Pantoprazol Accord
Pantoprazole sodium sesquihydrate — 40 mg powder for solution for injection
Quick Facts About Pantoprazol Accord
Key Takeaways
- Intravenous proton pump inhibitor: Pantoprazol Accord is used only when oral pantoprazole is not appropriate, and patients should switch to tablets as soon as possible
- Effective acid suppression: Irreversibly inhibits the proton pump, reducing gastric acid output within 1 hour of administration
- Important drug interactions: Significantly reduces absorption of HIV medications (atazanavir), antifungals (ketoconazole), and may increase methotrexate levels
- Long-term risks: Extended use beyond one year may increase risk of bone fractures, magnesium deficiency, and vitamin B12 deficiency
- Not for children: Pantoprazol Accord IV injection is not recommended for patients under 18 years of age
What Is Pantoprazol Accord and What Is It Used For?
Pantoprazol Accord contains pantoprazole, a selective proton pump inhibitor (PPI) that reduces stomach acid production. It is administered intravenously for treating reflux esophagitis, gastric and duodenal ulcers, and Zollinger-Ellison syndrome when oral therapy is not suitable.
Pantoprazole belongs to a class of medications called proton pump inhibitors (PPIs), which are among the most widely prescribed drugs worldwide for acid-related gastrointestinal disorders. As a selective and irreversible inhibitor of the hydrogen-potassium adenosine triphosphatase (H+/K+ ATPase) enzyme system, commonly known as the "proton pump," pantoprazole blocks the final step in the production of hydrochloric acid by the parietal cells lining the stomach. This mechanism makes it highly effective at controlling gastric acid secretion regardless of the stimulus that triggered it.
Pantoprazol Accord is specifically formulated as a powder for solution for intravenous injection, containing 40 mg of pantoprazole per vial. This intravenous formulation is reserved for patients who cannot take oral medication, for example those who are nil by mouth prior to surgery, critically ill patients in intensive care, or individuals with significant gastrointestinal conditions that prevent oral absorption. As soon as the treating physician determines that oral therapy is feasible, patients are switched to pantoprazole tablets.
The intravenous route provides a rapid onset of action, with antisecretory effects beginning within approximately one hour of administration and reaching peak effect within two to three hours. This makes it particularly valuable in acute clinical settings where prompt acid suppression is required, such as active upper gastrointestinal bleeding from peptic ulcers or severe erosive esophagitis.
Approved indications
Pantoprazol Accord is approved for use in adults only for the following conditions:
- Reflux esophagitis: Inflammation of the esophagus caused by the backward flow of gastric acid, often presenting with heartburn, regurgitation, and difficulty swallowing
- Gastric and duodenal ulcers: Open sores in the lining of the stomach or the first part of the small intestine (duodenum), which may cause pain, bleeding, and other complications
- Zollinger-Ellison syndrome: A rare condition in which one or more tumors (gastrinomas) form in the pancreas or duodenum, causing the stomach to produce excessive amounts of acid. This condition, along with other pathological hypersecretory conditions, may require higher and more frequent dosing
Pantoprazol Accord is intended as a short-term intravenous replacement for oral pantoprazole. Your healthcare provider will transition you to oral tablets as soon as your clinical condition allows. The intravenous formulation should not be used as a long-term maintenance therapy.
What Should You Know Before Taking Pantoprazol Accord?
Do not use Pantoprazol Accord if you are allergic to pantoprazole or any other proton pump inhibitor. Important warnings include risks of bone fractures with long-term use, low magnesium levels, vitamin B12 deficiency, and serious skin reactions. Tell your doctor about all medical conditions and medications.
Before receiving Pantoprazol Accord, it is essential that your healthcare provider has a complete picture of your medical history, current medications, and any known allergies. Proton pump inhibitors, while generally well tolerated, have several important safety considerations that require careful evaluation. The following sections detail the key contraindications, warnings, and precautions associated with this medication.
Contraindications
Pantoprazol Accord must not be used in the following circumstances:
- Hypersensitivity to pantoprazole: If you have previously experienced an allergic reaction to pantoprazole or any of the other ingredients in the formulation (including sodium hydroxide, which is used for pH adjustment)
- Allergy to other proton pump inhibitors: Cross-reactivity between PPIs is possible, so if you have had an allergic reaction to omeprazole, esomeprazole, lansoprazole, rabeprazole, or dexlansoprazole, you should inform your doctor before receiving pantoprazole
Warnings and precautions
Speak with your doctor, pharmacist, or nurse before receiving Pantoprazol Accord if any of the following apply:
Liver impairment: Patients with severe liver problems require special monitoring. Your doctor should check liver enzyme levels regularly during treatment. If liver enzymes become elevated, treatment should be discontinued. Patients with severe hepatic impairment should receive a maximum daily dose of 20 mg (half a vial).
HIV protease inhibitors: If you are taking HIV medications such as atazanavir, you must inform your doctor, as pantoprazole can significantly reduce the absorption and effectiveness of these critical medications. Special dosing adjustments or alternative acid-suppressing strategies may be necessary.
Bone fracture risk: Long-term use of proton pump inhibitors, particularly at high doses and for durations exceeding one year, has been associated with a modestly increased risk of hip, wrist, and spine fractures. This risk is particularly relevant for patients with osteoporosis or those taking corticosteroids, which independently increase fracture risk. Your doctor may recommend calcium and vitamin D supplementation during extended PPI therapy.
Hypomagnesemia: Use of PPIs for periods exceeding three months can lead to clinically significant decreases in serum magnesium levels. Symptoms of low magnesium include fatigue, involuntary muscle movements, confusion, seizures, dizziness, and rapid heart rate. Low magnesium can also cause secondary decreases in potassium and calcium levels. If you experience any of these symptoms, contact your healthcare provider immediately. Regular monitoring of magnesium levels is recommended for patients on prolonged therapy.
Vitamin B12 deficiency: Prolonged acid suppression may impair the absorption of vitamin B12 (cyanocobalamin), which requires an acidic gastric environment for release from dietary proteins. Symptoms of B12 deficiency include extreme fatigue, tingling sensations, a sore or red tongue, mouth ulcers, muscle weakness, visual disturbances, memory problems, and depression. Your doctor may monitor B12 levels during long-term treatment.
Severe skin reactions: Serious cutaneous adverse reactions have been reported with pantoprazole use, including Stevens-Johnson syndrome (SJS), toxic epidermal necrolysis (TEN), drug reaction with eosinophilia and systemic symptoms (DRESS), and erythema multiforme. If you develop a skin rash, particularly in sun-exposed areas, or experience any symptoms such as blistering, peeling skin, mouth sores, or general deterioration, stop treatment immediately and seek urgent medical attention.
Chromogranin A testing: Pantoprazole can elevate chromogranin A (CgA) levels, a biomarker used in the diagnosis of neuroendocrine tumors. If you are scheduled for a CgA blood test, inform the laboratory that you are taking a proton pump inhibitor, as this may produce false-positive results. Treatment should ideally be stopped at least 14 days before CgA measurement.
- Unintentional weight loss
- Repeated vomiting or vomiting blood (which may appear like dark coffee grounds)
- Difficulty swallowing or pain when swallowing
- Pale appearance and weakness (signs of anemia)
- Black, tarry stools (possible gastrointestinal bleeding)
- Severe or persistent diarrhea (possible Clostridioides difficile infection)
- Chest pain or severe abdominal pain
These symptoms may indicate a more serious underlying condition that requires investigation. Pantoprazole can mask cancer symptoms, potentially delaying diagnosis.
Pregnancy and breastfeeding
There is insufficient clinical data regarding the safety of pantoprazole during pregnancy. Animal reproduction studies have not demonstrated direct harmful effects on embryonic or fetal development; however, as with all medications, caution is warranted. Pantoprazole has been detected in human breast milk. If you are pregnant, breastfeeding, think you may be pregnant, or are planning to have a baby, consult your doctor before receiving this medication.
Pantoprazol Accord should only be used during pregnancy or breastfeeding if your physician has determined that the expected benefit to you outweighs the potential risk to the fetus or infant. The European Medicines Agency (EMA) and the U.S. Food and Drug Administration (FDA) both classify pantoprazole as a medication that should be used in pregnancy only when clearly needed.
Driving and operating machinery
Pantoprazol Accord has no or negligible effect on the ability to drive or operate machinery under normal circumstances. However, if you experience side effects such as dizziness or visual disturbances, you should refrain from driving or operating machinery until these symptoms resolve.
Sodium content
This medicine contains less than 1 mmol sodium (23 mg) per vial, meaning it is essentially sodium-free. This is relevant for patients on sodium-restricted diets.
How Does Pantoprazol Accord Interact with Other Drugs?
Pantoprazol Accord interacts with several important medications including HIV drugs (atazanavir), antifungals (ketoconazole), cancer treatments (methotrexate, erlotinib), blood thinners (warfarin), and antidepressants (fluvoxamine). Always tell your doctor about all medications you take, including over-the-counter products and herbal supplements.
Drug interactions with proton pump inhibitors occur primarily through two mechanisms: pH-dependent absorption (drugs that require an acidic gastric environment for proper absorption) and cytochrome P450 enzyme inhibition (drugs metabolized by the same liver enzymes as pantoprazole). Understanding these interactions is crucial for safe and effective therapy.
Pantoprazole is primarily metabolized by cytochrome P450 2C19 (CYP2C19), with minor contributions from CYP3A4. While pantoprazole has a lower potential for drug interactions compared to some other PPIs (notably omeprazole), several clinically significant interactions require attention.
Major interactions
| Drug | Effect | Recommendation |
|---|---|---|
| Atazanavir (and other HIV protease inhibitors) | Substantially reduced absorption of atazanavir due to increased gastric pH; may lead to treatment failure | Co-administration is not recommended. Consult HIV specialist for alternative strategies |
| Methotrexate (high-dose) | Pantoprazole may increase methotrexate blood levels by inhibiting its renal elimination | Temporary discontinuation of pantoprazole may be required during high-dose methotrexate therapy |
| Ketoconazole, Itraconazole, Posaconazole | Reduced absorption of these antifungal agents due to increased gastric pH | Avoid co-administration if possible. Monitor antifungal efficacy closely |
| Erlotinib | Reduced absorption of this cancer medication due to increased gastric pH | Avoid co-administration. Discuss alternatives with oncologist |
Minor interactions
| Drug | Effect | Recommendation |
|---|---|---|
| Warfarin / Phenprocoumon | Possible alteration of anticoagulant effect (rare cases of increased INR reported) | Monitor INR more frequently when starting or stopping pantoprazole |
| Fluvoxamine | Fluvoxamine inhibits CYP2C19, potentially increasing pantoprazole levels | Dose reduction of pantoprazole may be considered |
| Rifampicin | Rifampicin induces CYP enzymes, potentially reducing pantoprazole effectiveness | Monitor acid suppression efficacy; dose adjustment may be needed |
| St. John's Wort (Hypericum perforatum) | CYP enzyme induction may decrease pantoprazole levels | Avoid concomitant use if possible |
There have been reports that proton pump inhibitors may cause false-positive results in urine screening tests for tetrahydrocannabinol (THC). If you are required to undergo urine drug testing, inform the testing laboratory that you are taking pantoprazole so that confirmatory testing methods can be used.
What Is the Correct Dosage of Pantoprazol Accord?
The standard adult dose is 40 mg (one vial) given as an intravenous injection over 2-15 minutes once daily. For Zollinger-Ellison syndrome, the starting dose is 80 mg daily. Patients with severe liver impairment should not exceed 20 mg daily. The injection is not recommended for children under 18.
Pantoprazol Accord is always administered by a healthcare professional — a doctor or nurse — as an intravenous injection. The solution is prepared by dissolving the powder in 10 ml of 0.9% sodium chloride solution and administered over 2 to 15 minutes. The dosage depends on the specific condition being treated and individual patient factors.
Adults
Reflux esophagitis, gastric ulcers, and duodenal ulcers
40 mg (one vial) once daily by intravenous injection. Treatment should continue only until oral therapy is possible, at which point the patient should be switched to pantoprazole tablets.
Zollinger-Ellison syndrome and pathological hypersecretory conditions
Starting dose: 80 mg (two vials) once daily. The dose may then be adjusted based on gastric acid output measurements. If the daily dose exceeds 80 mg, it should be divided into two equal doses. A temporary increase to 160 mg (four vials) per day may be used to achieve rapid acid control. Once adequate acid suppression is achieved, the dose is titrated down to the lowest effective maintenance dose.
Dose adjustments
| Population | Dose | Notes |
|---|---|---|
| Standard adult dose | 40 mg once daily | For reflux esophagitis and peptic ulcers |
| Zollinger-Ellison (initial) | 80 mg once daily | May increase up to 160 mg/day; split into 2 doses if >80 mg |
| Severe liver impairment | Maximum 20 mg daily | Monitor liver enzymes regularly; discontinue if enzymes rise |
| Elderly patients | No dose adjustment | Standard dosing applies; monitor for adverse effects |
| Renal impairment | No dose adjustment | No accumulation expected |
| Children (<18 years) | Not recommended | Insufficient evidence of efficacy and safety in pediatric patients |
Missed dose
Since Pantoprazol Accord is administered by healthcare professionals in a clinical setting, missed doses are unlikely. However, if a dose is inadvertently skipped, it should be given as soon as possible. The next dose should then be administered at the regular scheduled time. Two doses should not be given simultaneously to compensate for a missed dose.
Overdose
Because doses are carefully controlled by healthcare professionals, overdose is very unlikely. There are no known specific symptoms of pantoprazole overdose. Doses up to 240 mg administered intravenously over two minutes have been well tolerated in clinical studies. Treatment of overdose would be symptomatic and supportive, as there is no specific antidote for pantoprazole. Pantoprazole is highly protein-bound and is therefore not readily dialyzable.
What Are the Side Effects of Pantoprazol Accord?
Common side effects include injection site inflammation (thrombophlebitis) and benign stomach polyps. Less common effects include headache, dizziness, diarrhea, nausea, and skin rash. Rare but serious reactions include severe allergic reactions, serious skin conditions (Stevens-Johnson syndrome), and liver damage. Stop treatment and seek emergency care for severe skin reactions or signs of anaphylaxis.
Like all medicines, Pantoprazol Accord can cause side effects, although not everybody gets them. The frequency and severity of side effects vary between individuals, and most side effects are mild and transient. The following categorization uses the standard medical frequency conventions established by the European Medicines Agency.
- Target-shaped or circular reddish patches on the trunk, with or without blisters, peeling skin, or sores in the mouth, throat, nose, or eyes (signs of Stevens-Johnson syndrome or toxic epidermal necrolysis)
- Widespread rash, high body temperature, and enlarged lymph nodes (signs of DRESS syndrome)
- Swelling of the tongue or throat, difficulty swallowing, hives, difficulty breathing, severe dizziness with rapid heartbeat (signs of anaphylaxis)
- Yellowing of the skin or eyes (signs of severe liver damage)
Common
- Inflammation and blood clotting at the injection site (thrombophlebitis)
- Benign polyps in the stomach (fundic gland polyps)
Uncommon
- Headache and dizziness
- Diarrhea, nausea, vomiting
- Bloating and gas (flatulence)
- Constipation and dry mouth
- Abdominal pain and discomfort
- Skin rash, redness, blisters, itching
- Weakness, fatigue, or general malaise
- Sleep disturbances (insomnia)
- Elevated liver enzymes (in blood tests)
- Hip, wrist, or spine fractures
Rare
- Distortion or complete loss of taste
- Visual disturbances including blurred vision
- Hives (urticaria)
- Joint pain and muscle pain
- Weight changes
- High fever
- Swelling of extremities (peripheral edema)
- Allergic reactions
- Depression
- Breast enlargement in men (gynecomastia)
- Elevated bilirubin and blood lipids
- Severe reduction in white blood cells (agranulocytosis) with high fever
Very Rare
- Disorientation and confusion
- Decreased platelet count (thrombocytopenia) with increased bleeding or bruising
- Decreased white blood cell count (leukopenia) leading to increased infections
- Simultaneous decrease in red blood cells, white blood cells, and platelets (pancytopenia)
Frequency Not Known
- Hallucinations, confusion (especially in patients with a history of these symptoms)
- Tingling, prickling, burning sensation, or numbness (paresthesia)
- Skin rash with joint pain
- Inflammation of the colon (colitis) causing persistent watery diarrhea
- Decreased sodium, magnesium, calcium, or potassium levels in blood
- Severe liver damage with jaundice
- Severe kidney inflammation (tubulointerstitial nephritis)
- Subacute cutaneous lupus erythematosus (skin rash in sun-exposed areas)
If you experience any side effects, including those not listed above, talk to your doctor, pharmacist, or nurse. You can also report side effects directly to your national medicines regulatory authority. Reporting helps provide more information on the safety of this medicine.
How Should You Store Pantoprazol Accord?
Store Pantoprazol Accord below 25°C in the original carton to protect from light. Keep out of reach of children. Do not use after the expiry date. Once reconstituted, the solution should be used within 12 hours at room temperature. Do not use if the solution is cloudy or contains particles.
Proper storage of pharmaceutical products is essential to maintain their efficacy and safety. Pantoprazol Accord, as a lyophilized (freeze-dried) powder, has specific storage requirements that must be followed to ensure the product remains stable and effective until its expiry date.
- Temperature: Store at or below 25°C (77°F). Do not refrigerate or freeze
- Light protection: Keep the vial in its original outer carton, as the product is sensitive to light
- After reconstitution: Chemical and physical stability of the reconstituted solution has been demonstrated for 12 hours at 25°C. From a microbiological perspective, the product should be used immediately unless the method of preparation excludes the risk of microbial contamination
- Visual inspection: Do not use if you notice visible changes such as cloudiness or precipitates in the reconstituted solution
- Single use only: Each vial is for single use. Any remaining solution should be discarded
- Disposal: Do not dispose of medicines in wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer needed, to help protect the environment
What Does Pantoprazol Accord Contain?
Each vial contains 42.29 mg of pantoprazole sodium sesquihydrate, equivalent to 40 mg of pantoprazole as the active substance. The only other ingredient is sodium hydroxide, used for pH adjustment. The product appears as a white to off-white freeze-dried powder.
Pantoprazol Accord has a straightforward formulation with minimal excipients, which reduces the risk of allergic reactions to inactive ingredients. The product is manufactured by Accord Healthcare Polska Sp. z o.o. in Pabianice, Poland, under the marketing authorization of Accord Healthcare B.V. based in Utrecht, Netherlands.
Composition
- Active substance: Pantoprazole 40 mg (as pantoprazole sodium sesquihydrate 42.29 mg)
- Excipient: Sodium hydroxide (for pH adjustment)
Reconstitution and administration
For healthcare professionals: The solution is prepared by injecting 10 ml of 0.9% sodium chloride injection into the vial containing the dry powder. This solution can be administered directly or after further dilution with 100 ml of 0.9% sodium chloride or 5% glucose solution. Glass or plastic containers should be used for dilution. The product must not be reconstituted or mixed with any solvents other than those specified. Administration is by intravenous injection over 2 to 15 minutes.
Available pack sizes
Pantoprazol Accord is available in packs of 1, 10, 20, or 50 vials. Not all pack sizes may be marketed in every country.
Frequently Asked Questions About Pantoprazol Accord
Pantoprazol Accord is an intravenous (IV) formulation of pantoprazole, meaning it is injected directly into a vein by a healthcare professional. Pantoprazole tablets are taken by mouth. The active ingredient and its mechanism of action are the same in both formulations. The IV form is used only when a patient cannot take oral medication — for example, in hospitalized patients who are unable to swallow, are nil by mouth before surgery, or have gastrointestinal conditions that prevent oral absorption. As soon as oral therapy becomes feasible, patients are switched from IV to tablet form.
When given intravenously, pantoprazole begins to reduce stomach acid production within approximately one hour. The maximum acid-suppressing effect is typically achieved within two to three hours after administration. This rapid onset is one of the advantages of the intravenous route compared to oral tablets, making it particularly useful in acute situations such as active gastrointestinal bleeding.
Since Pantoprazol Accord is administered intravenously, it bypasses the gastrointestinal tract entirely. Therefore, concurrent use of oral antacids does not affect its absorption or effectiveness. However, if you are taking antacids alongside other oral medications, consult your doctor, as antacids can interfere with the absorption of certain drugs.
Pantoprazol Accord IV injection is intended for short-term use only, until patients can switch to oral pantoprazole. Long-term use of any proton pump inhibitor (whether oral or IV) is associated with potential risks including bone fractures, magnesium deficiency, vitamin B12 deficiency, and an increased risk of certain infections. For patients requiring long-term PPI therapy, regular monitoring and periodic reassessment of the need for continued treatment are recommended by international guidelines including those from the American Gastroenterological Association (AGA).
No. Pantoprazol Accord intravenous injection is not recommended for children and adolescents under 18 years of age, as there is insufficient evidence to support its efficacy and safety in pediatric patients. For children requiring acid suppression therapy, your doctor will consider age-appropriate alternatives and formulations.
Before receiving Pantoprazol Accord, tell your doctor if you: have liver problems; are taking HIV medications (especially atazanavir); have osteoporosis or are at risk of bone fractures; are taking corticosteroids; have ever had a skin reaction to a proton pump inhibitor; are scheduled for a chromogranin A blood test; are pregnant, breastfeeding, or planning a pregnancy; or are taking any other medications including over-the-counter medicines and herbal supplements (especially St. John's Wort, methotrexate, warfarin, or antifungal medications).
References
This article is based on the following peer-reviewed sources and international medical guidelines:
- European Medicines Agency (EMA). Pantoprazole — Summary of Product Characteristics. European Medicines Agency. Updated 2025.
- World Health Organization (WHO). WHO Model List of Essential Medicines — 23rd List, 2023. Geneva: World Health Organization; 2023.
- Strand DS, Kim D, Peura DA. 25 Years of Proton Pump Inhibitors: A Comprehensive Review. Gut and Liver. 2017;11(1):27-37. doi:10.5009/gnl15502
- Freedberg DE, Kim LS, Yang YX. The Risks and Benefits of Long-term Use of Proton Pump Inhibitors: Expert Review and Best Practice Advice From the American Gastroenterological Association. Gastroenterology. 2017;152(4):706-715.
- U.S. Food and Drug Administration (FDA). Proton Pump Inhibitors: Drug Safety Communication — Low Magnesium Levels Can Be Associated With Long-Term Use. FDA Drug Safety Communication. 2011 (updated 2023).
- British National Formulary (BNF). Pantoprazole. National Institute for Health and Care Excellence (NICE). Updated 2025.
- Malfertheiner P, Megraud F, Rokkas T, et al. Management of Helicobacter pylori infection: the Maastricht VI/Florence consensus report. Gut. 2022;71(9):1724-1762.
- European Medicines Agency (EMA). Assessment Report on Proton Pump Inhibitors: Risk of Bone Fractures. Pharmacovigilance Risk Assessment Committee (PRAC). 2022.
About the Medical Editorial Team
This article was written and medically reviewed by the iMedic Medical Editorial Team, which includes specialists in gastroenterology, clinical pharmacology, and internal medicine.
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iMedic Medical Editorial Team
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