Zegerid (Omeprazole and Sodium Bicarbonate)

Zegerid (Omeprazole and Sodium bicarbonateis a combination of a proton pump inhibitor and a rapid relief antacid used to treat heartburn and peptic ulcer disease.

Zegerid (Omeprazole and sodium bicarbonate) Uses:

  • Short-term (4-8 weeks) treatment of active duodenal ulcer or active benign gastric ulcer.
  • Associated with gastroesophageal reflux disease (GERD), treatment of heartburn and other symptoms for up to 4 weeks.
  • Short-term (4-8 weeks) treatment of endoscopically diagnosed erosive esophagitis.
  • Maintenance healing of erosive esophagitis.
  • In critically ill patients, reduction of risk of upper gastrointestinal bleeding.
  • OTC labeling:
  • Short-term (2 weeks) treatment of frequent (2 days/week), uncomplicated heartburn

Zegrid (Omeprazole and sodium bicarbonate) Dose in Adults

Note:

  • For oral suspension, both strengths of Zegerid capsule & powder have identical sodium bicarbonate content, respectively.
  •  For one 40 mg dose, do not substitute two 20 mg capsules/packets.

Zegrid (Omeprazole and sodium bicarbonate) Dose in the treatment of Active duodenal ulcer:

  • P/O:
  • 20 mg once daily for 4-8 weeks

Zegrid (Omeprazole and sodium bicarbonate) Dose in the treatment of Gastric ulcers:

  • P/O:
  • 40 mg once daily for 4-8 weeks

Zegrid Dose in the treatment of Heartburn (OTC labeling):

  • P/O:
  • For 14 days, 20 mg once daily.
  • Unless instructed by healthcare provider, do not take for >14 days or more often than every 4 months.

Zegrid Dose in the treatment of Symptomatic GERD:

  • P/O:
  • For up to 4 weeks, 20 mg once daily.

Zegrid (Omeprazole and sodium bicarbonate) Dose in the treatment of Erosive esophagitis:

  • P/O:

  • For 4-8 weeks, 20 mg once daily.
  • Maintenance of healing:

  • 20 mg once daily for up to 12 months total therapy (including treatment period of 4-8 weeks)

Omeprazole and sodium bicarbonate) Dose for Risk reduction of upper GI bleeding in critically ill patients (Zegerid powder for oral suspension):

P/O:

  • Loading dose:
  • Day 1:

    • For two doses, 40 mg every 6 to 8 hours.
  • Maintenance dose:

    • For up to 14 days, 40 mg daily.
    • Therapy >14 days has not been evaluated

Zegrid (Omeprazole and sodium bicarbonate) Dose in Childrens

Note:

  • The dosage listed is for the omeprazole component.
  • Both strengths of Zegerid capsule & powder for oral suspension have identical sodium bicarbonate content.
  • For one 40 mg dose, do not substitute two 20 mg capsules/packets.
  •  The following dosage is recommended recognizing that this formulation has not received FDA approval for use in children despite an approved dosage for omeprazole in children & considering that omeprazole has been used safely in children as an extemporaneous formulation with sodium bicarbonate:

Zegerid (Omeprazole and sodium bicarbonate) Dose in the treatment of Erosive esophagitis:

  • Treatment:

Note:

  • The duration of therapy depends upon age.
  • Infant duration is up to 6 weeks & children and adolescent duration is 4-8 weeks.
  • Treatment may continue to an additional 4 weeks in children and adolescents with no response at 8 weeks.
  • An additional 4- to 8-week course may be considered for recurrence of erosive esophagitis or gastroesophageal reflux disease (GERD) symptoms (eg, heartburn).
    • Infants, Children, and Adolescents: Oral:

      • 3 to <5 kg:
        • 2.5 mg once daily.
      • 5 kg to <10 kg:
        • 5 mg once daily.
      • 10 kg to <20 kg:
        • 10 mg once daily.
      • ≥20 kg:
        • 20 mg once daily.
  • Maintenance of healing:

    • Children and Adolescents:

    • P/O:

      • 5 kg to <10 kg:
        • 5 mg once daily.
      • 10 kg to <20 kg:
        • 10 mg once daily.
      • ≥20 kg:
        • 20 mg once daily.

Zegerid (Omeprazole and Sodium bicarbonate) Dose in the treatment of symptomatic Gastroesophageal reflux disease (GERD):

Note:

  • Guidelines recommend a 4-8 week treatment course.
  • Consider possible wean if the improvement is seen after 4-8 weeks.
  • Reevaluate diagnosis and consider referral to a pediatric GI specialist if no response after 4-8 weeks.
  • Weight-based dosing:

    • Infants, Children, and Adolescents:

      • P/O:
        • 0.7-4 mg/kg/day.
      • The dose mostly reported to provide healing of esophagitis & relief of GERD symptoms is 1 mg/kg/day.
      • Max daily dose:
        • 40 mg/day.
  • Fixed dosing:

    • Children and Adolescents:

    • P/O:

      • 5 kg to <10 kg:
        • 5 mg once daily.
      • 10 kg to <20 kg:
        • 10 mg once daily.
      • ≥20 kg:
        • 20 mg once daily.
    • Discontinuation of therapy:

      • P/O:
      • Based on experience in adults, in order to avoid worsening or rebound symptoms, some experts recommend a step-down approach.
      • One recommendation says to decrease the dose by 50% over 2-4 weeks.
      • Alternate day therapy may be considered if the patient is already on the lowest possible dose.
      • Patients should be reevaluated if symptoms worsen during treatment or after discontinuation (Kim 2018).

Pregnancy Risk Factor C

  • Negative events with omeprazole have been documented in animal reproduction studies.
  • You can contact individual agents.

Use of sodium bicarbonate and Omeprazole during breastfeeding

  • Omeprazole secretes in breast milk.
  • A manufacturer recommends that the mother decide whether to stop nursing her infant or discontinue using the drug.
  • This is in consideration of the possibility of serious adverse reactions.
  • You can contact individual agents.

Zegerid (Omeprazole and sodium bicarbonate) Dose in Kidney Disease:

  • No dosage adjustment necessary.

Zegerid (Omeprazole and sodium bicarbonate) Dose in Liver Disease:

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

Common Side Effects Zegerid (Omeprazole and sodium bicarbonate):

  • Endocrine & metabolic:

    • Hypokalemia
    • Hyperglycemia
  • Respiratory:

    • Nosocomial pneumonia
  • Miscellaneous:

    • Fever

Less Common Side Effects of Zegerid (Omeprazole and sodium bicarbonate):

  • Cardiovascular:

    • Hypotension
    • Hypertension
    • Atrial Fibrillation
    • Ventricular Tachycardia
    • Bradycardia
    • Edema
    • Supraventricular Tachycardia
    • Tachycardia
  • Central Nervous System:

    • Hyperpyrexia
    • Agitation
  • Dermatological:

    • Skin Rash
    • Decubitus Ulcer
  • Endocrine & Metabolic:

    • Hypomagnesemia
    • Hypocalcemia
    • Hypophosphatemia
    • Hypervolemia
    • Hyponatremia
    • Hypoglycemia
    • Hyperkalemia
    • Hypernatremia
  • Gastrointestinal:

    • Constipation
    • Diarrhea
    • Oral Candidiasis
    • Decreased Gastrointestinal Motility
  • Genitourinary:

    • Urinary Tract Infection
  • Hematologic & Oncologic:

    • Thrombocytopenia
    • Anemia
    • Exacerbation Of Anemia
  • Hepatic:

    • Increased Liver Enzymes
  • Infection:

    • Sepsis
    • Candidiasis
  • Respiratory:

    • Acute Respiratory Distress
    • Pneumothorax

Contraindications to Zegerid (Omeprazole and sodium bicarbonate):

  • 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.

Warnings and precautions

  • Carcinoma

    • In long-term (2-year-old) experiments in rats, Omeprazole caused a dose-related rise in gastric cancerous tumors.
    • Although endoscopic and histologic evaluations of biopsy specimens taken from human stomachs have not found a risk from short-term omeprazole exposure, additional human data is required on the effects of sustained hypochlorhydria and hypergastrinemia to rule out the possibility that there may be an increased risk of the development of cancer in patients receiving long-term treatment.
  • Clostridium difficile-associated diarrhea (CDAD), formerly Clostridium, is now Clostridioides

    • The risk of developing CDAD in hospitalized patients may be increased by the use of proton pump inhibitors (PPIs).
    • Consider CDAD diagnosis for patients suffering from persistent diarrhea that doesn't improve.
    • The best PPI therapy for your condition is the one that has the lowest dosage and longest duration.
  • Cutaneous and systemic Lupus Erythematosus

    • It can be a new onset of or an exacerbation autoimmune disease. Most cases are cutaneous lupus erythematosus, but subacute CLE is more common.
    • Systemic lupus is less common and usually occurs in the young to elderly.
    • Stop using therapy if you experience symptoms of CLE/SLE. Refer to a specialist immediately for further evaluation.
    • Most patients feel better within 4-12 weeks after stopping omeprazole.
  • Fractures

    • Proton pump inhibitor (PPI), therapy may increase the incidence of osteoporosis-related fractures of bones in the hip, spine and wrist.
    • It is important to examine patients on long-term or high-dose therapy.
    • To reduce fractures, you should use the lowest possible dose for the shortest time.
  • Polyps of the fundic gland:

    • Proton pump inhibitors (PPIs), especially if used for a long time of more than one year, can increase the risk of fundic polyps.
    • It may be without any symptoms but it can cause nausea, vomiting, and abdominal pain.
    • Anemia and GI bleeding may occur in patients with ulcerated polyps.
    • The diagnosis of small intestinal blockage may increase the risk by polyps.
    • Use the lowest possible dose and the shortest duration of PPI therapy, depending on the condition being treated.
  • Hypomagnesemia:

    • Rarely reported, often with prolonged PPI usage of >3 months (most patients >1 year).
    • It may be symptomatic, or asymptomatic.
    • Severe cases may cause tetany, seizures & cardiac arrhythmias.
    • Consider obtaining serum magnesium levels before you begin long-term treatment, especially if you are taking digoxin, diuretics or any other drugs that can cause hypomagnesemia. Also, periodically thereafter.
    • Magnesium supplementation may be able to correct hypomagnesemia, but discontinuation of omeprazole may prove necessary.
    • Magnesium levels usually return to normal within a week.
  • Interstitial nephritis:

    • Patients who have taken PPIs have been shown to develop acute interstitial Nephritis.
    • It can occur during therapy at any time and is usually due to an idiopathic allergic reaction.
    • If acute interstitial Nephritis occurs, discontinue use.
  • Vitamin B deficiency:

    • PPIs can cause vitamin B malabsorption and subsequent vitamin B deficiency if they are continued for longer periods (>=2 year).
    • The severity of the deficiency depends on the dose. It is more severe in women than in those who are younger (30 years).
    • The prevalence of the disease is reduced after discontinuation of therapy (Lam 2013, p.
  • Bartter's syndrome

    • Patients with Bartter’s syndrome should be cautious.
    • Contains sodium bicarbonate.
  • Gastric cancer:

    • Gastric malignancy can still be present despite symptoms being relieved.
  • Gastrointestinal infection (eg, Salmonella, Campylobacter):

    • These infections may be more likely if you use PPIs.
  • Hepatic impairment

    • Patients with hepatic dysfunction may have a higher bioavailability.
    • You should consider reducing dosage, especially if you want to prevent erosive effects.
  • Hypocalcemia:

    • Hypocalcemia patients should be treated with caution
    • contains sodium bicarbonate.
  • Hypokalemia

    • Hypokalemia patients should be treated with caution
    • Contains sodium bicarbonate.
  • Respiratory alkalosis

    • Use caution in patients suffering from respiratory alkalosis.
    • Contains sodium bicarbonate.

Omeprazole and sodium bicarbonate: Drug Interaction

Risk Factor C (Monitor therapy)

AcetaZOLAMIDE

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

Alpha-/Beta-Agonists (Indirect-Acting)

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

Amantadine

Alkalinizing Agents may increase the serum concentration of Amantadine.

Antihepaciviral Combination Products

May decrease the serum concentration of Omeprazole.

Antipsychotic Agents (Phenothiazines

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

Bisphosphonate Derivatives

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

Bromperidol

Antacids may decrease the absorption of Bromperidol.

Capecitabine

Proton Pump Inhibitors may diminish the therapeutic effect of Capecitabine.

Captopril

Antacids may decrease the serum concentration of Captopril.

Cefpodoxime

Antacids may decrease the serum concentration of Cefpodoxime.

Cefpodoxime

Proton Pump Inhibitors may decrease the serum concentration of Cefpodoxime.

CloBAZam

Omeprazole may increase serum concentrations of the active metabolite(s) of CloBAZam.

CloZAPine

Omeprazole may decrease the serum concentration of CloZAPine. Omeprazole may increase the serum concentration of CloZAPine.

CycloSPORINE (Systemic

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

CYP2C19 Inducers (Moderate

May decrease the serum concentration of CYP2C19 Substrates (High risk with Inducers).

Cysteamine (Systemic)

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

Cysteamine (Systemic

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

Darunavir

May decrease the serum concentration of Omeprazole.

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.

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.

Flecainide

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

Fluconazole

May increase the serum concentration of Proton Pump Inhibitors.

Fosphenytoin

Omeprazole may increase the serum concentration of Fosphenytoin. Fosphenytoin may decrease the serum concentration of Omeprazole.

Indinavir

Proton Pump Inhibitors may decrease the serum concentration of Indinavir.

Lithium

Sodium Bicarbonate may increase the excretion of Lithium.

Lumacaftor

May decrease the serum concentration of CYP2C19 Substrates (High risk with Inducers).

Mecamylamine

Alkalinizing Agents may increase the serum concentration of Mecamylamine.

Memantine

Alkalinizing Agents may increase the serum concentration of Memantine.

Methotrexate

Proton Pump Inhibitors may increase the serum concentration of Methotrexate.

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.

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.

Mycophenolate

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

Nalmefene

Omeprazole may decrease the serum concentration of Nalmefene.

Phenytoin

May decrease the serum concentration of Omeprazole. Omeprazole may increase the serum concentration of Phenytoin.

QuiNIDine

Antacids may decrease the excretion of QuiNIDine.

QuiNINE

Alkalinizing Agents may increase the serum concentration of QuiNINE.

Raltegravir

Proton Pump Inhibitors may increase the serum concentration of Raltegravir.

Rosuvastatin

Antacids may decrease the serum concentration of Rosuvastatin.

Saquinavir

Proton Pump Inhibitors may increase the serum concentration of Saquinavir.

SORAfenib

Proton Pump Inhibitors may decrease the absorption of SORAfenib.

Tipranavir

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

Vitamin K Antagonists (eg, warfarin)

Omeprazole may increase the serum concentration of Vitamin K Antagonists.

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.

Risk Factor D (Consider therapy modification)

Amphetamines

Alkalinizing Agents may decrease the excretion of Amphetamines. Management: Consider alternatives to using amphetamines and alkalinizing agents in combination. If these agents must be used together, patients should be monitored closely for excessive amphetamine effects.

Atazanavir

Antacids may decrease the absorption of Atazanavir.

Atazanavir

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

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.

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.

Bosutinib

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

Bosutinib

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

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.

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.

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.

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.

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.

Citalopram

Omeprazole may increase the serum concentration of Citalopram. Management: Limit citalopram dose to a maximum of 20 mg/day if used with omeprazole.

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.

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.

CYP2C19 Inducers (Strong)

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

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.

Dabrafenib

May decrease the serum concentration of CYP2C19 Substrates (High risk with Inducers). 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).

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.

Enzalutamide

May decrease the serum concentration of CYP2C19 Substrates (High risk with Inducers). 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.

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.

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.

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.

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.

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.

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 Isomaltoside; Iron Sucrose.

Itraconazole

Proton Pump Inhibitors may increase the serum concentration of Itraconazole. Proton Pump Inhibitors may decrease the serum concentration of Itraconazole. Management: Administer Sporanox brand itraconazole at least 2 hours before or 2 hours after administration of any proton pump inhibitors (PPIs). Exposure to Tolsura brand itraconazole may be increased by PPIs; consider itraconazole dose reduction.

Itraconazole

Antacids may decrease the serum concentration of Itraconazole. Antacids may increase the serum concentration of Itraconazole. Management: Administer Sporanox brand itraconazole at least 2 hours before or 2 hours after administration of any antacids. Exposure to Tolsura brand itraconazole may be increased by antacids; consider itraconazole dose reduction.

Ketoconazole (Systemic)

Proton Pump Inhibitors may decrease the serum concentration of Ketoconazole (Systemic). Ketoconazole (Systemic) may increase the serum concentration of Proton Pump Inhibitors. Management: Avoid concomitant administration of proton pump inhibitors (PPIs) and ketoconazole when possible due to the risk of ketoconazole therapeutic failure. Administration of ketoconazole with an acidic beverage (eg, cola) may facilitate ketoconazole absorption.

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.

Lanthanum

Antacids may diminish the therapeutic effect of Lanthanum.

Ledipasvir

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

Ledipasvir

Proton Pump Inhibitors may decrease the serum concentration of Ledipasvir. Management: PPI doses equivalent to omeprazole 20 mg or lower may be given with ledipasvir under fasted conditions. Administration with higher doses of PPIs, 2 hours after a PPI, or in combination with food and PPIs may reduce ledipasvir bioavailability.

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.

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 sustainedrelease mesalamine products.

Methenamine

Antacids may diminish the therapeutic effect of Methenamine.

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 ironcontaining multivitamin preparations and antacids by as much time as possible in order to minimize impact on therapeutic efficacy of the iron preparation.

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.

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.

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.

Posaconazole

Proton Pump Inhibitors may decrease the serum concentration of Posaconazole.

Potassium Phosphate

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

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.

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.

Secretin

Proton Pump Inhibitors may diminish the diagnostic effect of Secretin. Specifically, use of PPIs may cause a hyperresponse in gastrin secretion in response to secretin stimulation testing, falsely suggesting gastrinoma. Management: Avoid concomitant use of proton pump inhibitors (PPIs) and secretin, and discontinue PPIs several weeks prior to secretin administration, with the duration of separation determined by the specific PPI. See full monograph for details.

Sotalol

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

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.

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.

Tetracyclines

Antacids may decrease the absorption of Tetracyclines. Management: Separate administration of antacids and oral tetracycline derivatives by several hours when possible to minimize the extent of this potential interaction. Exceptions: Eravacycline.

Risk Factor X (Avoid combination)

Acalabrutinib

Proton Pump Inhibitors may decrease the serum concentration of Acalabrutinib.

Cefuroxime

Proton Pump Inhibitors may decrease the absorption of Cefuroxime.

Dacomitinib

Proton Pump Inhibitors may decrease the serum concentration of Dacomitinib. Management: Avoid concurrent use of dacomitinib with proton pump inhibitors. Antacids may be used. Histamine H2-receptor antagonists (HR2A) may be used if dacomitinib is given at least 6 hours before or 10 hours after the H2RA.

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.

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.

Erlotinib

Proton Pump Inhibitors may decrease the serum concentration of Erlotinib.

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.

Neratinib

Proton Pump Inhibitors may decrease the serum concentration of Neratinib. Specifically, proton pump inhibitors may reduce neratinib absorption.

PAZOPanib

Proton Pump Inhibitors may decrease the serum concentration of PAZOPanib.

Pexidartinib

Proton Pump Inhibitors may decrease the serum concentration of Pexidartinib. Management: If acid-reduction is needed, consider administering an antacid 2 hours before or after pexidartinib, or administer pexidartinib 2 hours before or 10 hours after an H2 receptor antagonist.

RifAMPin

May decrease the serum concentration of Omeprazole.

Rilpivirine

Proton Pump Inhibitors may decrease the serum concentration of Rilpivirine.

St John's Wort

May decrease the serum concentration of Omeprazole.

Velpatasvir

Proton Pump Inhibitors may decrease the serum concentration of Velpatasvir.

Monitoring Parameters:

None mentioned. See individuals agents

How to administer Zegerid (Omeprazole and sodium bicarbonate)?

Note:

  • Both Zegerid powder and capsule have the same sodium bicarbonate contents for oral suspension.
  • For one 40 mg dose, do not substitute two 20 mg capsules/packets.

Zegerid Capsule:

 

  • Should be taken whole with water.
  • Do not chew, crush or crush.
  • Capsules shouldn't be opened, sprinkled onto food, or administered via the NG.
  • Taken at least one hour before breakfast is best.

Powder for oral suspension:

  • P/O
    • Take the medication 1 hour before you eat.
    • Mix it with 15-30ml of water.
    • Stir well & drink immediately.
    • Drink the water from the cup.
    • Use no other liquids or sprinkle food with them.
  • Nasogastric/orogastric tube:

    • Mix 20 mL water with the powder and then immediately administer.
    • Additional 20 mL water is added to the flush tube.
    • Enteral feeding should be stopped for at least 3 hours prior to administering and 1 hour after.

Mechanism of action of Zegerid (Omeprazole and sodium bicarbonate):

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

Onset of action:

  • Antisecretory:
  • ~1 hour.
  • Peak antisecretory effect:
  • 2 hours.
  • Full therapeutic effect:
  • 1-4 days

Duration:

  • 72 hours.
  • 50% of max effect at 24 hours

Absorption:

  • Rapid

Protein binding:

  • ~95%

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

Bioavailability: P/O:

  • ~30%-40%.
  • Hepatic dysfunction:
  • ~100%.
  • Asians:
  • AUC increased up to 4 times compared to Caucasians

Half-life elimination:

  • ~1 hour (range: 0.4-3.2 hours).
  • Hepatic dysfunction:
  • ~3 hours

Time to peak, serum:

  • ~30 mins

Excretion:

  • Urine (77% as metabolites, very small amount as unchanged drug).
  • Feces

Clearance:

  • 500 to 600 mL/min.
  • Chronic hepatic disease:
  • 70 mL/min

International Brands of Omeprazole and sodium bicarbonate:

  • OmePPi
  • Zegerid
  • Zegerid OTC
  • Trinsica 20
  • Trinsica 40
  • Zegacid
  • Zerocid

Omeprazole and sodium bicarbonate Brand Names in Pakistan:

Omeprazole and sodium bicarbonate Suspension 20 mg/Sachet

Omega Rapid Ferozsons Laboratoies Ltd.

Omeprazole and sodium bicarbonate Suspension 40 mg/Sachet

Omega Rapid Ferozsons Laboratoies Ltd.

Omeprazole and sodium bicarbonate Sachet 20 mg

Ampra Chas. A. Mendoza
Omenate Panacea Pharmaceuticals
Omezonate Global Pharmaceuticals
Risek Insta Getz Pharma Pakistan (Pvt) Ltd.
Ruling Plus High - Q International

Omeprazole and sodium bicarbonate Sachet 40 mg

Ampra Chas. A. Mendoza
Omenate-D Panacea Pharmaceuticals
Omezonate Global Pharmaceuticals
Risek Insta Getz Pharma Pakistan (Pvt) Ltd.
Ruling Plus High - Q International

Omeprazole and sodium bicarbonate Tablets 20 mg

Omepid Maark Pharma

Omeprazole and sodium bicarbonate Tablets 40 mg

Omefast Plus Efroze Chemical Industries (Pvt) Ltd.

Omeprazole and sodium bicarbonate Capsules 20 mg

Bimep Spl Pharmaceuticals (Pvt) Ltd
Bios Werrick Pharmaceuticals
Encid Wilsons Pharmaceuticals
Epraco Gray`S Pharmaceuticals
Erifass Fassgen Pharmaceuticals
Faast Consolidated Chemical Laboratories (Pvt) Ltd.
Magfast Panacea Pharmaceuticals
Magfast Panacea Pharmaceuticals
Mapra Linear Pharma
Mapra Linear Pharma
Mep-B Genix Pharma (Pvt) Ltd
Mep-B Genix Pharma (Pvt) Ltd
Neusec Plus Biorex Pharmaceuticals
Neusec Plus Biorex Pharmaceuticals
Noazol Plus Noa Hemis Pharmaceuticals
Noazol Plus Noa Hemis Pharmaceuticals
Omced-S Shrooq Pharmaceuticals
Omefast Efroze Chemical Industries (Pvt) Ltd.
Omega Ferozsons Laboratoies Ltd.
Omega Ferozsons Laboratoies Ltd.
Omeprafast Bio Labs (Pvt) Ltd.
Omeprowan Plus Swan Pharmaceuticals(Pvt) Ltd
Omeprowan Plus Swan Pharmaceuticals(Pvt) Ltd
Omexia Gt Pharma
Omezac Plus Hilton Pharma (Pvt) Limited
Omezac Plus Hilton Pharma (Pvt) Limited
Omi-B Miracle Pharmaceuticals(Pvt) Ltd
Omi-B Miracle Pharmaceuticals(Pvt) Ltd
Omnat Plus Accurate Medical Suppliers
Omnat Plus Accurate Medical Suppliers
Omnimint Xenon Pharmaceuticals (Pvt) Ltd.
Omrel Plus Well & Well Pharma (Pvt) Ltd
Omrel Plus Well & Well Pharma (Pvt) Ltd
Omsod Reliance Pharma
Opepzole Global Pharmaceuticals
Opepzole Global Pharmaceuticals
Operos Medizan Labs (Pvt) Ltd
Operos Medizan Labs (Pvt) Ltd
Opizol Paramount Pharmaceuticals
Ozop Sb Medisure Laboratories Pakistan (Pvt.) Ltd.
Pramax Max Pharmaceuticals
Pramax Max Pharmaceuticals
Prenat S.J. & G. Fazul Ellahie (Pvt) Ltd.
Prenat S.J. & G. Fazul Ellahie (Pvt) Ltd.
Sante Plus Macter International (Pvt) Ltd.
Teph Insta Sami Pharmaceuticals (Pvt) Ltd.
Xift S.J. & G. Fazul Ellahie (Pvt) Ltd.
Zoltar Insta Pharmevo (Pvt) Ltd.

Omeprazole and sodium bicarbonate Capsules 40 mg

Bios Werrick Pharmaceuticals
Encid Wilsons Pharmaceuticals
Erifass D Fassgen Pharmaceuticals
Faast Consolidated Chemical Laboratories (Pvt) Ltd.
Magfast D Panacea Pharmaceuticals
Magfast D Panacea Pharmaceuticals
Mep-B Genix Pharma (Pvt) Ltd
Neusec Plus Biorex Pharmaceuticals
Noazol Plus Noa Hemis Pharmaceuticals
Omega Ferozsons Laboratoies Ltd.
Omeprafast Bio Labs (Pvt) Ltd.
Omeprowan Plus Swan Pharmaceuticals(Pvt) Ltd
Omexia Gt Pharma
Omezac Plus Hilton Pharma (Pvt) Limited
Omi-B Miracle Pharmaceuticals(Pvt) Ltd
Omnat Plus Accurate Medical Suppliers
Omnimint Xenon Pharmaceuticals (Pvt) Ltd.
Omsod Reliance Pharma
Opepzole Global Pharmaceuticals
Opizol Paramount Pharmaceuticals
Ozop Sb Medisure Laboratories Pakistan (Pvt.) Ltd.
Pramax Max Pharmaceuticals
Prenat S.J. & G. Fazul Ellahie (Pvt) Ltd.
Sante Plus Macter International (Pvt) Ltd.
Teph Insta Sami Pharmaceuticals (Pvt) Ltd.
Xift S.J. & G. Fazul Ellahie (Pvt) Ltd.
Zoltar Insta Pharmevo (Pvt) Ltd.

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