G-Omeprazole 40 mg/vial (IV Injection)

Indications

• Gastric and duodenal ulcer
• NSAID-associated duodenal and gastric ulcer
• As 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

• Substituted benzimidazole
• 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
• Secretory activity returns gradually over 3 to 5 days after discontinuation

Dosage

• Oral administration
• 20 mg once daily for benign gastric and duodenal ulcer for 4-8 weeks
• 40 mg daily for severe or recurrent cases
• 20 mg once daily for NSAID-associated duodenal or gastric ulcer
• 20 mg once daily for gastro-esophageal reflux disease for 4-8 weeks
• 40 mg once daily for refractory cases of gastro-esophageal reflux disease
• 10-20 mg daily for long-term management of acid reflux disease
• 10-20 mg once daily for acid-related dyspepsia for 2-4 weeks

Administration

• Oral administration
• Intravenous injection
• Intravenous infusion over 20-30 minutes or more
• Reconstitution of injection and infusion
• Slow intravenous injection over at least 2 to 5 minutes
• Use within specified time after reconstitution

Interaction

• Decreased intragastric acidity affecting absorption of ketoconazole
• Metabolism in the liver through cytochrome P450
• Potential delay in elimination of diazepam, phenytoin, and warfarin
• Possible increase in plasma concentrations of omeprazole and clarithromycin during concomitant administration

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, nausea/vomiting, and abdominal pain
• Dry mouth, stomatitis, and candidiasis
• Dizziness, somnolence, insomnia, and vertigo
• Reversible mental confusion, agitation, depression, and hallucinations
• Arthritic and myalgic symptoms

Pregnancy & Lactation

• No adverse effects on pregnancy or on the health of the fetus/newborn child based on epidemiological studies
• Usage during pregnancy possible
• No information available on passage into breast milk or its effects on the neonate
• Discontinuation of breastfeeding if essential use of omeprazole is considered

Precautions & Warnings

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

Therapeutic Class

Proton Pump Inhibitor

Storage Conditions

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
• Aspra 20 mg (Capsule (Enteric Coated)) - apex-pharmaceuticals-ltd
• AU-20 20 mg (Capsule (Enteric Coated)) - decent-pharma-laboratories-ltd
• Aumi 20 mg (Capsule (Enteric Coated)) - hudson-pharmaceuticals-ltd