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Zegerid Generic Name & Formulations
Legal Class
Rx
General Description
Omeprazole, sodium bicarbonate; 20mg/1100mg, 40mg/1100mg; caps; contains 304mg Na+/cap.
Pharmacological Class
Proton pump inhibitor + antacid.
See Also
How Supplied
Caps—30; Susp—30 packets
Manufacturer
Generic Availability
YES
Mechanism of Action
Omeprazole suppresses gastric acid secretion by specific inhibition of the (H+/K+)-ATPase enzyme system on the surface of the gastric parietal cell. Sodium bicarbonate raises the gastric pH and protects omeprazole from acid degradation.
Zegerid Indications
Indications
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).
Zegerid Dosage and Administration
Adult
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.
Children
<18yrs: not established.
Administration
Take on empty stomach. Swallow whole with water only. Do not open caps and sprinkle contents on food. Due to sodium bicarbonate component, two 20mg caps are not equivalent to one 40mg cap.
Nursing Considerations
Take on empty stomach. Swallow whole with water only. Do not open caps and sprinkle contents on food. Due to sodium bicarbonate component, two 20mg caps are not equivalent to one 40mg cap.
Zegerid Contraindications
Contraindications
Concomitant rilpivirine-containing products.
Zegerid Boxed Warnings
Not Applicable
Zegerid Warnings/Precautions
Warnings/Precautions
Symptomatic response does not preclude gastric malignancy. Discontinue and evaluate if acute tubulointerstitial nephritis, severe cutaneous adverse reactions, or cutaneous/systemic lupus erythematosus occurs. Sodium-restricted diets. CHF. Avoid in Bartter's syndrome, hypokalemia, hypocalcemia, or acid-base balance abnormalities. Long-term therapy (eg, >3yrs) may lead to malabsorption/deficiency of Vit. B12. 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. Hepatic impairment or Asian patients: avoid use for maintenance of healing of EE. Pregnancy. Nursing mothers.
Zegerid Pharmacokinetics
Distribution
Plasma protein bound: ~95%.
Elimination
Renal (77%), fecal, biliary.
Zegerid Interactions
Interactions
Avoid concomitant clopidogrel, St. John's Wort, rifampin, atazanavir, nelfinavir. May potentiate citalopram, cilostazol, diazepam, digoxin, phenytoin, warfarin (monitor INR/PT), tacrolimus, saquinavir, methotrexate (esp. high-dose); monitor. Potentiated by voriconazole. May alter absorption of pH-dependent drugs (eg, erlotinib, dasatinib, nilotinib, ketoconazole, itraconazole, mycophenolate mofetil, iron salts). Monitor drugs metabolized by CYP450 (eg, cyclosporine, disulfiram). Long-term use of bicarbonate with calcium or milk may cause milk-alkali syndrome. Concomitant digoxin, diuretics may predispose patients to hypomagnesemia. May interfere with neuroendocrine tumor diagnostic investigations, secretin stimulation tests; interrupt therapy for ≥14 days. May result in false (+) urine tests for tetrahydrocannabinol.
Zegerid Adverse Reactions
Adverse Reactions
Headache, abdominal pain, nausea, diarrhea, vomiting, flatulence; bone fracture; possible C. difficile associated diarrhea; rare: hypomagnesemia and mineral metabolism.
Zegerid Clinical Trials
See Literature
Zegerid Note
Not Applicable
Zegerid Patient Counseling
See Literature
