Anasec 40 mg/vial (IV Injection)

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 lasting up to 72 hours
• Gradual return of secretory activity over 3 to 5 days upon discontinuation

Dosage

• Dosage for benign gastric and duodenal ulcer
• Dosage for NSAID-associated duodenal or gastric ulcer
• Dosage for gastro-esophageal reflux disease
• Dosage for long-term management of acid reflux disease
• Dosage for acid-related dyspepsia
• Dosage for prophylaxis of acid aspiration
• Dosage for Zollinger-Ellison syndrome
• Dosage for Helicobacter pylori eradication regimen in peptic ulcer disease
• Pediatric dosage in severe ulcerating reflux esophagitis

Administration

• Directions for use of IV Injection
• Directions for use of IV Infusion
• Instructions for intravenous administration only
• Reconstitution guidelines for IV injection
• Guidelines for IV infusion over a period of 20-30 minutes or more
• Preparation of IV solution using saline or 5% Dextrose for infusion
• Precautions for not mixing with other drugs in the same infusion set

Interaction

• Impact on absorption of ketoconazole
• Metabolism through cytochrome P450 affecting elimination of diazepam, phenytoin, and warfarin
• Monitoring of patients receiving warfarin or phenytoin
• Potential changes in blood concentration of phenytoin and coagulation time with concurrent treatment
• Increased plasma concentrations during coadministration with clarithromycin
• No evidence of interaction with phenacetin, theophylline, caffeine, etc.
• Increased bioavailability of digoxin with simultaneous treatment

Contraindications

• Known hypersensitivity to omeprazole
• Need to exclude possibility of malignancy before treatment

Side Effects

• Mild and reversible adverse reactions
• Reports of skin rash, urticaria, and pruritus
• Occasional cases of atrophic gastritis
• Gastrointestinal reactions including diarrhea, nausea/vomiting, flatulence, and abdominal pain
• Isolated cases of paraesthesia, dizziness, and insomnia
• Reports of reversible mental confusion, agitation, and depression
• Cases of arthritic and myalgic symptoms
• Occasional reports of blurred vision, taste disturbance, and peripheral edema

Pregnancy & Lactation

• No adverse effects on pregnancy or newborn health based on prospective studies
• Use during pregnancy
• No information available on passage into breast milk
• Discontinuation of breastfeeding if essential use is considered

Precautions & Warnings

• Avoid concomitant use with clopidogrel
• Possible association with increased risk for osteoporosis-related fractures
• Occasional presence of atrophic gastritis in long-term use
• 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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