ZEGERID for ORAL SUSPENSION Rx
Generic Name and Formulations:
Omeprazole 20mg, 40mg; sodium bicarbonate 1680mg; per packet; pwd; contains 460mg Na+/packet (as sodium bicarbonate).
Salix Pharmaceuticals, Inc.
Indications for ZEGERID for ORAL SUSPENSION:
Short-term treatment of active benign gastric ulcer, active duodenal ulcer, erosive esophagitis (EE). Symptomatic GERD. Maintenance of healing of EE. To reduce risk of upper GI bleed in critically ill patients (40mg oral susp only).
Take on empty stomach. Caps: swallow whole with water only. Susp: mix in 15–30mL water only; drink immediately; refill cup with water and drink; or, may give via NG/OG tube (see full labeling). Due to sodium bicarbonate component, two 20mg packets or caps are not equivalent to one 40mg packet or cap. ≥18yrs: 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. Maintenance of healing of EE: 20mg once daily. GI bleed risk reduction: Day 1: initially 40mg susp once then 40mg susp 6–8hrs later, then 40mg susp once daily for up to 14 days. Hepatic impairment or Asian: consider reduced dose.
<18yrs: not established.
Symptomatic response does not preclude gastric malignancy. Bartter's syndrome. Sodium-restricted diets. Hypokalemia. Hypocalcemia. Acid-base abnormalities. 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. Use lowest effective dose for shortest duration. Pregnancy (Cat.C). Nursing mothers: not recommended.
Avoid concomitant clopidogrel, St. John's Wort, rifampin. May potentiate diazepam, phenytoin, warfarin (monitor INR/PT), tacrolimus, saquinavir, clarithromycin, methotrexate (esp. high-dose). Potentiated by voriconazole, clarithromycin. May alter absorption of pH-dependent drugs (eg, ketoconazole, ampicillin, iron, digoxin). May antagonize atazanavir, nelfinavir: not recommended. Monitor drugs metabolized by CYP450 (eg, cyclosporine, disulfiram, benzodiazepines). Long-term use with calcium or milk may cause milk-alkali syndrome. Concomitant digoxin, diuretics may predispose patients to hypomagnesemia. May interfere with neuroendocrine diagnostic tests.
Headache, abdominal pain, nausea, diarrhea, vomiting, flatulence, dizziness, rash, constipation, cough, back pain; bone fracture, metabolic alkalosis; rare: atrophic gastritis, hypomagnesemia (w. prolonged PPI therapy), possible C. difficile associated diarrhea.
Hepatic. 95% protein bound.
Renal (major), fecal, biliary.
Caps—30; Susp—30 packets/box