Product Details

 Action Suppresses gastric acid secretion by blocking “acid (proton) pump” within gastric parietal cell.

 Indications Short-term treatment of active duodenal ulcer, gastroesophageal reflux disease (GERD), including erosive esophagitis and symptomatic GERD; long-term treatment of pathologic hypersecretory conditions (eg, Zollinger-Ellison syndrome, multiple endocrine adenomas, systemic mastocytosis); to maintain healing of erosive esophagitis; in combination with clarithromycin to eradicate H. pylori, use clarithromycin and amoxicillin in combination with omeprazole in patients with a 1-yr history of duodenal ulcers or active duodenal ulcers to eradicate H. pylori ; short-term treatment of active benign gastric ulcer.

Posterior laryngitis; enhanced efficacy of pancreatin for treatment of steatorrhea in cystic fibrosis.

 Contraindications Standard considerations.

 Route/Dosage

Active Duodenal Ulcer

Adults: PO 20 mg/day for 4 to 8 wk.

Erosive Esophagitis

Adults: PO 20 mg/day for 4 to 8 wk. Maintenance: 20 mg/day.

Pathologic Hypersecretory Conditions

Adults: PO Initial dose: 60 mg/day. Doses up to 120 mg tid have been given. Divide daily doses more then 80 mg.

H. pylori

Adults (triple therapy): PO 20 mg omeprazole plus clarithromycin 500 mg plus amoxicillin 1000 mg each given bid for 10 days; continue omeprazole 20 mg/day for an additional 18 days if an ulcer is present at start of therapy. Adults (dual therapy): PO 40 mg omeprazole once daily plus clarithromycin 500 mg tid for 14 days; continue omeprazole 20 mg/day for an additional 14 days if an ulcer is present at start of therapy.

Gastric ulcer

Adults: PO 40 mg once daily for 4 to 8 wk.

GERD

Adults (without esophageal lesions): PO 20 mg/day for 4 wk. Adults (with erosive esophagitis): PO 20 mg/day for 4 to 8 wk.

 Interactions

Benzodiazepines: Clearance of benzodiazepines may be decreased. Cilostazol: Plasma levels may be increased by omeprazole, increasing the therapeutic and adverse effects. Clarithromycin: Serum concentrations of clarithromycin and omeprazole may be increased. Drugs depending on gastric pH for bioavailability (eg, ketoconazole, iron salts, ampicillin): Absorption of these drugs may be affected. Phenytoin: Decreased plasma clearance and increased phenytoin half-life. Warfarin: Prolonged warfarin elimination.

 Lab Test Interferences None well documented.

 Adverse Reactions

CARDIOVASCULAR: Angina; tachycardia; bradycardia; palpitation. CNS: Headache; dizziness. DERMATOLOGIC: Rash. GI: Diarrhea; abdominal pain; acid regurgitation; nausea; vomiting; constipation; flatulence. RESPIRATORY: Cough; upper respiratory tract infection. OTHER: Asthenia; back pain.

 Precautions

Pregnancy: Category C. Lactation: Undetermined. Children: Safety and efficacy in children not established.

 Administration/Storage

• Do not open, chew, or crush capsule. Instruct patient to swallow capsule whole.
• Divide daily doses greater than 80 mg.
• Give before meals or as one-time daily dose. If medication is administered once daily, give before dinner.
• Store at room temperature in original container tightly closed and protected from light.

 Assessment/Interventions

• Obtain patient history, including drug history and any known allergies.
• Review baseline CBC and LFT results, and monitor as indicated.
• Assess for coffee ground emesis, tarry stools, or constipation.
• Assess for any symptoms of hyperacidity (eg, dyspepsia, nausea, vomiting).
• Monitor elimination patterns and document any problems such as constipation.
• Assess skin for rashes or hives.
• Encourage adequate fluid intake and roughage in diet.

 Patient/Family Education

• Advise patient not to chew or crush medication, and to swallow medication whole.
• Remind patient to take medication before meals.
• Inform patient that antacids may be taken concurrently with omeprazole.
• Advise patient to avoid tasks requiring alertness until response to medication is established.
• Caution patient to report the following symptoms to health care provider: cramping, diarrhea, rash, hives.

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Copyright © 2003 Facts and Comparisons
David S. Tatro
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