Monograph Details
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Gastrointestinal Tract
> Hyperacidity, GERD, and ulcers
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PRILOSEC |
| Manufacturer |
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AstraZeneca Pharmaceuticals |
| Legal Classification |
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Rx
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| Pharmacological Class |
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Acid pump inhibitor. |
| Generic Name |
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Omeprazole 10mg, 20mg, 40mg; caps containing e-c delayed release granules. |
| Indications |
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Triple therapy (w. amoxicillin + clarithromycin) or dual therapy (w. amoxicillin) for H. pylori eradication in duodenal ulcer disease. Short-term treatment of active benign gastric ulcer, active duodenal ulcer, erosive esophagitis (EE), symptomatic GERD. Maintenance of healing of EE. Pathological hypersecretory conditions. |
| Children |
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Take before eating. Swallow whole, or may mix contents of caps in applesauce and take immediately; do not crush or chew granules; follow with water. <2 years: not recommended. 2–16 years: GERD, EE: <20kg: 10mg daily; >20kg: 20mg daily. |
| Adults |
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Take before eating. Swallow whole, or may mix contents of caps in applesauce and take immediately; do not crush or chew granules; follow with water. Triple therapy: omeprazole 20mg + clarithromycin 500mg + amoxicillin 1g, all every 12 hrs for 10 days; then (if ulcer was present at start): omeprazole 20mg once daily in the AM on days 11–28. Dual therapy (clarithromycin resistance more likely to develop than with triple therapy): omeprazole 40mg once daily in the AM + clarithromycin 500mg three times daily on days 1–14; then (if ulcer was present at start) omeprazole 20mg once daily in the AM on days 15–28. Active duodenal ulcer: 20mg once daily for 4 wks; may continue 4 more wks. Gastric ulcer: 40mg once daily for 4–8 weeks. GERD (no esophageal lesions): 20mg once daily for up to 4 weeks. EE with GERD symptoms: 20mg once daily for 4–8 wks; may give up to 4 more wks (if relapse of erosive esophagitis or GERD symptoms occurs may give additional 4–8 wk course). Maintenance of healing of EE: 20mg once daily. Hypersecretory conditions: initially 60mg once daily, then adjust; doses up to 120mg 3 times daily have been used; give doses >80mg/day in divided doses. Hepatic impairment or Asian: consider reducing dose. |
| Precautions |
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Pregnancy (Cat.C). Nursing mothers: not recommended. |
| Interactions |
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May potentiate diazepam, phenytoin, warfarin. May alter absorption of pH-dependent drugs (eg, ketoconazole, digoxin, iron, ampicillin). May antagonize atazanavir. Monitor drugs metabolized by CYP450 (eg, cyclosporine, disulfiram, benzodiazepines). Give at least 30 minutes before sucralfate. May give antacids concomitantly. |
| Adverse Reactions |
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Headache, diarrhea, dizziness, rash, constipation, cough, back or abdominal pain. |
| Extra Text |
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Note: See Amoxil or Trimox entry for more information on amoxicillin. See Biaxin entry for more information on clarithromycin. |
| How Supplied |
Caps 10mg, 20mg—30, 1000
Caps 40mg—30, 100, 1000 |
| Additional Resources |
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• Related Prescribing Note |
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