Roceptin 20 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
• Gradual return of secretory activity over 3 to 5 days after discontinuation

Dosage

• 20 mg once daily for benign gastric and duodenal ulcer
• 10-20 mg daily for long-term management of acid reflux disease
• 40 mg once daily for prophylaxis of acid aspiration
• 20 mg twice daily for H. pylori eradication regimen in peptic ulcer disease
• 10-20 mg once daily for severe ulcerating reflux esophagitis (Child>1 year)

Administration

• IV Injection for prophylaxis of acid aspiration, duodenal ulcer, gastric ulcer, or reflux oesophagitis
• IV Infusion over a period of 20-30 minutes or more
• Reconstitution of Omeprazole IV infusion with saline or 5% Dextrose
• Avoid mixing or co-administration with any other drug in the same infusion set

Interaction

• Reduced absorption of ketoconazole during Roceptin treatment
• Metabolized in the liver through cytochrome P450
• Possible delay in the elimination of diazepam, phenytoin, and warfarin
• Increased plasma concentrations during concomitant administration with clarithromycin
• No evidence of interaction with phenacetin, theophylline, caffeine, propranolol, metoprolol, cyclosporin, lidocaine, quinidine, estradiol, amoxycillin, or antacids
• No impact on absorption by alcohol or food

Contraindications

• Known hypersensitivity to Omeprazole
• Suspected gastric ulcer with possibility of malignancy

Side Effects

• Skin rash, urticaria, and pruritus
• Photosensitivity, bullous eruption, and erythema multiforme
• Diarrhoea, headache, constipation, and nausea/vomiting
• Dry mouth, stomatitis, and candidiasis
• Paraesthesia, dizziness, and feeling faint
• Somnolence, insomnia, and vertigo
• Reversible mental confusion, agitation, and depression
• Arthritic and myalgic symptoms
• Blurred vision, taste disturbance, and peripheral oedema
• Increased sweating, gynaecomastia, and leucopenia
• Thrombocytopenia, agranulocytosis, and pancytopenia
• Anaphylactic shock, malaise, and fever
• Bronchospasm, encephalopathy, and hepatitis
• Increases in liver enzymes

Pregnancy & Lactation

• No adverse effects on pregnancy or fetus/newborn child
• Use during pregnancy possible
• Effect on breast milk and neonate unknown
• Discontinuation of breast-feeding if essential use of Omeprazole

Therapeutic Class

• Proton Pump Inhibitor

Storage Conditions

• Keep in a dry place away from light and heat

Precautions & Warnings

• Avoid concomitant use with clopidogrel
• Increased risk for osteoporosis-related fractures with PPI therapy
• Atrophic gastritis noted in patients treated long-term with Roceptin
• Concomitant use with methotrexate may lead to toxicities

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