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Omeprazole and Sodium Bicarbonate

Pronunciation

(oh MEP ra zole & SOW dee um bye KAR bun ate)

Index Terms

  • Omeprazole/Sodium Bicarbonate
  • Sodium Bicarbonate and Omeprazole

Dosage Forms

Excipient information presented when available (limited, particularly for generics); consult specific product labeling.

Capsule, Oral:

Zegerid: Omeprazole 20 mg [immediate release] and sodium bicarbonate 1100 mg [contains sodium 304 mg (13 mEq) per capsule]

Zegerid: Omeprazole 40 mg [immediate release] and sodium bicarbonate 1100 mg [contains sodium 304 mg (13 mEq) per capsule]

Zegerid OTC: Omeprazole 20 mg [immediate release] and sodium bicarbonate 1100 mg [contains sodium 303 mg (13 mEq) per capsule]

Generic: Omeprazole 20 mg [immediate release] and sodium bicarbonate 1100 mg; Omeprazole 40 mg [immediate release] and sodium bicarbonate 1100 mg

Powder for suspension, Oral:

Zegerid: Omeprazole 20 mg and sodium bicarbonate 1680 mg per packet (30s) [contains sodium 460 mg (20 mEq) per packet]

Zegerid: Omeprazole 40 mg and sodium bicarbonate 1680 mg per packet (30s) [contains sodium 460 mg (20 mEq) per packet]

Generic: Omeprazole 20 mg and sodium bicarbonate 1680 mg per packet (30s); Omeprazole 40 mg and sodium bicarbonate 1680 mg per packet (30s)

Brand Names: U.S.

  • Zegerid
  • Zegerid OTC [OTC]

Pharmacologic Category

  • Proton Pump Inhibitor
  • Substituted Benzimidazole

Pharmacology

Suppresses gastric basal and stimulated acid secretion by inhibiting the parietal cell H+/K+ ATP pump

Absorption

Rapid

Metabolism

Extensively hepatic via CYP2C19 primarily and to a lesser extent via 3A4 to hydroxy, desmethyl, and sulfone metabolites (all inactive); saturable first pass effect

Excretion

Urine (77% as metabolites, very small amount as unchanged drug); feces

Clearance: 500 to 600 mL/minute; chronic hepatic disease: 70 mL/minute

Onset of Action

Antisecretory: ~1 hour; Peak antisecretory effect: 2 hours; Full therapeutic effect: 1 to 4 days

Time to Peak

Serum: ~30 minutes

Duration of Action

72 hours; 50% of maximum effect at 24 hours

Half-Life Elimination

~1 hour (range: 0.4 to 3.2 hours); Hepatic dysfunction: ~3 hours

Protein Binding

~95%

Use: Labeled Indications

Short-term (4 to 8 weeks) treatment of active duodenal ulcer or active benign gastric ulcer; treatment of heartburn and other symptoms associated with gastroesophageal reflux disease (GERD) for up to 4 weeks; short-term (4 to 8 weeks) treatment of endoscopically diagnosed erosive esophagitis; maintenance healing of erosive esophagitis; reduction of risk of upper gastrointestinal bleeding in critically ill patients

OTC labeling: Short-term (2 weeks) treatment of frequent (2 days/week), uncomplicated heartburn

Contraindications

Hypersensitivity (eg, anaphylaxis, anaphylactic shock, angioedema, bronchospasm, acute interstitial nephritis, urticaria) to omeprazole, other substituted benzimidazole proton pump inhibitors, or any component of the formulation

Dosing: Adult

Note: Both strengths of Zegerid capsule and powder for oral suspension have identical sodium bicarbonate content, respectively. Do not substitute two 20 mg capsules/packets for one 40 mg dose.

Active duodenal ulcer: Oral: 20 mg once daily for 4 to 8 weeks

Gastric ulcers: Oral: 40 mg once daily for 4 to 8 weeks

Heartburn (OTC labeling): Oral: 20 mg once daily for 14 days. Do not take for >14 days or more often than every 4 months, unless instructed by healthcare provider.

Symptomatic GERD: Oral: 20 mg once daily for up to 4 weeks

Erosive esophagitis: Oral: 20 mg once daily for 4 to 8 weeks; maintenance of healing: 20 mg once daily for up to 12 months total therapy (including treatment period of 4 to 8 weeks)

Risk reduction of upper GI bleeding in critically ill patients (Zegerid powder for oral suspension): Oral:

Loading dose: Day 1: 40 mg every 6 to 8 hours for two doses

Maintenance dose: 40 mg daily for up to 14 days; therapy >14 days has not been evaluated

Dosing: Geriatric

Refer to adult dosing.

Dosing: Renal Impairment

No dosage adjustment necessary.

Dosing: Hepatic Impairment

There are no dosage adjustments provided in the manufacturer’s labeling. However, based on increased bioavailability, a dosage reduction should be considered, especially for maintenance of healing of erosive esophagitis

Extemporaneously Prepared

A 2 mg/mL oral suspension may be made with omeprazole-sodium bicarbonate powder and water. Pour the contents of six 20 mg omeprazole-sodium bicarbonate packets into a glass mortar. Add 30 mL water to the powder and mix to a uniform paste; mix while adding water in incremental proportions to almost 60 mL; transfer to a 60 mL bottle, rinse mortar with water, and add sufficient quantity of water to make 60 mL. Label "shake well" and "refrigerate". Stable for 45 days refrigerated.

Johnson CE, Cober MP, and Ludwig JL, "Stability of Partial Doses of Omeprazole-Sodium Bicarbonate Oral Suspension," Ann Pharmacother, 2007, 41(12):1954-61.17956960

Administration

Note: Both strengths of Zegerid capsule and powder for oral suspension have identical sodium bicarbonate content, respectively. Do not substitute two 20 mg capsules/packets for one 40 mg dose.

Capsule: Should be swallowed whole with water (do not use other liquids); do not chew or crush. Capsules should not be opened, sprinkled on food, or administered via NG. Best if taken at least 1 hour before breakfast.

Powder for oral suspension:

Oral: Administer 1 hour before a meal. Mix with 15 to 30 mL of water; stir well and drink immediately. Rinse cup with water and drink. Do not use other liquids or sprinkle on food.

Nasogastric/orogastric tube: Mix well with 20 mL of water (do not use other liquids) and administer immediately; flush tube with an additional 20 mL of water. Suspend enteral feeding for 3 hours before and 1 hour after administering.

Dietary Considerations

Take 1 hour before a meal. Contains sodium; use with caution in patients on sodium-restricted diets.

Storage

Capsules, powder for oral suspension: Store at 25°C (77°F); excursions permitted to 15°C to 30°C (59°F to 86°F). Protect from light.

OTC capsules: Store at 20°C to 25°C (68°F to 77°F).

Drug Interactions

AcetaZOLAMIDE: May enhance the adverse/toxic effect of Sodium Bicarbonate. Specifically, the risk of renal calculus formation may be increased. Monitor therapy

Alpha-/Beta-Agonists (Indirect-Acting): Alkalinizing Agents may increase the serum concentration of Alpha-/Beta-Agonists (Indirect-Acting). Monitor therapy

Amphetamines: Alkalinizing Agents may decrease the excretion of Amphetamines. Consider therapy modification

Antihepaciviral Combination Products: May decrease the serum concentration of Omeprazole. Monitor therapy

Antipsychotic Agents (Phenothiazines): Antacids may decrease the absorption of Antipsychotic Agents (Phenothiazines). Monitor therapy

Atazanavir: Antacids may decrease the absorption of Atazanavir. Consider therapy modification

Atazanavir: Proton Pump Inhibitors may decrease the serum concentration of Atazanavir. Management: See full drug interaction monograph for details. Consider therapy modification

Bisacodyl: Antacids may diminish the therapeutic effect of Bisacodyl. Antacids may cause the delayed-release bisacodyl tablets to release drug prior to reaching the large intestine. Gastric irritation and/or cramps may occur. Consider therapy modification

Bismuth Subcitrate: Antacids may diminish the therapeutic effect of Bismuth Subcitrate. Management: Avoid administration of antacids within 30 minutes of bismuth subcitrate (tripotassium bismuth dicitrate) administration. Consider therapy modification

Bisphosphonate Derivatives: Proton Pump Inhibitors may diminish the therapeutic effect of Bisphosphonate Derivatives. Monitor therapy

Bosentan: CYP2C9 Inhibitors (Moderate) may increase the serum concentration of Bosentan. Management: Concomitant use of both a CYP2C9 inhibitor and a CYP3A inhibitor or a single agent that inhibits both enzymes with bosentan is likely to cause a large increase in serum concentrations of bosentan and is not recommended. See monograph for details. Monitor therapy

Bosutinib: Proton Pump Inhibitors may decrease the serum concentration of Bosutinib. Management: Consider alternatives to proton pump inhibitors, such as antacids or H2 receptor antagonists. Administer alternative agents more than 2 hours before or after bosutinib. Consider therapy modification

Bosutinib: Antacids may decrease the serum concentration of Bosutinib. Management: Administer antacids more than 2 hours before or after bosutinib. Consider therapy modification

Calcium Polystyrene Sulfonate: Antacids may enhance the adverse/toxic effect of Calcium Polystyrene Sulfonate. The combined use of these two agents may result in metabolic alkalosis and/or loss of efficacy of the cation exchange resin. Management: To minimize this interaction, consider: a)separating doses by 2 or more hours; b)rectal administration of the exchange resin; or c)alternatives to antacids. Monitor for metabolic alkalosis and attenuation of CPS effects. Avoid magnesium hydroxide. Consider therapy modification

Cannabis: CYP2C9 Inhibitors (Moderate) may increase the serum concentration of Cannabis. More specifically, tetrahydrocannabinol serum concentrations may be increased. Monitor therapy

Capecitabine: Proton Pump Inhibitors may diminish the therapeutic effect of Capecitabine. Monitor therapy

Captopril: Antacids may decrease the serum concentration of Captopril. Monitor therapy

Carvedilol: CYP2C9 Inhibitors (Moderate) may increase the serum concentration of Carvedilol. Specifically, concentrations of the S-carvedilol enantiomer may be increased. Monitor therapy

Cefditoren: Antacids may decrease the serum concentration of Cefditoren. Management: Concomitant use of cefditoren with antacids is not recommended. Consider alternative methods to control acid reflux (eg, diet modification) or alternative antimicrobial therapy. If antacid therapy can not be avoided, separate dosing by several hours. Consider therapy modification

Cefditoren: Proton Pump Inhibitors may decrease the serum concentration of Cefditoren. Management: If possible, avoid use of cefditoren with proton pump inhibitors (PPIs). Consider alternative methods to minimize/control acid reflux (eg, diet modification) or alternative antimicrobial therapy if use of PPIs can not be avoided. Consider therapy modification

Cefpodoxime: Antacids may decrease the serum concentration of Cefpodoxime. Monitor therapy

Cefuroxime: Antacids may decrease the serum concentration of Cefuroxime. Management: Consider administering antacids and cefuroxime at least 2 hours apart. Consider therapy modification

Chloroquine: Antacids may decrease the serum concentration of Chloroquine. Management: Separate administration of antacids and chloroquine by at least 4 hours to minimize any potential negative impact of antacids on chloroquine bioavailability. Consider therapy modification

Cilostazol: CYP2C19 Inhibitors may increase the serum concentration of Cilostazol. Management: Consider reducing the cilostazol dose to 50 mg twice daily in patients who are also receiving inhibitors of CYP2C19. Consider therapy modification

Citalopram: CYP2C19 Inhibitors (Moderate) may increase the serum concentration of Citalopram. Management: Limit citalopram dose to a maximum of 20 mg/day if used with a moderate CYP2C19 inhibitor. Patients using this combination should be monitored closely for evidence of citalopram toxicity (e.g., serotonin syndrome, QT prolongation, etc.). Consider therapy modification

Clopidogrel: Omeprazole may diminish the antiplatelet effect of Clopidogrel. Omeprazole may decrease serum concentrations of the active metabolite(s) of Clopidogrel. Management: Clopidogrel labeling recommends avoiding concurrent omeprazole due to a possible decrease in clopidogrel effectiveness. Rabeprazole or pantoprazole may be lower-risk alternatives to omeprazole. Consider therapy modification

CloZAPine: Omeprazole may decrease the serum concentration of CloZAPine. Omeprazole may increase the serum concentration of CloZAPine. Monitor therapy

Corticosteroids (Oral): Antacids may decrease the bioavailability of Corticosteroids (Oral). Management: Consider separating doses by 2 or more hours. Budesonide enteric coated tablets could dissolve prematurely if given with drugs that lower gastric acid, with unknown impact on budesonide therapeutic effects. Consider therapy modification

CycloSPORINE (Systemic): Omeprazole may increase the serum concentration of CycloSPORINE (Systemic). Monitor therapy

CYP2C19 Inducers (Strong): May increase the metabolism of CYP2C19 Substrates. Management: Consider an alternative for one of the interacting drugs. Some combinations may be specifically contraindicated. Consult appropriate manufacturer labeling. Consider therapy modification

CYP2C19 Substrates: CYP2C19 Inhibitors (Moderate) may decrease the metabolism of CYP2C19 Substrates. Monitor therapy

CYP2C9 Substrates: CYP2C9 Inhibitors (Moderate) may decrease the metabolism of CYP2C9 Substrates. Monitor therapy

Cysteamine (Systemic): Proton Pump Inhibitors may diminish the therapeutic effect of Cysteamine (Systemic). Monitor therapy

Cysteamine (Systemic): Antacids may diminish the therapeutic effect of Cysteamine (Systemic). Monitor therapy

Dabigatran Etexilate: Antacids may decrease the serum concentration of Dabigatran Etexilate. Management: Dabigatran etexilate Canadian product labeling recommends avoiding concomitant use with antacids for 24 hours after surgery. In other situations, administer dabigatran etexilate 2 hours prior to antacids. Monitor clinical response to dabigatran therapy. Consider therapy modification

Dabrafenib: May decrease the serum concentration of CYP2C19 Substrates. Management: Seek alternatives to the CYP2C19 substrate when possible. If concomitant therapy cannot be avoided, monitor clinical effects of the substrate closely (particularly therapeutic effects). Consider therapy modification

Dabrafenib: Proton Pump Inhibitors may decrease the serum concentration of Dabrafenib. Dabrafenib may decrease the serum concentration of Proton Pump Inhibitors. Management: Seek alternatives to the proton pump inhibitor when possible. If concomitant therapy cannot be avoided, monitor for diminished effects of both drugs. Consider therapy modification

Darunavir: May decrease the serum concentration of Omeprazole. Monitor therapy

Dasatinib: Proton Pump Inhibitors may decrease the serum concentration of Dasatinib. Management: Antacids (taken 2 hours before or after dasatinib administration) can be used in place of the proton pump inhibitor if some acid-reducing therapy is needed. Avoid combination

Delavirdine: Proton Pump Inhibitors may decrease the serum concentration of Delavirdine. Management: Chronic therapy with proton pump inhibitors (PPIs) should be avoided in patients treated with delavirdine. The clinical significance of short-term PPI therapy with delavirdine is uncertain, but such therapy should be undertaken with caution. Avoid combination

Dexmethylphenidate: Antacids may increase the absorption of Dexmethylphenidate. Specifically, antacids may interfere with the normal release of drug from the extended-release capsules (Focalin XR brand), which could result in both increased absorption (early) and decreased delayed absorption. Monitor therapy

Dexmethylphenidate: Proton Pump Inhibitors may increase the absorption of Dexmethylphenidate. Specifically, proton pump inhibitors may interfere with the normal release of drug from the extended-release capsules (Focalin XR brand), which could result in both increased absorption (early) and decreased delayed absorption. Monitor therapy

Dronabinol: CYP2C9 Inhibitors (Moderate) may increase the serum concentration of Dronabinol. Monitor therapy

Elvitegravir: Antacids may decrease the serum concentration of Elvitegravir. Management: Separate administration of antacids and elvitegravir-containing products by at least 2 hours in order to minimize the risk for an interaction. Consider therapy modification

Enzalutamide: May decrease the serum concentration of CYP2C19 Substrates. Conversely, concentrations of active metabolites may be increased for those drugs activated by CYP2C19. Management: Concurrent use of enzalutamide with CYP2C19 substrates that have a narrow therapeutic index should be avoided. Use of enzalutamide and any other CYP2C19 substrate should be performed with caution and close monitoring. Consider therapy modification

Erlotinib: Proton Pump Inhibitors may decrease the serum concentration of Erlotinib. Avoid combination

Escitalopram: Omeprazole may increase the serum concentration of Escitalopram. Management: Monitor for increased escitalopram toxicity with concomitant use of omeprazole. Recommendations for management of this interaction found in product labeling may differ by country. Consult appropriate labeling. Consider therapy modification

Flecainide: Sodium Bicarbonate may diminish the arrhythmogenic effect of Flecainide. Sodium Bicarbonate may increase the serum concentration of Flecainide. Monitor therapy

Fluconazole: May increase the serum concentration of Proton Pump Inhibitors. Monitor therapy

Fosinopril: Antacids may decrease the serum concentration of Fosinopril. Management: The US and Canadian fosinopril manufacturer labels recommend separating the doses of antacids and fosinopril by 2 hours. Consider therapy modification

Fosphenytoin: Omeprazole may increase the serum concentration of Fosphenytoin. Fosphenytoin may decrease the serum concentration of Omeprazole. Monitor therapy

Gabapentin: Antacids may decrease the serum concentration of Gabapentin. Management: Administer gabapentin at least 2 hours after antacid administration. Monitor patients closely for evidence of reduced response to gabapentin therapy when both of these drugs are being used. Consider therapy modification

Gefitinib: Proton Pump Inhibitors may decrease the serum concentration of Gefitinib. Management: Avoid use of proton pump inhibitors (PPIs) with gefitinib when possible. If required, administer gefitinib 12 hours after administration of the PPI or 12 hours before the next dose of the PPI. Consider therapy modification

Gefitinib: Antacids may decrease the serum concentration of Gefitinib. Management: Administer gefitinib at least 6 hours before or after administration of an antacid, and closely monitor clinical response to gefitinib. Consider therapy modification

HMG-CoA Reductase Inhibitors: Antacids may decrease the serum concentration of HMG-CoA Reductase Inhibitors. Monitor therapy

Hyoscyamine: Antacids may decrease the serum concentration of Hyoscyamine. Management: Administer immediate release hyoscyamine before meals and antacids after meals when these agents are given in combination. Consider therapy modification

Indinavir: Proton Pump Inhibitors may decrease the serum concentration of Indinavir. Monitor therapy

Iron Salts: Antacids may decrease the absorption of Iron Salts. Exceptions: Ferric Carboxymaltose; Ferric Citrate; Ferric Gluconate; Ferric Hydroxide Polymaltose Complex; Ferric Pyrophosphate Citrate; Ferumoxytol; Iron Dextran Complex; Iron Sucrose. Consider therapy modification

Isoniazid: Antacids may decrease the absorption of Isoniazid. Consider therapy modification

Itraconazole: Proton Pump Inhibitors may decrease the serum concentration of Itraconazole. Consider therapy modification

Itraconazole: Antacids may decrease the serum concentration of Itraconazole. Management: Administer itraconazole at least 1 hour after and 2 hours before administration of any antacids. Itraconazole oral suspension may be less sensitive to the effects of decreased gastric acidity. Consider therapy modification

Ketoconazole (Systemic): Proton Pump Inhibitors may decrease the serum concentration of Ketoconazole (Systemic). Ketoconazole (Systemic) may increase the serum concentration of Proton Pump Inhibitors. Consider therapy modification

Ketoconazole (Systemic): Antacids may decrease the serum concentration of Ketoconazole (Systemic). Management: Administer oral ketoconazole at least 2 hours prior to use of any antacid product. Monitor patients closely for signs of inadequate clinical response to ketoconazole. Consider therapy modification

Ledipasvir: Antacids may decrease the serum concentration of Ledipasvir. Management: Separate the administration of ledipasvir and antacids by 4 hours. Consider therapy modification

Ledipasvir: Proton Pump Inhibitors may decrease the serum concentration of Ledipasvir. Management: Avoid the use of PPIs at doses greater than the equivalent of omeprazole 20 mg, avoid administration of PPIs within 2 hours prior to ledipasvir dosing, and avoid use of PPIs in combination with food. Consider therapy modification

Lithium: Sodium Bicarbonate may increase the excretion of Lithium. Monitor therapy

Lumacaftor: May decrease the serum concentration of CYP2C19 Substrates. Monitor therapy

Mecamylamine: Alkalinizing Agents may increase the serum concentration of Mecamylamine. Monitor therapy

Memantine: Alkalinizing Agents may increase the serum concentration of Memantine. Monitor therapy

Mesalamine: Antacids may diminish the therapeutic effect of Mesalamine. Antacid-mediated increases in gastrointestinal pH may cause the premature release of mesalamine from specific sustained-release mesalamine products. Management: Avoid concurrent administration of antacids with sustained-release mesalamine products. Separating antacid and mesalamine administration, and/or using lower antacid doses may be adequate means of avoiding this interaction. Consider therapy modification

Mesalamine: Proton Pump Inhibitors may diminish the therapeutic effect of Mesalamine. Proton pump inhibitor-mediated increases in gastrointestinal pH may cause the premature release of mesalamine from specific sustained-release mesalamine products. Management: Consider avoiding concurrent administration of high-dose proton pump inhibitors (PPIs) with sustained-release mesalamine products. Consider therapy modification

Methenamine: Antacids may diminish the therapeutic effect of Methenamine. Consider therapy modification

Methotrexate: Proton Pump Inhibitors may increase the serum concentration of Methotrexate. Monitor therapy

Methylphenidate: Antacids may increase the absorption of Methylphenidate. Specifically, antacids may interfere with the normal release of drug from the extended-release capsules (Ritalin LA brand), which could result in both increased absorption (early) and decreased delayed absorption. Monitor therapy

Methylphenidate: Proton Pump Inhibitors may increase the absorption of Methylphenidate. Specifically, proton pump inhibitors may interfere with the normal release of drug from the extended-release capsules (Ritalin LA brand), which could result in both increased absorption (early) and decreased delayed absorption. Monitor therapy

Multivitamins/Minerals (with ADEK, Folate, Iron): Antacids may decrease the serum concentration of Multivitamins/Minerals (with ADEK, Folate, Iron). Specifically, antacids may decrease the absorption of orally administered iron. Management: Separate dosing of oral iron-containing multivitamin preparations and antacids by as much time as possible in order to minimize impact on therapeutic efficacy of the iron preparation. Consider therapy modification

Mycophenolate: Proton Pump Inhibitors may decrease the serum concentration of Mycophenolate. Specifically, concentrations of the active mycophenolic acid may be reduced. Monitor therapy

Nalmefene: Omeprazole may decrease the serum concentration of Nalmefene. Monitor therapy

Nelfinavir: Proton Pump Inhibitors may decrease serum concentrations of the active metabolite(s) of Nelfinavir. Proton Pump Inhibitors may decrease the serum concentration of Nelfinavir. Avoid combination

Nilotinib: Proton Pump Inhibitors may decrease the serum concentration of Nilotinib. Management: Avoid this combination when possible since separation of doses is not likely to be an adequate method of minimizing the interaction. Consider therapy modification

Nilotinib: Antacids may decrease the serum concentration of Nilotinib. Management: Separate the administration of nilotinib and any antacid by at least 2 hours whenever possible in order to minimize the risk of a significant interaction. Consider therapy modification

PAZOPanib: Proton Pump Inhibitors may decrease the serum concentration of PAZOPanib. Avoid combination

PenicillAMINE: Antacids may decrease the serum concentration of PenicillAMINE. Consider therapy modification

Phenytoin: May decrease the serum concentration of Omeprazole. Omeprazole may increase the serum concentration of Phenytoin. Monitor therapy

Phosphate Supplements: Antacids may decrease the absorption of Phosphate Supplements. Management: This applies only to oral phosphate administration. Separating administer of oral phosphate supplements from antacid administration by as long as possible may minimize the interaction. Exceptions: Sodium Glycerophosphate Pentahydrate. Consider therapy modification

Posaconazole: Proton Pump Inhibitors may decrease the serum concentration of Posaconazole. Consider therapy modification

Potassium Acid Phosphate: Antacids may decrease the serum concentration of Potassium Acid Phosphate. Management: Consider separating administration of antacids and oral potassium phosphate by at least 2 hours to decrease risk of a significant interaction. Consider therapy modification

QuiNIDine: Antacids may decrease the excretion of QuiNIDine. Monitor therapy

QuiNINE: Alkalinizing Agents may increase the serum concentration of QuiNINE. Monitor therapy

Raltegravir: Proton Pump Inhibitors may increase the serum concentration of Raltegravir. Monitor therapy

RifAMPin: May decrease the serum concentration of Omeprazole. Avoid combination

Rilpivirine: Proton Pump Inhibitors may decrease the serum concentration of Rilpivirine. Avoid combination

Riociguat: Antacids may decrease the serum concentration of Riociguat. Management: Separate the administration of antacids and riociguat by at least 1 hour in order to minimize any potential interaction. Consider therapy modification

Risedronate: Proton Pump Inhibitors may diminish the therapeutic effect of Risedronate. Proton Pump Inhibitors may increase the serum concentration of Risedronate. This applies specifically to use of delayed-release risedronate. Avoid combination

Saquinavir: Proton Pump Inhibitors may increase the serum concentration of Saquinavir. Monitor therapy

Sotalol: Antacids may decrease the serum concentration of Sotalol. Management: Avoid simultaneous administration of sotalol and antacids. Administer antacids 2 hours after sotalol. Consider therapy modification

St John's Wort: May decrease the serum concentration of Omeprazole. Avoid combination

Sulpiride: Antacids may decrease the serum concentration of Sulpiride. Management: Separate administration of antacids and sulpiride by at least 2 hours in order to minimize the impact of antacids on sulpiride absorption. Consider therapy modification

Tacrolimus (Systemic): Proton Pump Inhibitors may increase the serum concentration of Tacrolimus (Systemic). Management: Tacrolimus dose adjustment may be required. Rabeprazole, pantoprazole, or selected H2-receptor antagonists (i.e., ranitidine or famotidine) may be less likely to interact. Genetic testing may predict patients at highest risk. Consider therapy modification

Tetracycline Derivatives: Antacids may decrease the absorption of Tetracycline Derivatives. Consider therapy modification

Tetrahydrocannabinol: CYP2C9 Inhibitors (Moderate) may increase the serum concentration of Tetrahydrocannabinol. Monitor therapy

Tipranavir: May decrease the serum concentration of Proton Pump Inhibitors. These data are derived from studies with Ritonavir-boosted Tipranavir. Monitor therapy

TiZANidine: CYP1A2 Inhibitors (Weak) may increase the serum concentration of TiZANidine. Management: Avoid these combinations when possible. If combined use cannot be avoided, initiate tizanidine at an adult dose of 2 mg and increase in 2-4 mg increments based on patient response. Monitor for increased effects of tizanidine, including adverse reactions. Consider therapy modification

Trientine: Antacids may decrease the absorption of Trientine. Management: Separate trientine dosing from other oral drugs (eg, antacids) by at least 1 hour. Monitor for decreased therapeutic effects of trientine if an antacid is initiated/dose increased, or increased effects if an antacid is discontinued/dose decreased. Consider therapy modification

Velpatasvir: Proton Pump Inhibitors may decrease the serum concentration of Velpatasvir. Avoid combination

Vitamin K Antagonists (eg, warfarin): Omeprazole may increase the serum concentration of Vitamin K Antagonists. Monitor therapy

Voriconazole: May increase the serum concentration of Proton Pump Inhibitors. Proton Pump Inhibitors may increase the serum concentration of Voriconazole. Management: In patients receiving omeprazole 40 mg/day or greater, reduce omeprazole dose by half when initiating voriconazole. Monitor therapy

Test Interactions

Omeprazole may falsely elevate serum chromogranin A (CgA) levels. The increased CgA level may cause false-positive results in the diagnosis of a neuroendocrine tumor. Temporarily stop omeprazole ≥14 days prior to assessing CgA level; repeat test if CgA level is initially elevated; use the same laboratory for all testing of CgA levels.

Adverse Reactions

Percentages of adverse events reported from a controlled clinical trial of 359 critically-ill patients receiving the oral powder for suspension

>10%:

Central nervous system: Pyrexia (20%)

Endocrine & metabolic: Hypokalemia (12%), hyperglycemia (11%)

Respiratory: Nosocomial pneumonia (11%)

1% to 10%:

Cardiovascular: Hypotension (10%), hypertension (8%), atrial fibrillation (6%), ventricular tachycardia (5%), bradycardia (4%), tachycardia (3%), supraventricular tachycardia (3%), edema (3%)

Central nervous system: Hyperpyrexia (5%), agitation (3%)

Dermatological: Rash (6%), decubitus ulcer (3%)

Endocrine & metabolic: Hypomagnesemia (10%), hypocalcemia (6%), hypophosphatemia (6%), fluid overload (5%), hypoglycemia (3%), hyponatremia (4%), hypernatremia (2%), hyperkalemia (2%)

Gastrointestinal: Constipation (5%), diarrhea (4%), hypomotility (2%)

Genitourinary: Urinary tract infection (2%)

Hematological: Thrombocytopenia (10%), anemia (8%), anemia increased (2%)

Hepatic: LFTs increased (2%)

Respiratory: ARDS (3%), respiratory failure (2%), pneumothorax (1%)

Miscellaneous: Sepsis (5%), oral candidiasis (4%), candidal infection (2%)

<1%, postmarketing, and/or case reports: Agranulocytosis, allergic reactions, alopecia, anaphylaxis, angina, angioedema, anorexia, atrophic gastritis, benign gastric polyps, bronchospasm, Clostridium difficile-associated diarrhea (CDAD), creatinine increased, depression, erythema multiforme, esophageal candidiasis, fracture, glycosuria, gynecomastia, hallucinations, hematuria, hemifacial dysesthesia, hemolytic anemia, hepatic encephalopathy, hepatic failure, hepatic necrosis, hepatotoxicity (idiosyncratic) (Chalasani, 2014), hypersensitivity, interstitial nephritis, leukocytosis, leukopenia, liver disease (hepatocellular, cholestatic, mixed), metabolic alkalosis, microscopic pyuria, microscopic colitis, mucosal atrophy (tongue), neutropenia, optic neuritis, optic neuropathy, osteoporosis-related fracture, pancreatitis, pancytopenia, photosensitivity, pneumonia (CAP), proteinuria, psychiatric disturbance, purpura, seizure, Stevens-Johnson syndrome, taste perversion, tinnitus, toxic epidermal necrolysis, vertigo, xerostomia

Warnings/Precautions

Concerns related to adverse effects:

• Atrophic gastritis: Atrophic gastritis (observed on biopsy) has been reported with long-term use.

• Carcinoma: In long-term (2-year) studies in rats, omeprazole produced a dose-related increase in gastric carcinoid tumors. While available endoscopic evaluations and histologic examinations of biopsy specimens from human stomachs have not detected a risk from short-term exposure to omeprazole, further human data on the effect of sustained hypochlorhydria and hypergastrinemia are needed to rule out the possibility of an increased risk for the development of tumors in humans receiving long-term therapy.

Clostridium difficile-associated diarrhea (CDAD): Use of proton pump inhibitors (PPIs) may increase risk of CDAD, especially in hospitalized patients; consider CDAD diagnosis in patients with persistent diarrhea that does not improve. Use the lowest dose and shortest duration of PPI therapy appropriate for the condition being treated.

• Fractures: Increased incidence of osteoporosis-related bone fractures of the hip, spine, or wrist may occur with proton pump inhibitor (PPI) therapy. Patients on high-dose or long-term therapy should be monitored. Use the lowest effective dose for the shortest duration of time, use vitamin D and calcium supplementation, and follow appropriate guidelines to reduce risk of fractures in patients at risk.

• Hypomagnesemia: Reported rarely, usually with prolonged PPI use of >3 months (most cases >1 year of therapy). May be symptomatic or asymptomatic; severe cases may cause tetany, seizures, and cardiac arrhythmias. Consider obtaining serum magnesium concentrations prior to beginning long-term therapy, especially if taking concomitant digoxin, diuretics, or other drugs known to cause hypomagnesemia; and periodically thereafter. Hypomagnesemia may be corrected by magnesium supplementation, although discontinuation of omeprazole may be necessary; magnesium levels typically return to normal within 1 week of stopping.

• Interstitial nephritis: Acute interstitial nephritis has been observed in patients taking PPIs; may occur at any time during therapy and is generally due to an idiopathic hypersensitivity reaction. Discontinue if acute interstitial nephritis develops

• Vitamin B12 deficiency: Prolonged treatment (≥2 years) of PPIs may lead to vitamin B12 malabsorption and subsequent vitamin B12 deficiency. The magnitude of the deficiency is dose related and the association is stronger in females and those younger in age (<30 years); prevalence is decreased after discontinuation of therapy (Lam 2013).

Disease-related concerns:

• Bartter’s syndrome: Use with caution in patients with Bartter’s syndrome; contains sodium bicarbonate.

• Gastric malignancy: Relief of symptoms does not preclude the presence of a gastric malignancy.

• Gastrointestinal infection (eg, Salmonella, Campylobacter): Use of PPIs may increase risk of these infections.

• Hepatic impairment: Bioavailability may be increased in patients with hepatic dysfunction; consider dosage reductions, especially for maintenance of healing of erosive esophagitis.

• Hypocalcemia: Use with caution in patients with hypocalcemia; contains sodium bicarbonate.

• Hypokalemia: Use with caution in patients with hypokalemia; contains sodium bicarbonate.

• Respiratory alkalosis: Use with caution in patients with respiratory alkalosis; contains sodium bicarbonate.

Concurrent drug therapy issues:

• Clopidogrel: PPIs may diminish the therapeutic effect of clopidogrel, thought to be due to reduced formation of the active metabolite of clopidogrel. The manufacturer of clopidogrel recommends either avoidance of both omeprazole (even when scheduled 12 hours apart) and esomeprazole or use of a PPI with comparatively less effect on the active metabolite of clopidogrel (eg, pantoprazole). In contrast to these warnings, others have recommended the continued use of PPIs, regardless of the degree of inhibition, in patients with a history of GI bleeding or multiple risk factors for GI bleeding who are also receiving clopidogrel since no evidence has established clinically meaningful differences in outcome; however, a clinically significant interaction cannot be excluded in those who are poor metabolizers of clopidogrel (Abraham 2010; Levine 2011).

• Drug-drug interactions: Potentially significant interactions may exist, requiring dose or frequency adjustment, additional monitoring, and/or selection of alternative therapy. Consult drug interactions database for more detailed information.

Special populations:

• Asian ethnicity: Bioavailability may be increased in patients of Asian descent; consider dosage reductions, especially for maintenance of healing of erosive esophagitis.

• Elderly: Bioavailability may be increased in the elderly.

• Sodium-restricted diets: Use with caution in patients on sodium-restricted diets; contains sodium bicarbonate.

Dosage form specific issues:

• Polysorbate 80: Some dosage forms may contain polysorbate 80 (also known as Tweens). Hypersensitivity reactions, usually a delayed reaction, have been reported following exposure to pharmaceutical products containing polysorbate 80 in certain individuals (Isaksson 2002; Lucente 2000; Shelley 1995). Thrombocytopenia, ascites, pulmonary deterioration, and renal and hepatic failure have been reported in premature neonates after receiving parenteral products containing polysorbate 80 (Alade 1986; CDC 1984). See manufacturer’s labeling.

Other warnings/precautions:

• Self-medication (OTC use): When used for self-medication (OTC), patients should be instructed not to use if they have difficulty swallowing, are vomiting blood, or have bloody or black stools. Prior to use, patients should contact healthcare provider if they have heartburn for >3 months, heartburn with dizziness, lightheadedness, or sweating, MI symptoms, frequent chest pain, frequent wheezing (especially with heartburn), unexplained weight loss, nausea/vomiting, stomach pain, on a sodium-restricted diet, or are taking antifungals, HIV antivirals, diazepam, digoxin, tacrolimus, warfarin or other prescription medications. Patients should stop use and consult a healthcare provider if heartburn continues or worsens, or if they need to take for >14 days or more often than every 4 months. Patients should be informed that it may take 1 to 4 days for full effect to be seen.

Pregnancy Risk Factor

C

Pregnancy Considerations

Adverse events have been observed in animal reproduction studies with omeprazole. Refer to individual agents.

Patient Education

• Discuss specific use of drug and side effects with patient as it relates to treatment. (HCAHPS: During this hospital stay, were you given any medicine that you had not taken before? Before giving you any new medicine, how often did hospital staff tell you what the medicine was for? How often did hospital staff describe possible side effects in a way you could understand?)

• Patient may experience diarrhea or flatulence. Have patient report immediately to prescriber signs of low magnesium (mood changes; muscle pain or weakness; muscle cramps or spasms; seizures; tremors; lack of appetite; severe nausea or vomiting; or an abnormal heartbeat, signs of kidney problems (urinary retention, blood in urine, change in amount of urine passed, or weight gain), signs of low potassium (muscle pain or weakness, muscle cramps, or an abnormal heartbeat), signs of high blood sugar (confusion, feeling sleepy, more thirst, hunger, passing urine more often, flushing, fast breathing, or breath that smells like fruit), severe dizziness, passing out, confusion, severe nausea, severe vomiting, burning or numbness feeling, severe abdominal pain, severe headache, bruising, bleeding, bone pain, angina, shortness of breath, chills, pharyngitis, excessive weight loss, severe loss of strength and energy, signs of Clostridium difficile (C. diff)-associated diarrhea (stomach pain or cramps, very loose or watery stools, or bloody stools), or signs of Stevens-Johnson syndrome/toxic epidermal necrolysis (red, swollen, blistered, or peeling skin [with or without fever]; red or irritated eyes; or sores in mouth, throat, nose, or eyes) (HCAHPS).

• Educate patient about signs of a significant reaction (eg, wheezing; chest tightness; fever; itching; bad cough; blue skin color; seizures; or swelling of face, lips, tongue, or throat). Note: This is not a comprehensive list of all side effects. Patient should consult prescriber for additional questions.

Intended Use and Disclaimer: Should not be printed and given to patients. This information is intended to serve as a concise initial reference for healthcare professionals to use when discussing medications with a patient. You must ultimately rely on your own discretion, experience, and judgment in diagnosing, treating, and advising patients.

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