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Omeprazole/Sodium Bicarbonate

    Brands

    DEA Class; Rx, OTC

    Common Brand Names; Zegerid, Zegerid OTC, Konvomep

    • Antacids, Combos; 
    • Proton Pump Inhibitors

    Oral immediate-release proton pump inhibitor (PPI) combined with a sodium bicarbonate buffer
    Prescription products used for GERD, erosive esophagitis, gastric and duodenal ulcer, and stress ulcer prophylaxis in critically ill patients
    Nonprescription products used for short-term use (14 days) to treat frequent heartburn

     Indicated for the treatment of active duodenal ulcer.

    For the short-term treatment of active benign gastric ulcer.
    For the treatment of gastroesophageal reflux disease (GERD).
    For the treatment of erosive esophagitis (erosive GERD).
    For stress gastritis prophylaxis in critically ill patients.
    For the non-prescription treatment of frequent pyrosis (heartburn) that occurs 2 or more days a week.
    For the treatment of eosinophilic esophagitis (EoE).

    Hypersensitivity drugs or components of the formulation

    Patients receiving rilpivirine containing products

    • Pyrexia (20%)
    • Hypokalemia (12%)
    • Hyperglycemia (11%)
    • Nosocomial pneumonia (11%)
    • Hypotension (10%)
    • Hypomagnesemia (10%)
    • Hypertension (8%)
    • Atrial fibrillation (6%)
    • Hypocalcemia (6%)
    • Rash (6%)
    • Tachycardia (5%)
    • Constipation (5%)
    • Sepsis (5%)
    • Hyperpyrexia (5%)
    • Oral candidiasis (4%)
    • Bradycardia (4%)
    • Diarrhea (4%)
    • Edema (3%)
    • Supraventricular tachycardia (3%)
    • Decubitus ulcer (3%)
    • Agitation (3%)
    • Hypernatremia (2%)
    • Hyperkalemia (2%)
    • Urinary tract infection (2%)
    • Hypomotility (2%)
    • Candidal infection (2%)

    Atrophic gastritis reported with long term use

    Acute interstitial nephritis may occur at any point during PPI therapy and is generally attributed to an idiopathic hypersensitivity reaction; discontinue treatment if acute interstitial nephritis develops

    PPIs are possibly associated with increased incidence of Clostridium difficile-associated diarrhea (CDAD); consider diagnosis of CDAD for patients taking PPIs who have diarrhea that does not improve

    Cutaneous lupus erythematosus (CLE) and systemic lupus erythematosus (SLE) reported with PPIs; avoid using for longer than medically indicated; discontinue if signs or symptoms consistent with CLE or SLE are observed and refer patient to specialist; most patients improve with discontinuation of PPI alone in 4-12 weeks; serological testing (eg, ANA) may be positive and elevated serological test results may take longer to resolve than clinical manifestations

    May require dosage reduction with liver disease

    Bioavailability may be increased in the elderly

    Shown to cause gastric carcinoid tumors in rats with increased doses, but risk in humans unconfirmed

    Published observational studies suggest that PPI therapy may be associated with an increased risk for osteoporosis-related fractures of the hip, wrist, or spine, particularly with prolonged (>1 year), high-dose therapy

    Gastric atrophy reported with long term use

    Relief of symptoms does not eliminate the possibility of a gastric malignancy

    Therapy increases risk of salmonella, campylobacter and other infections

    PPI therapy is associated with increased risk of fundic gland polyp; risk increases with long-term use >1 year; patient may be asymptomatic; problem usually identified incidentally on endoscopy; use shortest duration of therapy appropriate to condition being treated

    Acute tubulointerstitial nephritis (TIN) reported in patients taking PPIs; may occur at any point during PPI therapy; patients may present with varying signs and symptoms from symptomatic hypersensitivity reactions to non-specific symptoms of decreased renal function (eg, malaise, nausea, anorexia); in reported case series, some patients were diagnosed on biopsy and in absence of extra-renal manifestations (eg, fever, rash or arthralgia); discontinue therapy and evaluate patients with suspected acute TIN

    There are no adequate and well-controlled studies in pregnant women

    Available data from the published literature suggest both components, omeprazole and sodium bicarbonate, are present in human milk

    Adults

    40 mg/day PO (omeprazole 40 mg; 1100 mg sodium bicarbonate) for oral capsules and 40 mg/day PO (omeprazole 40 mg; 1680 mg sodium bicarbonate) for packets for oral suspension are recommended by the manufacturer; however, doses up to 80 mg/day have been studied for nocturnal acid breakthrough.

    Elderly

    40 mg/day PO (omeprazole 40 mg; 1100 mg sodium bicarbonate) for oral capsules and 40 mg/day PO (omeprazole 40 mg; 1680 mg sodium bicarbonate) for packets for oral suspension are recommended by the manufacturer; however, doses up to 80 mg/day have been studied for nocturnal acid breakthrough.

    Adolescents

    Safety and efficacy have not been established.

    Children

    Safety and efficacy have not been established.

    Omeprazole/sodium bicarbonate

    capsule

    • 20mg/1.1g (Zegerid, Zegerid OTC)
    • 40mg/1.1g (Zegerid)

    powder packet for suspension

    • 20mg/1.68g (Zegerid, Zegerid OTC)
    • 40mg/1.68g (Zegerid)

    oral suspension (Konvomep)

    • 2-bottle kit: 1 bottle contains omeprazole powder, the other contains sodium bicarbonate diluent
    • After reconstitution: (2mg/84mg)/mL in 90-mL, 150-mL, or 300-mL bottles