omeprazole/sodium bicarbonate (Rx, OTC)

Brand and Other Names:Zegerid, Zegerid OTC
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Dosing & Uses

AdultPediatric

Dosage Forms & Strengths

capsule

  • 20mg/1.1g
  • 40mg/1.1g

powder packet for suspension

  • 20mg/1.680g
  • 40mg/1.680g
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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

Safety and efficacy not established

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Interactions

Interaction Checker

and omeprazole/sodium bicarbonate

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    Interactions Found

    Contraindicated

      Serious - Use Alternative

        Significant - Monitor Closely

          Minor

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            Adverse 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

            Postmarketing Reports

            Cutaneous and systemic lupus erythematosus

            Cyanocobalamin (vitamin B-12) deficiency

            Clostridium difficile-Associated Diarrhea

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            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

            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

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            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

            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.

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            Pharmacology

            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

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            Formulary

            FormularyPatient Discounts

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            Tier Description
            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.
            Code Definition
            PA Prior Authorization
            Drugs that require prior authorization. This restriction requires that specific clinical criteria be met prior to the approval of the prescription.
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            Drugs that have step therapy associated with each prescription. This restriction typically requires that certain criteria be met prior to approval for the prescription.
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            Drugs that have restrictions other than prior authorization, quantity limits, and step therapy associated with each prescription.
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