omeprazole/sodium bicarbonate (Zegerid, Zegerid OTC)
Classes: Proton Pump Inhibitors; Antacids, Combos
Dosing and uses of Zegerid, Zegerid OTC (omeprazole/sodium bicarbonate)
Adult dosage forms and strengths
capsule
- 20mg/1.1g
- 40mg/1.1g
powder packet for suspension
- 20mg/1.680g
- 40mg/1.680g
Duodenal Ulcer (Active)
20 mg omeprazole PO qDay for 4-8 weeks
Gastric Ulcer
Indicated for short-term treatment of active benign gastric ulcer
40 mg omeprazole PO qDay for 4-8 weeks
Erosive Esophagitis
Indicated for maintenance of healing erosive esophagitis
20 mg omeprazole PO qDay for 4-8 weeks
Symptomatic GERD
20 mg omeprazole PO qDay for up to 4 weeks
Upper GI Bleeding (Critically-ill Patients)
Indicated for risk reduction of upper GI bleeding in critically ill patients
Loading dose (day 1): 40 mg oral suspension PO q6-8hr for 2 doses
Maintenance dose: 40 mg oral suspension PO qDay for up to 14 days
Heartburn (OTC Label)
20 mg PO qDay for 14 days; not to exceed 14 days or more often than every 4 months unless under the supervision of a healthcare professionaL
Pediatric dosage forms and strengths
Safety and efficacy not established
Zegerid, Zegerid OTC (omeprazole/sodium bicarbonate) adverse (side) effects
>10%
Pyrexia (20%)
Hypokalemia (12%)
Hyperglycemia (11%)
Nosocomial pneumonia (11%)
1-10%
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%)
<1%
Angina
Fracture
Glycosuria
Anemia
Hepatic failure
Benign gastric polyps
Agranulocytosis
Alopecia
Increased creatinine
Hemolytic anemia
Angioedema
Gynecomastia
Anorexia
Hepatic encephalopathy
Metabolic alkalosis
Pancreatitis
Photosensitivity
Liver disease
Warnings
Contraindications
Hypersensitivity drugs or components of the formulation
Cautions
Atrophic gastritis reported with long term use
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
Contains sodium bicarbonate; use with caution in patients with Bartter’s syndrome
Use with caution in patients with respiratory alkalosis due to the presence of sodium bicarbonate
May require dosage reduction with liver disease Bioavailability may be increased in the elderly
Use caution in patients with hypokalemia or hypocalcemia; contains sodium bicarbonate
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
Hypomagnesemia may occur with prolonged use (>1 year); adverse effects may result and include tetany, arrhythmias, and seizures; in 25% of cases reviewed, magnesium supplementation alone did not improve low serum magnesium levels and the PPI had to be discontinued
Decreased gastric acidity increases serum chromogranin A (CgA) levels and may cause false-positive diagnostic results for neuroendocrine tumors; temporarily discontinue PPIs before assessing CgA levels
Inhibits hepatic isoenzyme CYP2C19 and may alter metabolism of drugs that are CYP2C19 substrates
Proton pump inhibitors may decrease the efficacy of clopidogrel by reducing the formation of the active metabolite 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
Pregnancy and lactation
Pregnancy category: C
Lactation: Distributes into human breast milk; avoid use
Breast milk peak concentration time ~3 hr following 20 mg dose (peak concentration <7% of peak serum concentrations)
Because of the potential for serious adverse reactions in nursing infants from omeprazole, and the potential for tumorigenicity shown in rat carcinogenicity studies, a decision should be made to discontinue nursing or to discontinue the drug, taking into account the importance of the drug to the mother
In addition, sodium bicarbonate should be used with caution in nursing mothers
Pregnancy categories
A: Generally acceptable. Controlled studies in pregnant women show no evidence of fetal risk.
B: May be acceptable. Either animal studies show no risk but human studies not available or animal studies showed minor risks and human studies done and showed no risk.
C: Use with caution if benefits outweigh risks. Animal studies show risk and human studies not available or neither animal nor human studies done.
D: Use in LIFE-THREATENING emergencies when no safer drug available. Positive evidence of human fetal risk.
X: Do not use in pregnancy. Risks involved outweigh potential benefits. Safer alternatives exist.
NA: Information not available.
Pharmacology of Zegerid, Zegerid OTC (omeprazole/sodium bicarbonate)
Mechanism of action
PPI; binds to H+/K+-exchanging ATPase (proton pump) in gastric parietal cells, resulting in suppression of basal and stimulated acid secretion
Absorption
Bioavailability: 30-40%
Onset: 1 hr (antisecretory effect); 2 hr peak antisecretory effect); 1-4 days (full therapeutic effect)
Duration: 72 hr
Peak plasma time: 30 min
Distribution
Protein bound: 95%
Metabolism
Metabolized by liver
Elimination
Half-life: 0.4-3.2 hr (normal hepatic function); 3 hr (hepatic deficiency)
Excretion: Urine (77%); feces
