Xerosec 40 mg (Capsule (Enteric Coated))

Indications

• Gastric and duodenal ulcer
• NSAID-associated duodenal and gastric ulcer
• Prophylaxis in patients with a history of NSAID-associated duodenal and gastric ulcer
• Gastro-esophageal reflux disease
• Long-term management of acid reflux disease
• Acid-related dyspepsia
• Severe ulcerating reflux esophagitis
• Prophylaxis of acid aspiration during general anesthesia
• Zollinger-Ellison syndrome
• Helicobacter pylori-induced peptic ulcer

Pharmacology

• Inhibitor of gastric acid secretion
• Blocks hydrogen-potassium-adenosine triphosphatase (H+/K+ ATPase) enzyme system
• Onset of the antisecretory effect occurs within one hour
• Maximum effect occurs within two hours
• Inhibition of secretion lasts up to 72 hours
• Secretory activity returns gradually over 3 to 5 days after discontinuation

Dosage

• 20 mg once daily for benign gastric and duodenal ulcer
• 40 mg daily for severe or recurrent cases of gastric ulcer
• Maintenance dose of 20 mg once daily for recurrent duodenal ulcer
• 10-20 mg daily for prevention of relapse in duodenal ulcer
• 20 mg once daily for NSAID-associated duodenal or gastric ulcer
• 20 mg once daily for gastro-esophageal reflux disease
• 40 mg once daily for refractory gastro-esophageal reflux disease
• 10-20 mg daily for long-term management of acid reflux disease
• 10-20 mg once daily for acid-related dyspepsia
• 40 mg for prophylaxis of acid aspiration before surgery
• Initial 60 mg once daily for Zollinger-Ellison syndrome
• Recommended dose of 20 mg twice daily for H. pylori eradication regimen

Administration

• Omeprazole IV injection is for intravenous administration only
• IV injection should be given slowly over a period of 5 minutes
• IV infusion should be given over a period of 20-30 minutes or more
• Reconstituted solution should be used within 4 hours
• IV infusion solution should be used within 12 hours when dissolved in saline
• IV infusion solution should be used within 6 hours when dissolved in 5% Dextrose

Interaction

• Decreased intragastric acidity may reduce absorption of ketoconazole
• Metabolised in the liver through cytochrome P450, can delay the elimination of diazepam, phenytoin, and warfarin
• Concomitant treatment with Xerosec can affect plasma concentrations of other drugs
• No evidence of interaction with phenacetin, theophylline, caffeine, propranolol, and more

Contraindications

• Known hypersensitivity to omeprazole
• Exclusion of malignancy before treatment if gastric ulcer is suspected

Side Effects

• Adverse reactions have generally been mild and reversible
• Skin rash, urticaria and pruritus have been reported
• Diarrhoea and headache reported in some cases
• Other gastrointestinal reactions include constipation, nausea/vomiting, flatulence, and abdominal pain
• Dizziness, light headedness, and feeling faint associated with treatment
• Reversible mental confusion, agitation, depression, and hallucinations in severely ill patients

Pregnancy & Lactation

• Results from prospective epidemiological studies indicate no adverse effects on pregnancy
• No information available on the passage of omeprazole into breast milk or its effects on the neonate
• Safety and effectiveness not established in pediatric patients less than 18 years of age

Precautions & Warnings

• Avoid concomitant use of clopidogrel and Xerosec
• PPI therapy may be associated with an increased risk for osteoporosis-related fractures
• Atrophic gastritis noted occasionally in patients treated long-term with Xerosec
• Concomitant use of PPIs with methotrexate may lead to methotrexate toxicities

Therapeutic Class

• Proton Pump Inhibitor

Storage Conditions

• Keep in a dry place away from light and heat
• Keep out of the reach of children

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