SB-Omec 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 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
• 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 cases
• 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 and 2-6 hours before surgery for acid aspiration prophylaxis
• 60 mg once daily for Zollinger-Ellison syndrome
• 20 mg twice daily in Helicobacter pylori eradication regimen
• 10-20 mg once daily for 4-12 weeks in severe ulcerating reflux esophagitis (paediatric use)

Administration

• IV injection for prophylaxis of acid aspiration, duodenal ulcer, gastric ulcer, reflux oesophagitis
• IV infusion for prophylaxis of acid aspiration, duodenal ulcer, gastric ulcer, reflux oesophagitis
• IV infusion for Zollinger-Ellison syndrome
• Oral administration

Interaction

• Decreased intragastric acidity affecting absorption of ketoconazole
• Metabolism in the liver through cytochrome P450, affecting diazepam, phenytoin, and warfarin elimination
• Plasma concentrations increased during concomitant administration with certain drugs
• No evidence of interaction with phenacetin, theophylline, caffeine, and more

Contraindications

• Known hypersensitivity to Omeprazole
• Gastric ulcer where malignancy is suspected

Side Effects

• Skin rash, urticaria, photosensitivity
• Diarrhoea, headache
• Constipation, nausea/vomiting, flatulence, abdominal pain
• Other gastrointestinal reactions
• Dizziness, somnolence, insomnia, vertigo
• Reversible mental confusion, agitation, depression, hallucinations
• Arthritic and myalgic symptoms
• Changes in liver enzymes

Pregnancy & Lactation

• No adverse effects on pregnancy or the health of the fetus/newborn child
• No information available on the passage of Omeprazole into breast milk or its effects on the neonate

Precautions & Warnings

• Avoid concomitant use of clopidogrel
• Possible association with increased risk for osteoporosis-related fractures, atrophic gastritis, and 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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