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PRILOSEC for ORAL SUSPENSION
Hyperacidity, GERD, and ulcers
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Drug Name:

PRILOSEC for ORAL SUSPENSION Rx

Generic Name and Formulations:
Omeprazole 2.5mg, 10mg; per packet; e-c delayed-release granules.

Company:
AstraZeneca Pharmaceuticals

Therapeutic Use:

Indications for PRILOSEC for ORAL SUSPENSION:

Triple therapy (w. amoxicillin + clarithromycin) or dual therapy (w. clarithromycin) 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.

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. GERD (no esophageal lesions): 20mg once daily for up to 4 weeks. EE with GERD symptoms: 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: consider reducing dose (esp. for maintenance of healing of EE).

Children:

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. <1yr: not established. 1–16yrs: GERD, EE: 5–<10kg: 5mg daily. 10–<20kg: 10mg daily; ≥20kg: 20mg daily.

Warnings/Precautions:

Gastric malignancy. Discontinue if acute interstitial nephritis occurs. Long-term therapy may lead to malabsorption/deficiency of Vit. B12 or atrophic gastritis. Increased risk of osteoporosis-related fractures (hip, wrist or spine) with long-term and multiple daily dose PPI therapy. Monitor magnesium levels with long-term therapy. Use lowest dose for shortest duration. Pregnancy. Nursing mothers.

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.

See Also:

PRILOSEC

Pharmacological Class:

Proton pump inhibitor.

Adverse Reactions:

Headache, abdominal pain, nausea, vomiting, diarrhea, flatulence; bone fracture, hypomagnesemia (w. prolonged PPI therapy), possible C. difficile-associated diarrhea. Children: also, respiratory system events, fever.

Note:

Note: See Amoxil entry for more information on amoxicillin. See Biaxin entry for more information on clarithromycin.

Metabolism:

Hepatic (CYP450). 95% protein bound.

Elimination:

Renal, fecal.

Generic Availability:

Caps (YES); susp (NO)

How Supplied:

Caps 10mg—30; 20mg—30, 1000; 40mg—30, 100; Packets—30

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