Dosing & Uses
Dosage Forms & Strengths
powder packet for suspension
Duodenal Ulcer (Active)
20 mg omeprazole PO qDay for 4-8 weeks
Indicated for short-term treatment of active benign gastric ulcer
40 mg omeprazole PO qDay for 4-8 weeks
Indicated for maintenance of healing erosive esophagitis
20 mg omeprazole PO qDay for 4-8 weeks
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
Safety and efficacy not established
Serious - Use Alternative
Significant - Monitor Closely
Nosocomial pneumonia (11%)
Atrial fibrillation (6%)
Oral candidiasis (4%)
Supraventricular tachycardia (3%)
Decubitus ulcer (3%)
Urinary tract infection (2%)
Candidal infection (2%)
Benign gastric polyps
Cutaneous and systemic lupus erythematosus
Cyanocobalamin (vitamin B-12) deficiency
Clostridium difficile-Associated Diarrhea
Hypersensitivity drugs or components of the formulation
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
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 (e.g. ANA) may be positive and elevated serological test results may take longer to resolve than clinical manifestations
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; consider monitoring magnesium levels prior to initiation of PPI treatment and periodically
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; consider additional follow-up and diagnostic testing in adult patients who have suboptimal response or early symptomatic relapse after completing treatment with a PPI
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
May elevate and/or prolong serum concentrations of methotrexate and/or its metabolite when administered oncomitantly with PPIs, possibly leading to toxicity; consider a temporary withdrawal of PPI therapy therapy with high dose methotrexate administration
Pregnancy & 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
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.
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
Onset: 1 hr (antisecretory effect); 2 hr peak antisecretory effect); 1-4 days (full therapeutic effect)
Duration: 72 hr
Peak plasma time: 30 min
Protein bound: 95%
Metabolized by liver
Half-life: 0.4-3.2 hr (normal hepatic function); 3 hr (hepatic deficiency)
Excretion: Urine (77%); feces
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The above information is provided for general informational and educational purposes only. Individual plans may vary and formulary information changes. Contact the applicable plan provider for the most current information.
|1||This drug is available at the lowest co-pay. Most commonly, these are generic drugs.|
|2||This drug is available at a middle level co-pay. Most commonly, these are "preferred" (on formulary) brand drugs.|
|3||This drug is available at a higher level co-pay. Most commonly, these are "non-preferred" brand drugs.|
|4||This drug is available at a higher level co-pay. Most commonly, these are "non-preferred" brand drugs or specialty prescription products.|
|5||This drug is available at a higher level co-pay. Most commonly, these are "non-preferred" brand drugs or specialty prescription products.|
|6||This drug is available at a higher level co-pay. Most commonly, these are "non-preferred" brand drugs or specialty prescription products.|
|NC||NOT COVERED – Drugs that are not covered by the plan.|
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