Xeldrin 20

Indications of Xeldrin 20

Omeprazole is prescribed for:

• Treatment of ulcers in the stomach and duodenum
• Duodenal and gastric ulcers associated with nonsteroidal anti-inflammatory drugs (NSAIDs)
• Preventative treatment for patients with a history of NSAID-related duodenal or gastric ulcers
• Management of gastroesophageal reflux disease (GERD)
• Long-term management of acid reflux disease
• Relief of dyspepsia caused by stomach acid
• Treatment of reflux esophagitis with ulcers
• Prevention of acid aspiration during general anesthesia

Pharmaceutical Name

Xeldrin 20
Manufacturer: ACI Limited

Pharmacology

Omeprazole is a substituted benzimidazole that acts as a gastric acid secretion inhibitor. It blocks the H+/K+ ATPase enzyme system in gastric parietal cells, suppressing acid secretion. The antisecretory effect begins within one hour of oral administration, peaks at two hours, and can last up to 72 hours. After discontinuation, gastric acid secretion gradually resumes over 3 to 5 days.

Dosage

Oral Administration:

• Benign Gastric and Duodenal Ulcers:

  • 20 mg once daily for 4 weeks (duodenal) or 8 weeks (gastric).
  • In severe or recurrent cases, the dose may be increased to 40 mg daily.
  • For maintenance in recurrent duodenal ulcers, 20 mg daily; for relapse prevention, 10-20 mg daily.

• NSAID-associated Ulcers:

  • 20 mg once daily for 4 weeks, extend for another 4 weeks if not healed.
  • 20 mg once daily for prophylaxis in patients with a history of NSAID-related ulcers.

• Gastroesophageal Reflux Disease (GERD):

  • 20 mg once daily for 4 weeks, extend for another 4-8 weeks if not fully healed.
  • 40 mg once daily may be given for 8 weeks in refractory cases; the maintenance dose is 20 mg daily.

• Long-term Acid Reflux Management: 10-20 mg daily.

• Acid-related Dyspepsia: 10-20 mg once daily for 2-4 weeks.

• Prophylaxis of Acid Aspiration: 40 mg the night before surgery and 40 mg 2-6 hours before the procedure.

• Zollinger-Ellison Syndrome: Start with 60 mg once daily; the usual range is 20-120 mg daily (for doses over 80 mg, split into two doses).

• Helicobacter Pylori Eradication: 20 mg twice daily in conjunction with antibiotics (options include amoxicillin and metronidazole or clarithromycin).

• Pediatric Use (for severe ulcerating reflux esophagitis):

  • If body weight is 10-20 kg, 10-20 mg once daily for 4-12 weeks.
  • If body weight exceeds 20 kg, 20-40 mg once daily for 4-12 weeks.

IV Injection:

• Prophylaxis of Acid Aspiration: 40 mg administered slowly (over 5 minutes) one hour before surgery.
• Ulcers or Reflux Esophagitis (when oral intake is not possible): 40 mg IV once daily.
• Zollinger-Ellison Syndrome: Initial dose of 60 mg IV daily; higher doses may be needed, divided into two doses if exceeding 60 mg.

Administration

IV Injection Directions:

• Omeprazole is provided as a lyophilized powder for intravenous use only; do not administer by any other route.
• Reconstitute by adding 10 mL of water for injection to the powder vial. Administer slowly over 2 to 5 minutes at a maximum rate of 4 mL/min. Use freshly prepared solutions within 4 hours of reconstitution.

IV Infusion Directions:

• For IV infusion, dissolve the vial contents in 100 mL saline or 5% dextrose.
• Infuse over 20-30 minutes or longer.
• Use solutions within 12 hours when in saline, or within 6 hours when in dextrose. Do not mix or co-administer with other medications in the same infusion set.

Interaction

Omeprazole may prolong the clearance of diazepam, warfarin, and phenytoin. Dosing adjustments may be necessary for warfarin or phenytoin if omeprazole is added to treatment. There is no evidence of interaction with theophylline, propranolol, or antacids.

Contraindications

Omeprazole is contraindicated in patients with known hypersensitivity to any of its components.

Side Effects

Generally well tolerated, omeprazole may cause mild and temporary side effects, including:

• Nausea
• Abdominal cramps
• Paresthesia
• Dizziness
• Headaches

These side effects usually do not require dosage adjustments.

Pregnancy & Lactation

Omeprazole is classified as Category C by the FDA. While animal studies show no teratogenic effects, human studies are limited. It is unclear if omeprazole is excreted in breast milk; therefore, breastfeeding should be discontinued if omeprazole is needed.

Precautions & Warnings

Before starting omeprazole treatment, consider the possibility of gastric malignancy, as treatment may mask symptoms and delay diagnosis.

Therapeutic Class

Proton Pump Inhibitor

Storage Conditions

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