Xerosec 20 mg (Capsule (Enteric Coated))

Indications

• Gastric and duodenal ulcer
• 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 within 3 to 5 days after discontinuation

Dosage

• 20 mg once daily for benign gastric and duodenal ulcer
• 40 mg once daily for severe or recurrent cases of ulcer
• 20 mg once daily for 4 weeks in NSAID-associated duodenal or gastric ulcer
• 10-20 mg once daily for acid-related dyspepsia
• 40 mg dose for prophylaxis of acid aspiration during general anesthesia
• 60 mg once daily for Zollinger-Ellison syndrome
• 20 mg twice daily for Helicobacter pylori eradication regimen

Administration

• IV Injection given slowly over a period of 5 minutes
• IV Infusion given over a period of 20-30 minutes or more
• Reconstituted solution should be used within 4 hours
• Reconstituted solution should not be mixed with other drugs in the same infusion set

Interaction

• Decreased absorption of ketoconazole during Xerosec treatment
• Delayed elimination of diazepam, phenytoin, and warfarin
• Increased plasma concentrations of Xerosec and clarithromycin
• No interaction with phenacetin, theophylline, caffeine, propranolol, etc

Contraindications

• Known hypersensitivity to omeprazole
• Suspected gastric ulcer without exclusion of malignancy

Side Effects

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

Pregnancy & Lactation

• No adverse effects on pregnancy or fetus/newborn child
• Use during pregnancy deemed safe
• Discontinue breastfeeding if essential to use omeprazole

Precautions & Warnings

• Avoid concomitant use with clopidogrel
• Possible association with increased risk for osteoporosis-related fractures
• Atrophic gastritis observed in long-term treatment
• Potential for methotrexate toxicities with concomitant use

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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