to omeprazole. If gastric ulcers are suspected, malignancy should be ruled out before starting treatment, as omeprazole can mask symptoms and delay diagnosis.

Side Effects

Xeldrin is generally well-tolerated. Side effects, if present, are usually mild and reversible. Common reactions include:

• Skin Reactions: Rash, pruritus, and urticaria (often resolved after discontinuation).
• Gastrointestinal: Diarrhea, constipation, flatulence, nausea/vomiting, and abdominal pain.
• Central Nervous System: Dizziness, headache, somnolence, and mental confusion in severely ill patients.
• Other Reactions: Photosensitivity, alopecia, vertigo, and arthralgia. Serious reactions, like liver enzyme elevation and hepatitis, are rare.

Pregnancy & Lactation

Omeprazole has not shown adverse effects in pregnancy based on multiple studies. It is generally considered safe during pregnancy, but caution should be exercised. No data is available on its presence in breast milk; breastfeeding should be discontinued if Omeprazole use is necessary.

Use in Children & Adolescents

The safety and effectiveness of Omeprazole have not been established for children under 18 years of age.

Precautions & Warnings

• Clopidogrel: Avoid co-administration as it may reduce the pharmacological activity of clopidogrel.
• Osteoporosis Risk: Long-term PPI use may be linked to an increased risk of fractures, especially of the hip, wrist, or spine.
• Gastric Atrophy: Prolonged use may lead to atrophic gastritis.
• Methotrexate: Co-administration with methotrexate may lead to increased toxicity.

Therapeutic Class

• Proton Pump Inhibitor (PPI)

Storage Conditions

Store in a cool, dry place away from light and heat. Keep out of reach of children.