Omilux 20 mg (Capsule (Enteric Coated))

Indications

• Gastric and duodenal ulcer
• NSAID-associated duodenal and gastric ulcer
• As 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 antisecretory effect within one hour
• Maximum effect occurring within two hours
• Inhibition of secretion lasts up to 72 hours
• Gradual return of secretory activity over 3 to 5 days post discontinuation

Dosage

• 20 mg once daily for benign gastric and duodenal ulcer
• 20 mg once daily for NSAID-associated duodenal or gastric ulcer
• 20 mg once daily for 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 on the preceding evening, then 40 mg 2-6 hours before surgery for prophylaxis of acid aspiration

Administration

• For intravenous administration only
• Slow intravenous injection required
• Intravenous infusion over a period of 20-30 minutes
• Reconstituted solution should be used within specified time
• Cannot be mixed or co-administered with other drugs in the same infusion set

Interaction

• Decreased intragastric acidity affecting the absorption of ketoconazole
• Metabolized in the liver through cytochrome P450
• Potential delay in elimination of diazepam, phenytoin, and warfarin
• Monitoring recommended for patients receiving warfarin or phenytoin
• Plasma concentrations increased during concomitant administration with certain drugs
• No evidence of interaction with specific medications

Contraindications

• Known hypersensitivity to omeprazole
• Suspicion of gastric ulcer without excluding malignancy

Side Effects

• Mild and reversible adverse reactions
• Skin rash, urticaria, and pruritus reported
• Photosensitivity, bullous eruption, and erythema multiforme in isolated cases
• Diarrhea and headache, which may be severe enough to require discontinuation of therapy
• Other gastrointestinal reactions such as constipation, nausea/vomiting, and abdominal pain
• Dizziness, light headedness, and feeling faint reported

Pregnancy & Lactation

• No adverse effects on pregnancy or fetal health reported
• Safe for use during pregnancy
• No information available on passage into breast milk or effects on the neonate
• Breastfeeding should be discontinued if essential

Precautions & Warnings

• Avoid concomitant use with clopidogrel
• Potential association with increased risk for osteoporosis-related fractures
• Atrophic gastritis noted occasionally with long-term use
• Concomitant use 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

Related Brands

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