Onelock 40 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 anti-secretory 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
• 20 mg twice daily for Helicobacter pylori eradication regimen
• 40 mg (on the preceding evening) and 40 mg (2-6 hours before surgery) for prophylaxis of acid aspiration
• 60 mg once daily for Zollinger-Ellison syndrome
• 10-20 mg daily for long-term management of acid reflux disease

Administration

• Omeprazole IV injection should be given as a slow intravenous injection
• Omeprazole IV infusion should be given over a period of 20-30 minutes or more
• Reconstituted solution should not be mixed or co-administered with any other drug in the same infusion set

Interactions

• Decreased intragastric acidity may reduce absorption of ketoconazole
• Metabolized in the liver through cytochrome P450
• Can delay the elimination of diazepam, phenytoin, and warfarin
• Plasma concentrations of Omeprazole and clarithromycin are increased during concomitant administration
• Absorption of Omeprazole is not affected by alcohol or food
• Simultaneous treatment with Omeprazole and digoxin results in a 10% increase in the bioavailability of digoxin

Contraindications

• Known hypersensitivity to Omeprazole
• Suspicion of gastric ulcer where malignancy should be excluded before treatment

Side Effects

• Skin rash, urticaria, and pruritus
• Photosensitivity, bullous eruption, and erythema multiforme
• Diarrhea, headache, constipation, and nausea/vomiting
• Dry mouth, stomatitis, and candidiasis
• Dizziness, light-headedness, and somnolence
• Reversible mental confusion, agitation, and depression
• Arthritic and myalgic symptoms
• Blurred vision, taste disturbance, and peripheral edema
• Increases in liver enzymes

Pregnancy & Lactation

• No adverse effects of Omeprazole on pregnancy or on the health of the fetus/newborn child
• Use during pregnancy is indicated
• No information available on the passage of Omeprazole into breast milk or its effects on the neonate
• Breastfeeding should be discontinued if the use of Omeprazole is considered essential
• Safety and effectiveness in pediatric patients less than 18 years of age have not been established

Precautions & Warnings

• Avoid concomitant use of clopidogrel and Omeprazole
• Observational studies suggest an increased risk for osteoporosis-related fractures with PPI therapy
• Atrophic gastritis has been noted occasionally in gastric corpus biopsies from patients treated long-term with Omeprazole
• 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

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