Generic Name and Formulations:
Omeprazole 10mg, 20mg, 40mg; caps containing e-c delayed release granules.
Company:
AstraZeneca Pharmaceuticals
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.
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 minutes to thicken, stir and drink within 30 minutes. NG or gastric tube: see full labeling. 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 (esp. for maintenance of healing of EE).
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 minutes to thicken, stir and drink within 30 minutes. NG or gastric tube: see full labeling. <1yr: not recommended. 1–16yrs: GERD, EE: 5<10kg: 5mg daily. 10<20kg: 10mg daily; ≥20kg: 20mg daily.
Proton pump inhibitor.
Gastric malignancy. Increased risk of osteoporosis-related fractures of the hip, wrist or spine with long-term and multiple daily dose PPI therapy. Monitor magnesium levels with long-term therapy. Pregnancy (Cat.C). Nursing mothers: not recommended.
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. 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, digoxin, iron salts, ampicillin). Monitor drugs metabolized by CYP450 (eg, cyclosporine, disulfiram, benzodiazepines). May give antacids concomitantly. May interfere with neuroendocrine diagnostic tests.
Headache, abdominal pain, GI upset, flatulence; bone fracture, hypomagnesemia (w. prolonged PPI therapy), possible C. difficile associated diarrhea. Children: also, respiratory system events, fever.
Note: See Amoxil entry for more information on amoxicillin. See Biaxin entry for more information on clarithromycin.
Hepatic (CYP450). 95% protein bound.
Renal, fecal.
Caps (YES); susp (NO)
Caps 10mg—30; 20mg—30, 1000; 40mg—30, 100; packets—30