Trade Names:Zegerid- Capsules omeprazole 20 mg/sodium bicarbonate 1,100 mg- Capsules omeprazole 40 mg/sodium bicarbonate 1,100 mg- Powder for oral suspension omeprazole 20 mg/sodium bicarbonate 1,680 mg- Powder for oral suspension omeprazole 40 mg/sodium bicarbonate 1,680 mg
Short-term treatment of active duodenal ulcer; short-term treatment of active benign gastric ulcer; treatment of heartburn and other symptoms associated with gastroesophageal reflux disease (GERD); short-term treatment of erosive esophagitis; maintain healing of erosive esophagitis; reduction of risk of upper GI bleeding in critically ill patients (oral suspension).
Standard considerations.
PO 20 mg once daily for 4 wk. May require additional 4 wk of therapy.
Benign Gastric UlcerAdultsPO 40 mg once daily for 4 to 8 wk.
GERDAdultsPO 20 mg once daily for up to 4 wk.
Erosive EsophagitisAdultsPO 20 mg once daily for 4 to 8 wk.
Maintenance of Healing of Erosive EsophagitisAdultsPO 20 mg once daily.
Reduction of Risk of Upper GI Bleeding in Critically Ill Patients (40 mg Suspension Only)AdultsPO Oral suspension 40 mg initially followed by 40 mg 6 to 8 h later and 40 mg daily thereafter for 14 days.
Store at 59° to 86°F.
Atazanavir plasma concentrations may be reduced, decreasing the efficacy.
Benzodiazepines, cyclosporine, disulfiramMay need to adjust dose of these drugs.
Cilostazol, tacrolimusSerum concentrations of these agents may be elevated by omeprazole, increasing the risk of adverse reactions.
ClarithromycinOmeprazole and clarithromycin plasma concentrations may be elevated.
Drugs dependent on gastric pH for bioavailability (eg, ampicillin, cyanocobalamin, digoxin, ketoconazole, indinavir, iron salts)Absorption of these agents may be reduced.
Drugs that undergo hepatic oxidation (eg, diazepam, phenytoin, warfarin)Elimination of these agents may be prolonged.
Hydantoins (eg, phenytoin)Hydantoin Cl may be decreased while the t ½ is increased.
St. John's wortOmeprazole plasma concentrations may be reduced, decreasing the efficacy.
WarfarinIncreased INR and PT, which may lead to abnormal bleeding and increase the risk of death.
None well documented.
Hypotension (10%); hypertension (8%); atrial fibrillation (6%); ventricular tachycardia (5%); bradycardia (4%); supraventricular tachycardia, tachycardia (3%).
Agitation (3%); seizures, tetany (sodium bicarbonate).
Rash (6%); decubitus ulcer (3%).
Constipation (5%); diarrhea, oral candidiasis (4%); gastric hypomotility (2%).
UTI (2%).
Thrombocytopenia (10%); anemia (8%).
Hypokalemia (12%); hyperglycemia (11%); hypomagnesemia (10%); hypocalcemia, hypophosphatemia (6%); fluid overload (5%); hyponatremia (4%); hypoglycemia (3%); hyperkalemia, hypernatremia, LFTs abnormal (2%); metabolic alkalosis (sodium bicarbonate).
Nosocomial pneumonia (11%); acute respiratory distress syndrome (3%); respiratory failure (2%); pneumothorax (1%).
Pyrexia (20%); hyperpyrexia, sepsis (5%); edema (3%); candidal infection (2%).
Category C .
Excreted.
Safety and efficacy not established.
Sodium bicarbonate is contraindicated in patients with metabolic acidosis and hypocalcemia; use with caution in patients with Bartter syndrome, hypokalemia, respiratory alkalosis, and problems with acid-base balance. Long-term use of bicarbonate with calcium or milk can cause milk-alkali syndrome.
Has been reported in gastric corpus biopsies in patients treated with long-term omeprazole.
Consider sodium content in patients on a sodium-restricted diet.
Blurred vision, confusion, diaphoresis, drowsiness, dry mouth, flushing, headache, nausea, tachycardia, vomiting.
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