Aspra 20 mg (Capsule (Enteric Coated))

Indications

• Treatment of gastric and duodenal ulcer
• NSAID-associated duodenal and gastric ulcer treatment
• Prophylaxis in patients with a history of NSAID-associated duodenal and gastric ulcer
• Gastro-esophageal reflux disease treatment
• Long-term management of acid reflux disease
• Treatment of acid-related dyspepsia
• Severe ulcerating reflux esophagitis treatment
• Prophylaxis of acid aspiration during general anesthesia
• Zollinger-Ellison syndrome treatment
• Helicobacter pylori-induced peptic ulcer treatment

Pharmacology

• Inhibitor of gastric acid secretion
• Blocks hydrogen-potassium-adenosine triphosphatase (H+/K+ ATPase) enzyme system in the gastric parietal cell
• Onset of antisecretory effect occurs within one hour
• Maximum effect occurs within two hours
• Inhibition of secretion lasts up to 72 hours
• Gradual return of secretory activity over 3 to 5 days after discontinuation

Dosage

• Oral administration for different conditions
• Dosage range from 10 mg to 120 mg daily
• Dosage adjustments based on severity and recurrence
• Pediatric use dosage based on body weight

Administration

• Direction for use of IV Injection
• Direction for use of IV Infusion
• Intravenous administration only
• Recommended infusion duration
• Reconstitution guidelines
• Use within specified time after reconstitution

Interaction

• Impact on the absorption of ketoconazole
• Metabolism through cytochrome P450
• Potential delay in elimination of diazepam, phenytoin, and warfarin
• Recommendation for monitoring patients receiving warfarin or phenytoin
• Increased plasma concentrations during concomitant administration with certain drugs
• No evidence of interaction with specific drugs
• Increased bioavailability of digoxin due to increased intragastric pH

Contraindications

• Known hypersensitivity to omeprazole
• Exclusion of malignancy before treatment in suspected gastric ulcer cases

Side Effects

• Mild and reversible adverse reactions
• Reported skin reactions such as rash, urticaria, and pruritus
• Gastrointestinal reactions including diarrhoea, constipation, and nausea/vomiting
• Neurological symptoms like headache and paraesthesia
• Other reported symptoms like dizziness, insomnia, and mental confusion
• Reversible arthritic and myalgic symptoms
• Observation of liver enzyme increases

Pregnancy & Lactation

• No adverse effects on pregnancy or fetus/newborn child from epidemiological studies
• Safe to use during pregnancy
• No available information on passage into breast milk or effects on the neonate
• Discontinuation of breastfeeding recommended if essential use of omeprazole

Precautions & Warnings

• Avoid concomitant use with clopidogrel
• Potential association with increased risk for osteoporosis-related fractures
• Noted occurrence of atrophic gastritis in long-term treatment
• Potential methotrexate toxicities with concomitant use of PPIs

Therapeutic Class

• Proton Pump Inhibitor

Storage Conditions

• Keep in a dry place
• Away from light and heat
• Keep out of the reach of children

Related Brands

• Anasec 20 mg (Capsule (Enteric Coated)) - novo-healthcare-and-pharma-ltd
• Anasec 40 mg/vial (IV Injection) - novo-healthcare-and-pharma-ltd