ZEGERID omeprazole and sodium bicarbonate 40 mg; 1680 mg Powder, For Suspension, 3 packets
🆔 Identity & classification
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This medicine belongs to the Salt solutions class.
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🩺 Clinical
- It's blocking the pump in your stomach lining that produces acid — pretty much turning it off at the source. Less acid means ulcers can heal, acid reflux symptoms ease up, and the...
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🧪 Inactive Ingredients / Excipients
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💲 Pricing
A drug doesn't have one price. Each row is a different public payment system, and none is what you'd pay at the counter — that depends on your insurance. The ⓘ on each row explains what it measures.
| Price system | Per mL | Per package |
|---|---|---|
| Retail pharmacies payNADAC · weekly | Not in the retail survey — common for institutional, discontinued, or low-volume packs. | |
| Medicaid paysCMS SDUD · 12 mo | No recent Medicaid claims on file for this NDC — rare and low-volume NDCs are suppressed in the public data. | |
| Medicare drug plans payPart D · quarterly | No Part D plan price is available for this NDC in our data. | |
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🔁 Therapeutic equivalents
| Product | Labeler | Pack | NADAC/unit | TE | Status | Price vs. this |
|---|---|---|---|---|---|---|
| Omeprazole and Sodium Bicarbonate 40 mg/1; 1680 mg 27241-0030-31 | Ajanta | 30 fors | $8.333 | AB | Availability likely | — |
| Omeprazole/Sodium Bicarbonate 40 mg/1720mg; 1680 mg/1720mg 64380-0183-02 | Strides | 30 pouches | $8.333 | AB | Availability likely | — |
| Omeprazole and Sodium Bicarbonate 40 mg/1; 1680 mg 70954-0798-20 | ANI | 30 packets | $8.333 | AB | Availability likely | — |
| Zegerid 40 mg/1; 1680 mgthis 68012-0054-03 | Santarus, | 3 packets | — | — | FDA listed | — |
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⏳ Availability & generic status
FDA-approved generic versions are listed, and recent pricing/market data suggests they may be available — see Therapeutic equivalents.
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💊 Medicaid utilization by pack size
📊 Medicare Part D spend CMS · PART D · 2025 (Q1-Q4)
📦 Packaging — all sizes for this product
| Package NDC | Description | Marketing start | Status |
|---|---|---|---|
| 68012-0054-03 You're viewing this | 3 PACKET in 1 CARTON (68012-054-03) / 1 POWDER, FOR SUSPENSION in 1 PACKET | 2014-06-15 | Active |
| 68012-0054-30 | 30 PACKET in 1 CARTON (68012-054-30) / 1 POWDER, FOR SUSPENSION in 1 PACKET | 2014-06-15 | Discontinued by firm |
This pack shows little to no recent Medicaid volume — a different pack size carries most fills. See all packs ↓
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| NDC identity (package / product / labeler codes) | ✓ Available |
| Labeler | ✓ Available |
| Product & package description | ✓ Available |
| Marketing category & status | ✓ Available |
| Active ingredient / dosage form / route | ✓ Available |
| FDA label (SPL via DailyMed) | ✓ Available |
| Package photos | ✓ Available |
| Inactive ingredients (structured) | — Not published for this NDC The labeler did not submit a structured excipient list, or no SPL is available. |
| NADAC pharmacy acquisition price (CMS) | — Not published for this NDC CMS publishes NADAC only for NDCs reported in its retail-pharmacy survey. |
| Orange Book / therapeutic-equivalence data | — Not published for this NDC Applies only to products approved under an NDA/ANDA; many listings are out of scope. |
| HCPCS J-code billing crosswalk | — Not published for this NDC Most self-administered / retail products have no J-code — that is normal. |
| Medicaid utilization (CMS SDUD) | — Not published for this NDC CMS reports utilization only for NDCs with Medicaid claims above its privacy threshold. |
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📄 Full prescribing information FDA SPL
🎯 Indications and Usage ▾
1 INDICATIONS AND USAGE ZEGERID for oral suspension and ZEGERID capsules are indicated in adults for the : • short-term treatment of active duodenal ulcer. Most patients heal within four weeks. Some patients may require an additional four weeks of therapy. • short-term treatment (4 to 8 weeks) of active benign gastric ulcer. • treatment of heartburn and other symptoms associated with GERD for up to 4 weeks. • short-term treatment (4 to 8 weeks) of EE due to acid-mediated GERD which has been diagnosed by endoscopy in adults. o The efficacy of ZEGERID used for longer than 8 weeks in patients with EE has not been established.
If a patient does not respond to 8 weeks of treatment, an additional 4 weeks of treatment may be given. If there is recurrence of EE or GERD symptoms (e.g., heartburn), additional 4 to 8-week courses of ZEGERID may be considered. • maintenance of healing of EE due to acid-mediated GERD. Controlled studies do not extend beyond 12 months.
ZEGERID for oral suspension is indicated in adults for the : • reduction of risk of upper GI bleeding in critically ill adult patients. ZEGERID is a proton pump inhibitor (PPI). ZEGERID for oral suspension and ZEGERID capsules are indicated in adults for: • Treatment of active duodenal ulcer ( 1 ) • Treatment of active benign gastric ulcer ( 1 ) • Treatment of erosive esophagitis (EE) due to acid-mediated gastroesophageal reflux disease (GERD) ( 1 ) • Maintenance of healing of EE ( 1 ) ZEGERID for oral suspension is indicated in adults for: • Reduction of risk of upper gastrointestinal (GI) bleeding in critically ill patients ( 1 )
⏱️ Dosage and Administration ▾
2 DOSAGE AND ADMINISTRATION Indication Recommended Adult Dosage ZEGERID for oral suspension or ZEGERID capsules Active Duodenal Ulcer 20 mg once daily for 4 weeks; some patients may require an additional 4 weeks Active Benign Gastric Ulcer 40 mg once daily for 4 to 8 weeks Treatment of Symptomatic GERD 20 mg once daily for up to 4 weeks Treatment of EE due to Acid-Mediated GERD 20 mg once daily for 4 to 8 weeks* Maintenance of Healing of EE due to Acid-Mediated GERD 20 mg once daily** 40 mg ZEGERID for oral suspension Reduction of Risk of Upper GI Bleeding in Critically Ill Patients 40 mg initially followed by 40 mg 6 to 8 hours later and 40 mg once daily thereafter for 14 days * an additional 4 weeks of treatment may be given if no response; if recurrence, additional 4 to 8-week courses may be considered. ** studied for 12 months.
2.1Important Administration Instructions • ZEGERID (omeprazole and sodium bicarbonate) is available as a capsule and as a powder for oral suspension in 20 mg and 40 mg strengths of omeprazole for adult use. All recommended doses throughout the labeling are based upon omeprazole. • The sodium content of ZEGERID capsules and ZEGERID for oral suspension should be taken into consideration when prescribing this product [see Warnings and Precautions ( 5.3 )] : o ZEGERID capsule: each 20 mg and 40 mg capsule contains 1,100 mg (13 mEq) of sodium bicarbonate.
The total content of sodium in each capsule is 304 mg. o ZEGERID for oral suspension: each 20 mg and 40 mg packet of contains 1,680 mg (20 mEq) of sodium bicarbonate. The total content of sodium in each packet is 460 mg. • Due to the sodium bicarbonate content of ZEGERID: • Do not substitute two packets of 20 mg ZEGERID for oral suspension with one packet of 40 mg ZEGERID for oral suspension. • Do not substitute two 20 mg ZEGERID capsules with one 40 mg ZEGERID capsule.
2.2Dosage Regimen The recommended dosage regimen by indication in adults of ZEGERID for oral suspension and ZEGERID capsules is summarized in Table 1 . Only 40 mg ZEGERID for oral suspension is indicated for the reduction of risk of upper GI bleeding in critically ill adult patients and the dosage regimen is summarized in Table 2 . All recommended dosages are based upon omeprazole content.
Table 1: Recommended Dosage Regimen of ZEGERID for Oral Suspension and ZEGERID Capsules in Adults by Indication Indication Dosage of ZEGERID for oral suspension or ZEGERID capsules Treatment Duration Treatment of Active Duodenal Ulcer 20 mg once daily 4 weeks Most patients heal within 4 weeks. Some patients may require an additional 4 weeks of therapy [see Clinical Studies ( 14.1 )]. The efficacy of ZEGERID used for longer than 8 weeks in patients with EE has not been established.
If a patient does not respond to 8 weeks of treatment, an additional 4 weeks of treatment may be given. If there is recurrence of EE or GERD symptoms (e.g., heartburn), additional 4 to 8-week courses of ZEGERID may be considered . Treatment of Active Benign Gastric Ulcer 40 mg once daily 4 to 8 weeks Treatment of Symptomatic GERD 20 mg once daily Up to 4 weeks Treatment of EE due to Acid-Mediated GERD 20 mg once daily 4 to 8 weeks Maintenance of Healing of EE due to Acid-Mediated GERD 20 mg once daily Controlled studies do not extend beyond 12 months.
Table 2: Recommended Dosage Regimen of 40 mg ZEGERID for Oral Suspension in Adults by Indication Indication Dosage of 40 mg ZEGERID for oral suspension Treatment Duration Reduction of Risk of Upper GI Bleeding in Critically Ill Patients 40 mg initially; followed by 40 mg 6 to 8 hours later; and 40 mg once daily thereafter 14 days
2.3Preparation and Administration ZEGERID Capsules • Swallow capsules intact with water. Do not open the capsule and do not administer with liquids other than water. • Take on an empty stomach at least one hour before a meal [see Clinical Pharmacology ( 12.3 )] . ZEGERID for Oral Suspension • ZEGERID for oral suspension is intended to be mixed with w…
💊 Dosage Forms and Strengths ▾
3 DOSAGE FORMS AND STRENGTHS ZEGERID is available as: Capsules • 20 mg: Each opaque, hard gelatin, white capsule, imprinted with the Santarus logo and “20”, contains 20 mg omeprazole and 1,100 mg sodium bicarbonate. • 40 mg: Each opaque, hard gelatin, colored dark blue and white capsule, imprinted with the Santarus logo and “40”, contains 40 mg omeprazole and 1,100 mg sodium bicarbonate. For Oral Suspension • 20 mg: white, flavored powder packaged in unit-dose packets. Each packet contains 20 mg omeprazole and 1,680 mg sodium bicarbonate. • 40 mg: white, flavored powder packaged in unit-dose packets.
Each packet contains 40 mg omeprazole and 1,680 mg sodium bicarbonate. For Capsules ( 3 ) : • 20 mg omeprazole and 1,100 mg sodium bicarbonate • 40 mg omeprazole and 1,100 mg sodium bicarbonate For Oral Suspension ( 3 ) : • 20 mg omeprazole and 1,680 mg sodium bicarbonate in unit-dose packets • 40 mg omeprazole and 1,680 mg sodium bicarbonate in unit-dose packets
⛔ Contraindications ▾
4 CONTRAINDICATIONS ZEGERID is contraindicated in patients with known hypersensitivity to substituted benzimidazoles or to any component of the formulation. Hypersensitivity reactions may include anaphylaxis, anaphylactic shock, angioedema, bronchospasm, acute tubulointerstitial nephritis, and urticaria [see Warnings and Precautions (5.2) , Adverse Reactions (6.2) ] . Proton pump inhibitors (PPIs), including ZEGERID, are contraindicated in patients receiving rilpivirine containing products [see Drug Interactions ( 7 )] . • Known hypersensitivity to any components of the formulation ( 4 ) • Patients receiving rilpivirine-containing products ( 4 , 7 )
⚠️ Warnings and Cautions ▾
5 WARNINGS AND PRECAUTIONS • Gastric Malignancy : In adults, symptomatic response does not preclude the presence of gastric malignancy. Consider additional follow-up and diagnostic testing. ( 5.1 ) • Acute Tubulointerstitial Nephritis: Discontinue treatment and evaluate patients.
( 5.2 ) • Sodium Bicarbonate Buffer Content : Take sodium content into consideration in patients on a sodium-restricted diet. Avoid in patients with Bartter’s syndrome, hypokalemia, hypocalcemia, and problems with acid-base balance. ( 5.3 ) • Clostridium difficile -Associated Diarrhea : PPI therapy may be associated with increased risk.
( 5.4 ) • Bone Fracture : Long-term and multiple daily dose PPI therapy may be associated with an increased risk for osteoporosis-related fractures of the hip, wrist, or spine. ( 5.5 ) • Severe Cutaneous Adverse Reactions: Discontinue at the first signs or symptoms of severe cutaneous adverse reactions or other signs of hypersensitivity and consider further evaluation. ( 5.6 ) • Cutaneous and Systemic Lupus Erythematosus : Mostly cutaneous; new onset or exacerbation of existing disease; discontinue ZEGERID and refer to specialist for evaluation.
( 5.7 ) • Interaction with Clopidogrel : Avoid concomitant use of ZEGERID. ( 5.8 ) • Cyanocobalamin (Vitamin B-12) Deficiency : Daily long-term use (e.g., longer than 3 years) may lead to malabsorption or a deficiency of cyanocobalamin. ( 5.9 ) • Hypomagnesemia and Mineral Metabolism : Reported rarely with prolonged treatment with PPIs.
( 5.10 ) • Interaction with St. John’s wort or Rifampin : Avoid concomitant use of ZEGERID. ( 5.11 , 7 ) • Interactions with Diagnostic Investigations for Neuroendocrine Tumors : Increased Chromogranin A (CgA) levels may interfere with diagnostic investigations for neuroendocrine tumors; temporarily stop ZEGERID at least 14 days before assessing CgA levels.
( 5.12 ) • Interaction with Methotrexate : Concomitant use with PPIs may elevate and/or prolong serum concentrations of methotrexate and/or its metabolite, possibly leading to toxicity. With high dose methotrexate administration, consider a temporary withdrawal of ZEGERID. ( 5.13 , 7 ) • Fundic Gland Polyps : Risk increases with long-term use, especially beyond one year.
Use the shortest duration of therapy. ( 5.14 )
5.1Presence of Gastric Malignancy In adults, symptomatic response to therapy with ZEGERID does not preclude the presence of gastric malignancy. Consider additional follow-up and diagnostic testing in adult patients who have a suboptimal response or an early symptomatic relapse after completing treatment with a proton pump inhibitor (PPI). In older patients, also consider an endoscopy.
5.2Acute Tubulointerstitial Nephritis Acute tubulointerstitial nephritis (TIN) has been observed in patients taking PPIs and may occur at any point during PPI therapy. Patients may present with varying signs and symptoms from symptomatic hypersensitivity reactions to non-specific symptoms of decreased renal function (e.g., malaise, nausea and anorexia). In reported case series, some patients were diagnosed on biopsy and in the absence of extra-renal manifestations (e.g., fever, rash or arthralgia).
Discontinue ZEGERID and evaluate patients with suspected acute TIN [see Contraindications (4) ] .
5.3Sodium Bicarbonate Buffer Content Each 20 mg and 40 mg ZEGERID capsule contains 1,100 mg (13 mEq) of sodium bicarbonate. The total content of sodium in each capsule is 304 mg. Each 20 mg and 40 mg packet of ZEGERID for oral suspension contains 1,680 mg (20 mEq) of sodium bicarbonate.
The total content of sodium in each packet is 460 mg. Chronic administration of bicarbonate with calcium or milk can cause milk-alkali syndrome. Chronic use of sodium bicarbonate may lead to systemic alkalosis, and increased sodium intake can produce edema and weight gain.
The sodium content of ZEGERID products should be taken into consideration when administering to patients on a sodium-restricted diet or those at risk for…
🤒 Adverse Reactions ▾
6 ADVERSE REACTIONS The following serious adverse reactions are described below and elsewhere in labeling: • Acute Tubulointerstitial Nephritis [see Warnings and Precautions ( 5.2 )] • Clostridium difficile -Associated Diarrhea [see Warnings and Precautions ( 5.4 )] • Bone Fracture [see Warnings and Precautions ( 5.5 )] • Severe Cutaneous Adverse Reactions [see Warnings and Precautions ( 5.6 )] • Cutaneous and Systemic Lupus Erythematosus [see Warnings and Precautions ( 5.7 )] • Cyanocobalamin (Vitamin B-12) Deficiency [see Warnings and Precautions ( 5.9 )] • Hypomagnesemia and Mineral Metabolism [see Warnings and Precautions ( 5.10 )] • Fundic Gland Polyps [see Warnings and Precautions ( 5.14 )] Most common adverse reactions (≥2%) are: headache, abdominal pain, nausea, diarrhea, vomiting, and flatulence.
( 6.1 ) To report SUSPECTED ADVERSE REACTIONS, contact Salix Pharmaceuticals at 1-800-321-4576 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.
6.1Clinical Trials Experience Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in practice. The safety of ZEGERID has been established, in part, based on oral studies of an oral delayed-release omeprazole product. Clinical Trials with Omeprazole In the U.S. clinical trial population of 465 adult patients, the adverse reactions summarized in Table 3 were reported to occur in 1% or more of patients on therapy with omeprazole.
Table 3: Adverse Reactions Occurring in 1% or More of Adult Patients in US Clinical Trials of Omeprazole Therapy Omeprazole % (n = 465) Placebo % (n = 64) Ranitidine % (n = 195) Headache 7 6 8 Diarrhea 3 3 2 Abdominal Pain 2 3 3 Nausea 2 3 4 Upper Respiratory Infection (URI) 2 2 3 Dizziness 2 0 3 Vomiting 2 5 2 Rash 2 0 0 Constipation 1 0 0 Cough 1 0 2 Asthenia 1 2 2 Back Pain 1 0 1 Table 4 summarizes the adverse reactions that occurred in 1% or more of omeprazole-treated patients from international double-blind and open-label clinical trials in which 2,631 patients and subjects received omeprazole.
Table 4: Adverse Reactions Occurring in 1% or More of Adult Patients in International Clinical Trials of Omeprazole Therapy Omeprazole % (N = 2631) Placebo % (N = 120) Abdominal Pain 5.2
3.3Nausea 4.0
6.7Diarrhea 3.7
2.5Vomiting 3.2
10.0Headache 2.9
2.5Flatulence 2.7
5.8Acid Regurgitation 1.9
3.3Constipation 1.5
0.8Asthenia 1.3
0.8Clinical Trial of 40 mg ZEGERID for Oral Suspension Adverse reactions reported in at least 3% of critically ill adult patients in a clinical trial of 40 mg ZEGERID for oral suspension compared to intravenous cimetidine for up to 14 days are presented in Table 5 . Table 5: Common Adverse Reactions reported in at least 3% of patients in either treatment group. by Body System and Preferred Term in a Randomized Controlled Trial of Critically Ill Adult Patients Treated up to 14 Days Body System Preferred Term ZEGERID 40 mg for oral suspension once daily % (N=178) Intravenous Cimetidine 1,200 mg per day % (N=181) Blood and Lymphatic System Disorders Anemia NOS 7.9
7.7Anemia NOS Aggravated 2.2
3.9Thrombocytopenia 10.1
6.1Cardiac Disorders Atrial Fibrillation 6.2
3.9Bradycardia NOS 3.9
2.8Supraventricular Tachycardia 3.4
1.1Tachycardia NOS 3.4
3.3Ventricular Tachycardia 4.5
3.3Gastrointestinal Disorders In this trial, clinically significant upper gastrointestinal bleeding was considered a serious adverse reaction, but it is not included in this table. Constipation 4.5
4.4Diarrhea NOS 3.9
8.3Gastric Hypomotility 1.7
3.3General Disorders and Administration Site Conditions Hyperpyrexia 4.5
1.7Edema NOS 2.8
6.1Pyrexia 20.2
16.0Infections and Infestations Candidal Infection NOS 1.7
3.9Oral Candidiasis 3.9
0.6Sepsis NOS 5.1
5.0Urinary Tract Infection 2.2
3.3Investigations Liver Function Tests NOS Abnormal 1.7
3.3 Metabolism and Nu…
🔄 Drug Interactions ▾
7 DRUG INTERACTIONS Tables 6 and 7 include drugs with clinically important drug interactions and interaction with diagnostics when administered concomitantly with omeprazole and instructions for preventing or managing them. Consult the labeling of concomitantly used drugs to obtain further information about interactions with PPIs. Table 6: Clinically Relevant Interactions Affecting Drugs Co-Administered with Omeprazole and Interaction with Diagnostics Antiretrovirals Clinical Impact: The effect of PPIs on antiretroviral drugs is variable.
The clinical importance and the mechanisms behind these interactions are not always known. • Decreased exposure of some antiretroviral drugs (e.g., rilpivirine, atazanavir and nelfinavir) when used concomitantly with omeprazole may reduce antiviral effect and promote the development of drug resistance [see Clinical Pharmacology ( 12.3 )] . • Increased exposure of other antiretroviral drugs (e.g., saquinavir) when used concomitantly with omeprazole may increase toxicity [see Clinical Pharmacology ( 12.3 )]. • There are other antiretroviral drugs which do not result in clinically relevant interactions with omeprazole.
Intervention: Rilpivirine-containing products: Concomitant use with ZEGERID is contraindicated [see Contraindications (4) ]. Atazanavir: Avoid concomitant use with ZEGERID. See prescribing information for atazanavir for dosing information.
Nelfinavir: Avoid concomitant use with ZEGERID. See prescribing information for nelfinavir. Saquinavir: See the prescribing information for saquinavir for monitoring of potential saquinavir-related toxicities.
Other antiretrovirals: See prescribing information for specific antiretroviral drugs. Warfarin Clinical Impact: Increased INR and prothrombin time in patients receiving PPIs, including omeprazole, and warfarin concomitantly. Increases in INR and prothrombin time may lead to abnormal bleeding and even death.
Intervention: Monitor INR and prothrombin time and adjust the dose of warfarin, if needed, to maintain target INR range. Methotrexate Clinical Impact: Concomitant use of omeprazole with methotrexate (primarily at high dose) may elevate and prolong serum concentrations of methotrexate and/or its metabolite hydroxymethotrexate, possibly leading to methotrexate toxicities. No formal drug interaction studies of high-dose methotrexate with PPIs have been conducted [see Warnings and Precautions (5.13) ].
Intervention: A temporary withdrawal of ZEGERID may be considered in some patients receiving high-dose methotrexate. CYP2C19 Substrates (e.g., clopidogrel, citalopram, cilostazol, phenytoin, diazepam) Clopidogrel Clinical Impact: Concomitant use of omeprazole 80 mg results in reduced plasma concentrations of the active metabolite of clopidogrel and a reduction in platelet inhibition [see Clinical Pharmacology ( 12.3 )]. There are no adequate combination studies of a lower dose of omeprazole or a higher dose of clopidogrel in comparison with the approved dose of clopidogrel .
Intervention: Avoid concomitant use with ZEGERID. Consider use of alternative anti-platelet therapy [see Warnings and Precautions (5.8) ]. Citalopram Clinical Impact: Increased exposure of citalopram leading to an increased risk of QT prolongation [see Clinical Pharmacology ( 12.3 )] .
Intervention: Limit the dose of citalopram to a maximum of 20 mg per day. See prescribing information for citalopram. Cilostazol Clinical Impact: Increased exposure of one of the active metabolites of cilostazol (3,4-dihydro-cilostazol) [see Clinical Pharmacology ( 12.3 )].
Intervention: Reduce the dose of cilostazol to 50 mg twice daily. See prescribing information for cilostazol. Phenytoin Clinical Impact: Potential for increased exposure of phenytoin.
Intervention: Monitor phenytoin serum concentrations. Dose adjustment may be needed to maintain therapeutic drug concentrations. See prescribing information for phenytoin.
Diazepam Clinical Impact: Increased exposure of diazepam [see Clinic…
👥 Use in Specific Populations ▾
8 USE IN SPECIFIC POPULATIONS Hepatic Impairment and Asian Patients : Avoid use for maintenance of healing of erosive esophagitis. ( 8.6 , 8.7 )
8.1Pregnancy Risk Summary There are no adequate and well-controlled studies with ZEGERID in pregnant women. ZEGERID contains omeprazole and sodium bicarbonate. Omeprazole There are no adequate and well-controlled studies with omeprazole in pregnant women.
Available epidemiologic data fail to demonstrate an increased risk of major congenital malformations or other adverse pregnancy outcomes with first trimester omeprazole use. Reproduction studies in rats and rabbits resulted in dose-dependent embryo-lethality at omeprazole doses that were approximately 3.4 to 34 times an oral human dose of 40 mg (based on a body surface area for a 60 kg person). Teratogenicity was not observed in animal reproduction studies with administration of oral esomeprazole (an enantiomer of omeprazole) magnesium in rats and rabbits during organogenesis with doses about 68 times and 42 times, respectively, an oral human dose of 40 mg esomeprazole or 40 mg omeprazole (based on body surface area for a 60 kg person).
Changes in bone morphology were observed in offspring of rats dosed through most of pregnancy and lactation at doses equal to or greater than approximately 34 times an oral human dose of 40 mg esomeprazole or 40 mg omeprazole. When maternal administration was confined to gestation only, there were no effects on bone physeal morphology in the offspring at any age ( see Data ). Sodium Bicarbonate Available data with sodium bicarbonate use in pregnant women are insufficient to identify a drug associated risk of major birth defects or miscarriage.
Published animal studies report that sodium bicarbonate administered to rats, mice or rabbits during pregnancy did not cause adverse developmental effects in offspring. The estimated background risks of major birth defects and miscarriage for the indicated population are unknown. All pregnancies have a background risk of birth defect, loss or other adverse outcomes.
In the U.S. general population, the estimated background risk of major birth defects and miscarriage in clinically recognized pregnancies is 2% to 4% and 15% to 20%, respectively. Data Human Data There are no adequate and well-controlled studies with ZEGERID in pregnant women. Four published epidemiological studies compared the frequency of congenital abnormalities among infants born to women who used omeprazole during pregnancy with the frequency of abnormalities among infants of women exposed to H 2 -receptor antagonists or other controls.
A population-based retrospective cohort epidemiological study from the Swedish Medical Birth Register, covering approximately 99% of pregnancies, from 1995-99, reported on 955 infants (824 exposed during the first trimester with 39 of these exposed beyond first trimester, and 131 exposed after the first trimester) whose mothers used omeprazole during pregnancy. The number of infants exposed in utero to omeprazole that had any malformation, low birth weight, low Apgar score, or hospitalization was similar to the number observed in this population.
The number of infants born with ventricular septal defects and the number of stillborn infants was slightly higher in the omeprazole-exposed infants than the expected number in this population. A population-based retrospective cohort study covering all live births in Denmark from 1996-2009 reported on 1,800 live births whose mothers used omeprazole during the first trimester of pregnancy and 837,317 live births whose mothers did not use any PPI. The overall rate of birth defects in infants born to mothers with first trimester exposure to omeprazole was 2.9% and 2.6% in infants born to mothers not exposed to any PPI during the first trimester.
A retrospective cohort study reported on 689 pregnant women exposed to either H 2 -blockers or omeprazole in the first trimester (134 exposed to omeprazole) and 1,572 pregnant wome…
🤰 Pregnancy ▾
8.1Pregnancy Risk Summary There are no adequate and well-controlled studies with ZEGERID in pregnant women. ZEGERID contains omeprazole and sodium bicarbonate. Omeprazole There are no adequate and well-controlled studies with omeprazole in pregnant women.
Available epidemiologic data fail to demonstrate an increased risk of major congenital malformations or other adverse pregnancy outcomes with first trimester omeprazole use. Reproduction studies in rats and rabbits resulted in dose-dependent embryo-lethality at omeprazole doses that were approximately 3.4 to 34 times an oral human dose of 40 mg (based on a body surface area for a 60 kg person). Teratogenicity was not observed in animal reproduction studies with administration of oral esomeprazole (an enantiomer of omeprazole) magnesium in rats and rabbits during organogenesis with doses about 68 times and 42 times, respectively, an oral human dose of 40 mg esomeprazole or 40 mg omeprazole (based on body surface area for a 60 kg person).
Changes in bone morphology were observed in offspring of rats dosed through most of pregnancy and lactation at doses equal to or greater than approximately 34 times an oral human dose of 40 mg esomeprazole or 40 mg omeprazole. When maternal administration was confined to gestation only, there were no effects on bone physeal morphology in the offspring at any age ( see Data ). Sodium Bicarbonate Available data with sodium bicarbonate use in pregnant women are insufficient to identify a drug associated risk of major birth defects or miscarriage.
Published animal studies report that sodium bicarbonate administered to rats, mice or rabbits during pregnancy did not cause adverse developmental effects in offspring. The estimated background risks of major birth defects and miscarriage for the indicated population are unknown. All pregnancies have a background risk of birth defect, loss or other adverse outcomes.
In the U.S. general population, the estimated background risk of major birth defects and miscarriage in clinically recognized pregnancies is 2% to 4% and 15% to 20%, respectively. Data Human Data There are no adequate and well-controlled studies with ZEGERID in pregnant women. Four published epidemiological studies compared the frequency of congenital abnormalities among infants born to women who used omeprazole during pregnancy with the frequency of abnormalities among infants of women exposed to H 2 -receptor antagonists or other controls.
A population-based retrospective cohort epidemiological study from the Swedish Medical Birth Register, covering approximately 99% of pregnancies, from 1995-99, reported on 955 infants (824 exposed during the first trimester with 39 of these exposed beyond first trimester, and 131 exposed after the first trimester) whose mothers used omeprazole during pregnancy. The number of infants exposed in utero to omeprazole that had any malformation, low birth weight, low Apgar score, or hospitalization was similar to the number observed in this population.
The number of infants born with ventricular septal defects and the number of stillborn infants was slightly higher in the omeprazole-exposed infants than the expected number in this population. A population-based retrospective cohort study covering all live births in Denmark from 1996-2009 reported on 1,800 live births whose mothers used omeprazole during the first trimester of pregnancy and 837,317 live births whose mothers did not use any PPI. The overall rate of birth defects in infants born to mothers with first trimester exposure to omeprazole was 2.9% and 2.6% in infants born to mothers not exposed to any PPI during the first trimester.
A retrospective cohort study reported on 689 pregnant women exposed to either H 2 -blockers or omeprazole in the first trimester (134 exposed to omeprazole) and 1,572 pregnant women unexposed to either during the first trimester. The overall malformation rate in offspring born to mothers with first trimester exposure to ome…
🧒 Pediatric Use ▾
8.4Pediatric Use Safety and effectiveness of ZEGERID have not been established in pediatric patients. Juvenile Animal Data Esomeprazole, an enantiomer of omeprazole, was shown to decrease body weight, body weight gain, femur weight, femur length, and overall growth at oral doses about 34 to 68 times a daily human dose of 40 mg esomeprazole or 40 mg omeprazole based on body surface area in a juvenile rat toxicity study. The animal to human dose multiples are based on the assumption of equal systemic exposure to esomeprazole in humans following oral administration of either 40 mg esomeprazole or 40 mg omeprazole.
A 28-day toxicity study with a 14-day recovery phase was conducted in juvenile rats with esomeprazole magnesium at doses of 70 to 280 mg/kg/day (about 17 to 68 times a daily oral human dose of 40 mg esomeprazole or 40 mg omeprazole on a body surface area basis). An increase in the number of deaths at the high dose of 280 mg/kg/day was observed when juvenile rats were administered esomeprazole magnesium from postnatal day 7 through postnatal day 35. In addition, doses equal to or greater than 140 mg/kg/day (about 34 times a daily oral human dose of 40 mg esomeprazole or 40 mg omeprazole on a body surface area basis), produced treatment-related decreases in body weight (approximately 14%) and body weight gain, decreases in femur weight and femur length, and affected overall growth.
Comparable findings described above have also been observed in this study with another esomeprazole salt, esomeprazole strontium, at equimolar doses of esomeprazole.
🧓 Geriatric Use ▾
8.5Geriatric Use Omeprazole was administered to over 2,000 elderly individuals (≥65 years of age) in clinical trials in the U.S. and Europe. There were no differences in safety and effectiveness between the elderly and younger subjects. Other reported clinical experience has not identified differences in response between the elderly and younger subjects, but greater sensitivity of some older individuals cannot be ruled out.
Pharmacokinetic studies with buffered omeprazole have shown the elimination rate was somewhat decreased in the elderly and bioavailability was increased. The plasma clearance of omeprazole was 250 mL/min (about half that of young subjects). The plasma half-life averaged one hour, about twice that in nonelderly, healthy subjects taking ZEGERID.
However, no dosage adjustment is necessary in the elderly [see Clinical Pharmacology ( 12.3 )] .
🆘 Overdosage ▾
10 OVERDOSAGE If over-exposure occurs, call your Poison Control Center at 1-800-222-1222 for current information on the management of poisoning or overdosage. Omeprazole Reports have been received of overdosage with omeprazole in humans. Doses ranged up to 2,400 mg (120 times the usual recommended clinical dose).
Manifestations were variable, but included confusion, drowsiness, blurred vision, tachycardia, nausea, vomiting, diaphoresis, flushing, headache, dry mouth, and other adverse reactions similar to those seen in clinical experience with the recommended dosage [see Adverse Reactions ( 6 )]. Symptoms were transient, and no serious clinical outcome has been reported when omeprazole was taken alone. No specific antidote for omeprazole overdosage is known.
Omeprazole is extensively protein bound and is, therefore, not readily dialyzable. In the event of overdosage, treatment should be symptomatic and supportive. Sodium Bicarbonate Overdosage of sodium bicarbonate can cause electrolyte abnormalities (hypocalcemia, hypokalemia, hypernatremia), metabolic alkalosis, and seizures.
Institute supportive care and correct electrolyte abnormalities.
🧬 Clinical Pharmacology ▾
12 CLINICAL PHARMACOLOGY
12.1Mechanism of Action Omeprazole belongs to a class of antisecretory compounds, the substituted benzimidazoles, that suppress gastric acid secretion by specific inhibition of the H+/K+ ATPase enzyme system at the secretory surface of the gastric parietal cell. Because this enzyme system is regarded as the acid (proton) pump within the gastric mucosa, omeprazole has been characterized as a gastric acid-pump inhibitor, in that it blocks the final step of acid production. This effect is dose related and leads to inhibition of both basal and stimulated acid secretion irrespective of the stimulus.
12.2Pharmacodynamics Antisecretory Activity Results from a pharmacokinetic/pharmacodynamic (PK/PD) study of the antisecretory effect of repeated once-daily dosing of 40 mg and 20 mg of ZEGERID for oral suspension in healthy subjects are shown in Table 8 below. Table 8: Effect of ZEGERID for Oral Suspension on Intragastric pH, Day 7 Once-Daily Dosage of ZEGERID for Oral Suspension Parameter 40 mg omeprazole and 1,680 mg sodium bicarbonate (n = 24) 20 mg omeprazole and 1,680 mg sodium bicarbonate (n = 28) % Decrease from Baseline for Integrated Gastric Acidity (mmol•hr/L) 84% 82% Coefficient of Variation 20% 24% % Time Gastric pH > 4 P < 0.05 20 mg vs.
40 mg (Hours) 77% (18.6 h) 51% (12.2 h) Coefficient of Variation 27% 43% Median pH 5.2
4.2Coefficient of Variation 17% 37% Note: Values represent medians. All parameters were measured over a 24-hour period. Results from a separate PK/PD study of antisecretory effect on repeated once-daily dosing of 40 mg/1,100 mg and 20 mg/1,100 mg of ZEGERID capsules in healthy subjects show similar effects in general on the above three PD parameters as those for ZEGERID for oral suspension 40 mg/1,680 mg and 20 mg/1,680 mg, respectively.
The antisecretory effect lasts longer than would be expected from the very short (1 hour) plasma half-life, apparently due to irreversible binding to the parietal H+/K+ ATPase enzyme. Enterochromaffin-like (ECL) Cell Effects Human gastric biopsy specimens have been obtained from more than 3000 patients treated with omeprazole in long-term clinical trials. The incidence of ECL cell hyperplasia in these studies increased with time; however, no case of ECL cell carcinoids, dysplasia, or neoplasia has been found in these patients.
These studies are of insufficient duration and size to rule out the possible influence of long-term administration of omeprazole on the development of any premalignant or malignant conditions. Serum Gastrin Effects In studies involving more than 200 patients, serum gastrin levels increased during the first 1 to 2 weeks of once-daily administration of therapeutic doses of omeprazole in parallel with inhibition of acid secretion. No further increase in serum gastrin occurred with continued treatment.
In comparison with histamine H 2 -receptor antagonists, the median increases produced by 20 mg doses of omeprazole were higher (1.3 to 3.6-fold vs. 1.1- to 1.8-fold increase). Gastrin values returned to pretreatment levels, usually within 1 to 2 weeks after discontinuation of therapy.
Increased gastrin causes enterochromaffin-like cell hyperplasia and increased serum Chromogranin A (CgA) levels. The increased CgA levels may cause false positive results in diagnostic investigations for neuroendocrine tumors [see Warnings and Precautions (5.12) ] . Other Effects Systemic effects of omeprazole in the central nervous system (CNS), cardiovascular and respiratory systems have not been found to date.
Omeprazole, given in oral doses of 30 or 40 mg for 2 to 4 weeks, had no effect on thyroid function, carbohydrate metabolism, or circulating levels of parathyroid hormone, cortisol, estradiol, testosterone, prolactin, cholecystokinin or secretin. No effect on gastric emptying of the solid and liquid components of a test meal was demonstrated after a single dose of omeprazole 90 mg. In healthy subjects, a single intravenous dose of omeprazo…
🧬 Mechanism of Action ▾
12.1Mechanism of Action Omeprazole belongs to a class of antisecretory compounds, the substituted benzimidazoles, that suppress gastric acid secretion by specific inhibition of the H+/K+ ATPase enzyme system at the secretory surface of the gastric parietal cell. Because this enzyme system is regarded as the acid (proton) pump within the gastric mucosa, omeprazole has been characterized as a gastric acid-pump inhibitor, in that it blocks the final step of acid production. This effect is dose related and leads to inhibition of both basal and stimulated acid secretion irrespective of the stimulus.
📦 How Supplied / Storage and Handling ▾
16 HOW SUPPLIED/STORAGE AND HANDLING ZEGERID is supplied as: ZEGERID Capsules NDC Strength Quantity Description 68012‑102‑30 20 mg omeprazole and 1,100 mg sodium bicarbonate Bottles of 30 capsules Opaque, hard gelatin, white capsule, imprinted with the Santarus logo and “20” 68012‑104‑30 40 mg omeprazole and 1,100 mg sodium bicarbonate Bottles of 30 capsules Opaque, hard gelatin, colored dark blue and white capsule, imprinted with the Santarus logo and “40” ZEGERID for Oral Suspension NDC Strength Quantity Description 68012‑052‑30 20 mg omeprazole and 1,680 mg sodium bicarbonate Cartons of 30 unit‑dose packets White, flavored powder packaged in unit-dose packets 68012‑054‑30 40 mg omeprazole and 1,680 mg sodium bicarbonate Cartons of 30 unit‑dose packets White, flavored powder packaged in unit-dose packets.
Storage Store at 20° to 25°C (68° to 77°F); excursions permitted to 15° to 30°C (59° to 86°F) [see USP Controlled Room Temperature]. Keep container tightly closed. Protect from light and moisture.
📋 Description ▾
11 DESCRIPTION ZEGERID (omeprazole and sodium bicarbonate) is a combination of omeprazole, a proton-pump inhibitor, and sodium bicarbonate, an antacid. Omeprazole is a substituted benzimidazole, 5-methoxy-2-[[(4-methoxy-3,5-dimethyl-2-pyridinyl)methyl]sulfinyl]-1 H -benzimidazole, a racemic mixture of two enantiomers that inhibits gastric acid secretion. Its empirical formula is C 17 H 19 N 3 O 3 S, with a molecular weight of 345.42.
The structural formula is: Omeprazole is a white to off-white crystalline powder which melts with decomposition at about 155°C. It is a weak base, freely soluble in ethanol and methanol, slightly soluble in acetone and isopropanol and very slightly soluble in water. The stability of omeprazole is a function of pH; it is rapidly degraded in acid media but has acceptable stability under alkaline conditions.
ZEGERID is supplied as immediate-release capsules and unit-dose packets as powder for oral suspension. Each capsule contains either 40 mg or 20 mg of omeprazole and 1,100 mg of sodium bicarbonate with the following excipients: croscarmellose sodium and sodium stearyl fumarate. Packets of powder for oral suspension contain either 40 mg or 20 mg of omeprazole and 1,680 mg of sodium bicarbonate with the following excipients: sucralose, sucrose, xanthan gum, xylitol, and flavorings.
ZEGERID capsules and ZEGERID for oral suspension are immediate-release formulations that contain sodium bicarbonate which raises the gastric pH and thus protects omeprazole from acid degradation. chem
💬 Information for Patients ▾
17 PATIENT COUNSELING INFORMATION Advise the patient to read the FDA-approved patient labeling (Medication Guide). Acute Tubulointerstitial Nephritis Advise the patient to call their healthcare provider immediately if they experience signs and/or symptoms associated with acute tubulointerstitial nephritis [see Warnings and Precautions ( 5.2 )] . Sodium Bicarbonate Buffer Content Inform patients on a sodium-restricted diet or patients at risk of developing congestive heart failure of the sodium content of ZEGERID capsules (304 mg per capsule) and ZEGERID for oral suspension (460 mg per packet).
Advise patients that: • chronic use of bicarbonate with calcium or milk can cause milk-alkali syndrome • chronic use of sodium bicarbonate may systemic alkalosis • increased sodium intake can cause swelling and weight gain. If any of these occur, instruct patients to contact their healthcare provider [see Warnings and Precautions ( 5.3 )]. Clostridium difficile -Associated Diarrhea Advise the patient to immediately call their healthcare provider if they experience diarrhea that does not improve [see Warnings and Precautions ( 5.4 )] .
Bone Fracture Advise the patient to report any fractures, especially of the hip, wrist or spine, to their healthcare provider [see Warnings and Precautions ( 5.5 )] . Severe Cutaneous Adverse Reactions Advise the patient to discontinue ZEGERID and immediately call their healthcare provider at first appearance of a severe cutaneous adverse reaction or other sign of hypersensitivity [see Warnings and Precautions ( 5.6 )] . Cutaneous and Systemic Lupus Erythematosus Advise the patient to immediately call their healthcare provider for any new or worsening of symptoms associated with cutaneous or systemic lupus erythematosus [see Warnings and Precautions ( 5.7 )].
Cyanocobalamin (Vitamin B-12) Deficiency Advise the patient to report any clinical symptoms that may be associated with cyanocobalamin deficiency to their healthcare provider if they have been receiving ZEGERID for longer than 3 years [see Warnings and Precautions ( 5.9 )] . Hypomagnesemia and Mineral Metabolism Advise the patient to report any clinical symptoms that may be associated with hypomagnesemia, hypocalcemia, and/or hypokalemia to their healthcare provider, if they have been receiving ZEGERID for at least 3 months [see Warnings and Precautions ( 5.10 )] .
Drug Interactions Advise patients to report to their healthcare provider if they start treatment with rilpivirine-containing products, clopidogrel, St. John’s wort or rifampin, or if they take high-dose methotrexate [see Contraindications ( 4 ) and Warnings and Precautions ( 5.8 , 5.11 , 5.13 )]. Administration Instruct patients not to substitute: • Two packets of 20 mg ZEGERID for oral suspension with one packet of 40 mg ZEGERID for oral suspension. • Two 20 mg ZEGERID capsules with one 40 mg ZEGERID capsule. • Two packets of 20 mg ZEGERID for oral suspension with one packet of 40 mg ZEGERID for oral suspension. • Two 20 mg ZEGERID capsules with one 40 mg ZEGERID capsule. • Two packets of 20 mg ZEGERID for oral suspension with one packet of 40 mg ZEGERID for oral suspension. • Two 20 mg ZEGERID capsules with one 40 mg ZEGERID capsule.
Administration of ZEGERID Capsules • Instruct patients to swallow ZEGERID capsules intact with water. Do not open the capsule and do not administer with liquids other than water. • Instruct patients to take ZEGERID capsules on an empty stomach at least one hour before a meal [see Dosage and Administration ( 2.3 )] . Administration of ZEGERID for Oral Suspension • Advise patients that ZEGERID for oral suspension is intended to be mixed with water and administered orally or via a nasogastric (NG)/orogastric (OG) tube, as described in the Medication Guide. • Instruct patients to suspend enteral feeding approximately 3 hours before and 1 hour after administration of ZEGERID for oral suspension [see Dosage and Administration ( 2.3 )] .
Distributed by: Salix Pharmac…
💬 Medication Guide ▾
MEDICATION GUIDE ZEGERID ® (ze-ger-id) (omeprazole and sodium bicarbonate) for oral suspension and capsules, for oral use What is the most important information I should know about ZEGERID? ZEGERID may help your acid-related symptoms, but you could still have serious stomach problems. Talk with your doctor.
ZEGERID can cause serious side effects, including: • A type of kidney problem (acute tubulointerstitial nephritis). Some people who take proton pump inhibitor (PPI) medicines, including ZEGERID, may develop a kidney problem called acute tubulointerstitial nephritis that can happen at any time during treatment with ZEGERID. Call your doctor right away if you have a decrease in the amount that you urinate or if you have blood in your urine. • ZEGERID contains sodium bicarbonate.
Long-term use of bicarbonate with calcium or milk can cause a condition called “milk-alkali syndrome”. Long-term use of sodium bicarbonate can cause a condition called “systemic alkalosis”. Talk to your doctor about any questions you may have.
Too much sodium can cause swelling and weight gain. Tell your doctor if you are on a low-sodium diet or if you have Bartter’s Syndrome (a rare kidney disorder). Tell your doctor right away if you have confusion, shaking hands, dizziness, muscle twitching, nausea, vomiting, and numbness or tingling in the face, arms, or legs. • Diarrhea caused by an infection ( Clostridium difficile ) in your intestines.
Call your doctor right away if you have watery stools or stomach pain that does not go away. You may or may not have a fever. • Bone fractures (hip, wrist, or spine). Bone fractures in the hip, wrist or spine may happen in people who take multiple daily doses of PPI medicines and for a long period of time (a year or longer).
Tell your doctor if you have bone fracture, especially in the hip, wrist, or spine. Certain types of lupus erythematosus. Lupus erythematosus is an autoimmune disorder (the body’s immune cells attack other cells or organs in the body).
Some people who take PPI medicines, including ZEGERID, may develop certain types of lupus erythematosus or have worsening of the lupus they already have. Call your doctor right away if you have new or worsening joint pain or a rash on your cheeks or arms that gets worse in the sun. Talk to your doctor about your risk of these serious side effects.
ZEGERID can have other serious side effects. See “What are the possible side effects of ZEGERID?” What is ZEGERID? A prescription medicine called a proton pump inhibitor (PPI) used to reduce the amount of acid in your stomach.
ZEGERID for oral suspension and ZEGERID capsules is used in adults for: • up to 8 weeks for the healing of duodenal ulcers. • up to 8 weeks for the healing of stomach ulcers. • up to 4 weeks to treat heartburn and other symptoms that happen with gastroesophageal reflux disease (GERD). • up to 8 weeks for the healing and symptom relief of acid-related damage to the lining of the esophagus (called erosive esophagitis or EE). Your doctor may prescribe another 4 weeks of ZEGERID in patients whose EE does not heal. • maintaining healing of EE and to help prevent the return of heartburn symptoms caused by GERD.
It is not known if ZEGERID is safe and effective when used for longer than 12 months for this purpose. ZEGERID for oral suspension is used: • in critically ill adults to lower the risk of stomach bleeding (40 mg oral suspension only). It is not known if ZEGERID is safe and effective in children.
Do not take ZEGERID if you are: • allergic to omeprazole, any other PPI medicine, or any of the ingredients in ZEGERID. See the end of this Medication Guide for a complete list of ingredients in ZEGERID. • taking a medicine that contains rilpivirine, used to treat HIV-1 (Human Immunodeficiency Virus). Before taking ZEGERID, tell your doctor about all of your medical conditions, including if you: • have low magnesium, calcium, or potassium levels in your blood. • have problems with the acid-base (pH) bal…