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

Duodenal Ulcer

Indicated for active duodenal ulcer

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

Short-term treatment

  • Indicated for short-term treatment of erosive esophagitis (EE) due to acid-mediated gastroesophageal reflux disease (GERD) which has been diagnosed by endoscopy
  • 20 mg omeprazole PO qDay for 4-8 weeks
  • Use for longer than 8 weeks in patients with EE has not been established
  • If no response to 8 weeks of treatment, an additional 4 weeks of treatment may be given
  • If EE or GERD symptoms recur, consider an additional 4-8 week course

Maintenance of healing

  • 20 mg omeprazole PO qDay
  • Controlled studies do not extend beyond 12 months
  • Asian individuals and CYP2C19 poor metabolizers
    • Avoid omeprazole as maintenance therapy in CYP2C19 poor metabolizers or individuals of Asian descent
    • Asians have ~4-fold higher systemic exposure of omeprazole compared with Caucasians

Symptomatic GERD

20 mg omeprazole PO qDay for up to 4 weeks

Upper GI Bleeding

Oral suspension

  • Indicated for risk reduction of upper GI bleeding in critically ill patients
  • 40 mg PO initially; followed by 40 mg 6-8 hr later
  • Thereafter, 40 mg PO qDay 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

Dosage Modifications

Hepatic impairment

  • Mild-to-severe (Child-Pugh Class A, B, or C): Exposure to omeprazole substantially increased compared to healthy subjects
  • Avoid use in patients with hepatic impairment for maintenance of healing of erosive esophagitis

Safety and efficacy not established

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Interactions

Interaction Checker

and omeprazole/sodium bicarbonate

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        Significant - Monitor Closely

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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

            Fundic gland polyps

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            Warnings

            Contraindications

            Hypersensitivity drugs or components of the formulation

            Patients receiving rilpivirine containing products

            Cautions

            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

            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

            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

            Sodium bicarbonate content

            • Contains sodium bicarbonate; avoid use in patients with Bartter syndrome, hypokalemia, hypocalcemia, or problems with acid-base balance
            • Chronic bicarbonate administration with calcium or milk can cause milk-alkali syndrome
            • Chronic use of sodium bicarbonate may lead to systemic alkalosis, and increased sodium intake can produce edema and weight gain

            Drug interaction overview

            • May elevate and/or prolong serum concentrations of methotrexate and/or its metabolite when administered concomitantly with PPIs, possibly leading to toxicity; consider a temporary withdrawal of PPI therapy with high dose methotrexate administration
            • 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 patients who have suboptimal response or early symptomatic relapse after completing treatment with a PPI
            • Omeprazole can reduce the absorption of other drugs due to its effect on reducing intragastric acidity
            • Proton pump inhibitors may decrease the efficacy of clopidogrel by reducing the formation of the active metabolite
            • Inhibits hepatic isoenzyme CYP2C19 and may alter metabolism of drugs that are CYP2C19 substrates
            • Potential for increased exposure of tacrolimus, especially in transplant patients who are intermediate or poor metabolizers of CYP2C19
            • Antiretrovirals
              • Effect of PPIs on antiretroviral drugs varies
              • Decreased exposure of some antiretroviral drugs (eg, rilpivirine, atazanavir and nelfinavir) when used concomitantly with omeprazole may reduce antiviral effect and promote the development of drug resistant
              • Increased exposure of other antiretroviral drugs (eg, saquinavir) when used concomitantly with omeprazole may increase toxicity
              • Rilpivirine-containing products: Coadministration is contraindicated
              • Atazanavir or nelfinavir: Avoid concomitant use; see prescribing information for atazanavir or nelfinavir for dosing information
              • Saquinavir: See prescribing information for saquinavir for monitoring of potential saquinavir-related toxicities
              • Other antiretrovirals: See prescribing information for specific antiretroviral drugs
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            Pregnancy & Lactation

            Pregnancy

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

            Omeprazole

            • There are no adequate and well-controlled studies with omeprazole in pregnant women
            • Available epidemiologic data fail to demonstrate an increased risk of major congenital malformations or other adverse pregnancy outcomes with first trimester omeprazole use

            Sodium bicarbonate

            • Available data with use in pregnant women are insufficient to identify a drug associated risk of major birth defects or miscarriage
            • Published animal studies report that sodium bicarbonate administered to rats, mice or rabbits during pregnancy did not cause adverse developmental effects in offspring

            Lactation

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

            There are no clinical data on the effects of omeprazole or sodium bicarbonate on the breastfed infant or on milk production

            Consider developmental and health benefits of breastfeeding along with the mother's clinical need and any potential adverse effects on the breastfed infant from treatment or from the underlying maternal condition

            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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            Administration

            Oral Preparation

            Capsules

            • Swallow capsules intact with water
            • Do not open the capsule and do not administer with liquids other than water
            • Take on an empty stomach at least 1 hr before a meal

            Oral suspension

            • Mix powder with water and administered orally or via a nasogastric (NG) or orogastric (OG) tube
            • If administered orally, take on an empty stomach at least 1 hr before a meal
            • If administered via NG or OG tube, suspend enteral feeding ~3 hr before and 1 hr after the oral suspension

            Oral Administration

            Empty the contents of packet into small cup containing 5-10 mL of water

            Do not mix with liquids or foods other than water

            Stir well and drink immediately

            Refill cup with water and drink immediately

            NG or OG tube administration

            • Add 20 mL of water to a catheter tipped syringe and then add the contents of a packet
            • Use an appropriately-sized catheter tipped syringe
            • Do not mix with liquids or foods other than water
            • Shake syringe to dissolve the powder
            • Administer through NG or orogastric tube into the stomach right away
            • Refill syringe with an equal amount of water
            • Shake and flush any remaining contents from the NG tube or orogastric tube into the stomach

            Storage

            All formulations

            Store at 25ºC (77ºF); excursions permitted to 15-30ºC (59-86ºF)

            Keep container tightly closed

            Protect from light and moisture

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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.
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            NC NOT COVERED – Drugs that are not covered by the plan.
            Code Definition
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            Medscape prescription drug monographs are based on FDA-approved labeling information, unless otherwise noted, combined with additional data derived from primary medical literature.