Omel 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 antisecretory effect within one hour
• Maximum effect occurring within two hours
• Inhibition of secretion lasts up to 72 hours
• Return of secretory activity over 3 to 5 days after discontinuation

Dosage

• Dosage for benign gastric and duodenal ulcer
• Dosage for NSAID-associated duodenal or gastric ulcer
• Dosage for gastro-esophageal reflux disease
• Dosage for long-term management of acid reflux disease
• Dosage for acid-related dyspepsia
• Dosage for prophylaxis of acid aspiration
• Dosage for Zollinger-Ellison syndrome
• Dosage for Helicobacter pylori eradication regimen in peptic ulcer disease
• Pediatric use in severe ulcerating reflux esophagitis
• IV Injection dosage for prophylaxis of acid aspiration
• IV Injection dosage for duodenal ulcer, gastric ulcer or reflux oesophagitis
• IV Injection dosage for Zollinger-Ellison syndrome (ZES)

Administration

• Direction for use of IV Injection
• Direction for use of IV Infusion

Interaction

• Effect on ketoconazole absorption
• Metabolism through cytochrome P450
• Potential delay in elimination of diazepam, phenytoin, and warfarin
• Monitoring recommended for patients receiving warfarin or phenytoin
• Impact on plasma concentrations of Omel and clarithromycin
• Absence of interaction with certain drugs and substances

Contraindications

• Known hypersensitivity to omeprazole
• Need to exclude possibility of malignancy in suspected gastric ulcer before treatment

Side Effects

• Mild and reversible adverse reactions
• Skin rash, urticaria, and pruritus
• Diarrhea and headache
• Gastrointestinal reactions including constipation, nausea/vomiting, flatulence, and abdominal pain
• Other reported reactions such as dizziness, somnolence, insomnia, mental confusion, arthritic and myalgic symptoms, liver enzyme increases
• Rare reactions like anaphylactic shock, malaise, bronchospasm, and hepatic failure

Pregnancy & Lactation

• No adverse effects indicated on pregnancy or fetal health from three prospective epidemiological studies
• Usage during pregnancy considered safe
• No information available on passage into breast milk or effects on neonate
• Discontinuation of breastfeeding if essential use of omeprazole is considered

Precautions & Warnings

• Avoid concomitant use of clopidogrel
• Possible association of PPI therapy with increased risk for osteoporosis-related fractures
• Occasional occurrence of atrophic gastritis in long-term treated patients
• Potential for methotrexate toxicities with concurrent PPIs usage

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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