Version May 2024
Dosage guidance:
Dosing: All doses are based on the omeprazole component.
Clinical considerations: Avoid coadministration with other antisecretory agents due to decreased acid-inhibitory effects. If another antisecretory agent is needed, allow a sufficient time interval between administration (ie, morning omeprazole and bedtime H2RA) (ACG [Katz 2013]; Wolfe 2000; Wolfe 2020).
Gastroesophageal reflux disease, erosive or nonerosive:
Initial therapy:
Mild/intermittent disease (<2 episodes/week) and no evidence of erosive esophagitis:
Note: Some experts reserve proton pump inhibitors (PPIs) for patients who have residual acid reflux symptoms despite twice-daily H2RA (Kahrilas 2020).
Oral: 10 mg once daily; can increase to 20 mg once daily after 4 to 8 weeks if necessary. Discontinue once asymptomatic for 8 weeks (Festen 1999; Kahrilas 2020).
Severe and/or frequent symptoms (≥2 episodes/week) and/or erosive esophagitis:
Oral: 20 to 40 mg once daily; once symptoms are controlled, continue for at least 8 weeks (Kahrilas 2020; Province of British Columbia Ministry of Health 2015; Waghray 2019; Wolfe 2000). Subsequently, patients without erosive esophagitis or Barrett esophagus can taper to the lowest dose necessary to control symptoms (and/or switch to an H2RA blocker) then discontinue acid suppression once asymptomatic. Patients with erosive esophagitis or Barrett esophagus should continue long-term maintenance therapy with 20 mg once daily (Kahrilas 2020; Ramakrishnan 2002; Spechler 2020).
Residual symptoms despite 40 mg once daily therapy:
Note: Referral to a specialist is recommended.
Oral: Options include splitting the dose to 20 mg twice daily, increasing the dose to 40 mg twice daily, or switching to another PPI (ACG [Katz 2013]; Fass 2020; Wang 2009).
OTC labeling (patient-guided therapy): Heartburn, frequent symptoms (≥2 episodes/week):
Oral: 20 mg once daily for 14 days (maximum: 20 mg/day); may repeat a 14-day course every 4 months if needed. Seek medical referral if symptoms do not resolve within 14 days of treatment; do not take for >14 days or more often than every 4 months unless directed by a physician (manufacturer's labeling).
Peptic ulcer disease, treatment and secondary prevention:
Note: For patients on nonsteroidal anti-inflammatory drugs (NSAIDs) (including aspirin), the NSAID should be discontinued, if possible (Feldman 2020). If present, Helicobacter pylori infection should be treated first; uncomplicated H. pylori–associated ulcers may not need PPI treatment beyond that included in the eradication regimen (Vakil 2020a).
Uncomplicated ulcer:
Oral: 20 to 40 mg once daily. Duration depends on the size, location, and cause of the ulcer and ranges from 4 to 8 weeks. In patients with refractory or recurrent disease, may increase the dose to 20 to 40 mg twice daily (Vakil 2020a; Vakil 2020b).
Stress ulcer prophylaxis in select critically ill patients:
Note: Used in critically ill patients with risk factors for GI bleeding (eg, coagulopathy, mechanical ventilation for >48 hours, traumatic brain injury, history of GI ulceration or bleeding within past year, extensive burns) (SSC [Evans 2021]; Weinhouse 2022).
Oral or via NG tube (oral suspension or capsule [off label]): 40 mg once daily (ASHP 1999; Levy 1997) or 40 mg initially, then another 40 mg dose given 6 to 8 hours later, followed by 40 mg once daily (Conrad 2005; manufacturer’s labeling [Konvomep; Zegerid for oral suspension]). Discontinue prophylaxis once risk factors have resolved (SSC [Evans 2021]; Weinhouse 2022). Note: The capsule dosage form should not be given via NG tube.
Dosage adjustment for concomitant therapy: Significant drug interactions exist, requiring dose/frequency adjustment or avoidance. Consult drug interactions database for more information.
Discontinuation of therapy: In patients who have received continuous therapy for >6 months, some experts gradually taper therapy until discontinuation to avoid worsening or rebound symptoms. There is no single agreed upon discontinuation strategy. If the patient is receiving 40 mg once or twice daily, some experts decrease the dose by 50% every week. For patients receiving twice-daily dosing, the first dose reduction can be achieved by decreasing to once-daily AM dosing. Once patients are on the lowest dose for 1 week, discontinue therapy (Wolfe 2020). An alternative strategy is to decrease the dose by 50% over 2 to 4 weeks, then discontinue. If the patient is already on the lowest possible dose, alternate-day therapy may be considered (Kim 2018). In addition, as-needed therapy with an H2RA or an antacid can be used during the taper (Haastrup 2014).
No dosage adjustment necessary.
Mild to severe impairment (Child-Pugh class A, B, or C): There are no specific dosage adjustments provided in the manufacturer’s labeling. Exposure is significantly increased in patients with hepatic impairment. The manufacturer’s labeling recommends to avoid use for the maintenance healing of erosive esophagitis.
Refer to adult dosing. Bioavailability may be increased in older patients. Avoid scheduled use for >8 weeks unless given for high-risk patients (eg, oral corticosteroid or chronic NSAID use), patients with erosive esophagitis, Barrett esophagitis, a pathological hypersecretory condition, or if the patient has demonstrated a need for maintenance therapy (eg, failure of drug discontinuation trial or failure of H2 blockers) (Ref).
(For additional information see "Omeprazole and sodium bicarbonate: Pediatric drug information")
Dosage guidance:
Dosing: Dosage listed is for omeprazole component; both strengths of Zegerid capsule and powder for oral suspension have identical sodium bicarbonate content. Do not substitute two 20 mg capsules/packets for one 40 mg dose. Recognizing that this formulation has not received FDA approval for use in children despite an approved dosage for omeprazole in children and considering that omeprazole has been used safely in children as an extemporaneous formulation with sodium bicarbonate, the following dosage is recommended:
Erosive esophagitis:
Treatment: Note: Duration of therapy is dependent on age: Infant duration is up to 6 weeks and children and adolescent duration is 4 to 8 weeks. In children and adolescents with no response at 8 weeks, treatment may continue to an additional 4 weeks. For recurrence of erosive esophagitis or gastroesophageal reflux disease (GERD) symptoms (eg, heartburn), an additional 4- to 8-week course may be considered.
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: Oral:
5 kg to <10 kg: 5 mg once daily.
10 kg to <20 kg: 10 mg once daily.
≥20 kg: 20 mg once daily.
Gastroesophageal reflux disease (GERD), symptomatic: Note: Guidelines recommend a 4- to 8-week treatment course; if improvement seen after 4 to 8 weeks, consider possible wean; if no response after 4 to 8 weeks, reevaluate diagnosis and consider referral to pediatric GI specialist (NASPGHAN/ESPGHAN [Rosen 2018]).
Weight-based dosing: Infants, Children, and Adolescents: Oral: 0.7 to 4 mg/kg/day (AAP [Lightdale 2013]; NASPGHAN/ESPGHAN [Rosen 2018]); the dose most frequently reported to provide healing of esophagitis and relief of GERD symptoms is 1 mg/kg/day (Zimmerman 2001); maximum daily dose: 40 mg/day (NASPGHAN/ESPGHAN [Rosen 2018]).
Fixed dosing: Children and Adolescents: Oral:
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: Oral: Based on experience in adults, some experts recommend a step-down approach in order to avoid worsening or rebound symptoms. One recommendation is to decrease the dose by 50% over 2 to 4 weeks. If the patient is already on the lowest possible dose, alternate day therapy may be considered. If symptoms worsen during treatment or after discontinuation, patient should be reevaluated (Kim 2018).
Dosage adjustment for concomitant therapy: Significant drug interactions exist, requiring dose/frequency adjustment or avoidance. Consult drug interactions database for more information.
Altered kidney function: Infants, Children, and Adolescents: Oral:
Mild to severe impairment: There are no pediatric-specific recommendations available; based on experience in adult patients, no dosage adjustments are recommended.
There are no dosage adjustments provided in the manufacturer's labeling; however, based on increased bioavailability, a dosage adjustment should be considered, especially for maintenance of healing of erosive esophagitis. Pediatric-specific recommendations are not available.
The following adverse drug reactions and incidences are derived from product labeling unless otherwise specified. Adverse events reported from a trial of 178 critically ill adults receiving the oral powder for suspension. Also see individual agents.
>10%:
Endocrine & metabolic: Hyperglycemia (11%), hypokalemia (12%)
Respiratory: Hospital-acquired pneumonia (11%)
Miscellaneous: Fever (20%)
1% to 10%:
Cardiovascular: Atrial fibrillation (6%), bradycardia (4%), edema (3%), hypertension (8%), hypotension (10%), supraventricular tachycardia (3%), tachycardia (3%), ventricular tachycardia (5%)
Dermatological: Pressure ulcer (3%), skin rash (6%)
Endocrine & metabolic: Hyperkalemia (2%), hypernatremia (2%), hypervolemia (5%), hypocalcemia (6%), hypoglycemia (3%), hypomagnesemia (10%), hyponatremia (4%), hypophosphatemia (6%)
Gastrointestinal: Constipation (5%), decreased gastrointestinal motility (2%), diarrhea (4%), oral candidiasis (4%)
Genitourinary: Urinary tract infection (2%)
Hematologic & oncologic: Anemia (8%; exacerbation of anemia: 2%), thrombocytopenia (10%)
Hepatic: Abnormal hepatic function tests (2%)
Infection: Candidiasis (2%), sepsis (5%)
Nervous system: Agitation (3%), hyperpyrexia (5%)
Respiratory: Acute respiratory distress (3%), respiratory failure (2%)
<1%: Respiratory: Pneumothorax
Hypersensitivity (eg, anaphylaxis, anaphylactic shock, angioedema, bronchospasm, acute tubulointerstitial nephritis, urticaria) to omeprazole, other substituted benzimidazole proton pump inhibitors, or any component of the formulation; concomitant use with products that contain rilpivirine.
Significant drug interactions exist, requiring dose/frequency adjustment or avoidance. Consult drug interactions database for more information.
OTC labeling: When used for self-medication (OTC), do not use if trouble or pain when swallowing food; vomiting with blood, or bloody or black stools; heartburn with lightheadedness, sweating, or dizziness; chest pain or shoulder pain with shortness of breath, sweating, pain spreading to arms, neck, or shoulders, or lightheadedness; frequent chest pain.
Concerns related to adverse effects:
• 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.
• Clostridioides 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.
• Cutaneous and systemic lupus erythematosus: Has been reported as new onset or exacerbation of existing autoimmune disease; most cases were cutaneous lupus erythematosus (CLE), most commonly, subacute CLE (occurring within weeks to years after continuous therapy). Systemic lupus erythematosus (SLE) is less common (typically occurs within days to years after initiating treatment) and occurred primarily in young and older adults. Discontinue therapy if signs or symptoms of CLE or SLE occur and refer to specialist for evaluation; most patients improve 4 to 12 weeks after discontinuation of omeprazole.
• Dermatologic reactions: Severe cutaneous adverse reactions, including acute generalized exanthematous pustulosis, drug reaction with eosinophilia and systemic symptoms, Stevens-Johnson syndrome, and toxic epidermal necrolysis have been reported.
• 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.
• Fundic gland polyps: Use of proton pump inhibitors (PPIs) increases risk of fundic gland polyps, especially with long-term use >1 year. May occur without symptoms, but nausea, vomiting, or abdominal pain may occur; GI bleeding and/or anemia may occur with ulcerated polyps. Diagnosis of polyps may also increase risk for small intestinal blockage. Use the lowest dose and shortest duration of PPI therapy appropriate for the condition being treated.
• 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. Hypomagnesemia may lead to or exacerbate hypocalcemia in patients at risk (eg, hypoparathyroidism). Hypomagnesemia may also lead to hypokalemia. Hypomagnesemia and hypocalcemia may be corrected by magnesium/calcium supplementation, although discontinuation of omeprazole may be necessary.
• Tubulointerstitial nephritis: Acute tubulointerstitial nephritis has been observed in patients taking PPIs; may occur at any time during therapy. Patients may present with symptomatic hypersensitivity reaction to nonspecific symptoms of impaired kidney function (eg, anorexia, malaise, nausea); may be diagnosed with biopsy and in the absence of extra-renal manifestations (eg, fever, rash, arthralgia). Discontinue and evaluate patients if acute tubulointerstitial nephritis is suspected.
• 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:
• Acid-base balance disorders: Avoid use in patients with acid-base disorders; contains sodium bicarbonate.
• Bartter's syndrome: Avoid use 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.
• Heart failure: Use with caution in patients with heart failure.
• Hepatic impairment: Exposure is significantly increased in patients with hepatic impairment; avoid use for maintenance healing of erosive esophagitis.
• Hypocalcemia: Avoid use in patients with hypocalcemia; contains sodium bicarbonate.
• Hypokalemia: Avoid use in patients with hypokalemia; 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).
Special populations:
• Asian ethnicity: Exposure increased in patients of Asian descent; avoid use for maintenance of healing of erosive esophagitis.
• Older adult: Bioavailability may be increased in older adults.
• 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 kidney 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:
• Laboratory test interference: Serum chromogranin A (CgA) levels increase secondary to drug-induced decreases in gastric acid; may cause false-positive results in diagnostic investigations for neuroendocrine tumors. Temporarily stop omeprazole treatment at least 14 days before CgA test; if initial CgA levels are high, repeat test to confirm. Use same commercial laboratory for testing to prevent variable results.
• 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.
Use of gastric acid inhibitors, including proton pump inhibitors (PPIs) and H2 blockers, has been associated with an increased risk for development of acute gastroenteritis and community-acquired pneumonia in pediatric patients 4 to 36 months of age (Canani 2006). Routine use in preterm infants is not recommended (AAP [Eichenwald 2018]).
Gastric acid suppression medications have been associated with an increase in Clostridioides difficile infection (CDI) and recurrent CDI in pediatric patients (Nylund 2014). In a retrospective, observational, case control study of pediatric patients 1 to 18 years old who were hospitalized for diarrhea and abdominal pain, the use of PPIs was significantly higher in patients who tested positive for C. difficile compared to patients who tested negative for C. difficile (22.1% vs 5.9%) (Turco 2010). Consider CDI 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.
A large retrospective cohort study reviewed records for patients with a low baseline risk for fractures who were initiated on acid suppression therapy in the first year of life and evaluated the fracture risk in the first 5 years of life; a total of 97,286 patients were prescribed acid suppression therapy; 73% were prescribed H2 blockers, 9% were prescribed PPIs, and 18% were prescribed both. H2 blocker use alone was not associated with an increased fracture hazard; however, PPI use was associated with a 21% increase and use of PPI plus H2 blocker was associated with a 30% increase. Longer duration of therapy and earlier age at initiation seemed to also increase the fracture hazard. Study findings do not establish a causal relationship between PPI use and fractures. If acid suppression therapy is necessary in the first year of life, limiting therapy to a single drug and limiting the duration should be considered (Malchodi 2019). A second large cohort study reviewed records for 115,933 children <18 years initiated on a PPI. PPI initiation was associated with a statistically significant 11% relative increase in risk of any fracture in patients ≥6 years. The increased risk also seemed to be more pronounced with a longer cumulative duration of PPI use (Wang 2020).
Excipient information presented when available (limited, particularly for generics); consult specific product labeling.
Capsule, Oral:
OmePPi: Omeprazole 20 mg and sodium bicarbonate 1100 mg, Omeprazole 40 mg and sodium bicarbonate 1100 mg [contains sodium 304 mg (13 mEq) per capsule]
Zegerid: Omeprazole 20 mg and sodium bicarbonate 1100 mg, Omeprazole 40 mg and sodium bicarbonate 1100 mg [contains sodium 304 mg (13 mEq) per capsule]
Zegerid OTC: Omeprazole 20 mg and sodium bicarbonate 1100 mg [contains sodium 303 mg (13 mEq) per capsule] [DSC]
Generic: Omeprazole 20 mg and sodium bicarbonate 1100 mg; Omeprazole 40 mg and sodium bicarbonate 1100 mg
Powder for suspension, Oral:
Konvomep: Omeprazole 2 mg and sodium bicarbonate 84 mg per 1 mL (90 mL, 150 mL, 300 mL) [contains fd&c red #40, propylene glycol; strawberry flavor]
Zegerid: Omeprazole 20 mg and sodium bicarbonate 1680 mg per packet (30s) [contains sodium 460 mg (20 mEq) per packet]; 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)
Yes
Capsules (Omeprazole-Sodium Bicarbonate Oral)
20-1100 mg (per each): $104.84 - $113.77
40-1100 mg (per each): $13.34 - $113.77
Capsules (Zegerid Oral)
20-1100 mg (per each): $132.27
40-1100 mg (per each): $132.27
Pack (Omeprazole-Sodium Bicarbonate Oral)
20-1680 mg (per each): $104.84
40-1680 mg (per each): $104.84
Pack (Zegerid Oral)
20-1680 mg (per each): $132.27
40-1680 mg (per each): $132.28
Suspension (reconstituted) (Konvomep Oral)
2-84 mg/mL (per mL): $2.00
Disclaimer: A representative AWP (Average Wholesale Price) price or price range is provided as reference price only. A range is provided when more than one manufacturer's AWP price is available and uses the low and high price reported by the manufacturers to determine the range. The pricing data should be used for benchmarking purposes only, and as such should not be used alone to set or adjudicate any prices for reimbursement or purchasing functions or considered to be an exact price for a single product and/or manufacturer. Medi-Span expressly disclaims all warranties of any kind or nature, whether express or implied, and assumes no liability with respect to accuracy of price or price range data published in its solutions. In no event shall Medi-Span be liable for special, indirect, incidental, or consequential damages arising from use of price or price range data. Pricing data is updated monthly.
For most indications, administer 30 to 60 minutes before a meal; best if taken before breakfast (ACG [Katz 2013]). If administering twice daily, first dose should be administered before breakfast and the second dose before dinner (ACG [Katz 2013]; Hershcovici 2010).
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: Swallow 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.
Oral suspension (Konvomep):
Oral: After reconstitution, shake well before use.
NG/orogastric tube: After reconstitution, shake well and withdraw 20 mL of suspension into a syringe, then administer immediately; refill syringe with 20 mL of water and flush tube to administer any remaining suspension. Suspend enteral feeding for 3 hours before and 1 hour after administering.
Powder for oral suspension (Zegerid):
Oral: Administer 1 hour before a meal. Mix with 5 to 10 mL of water; stir well and drink immediately. Rinse cup with water and drink. Do not use other liquids or sprinkle on food.
NG/orogastric tube: Mix well with 20 mL of water (do not use other liquids); shake well and administer immediately; refill syringe with 20 mL of water, shake and flush tube to administer any remaining contents. Suspend enteral feeding for 3 hours before and 1 hour after administering.
Note: Both strengths of capsule and Zegerid powder for oral suspension have identical sodium bicarbonate content. Do not substitute two 20 mg capsules/packets for one 40 mg dose.
Capsule: Oral: 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. Administer on an empty stomach, 1 hour before a meal.
Powder for oral suspension:
Oral: Administer on an empty stomach, 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 mix with other liquids or food, only water.
Nasogastric/orogastric tube: Add 20 mL of water to a catheter-tipped syringe and then add contents of the prescribed packet, shake the suspension well, and administer immediately. Refill syringe with 20 mL of water, shake and flush remaining contents through tube. Suspend enteral feeding for 3 hours before and 1 hour after administering. Do not mix with other liquids or food, only water.
An FDA-approved patient medication guide, which is available with the product information and as follows, must be dispensed with this medication:
Konvomep: https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/213593s000lbl.pdf#page=28
Zegerid: https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/021849s020,021636s025lbl.pdf#page=31
Gastroesophageal reflux disease, erosive or nonerosive (Rx only):
Treatment of erosive esophagitis: Short-term treatment of erosive esophagitis (EE) due to acid-mediated gastroesophageal reflux disease (GERD) diagnosed by endoscopy in adults.
Maintenance healing of erosive esophagitis: Maintenance healing of EE due to acid-mediated GERD in adults.
Symptomatic gastroesophageal reflux disease: Treatment of heartburn and other symptoms associated with GERD for up to 4 weeks in adults.
Heartburn (OTC only): Treatment of frequent, uncomplicated heartburn (occurring ≥2 days per week) in adults.
Peptic ulcer disease, treatment of duodenal or gastric ulcers (Rx only): Short-term treatment of active duodenal or gastric ulcers in adults.
Stress ulcer prophylaxis in select critically ill patients: Reduction of risk of upper GI bleeding in critically ill adults (oral suspension).
Zegerid may be confused with Zestril
Beers Criteria: Omeprazole is identified in the Beers Criteria as a potentially inappropriate medication to be avoided (as scheduled use for >8 weeks) in patients 65 years and older due to its risk of C. difficile infection, pneumonia, GI malignancies, and bone loss/fractures unless given for high-risk patients (eg, oral corticosteroid or chronic NSAID use), patients with erosive esophagitis, Barrett esophagitis, a pathological hypersecretory condition, or if the patient has demonstrated a need for maintenance therapy (eg, failure of drug discontinuation trial or failure of H2 blockers) (Beers Criteria [AGS 2023]).
Refer to individual components.
Note: Interacting drugs may not be individually listed below if they are part of a group interaction (eg, individual drugs within “CYP3A4 Inducers [Strong]” are NOT listed). For a complete list of drug interactions by individual drug name and detailed management recommendations, use the Lexicomp drug interactions program by clicking on the “Launch drug interactions program” link above.
Acalabrutinib: Inhibitors of the Proton Pump (PPIs and PCABs) may decrease the serum concentration of Acalabrutinib. This interaction is only applicable to acalabrutinib capsules. Risk X: Avoid combination
Amphetamine: Inhibitors of the Proton Pump (PPIs and PCABs) may increase the absorption of Amphetamine. Risk C: Monitor therapy
Atazanavir: Inhibitors of the Proton Pump (PPIs and PCABs) may decrease the serum concentration of Atazanavir. Management: Avoid use in treatment-experienced patients. In treatment-naive patients, administer boosted atazanavir 12 hours after the PPI and the PPI dose should not exceed the equivalent of 20 mg omeprazole. Monitor for reduced atazanavir efficacy. Risk D: Consider therapy modification
Belumosudil: Inhibitors of the Proton Pump (PPIs and PCABs) may decrease the serum concentration of Belumosudil. Management: Increase the dose of belumosudil to 200 mg twice daily when coadministered with inhibitors of the proton pump (PPIs and PCABs). Risk D: Consider therapy modification
Bisphosphonate Derivatives: Inhibitors of the Proton Pump (PPIs and PCABs) may diminish the therapeutic effect of Bisphosphonate Derivatives. Risk C: Monitor therapy
Bosutinib: Inhibitors of the Proton Pump (PPIs and PCABs) may decrease the serum concentration of Bosutinib. Management: Consider alternatives to proton pump inhibitors and potassium-competitive acid blockers, such as short-acting antacids or histamine-2 receptor antagonists. Administer alternative agents more than 2 hours before or after bosutinib. Risk D: Consider therapy modification
Capecitabine: Inhibitors of the Proton Pump (PPIs and PCABs) may diminish the therapeutic effect of Capecitabine. Risk C: Monitor therapy
CarBAMazepine: May decrease the serum concentration of Omeprazole. Omeprazole may increase the serum concentration of CarBAMazepine. Risk C: Monitor therapy
Cefditoren: Inhibitors of the Proton Pump (PPIs and PCABs) may decrease the serum concentration of Cefditoren. Risk X: Avoid combination
Cefpodoxime: Inhibitors of the Proton Pump (PPIs and PCABs) may decrease the serum concentration of Cefpodoxime. Risk C: Monitor therapy
Cefuroxime: Inhibitors of the Proton Pump (PPIs and PCABs) may decrease the absorption of Cefuroxime. Risk X: Avoid combination
Cilostazol: Omeprazole may increase serum concentrations of the active metabolite(s) of Cilostazol. Omeprazole may increase the serum concentration of Cilostazol. Management: Reduce the cilostazol dose to 50 mg twice daily in patients who are also receiving omeprazole. Monitor clinical response to cilostazol closely. Risk D: Consider therapy modification
Citalopram: Omeprazole may increase the serum concentration of Citalopram. Management: Limit citalopram dose to a maximum of 20 mg/day if used with omeprazole. Monitor for evidence of citalopram toxicity (eg, serotonin syndrome, QT prolongation) in patients receiving this combination. Risk D: Consider therapy modification
CloBAZam: CYP2C19 Inhibitors (Weak) may increase serum concentrations of the active metabolite(s) of CloBAZam. CYP2C19 Inhibitors (Weak) may increase the serum concentration of CloBAZam. Risk C: Monitor therapy
Clofarabine: OAT1/3 Inhibitors may increase the serum concentration of Clofarabine. Risk C: Monitor therapy
Clopidogrel: Omeprazole may diminish the antiplatelet effect of Clopidogrel. Omeprazole may decrease serum concentrations of the active metabolite(s) of Clopidogrel. Risk X: Avoid combination
CloZAPine: Omeprazole may decrease the serum concentration of CloZAPine. Omeprazole may increase the serum concentration of CloZAPine. Risk C: Monitor therapy
CycloSPORINE (Systemic): Omeprazole may increase the serum concentration of CycloSPORINE (Systemic). Risk C: Monitor therapy
CYP2C19 Inducers (Moderate): May decrease the serum concentration of Omeprazole. Risk C: Monitor therapy
CYP2C19 Inducers (Strong): May decrease the serum concentration of Omeprazole. Risk X: Avoid combination
CYP2C19 Inhibitors (Moderate): May increase the serum concentration of Omeprazole. Risk C: Monitor therapy
CYP2C19 Inhibitors (Strong): May increase the serum concentration of Omeprazole. Risk C: Monitor therapy
Cysteamine (Systemic): Inhibitors of the Proton Pump (PPIs and PCABs) may diminish the therapeutic effect of Cysteamine (Systemic). Risk C: Monitor therapy
Dacomitinib: Inhibitors of the Proton Pump (PPIs and PCABs) may decrease the serum concentration of Dacomitinib. Management: Avoid concurrent use of dacomitinib with PPIs and PCABs. 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. Risk X: Avoid combination
Darunavir: May decrease the serum concentration of Omeprazole. Risk C: Monitor therapy
Dasatinib: Inhibitors of the Proton Pump (PPIs and PCABs) may decrease the serum concentration of Dasatinib. Management: Antacids (taken 2 hours before or after dasatinib administration) can be used in place of PPIs or PCABs if some acid-reducing therapy is needed. Risk X: Avoid combination
Delavirdine: Inhibitors of the Proton Pump (PPIs and PCABs) may decrease the serum concentration of Delavirdine. Management: Chronic therapy with PPIs or PCABs should be avoided in patients treated with delavirdine. The clinical significance of short-term PPI or PCAB therapy with delavirdine is uncertain, but such therapy should be undertaken with caution. Risk X: Avoid combination
Dextroamphetamine: Inhibitors of the Proton Pump (PPIs and PCABs) may increase the absorption of Dextroamphetamine. Specifically, the dextroamphetamine absorption rate from mixed amphetamine salt extended release (XR) capsules may be increased in the first hours after dosing. Risk C: Monitor therapy
Dichlorphenamide: OAT1/3 Inhibitors may increase the serum concentration of Dichlorphenamide. Risk C: Monitor therapy
Doxycycline: Inhibitors of the Proton Pump (PPIs and PCABs) may decrease the bioavailability of Doxycycline. Risk C: Monitor therapy
Enoxacin: Inhibitors of the Proton Pump (PPIs and PCABs) may decrease the absorption of Enoxacin. Risk C: Monitor therapy
Erlotinib: Inhibitors of the Proton Pump (PPIs and PCABs) may decrease the serum concentration of Erlotinib. Risk X: Avoid combination
Escitalopram: Omeprazole may increase the serum concentration of Escitalopram. Risk C: Monitor therapy
Fosphenytoin-Phenytoin: CYP2C19 Inhibitors (Weak) may increase the serum concentration of Fosphenytoin-Phenytoin. Risk C: Monitor therapy
Gefitinib: Inhibitors of the Proton Pump (PPIs and PCABs) may decrease the serum concentration of Gefitinib. Management: Avoid use of inhibitors of the proton pump (PPIs or PCABs) with gefitinib when possible. If required, administer gefitinib 12 hours after the PPI/PCAB or 12 hours before the next dose of the PPI/PCAB. Closely monitor clinical response to gefitinib. Risk D: Consider therapy modification
Gliclazide: Omeprazole may increase the serum concentration of Gliclazide. Risk C: Monitor therapy
Immune Checkpoint Inhibitors (Anti-PD-1, -PD-L1, and -CTLA4 Therapies): Inhibitors of the Proton Pump (PPIs and PCABs) may diminish the therapeutic effect of Immune Checkpoint Inhibitors (Anti-PD-1, -PD-L1, and -CTLA4 Therapies). Risk C: Monitor therapy
Indinavir: Inhibitors of the Proton Pump (PPIs and PCABs) may decrease the serum concentration of Indinavir. Risk C: Monitor therapy
Infigratinib: Inhibitors of the Proton Pump (PPIs and PCABs) may decrease serum concentrations of the active metabolite(s) of Infigratinib. Inhibitors of the Proton Pump (PPIs and PCABs) may decrease the serum concentration of Infigratinib. Risk X: Avoid combination
Itraconazole: Inhibitors of the Proton Pump (PPIs and PCABs) may increase the serum concentration of Itraconazole. This specifically applies to the super bioavailable itraconazole products (eg, Tolsura brand). Inhibitors of the Proton Pump (PPIs and PCABs) may decrease the serum concentration of Itraconazole. This specifically applies to the non-super bioavailable itraconazole products (eg, Sporanox brand and its generics). Management: Exposure to Tolsura brand itraconazole may be increased by PPIs or PCABs ; consider itraconazole dose reduction. Exposure to Sporanox brand itraconazole may be decreased. Give Sporanox brand itraconazole at least 2 hrs before or 2 hrs after PPIs or PCABs. Risk D: Consider therapy modification
Ketoconazole (Systemic): Inhibitors of the Proton Pump (PPIs and PCABs) may decrease the absorption of Ketoconazole (Systemic). Ketoconazole (Systemic) may increase the serum concentration of Inhibitors of the Proton Pump (PPIs and PCABs). Management: Administer ketoconazole with an acidic beverage, such as non-diet cola, to increase gastric acidity and improve absorption if concomitant use with proton pump inhibitors or potassium-competitive acid blockers is necessary. Risk D: Consider therapy modification
Ledipasvir: Inhibitors of the Proton Pump (PPIs and PCABs) may decrease the serum concentration of Ledipasvir. Management: PPI or PCAB doses equivalent to omeprazole 20 mg or lower may be given with ledipasvir under fasted conditions. Use of ledipasvir with higher doses or with food, or 2 hours after a these agents, may reduce ledipasvir bioavailability. Risk D: Consider therapy modification
Levoketoconazole: Inhibitors of the Proton Pump (PPIs and PCABs) may decrease the absorption of Levoketoconazole. Levoketoconazole may increase the serum concentration of Inhibitors of the Proton Pump (PPIs and PCABs). Risk X: Avoid combination
Lumacaftor and Ivacaftor: May decrease the serum concentration of CYP2C19 Substrates (High risk with Inducers). Risk C: Monitor therapy
Lumacaftor and Ivacaftor: May decrease the serum concentration of Inhibitors of the Proton Pump (PPIs and PCABs). Risk C: Monitor therapy
Mavacamten: CYP2C19 Inhibitors (Weak) may increase the serum concentration of Mavacamten. Management: Start mavacamten at 5 mg/day if stable on a weak CYP2C19 inhibitor. For those stable on mavacamten who are initiating a weak CYP2C19 inhibitor, reduce mavacamten dose by one dose level. Risk D: Consider therapy modification
Methotrexate: Inhibitors of the Proton Pump (PPIs and PCABs) may increase the serum concentration of Methotrexate. Management: Consider temporarily interrupting PPI or PCAB therapy in patients receiving high-dose methotrexate. If coadministered, monitor for increased methotrexate toxicity (eg, mucositis, myalgias) and/or delayed methotrexate elimination. Risk D: Consider therapy modification
Moclobemide: May increase the serum concentration of Omeprazole. Omeprazole may increase the serum concentration of Moclobemide. Risk C: Monitor therapy
Multivitamins/Minerals (with ADEK, Folate, Iron): Inhibitors of the Proton Pump (PPIs and PCABs) may decrease the serum concentration of Multivitamins/Minerals (with ADEK, Folate, Iron). Specifically, the absorption of iron may be decreased. Risk C: Monitor therapy
Mycophenolate: Inhibitors of the Proton Pump (PPIs and PCABs) may decrease the serum concentration of Mycophenolate. Specifically, concentrations of the active mycophenolic acid may be reduced. Risk C: Monitor therapy
Nelfinavir: Inhibitors of the Proton Pump (PPIs and PCABs) may decrease serum concentrations of the active metabolite(s) of Nelfinavir. Inhibitors of the Proton Pump (PPIs and PCABs) may decrease the serum concentration of Nelfinavir. Management: Due to potentially significant reductions in nelfinavir exposure, avoid concurrent use of nelfinavir with a PPI or PCAB when possible. If unavoidable, consider PPI or PCAB use for a short duration (less than 30 days) and closely monitor viral load. Risk D: Consider therapy modification
Neratinib: Inhibitors of the Proton Pump (PPIs and PCABs) may decrease the serum concentration of Neratinib. Specifically, proton pump inhibitors may reduce neratinib absorption. Risk X: Avoid combination
Nilotinib: Inhibitors of the Proton Pump (PPIs and PCABs) may decrease the serum concentration of Nilotinib. Management: Avoid this combination. Histamine H2 receptor antagonists (H2RAs) given 10 hours before or 2 hours after nilotinib, or antacids given 2 hours before or 2 hours after nilotinib are acceptable alternatives. Risk D: Consider therapy modification
Nirogacestat: Inhibitors of the Proton Pump (PPIs and PCABs) may decrease the serum concentration of Nirogacestat. Risk X: Avoid combination
Octreotide: Inhibitors of the Proton Pump (PPIs and PCABs) may decrease the serum concentration of Octreotide. Risk C: Monitor therapy
Palbociclib: Inhibitors of the Proton Pump (PPIs and PCABs) may diminish the therapeutic effect of Palbociclib. Specifically, this has been reported with the use of palbociclib capsules. Inhibitors of the Proton Pump (PPIs and PCABs) may decrease the serum concentration of Palbociclib. Specifically, this may occur with the use of palbociclib capsules, and to the greatest extent when taken without food. Management: Carefully evaluate potential risks and benefits of coadministration of palbociclib capsules and proton pump inhibitors or potassium-competitive acid blockers due to the risk of reduced palbociclib efficacy. Palbociclib capsules should be taken with food. Risk D: Consider therapy modification
PAZOPanib: Inhibitors of the Proton Pump (PPIs and PCABs) may decrease the serum concentration of PAZOPanib. Risk X: Avoid combination
Pexidartinib: Inhibitors of the Proton Pump (PPIs and PCABs) may decrease the serum concentration of Pexidartinib. Management: Avoid this combination. 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. Risk X: Avoid combination
Posaconazole: Inhibitors of the Proton Pump (PPIs and PCABs) may decrease the serum concentration of Posaconazole. Management: Avoid coadministration of PPIs or PCABs and posaconazole oral suspension. Posaconazole delayed-release tablets do not appear to be sensitive to this interaction and do not required dose adjustment if coadministered with PPIs or PCABs. Risk D: Consider therapy modification
Rilpivirine: Inhibitors of the Proton Pump (PPIs and PCABs) may decrease the serum concentration of Rilpivirine. Risk X: Avoid combination
Riociguat: Inhibitors of the Proton Pump (PPIs and PCABs) may decrease the serum concentration of Riociguat. Risk C: Monitor therapy
Risedronate: Inhibitors of the Proton Pump (PPIs and PCABs) may diminish the therapeutic effect of Risedronate. Inhibitors of the Proton Pump (PPIs and PCABs) may increase the serum concentration of Risedronate. This applies specifically to use of delayed-release risedronate. Management: Coadministration of PPIs or PCABs with delayed-release risedronate formulations is not recommended. Limit PPI/PCAB dose and duration during coadministration with risedronate as possible. Patients over age 70 are at higher risk of adverse effects. Risk D: Consider therapy modification
Saquinavir: Inhibitors of the Proton Pump (PPIs and PCABs) may increase the serum concentration of Saquinavir. Risk C: Monitor therapy
Secretin: Inhibitors of the Proton Pump (PPIs and PCABs) 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 PPIs or PCABs and secretin, and discontinue PPI or PCAB several weeks prior to secretin administration, with the duration of separation determined by the specific acid suppressant. See full monograph for details. Risk D: Consider therapy modification
Selpercatinib: Inhibitors of the Proton Pump (PPIs and PCABs) may decrease the serum concentration of Selpercatinib. Management: Coadministration of selpercatinib and PPIs or PCABs should be avoided. If coadministration cannot be avoided, selpercatinib and PPIs or PCABs should be administered simultaneously with food. Risk D: Consider therapy modification
SORAfenib: Inhibitors of the Proton Pump (PPIs and PCABs) may decrease the absorption of SORAfenib. Risk C: Monitor therapy
Sotorasib: Inhibitors of the Proton Pump (PPIs and PCABs) may decrease the serum concentration of Sotorasib. Risk X: Avoid combination
Sparsentan: Inhibitors of the Proton Pump (PPIs and PCABs) may decrease the serum concentration of Sparsentan. Risk X: Avoid combination
St John's Wort: May decrease the serum concentration of Omeprazole. Risk X: Avoid combination
Tacrolimus (Systemic): Inhibitors of the Proton Pump (PPIs and PCABs) may increase the serum concentration of Tacrolimus (Systemic). Risk C: Monitor therapy
Technetium Tc 99m Sestamibi: Inhibitors of the Proton Pump (PPIs and PCABs) may diminish the diagnostic effect of Technetium Tc 99m Sestamibi. Management: Consider holding/stopping proton pump inhibitor therapy for at least 3 days prior to the use technetium Tc 99m sestamibi in cardiac imaging procedures. Risk D: Consider therapy modification
Technetium Tc 99m Tetrofosmin: Inhibitors of the Proton Pump (PPIs and PCABs) may diminish the diagnostic effect of Technetium Tc 99m Tetrofosmin. Risk C: Monitor therapy
Thiazolidinediones: Inhibitors of the Proton Pump (PPIs and PCABs) may enhance the adverse/toxic effect of Thiazolidinediones. Specifically, the risk of osteoporosis or fracture may be increased. Risk C: Monitor therapy
Tipranavir: May decrease the serum concentration of Inhibitors of the Proton Pump (PPIs and PCABs). These data are derived from studies with Ritonavir-boosted Tipranavir. Risk C: Monitor therapy
Velpatasvir: Inhibitors of the Proton Pump (PPIs and PCABs) may decrease the serum concentration of Velpatasvir. Management: Sofosbuvir/velpatasvir should be administered with food and taken 4 hours before omeprazole 20 mg. Sofosbuvir/velpatasvir/voxilaprevir can be administered with omeprazole 20 mg. Use with other PPIs or PCABs has not been studied. Risk D: Consider therapy modification
Vitamin K Antagonists (eg, warfarin): Omeprazole may increase the serum concentration of Vitamin K Antagonists. Risk C: Monitor therapy
Voriconazole: Omeprazole may increase the serum concentration of Voriconazole. Voriconazole may increase the serum concentration of Omeprazole. Risk C: Monitor therapy
See individual agents.
Adverse events have been observed in animal reproduction studies with omeprazole. Refer to individual monographs for additional information.
Omeprazole is excreted in breast milk. According to the manufacturer, the decision to continue or discontinue breastfeeding during therapy should take into account the risk of infant exposure, the benefits of breastfeeding to the infant, and benefits of treatment to the mother. Refer to individual agents.
Take 1 hour before a meal. Contains sodium; use with caution in patients on sodium-restricted diets.
Magnesium (baseline and periodically thereafter; especially if taking concomitant digoxin, diuretics, or other drugs known to cause hypomagnesemia) and calcium (baseline and periodically in patients at risk [eg, hypoparathyroidism]).
Suppresses gastric basal and 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 to 4 days.
Duration: 72 hours; 50% of maximum 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: Oral: ~30% to 40%; Hepatic dysfunction: ~100%; Asians: AUC increased up to 4 times compared to Caucasians.
Half-life elimination: ~1 hour (range: 0.4 to 4.2 hours); Hepatic dysfunction: ~3 hours.
Time to peak, serum: ~0.25 to 3.5 hours.
Excretion: Urine (77% as metabolites, very small amount as unchanged drug); feces.
Clearance: 500 to 600 mL/minute; Chronic hepatic disease: 70 mL/minute.
Older adult: The elimination rate of omeprazole was somewhat decreased in older patients, and bioavailability was increased. Omeprazole was 76% bioavailable when a single omeprazole 40 mg dose (buffered solution) was administered to healthy older adult subjects versus 58% in younger subjects given the same dose. Nearly 70% of the dose was recovered in urine as metabolites of omeprazole and no unchanged drug was detected. The plasma clearance of omeprazole was 250 mL/minute (about half that of younger subjects) and its plasma half-life averaged 1 hour, similar to that of younger, healthy subjects.
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