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Omeprazole Generic Name & Formulations
Legal Class
Rx
General Description
Omeprazole 10mg, 20mg, 40mg; caps containing e-c del-rel granules.
Pharmacological Class
Proton pump inhibitor.
See Also
How Supplied
Caps—contact supplier; Packets—30
Manufacturer
Generic Availability
Caps (YES); susp (NO)
Mechanism of Action
Omeprazole suppresses gastric acid secretion by specific inhibition of the (H+, K+)-ATPase enzyme system at the secretory surface of the gastric parietal cell.
Omeprazole Indications
Indications
Triple therapy (w. amoxicillin + clarithromycin) or dual therapy (w. clarithromycin) for H. pylori eradication in duodenal ulcer disease in adults. Short-term treatment of active benign gastric ulcer and active duodenal ulcer in adults. Short-term treatment of erosive esophagitis (EE) in patients aged ≥1 month. Treatment of symptomatic GERD and maintenance of healing of EE in patients aged ≥1 year. Pathological hypersecretory conditions in adults.
Omeprazole Dosage and Administration
Adult
Take before eating. Caps: swallow whole, or may mix contents of caps in applesauce and take immediately; do not crush or chew granules; follow with water. Susp: Mix 2.5mg packet with 5mL of water; mix 10mg packet with 15mL of water. Leave 2–3 mins to thicken, stir and drink within 30 mins. NG or gastric tube: see full labeling. Triple therapy: omeprazole 20mg + clarithromycin 500mg + amoxicillin 1g, all every 12hrs 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 weeks; may continue 4 more weeks. Gastric ulcer: 40mg once daily for 4–8 weeks. Symptomatic GERD: 20mg once daily for up to 4 weeks. EE: 20mg once daily for 4–8 weeks; may give up to 4 more weeks (if relapse of erosive esophagitis or GERD symptoms occurs may give additional 4–8 week 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: reduce to 10mg once daily for maintenance of healing of EE.
Children
<1mo (EE), <1yr (symptomatic GERD, maintenance of healing of EE): not established. Take before eating. Caps: swallow whole, or may mix contents of caps in applesauce and take immediately; do not crush or chew granules; follow with water. Susp: Mix 2.5mg packet with 5mL of water; mix 10mg packet with 15mL of water. Leave 2–3 mins to thicken, stir and drink within 30 mins. NG or gastric tube: see full labeling. 1mo–<1yr: EE (3–<5kg): 2.5mg; (5–<10kg): 5mg; (≥10kg): 10mg; give once daily up to 6 weeks. 1–16yrs: EE (5–<10kg): 5mg; (10–<20kg): 10mg; (≥20kg): 20mg; give once daily for 4–8 weeks; may give up to 4 more weeks (if relapse of erosive esophagitis or GERD symptoms occurs may give additional 4–8 week course). Symptomatic GERD, maintenance of EE healing (5–<10kg): 5mg; (10–<20kg): 10mg; (≥20kg): 20mg; give once daily up to 4 weeks (GERD) or up to 12 months as in controlled studies (maintenance).
Administration
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.
Nursing Considerations
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.
Omeprazole Contraindications
Not Applicable
Omeprazole Boxed Warnings
Not Applicable
Omeprazole Warnings/Precautions
Warnings/Precautions
Gastric malignancy. Discontinue and evaluate if acute tubulointerstitial nephritis, severe cutaneous adverse reactions, or cutaneous/systemic lupus erythematosus occurs. Long-term therapy (eg, >3yrs) may lead to malabsorption/deficiency of Vit. B12 or atrophic gastritis. Monitor magnesium levels during prolonged therapy. Consider monitoring magnesium, calcium levels in those with preexisting risk of hypocalcemia (eg, hypoparathyroidism). Increased risk of fundic gland polyps with long-term use (esp. >1yr) or osteoporosis-related fractures (hip, wrist or spine) with long-term (>1yr) and multiple daily dose PPI therapy. Use lowest dose for shortest duration appropriate to condition. Pregnancy. Nursing mothers.
Omeprazole Pharmacokinetics
Distribution
Plasma protein bound: ~95%.
Elimination
Renal (~77%), fecal. Plasma half-life: 0.5–1 hour.
Omeprazole Interactions
Interactions
Concomitant St. John's wort, rifampin, atazanavir, nelfinavir: not recommended. Potentiates saquinavir, cilostazol; consider dose reduction of these drugs. May potentiate diazepam, phenytoin, warfarin, tacrolimus, methotrexate. Caution with drugs that may cause hypomagnesemia (eg, digoxin, diuretics); monitor. Potentiated by voriconazole; may need to adjust omeprazole dose in Zollinger-Ellison syndrome. Antagonizes clopidogrel; consider alternative anti-platelet therapy. May alter absorption of pH-dependent drugs (eg, ketoconazole, erlotinib, mycophenolate mofetil, digoxin, iron salts, ampicillin). Monitor drugs metabolized by CYP450 (eg, cyclosporine, disulfiram, benzodiazepines). May give antacids concomitantly. May interfere with neuroendocrine diagnostic tests; discontinue omeprazole 14 days prior to CgA level assessment.
Omeprazole Adverse Reactions
Adverse Reactions
Headache, abdominal pain, nausea, vomiting, diarrhea, flatulence; bone fracture, possible C. difficile-associated diarrhea; rare: hypomagnesemia and mineral metabolism. Children: also, respiratory system events, fever.
Omeprazole Clinical Trials
See Literature
Omeprazole Note
Notes
Note: See Amoxil entry for more information on amoxicillin. See Biaxin entry for more information on clarithromycin.
Omeprazole Patient Counseling
See Literature
