Pantoprazol SUN Pharma
Pantoprazole sodium sesquihydrate — 40 mg powder for solution for injection
Quick Facts About Pantoprazol SUN Pharma
Key Takeaways
- Intravenous proton pump inhibitor: Pantoprazol SUN Pharma 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 SUN Pharma IV injection is not recommended for patients under 18 years of age
What Is Pantoprazol SUN Pharma and What Is It Used For?
Pantoprazol SUN Pharma 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 is a member of the proton pump inhibitor (PPI) class, a group of medications widely prescribed worldwide for acid-related gastrointestinal disorders. As a selective and irreversible inhibitor of the hydrogen-potassium adenosine triphosphatase (H+/K+ ATPase) enzyme system — commonly referred to as the "proton pump" — pantoprazole blocks the final step in the production of hydrochloric acid by the parietal cells of the stomach lining. This end-stage mechanism makes it highly effective at controlling gastric acid output regardless of the stimulus triggering secretion, whether that be food intake, gastrin release, histamine, or vagal stimulation.
Pantoprazol SUN Pharma is supplied as a powder for solution for intravenous injection, with each vial containing 40 mg of pantoprazole (as pantoprazole sodium sesquihydrate). This parenteral formulation is reserved for clinical situations in which the oral route is not feasible or appropriate: for example, when a patient is nil by mouth before surgery, is critically ill in an intensive care setting, or has a gastrointestinal condition that impairs oral absorption. As soon as the treating clinician judges that oral therapy is tolerated, the patient is transitioned to pantoprazole tablets.
The intravenous route delivers a rapid onset of action. Antisecretory effects begin within approximately one hour after administration, and the maximum acid-suppressing effect is reached within two to three hours. This speed of action is particularly valuable in acute clinical scenarios where prompt control of gastric acidity is essential, such as active upper gastrointestinal bleeding from peptic ulcers, severe erosive esophagitis, or stress-related mucosal disease in critically ill patients.
Generic pantoprazole products manufactured by Sun Pharmaceutical Industries (marketed as Pantoprazol SUN Pharma in several European markets) are bioequivalent to the originator pantoprazole injections and meet the same stringent regulatory standards enforced by the European Medicines Agency (EMA) and national competent authorities. This means clinicians and patients can expect comparable efficacy and safety to other branded pantoprazole IV products.
Approved indications
Pantoprazol SUN Pharma is approved for use in adults only for the following conditions:
- Reflux esophagitis: Inflammation and ulceration of the esophagus caused by the backward flow of gastric acid, typically presenting with heartburn, acid regurgitation, chest discomfort, and in severe cases difficulty swallowing
- Gastric and duodenal ulcers: Open sores in the lining of the stomach or the first part of the small intestine (duodenum). These lesions may cause epigastric pain, bleeding, perforation, or gastric outlet obstruction if left untreated
- Zollinger-Ellison syndrome and other pathological hypersecretory states: A rare condition in which one or more gastrin-secreting tumors (gastrinomas) in the pancreas or duodenum drive excessive gastric acid production. These patients require higher and more frequent dosing to control acid output
Pantoprazol SUN Pharma is intended as a short-term intravenous substitute for oral pantoprazole. Your healthcare provider will switch you to oral tablets as soon as your clinical condition allows. The intravenous formulation should not be used as long-term maintenance therapy.
How pantoprazole works in the body
After intravenous infusion, pantoprazole is rapidly distributed and selectively accumulates in the acidic secretory canaliculi of gastric parietal cells. There, under the low-pH environment, pantoprazole is chemically activated to a reactive sulfenamide. This active form binds covalently to cysteine residues on the H+/K+ ATPase enzyme, permanently inactivating the proton pumps responsible for acid secretion. Because the bond is irreversible, acid suppression persists until new proton pumps are synthesized by the parietal cells — typically over 24 to 48 hours.
The plasma half-life of pantoprazole is short, approximately one hour, but the duration of its pharmacological effect far exceeds the duration of detectable drug in the bloodstream. This disconnect between pharmacokinetics and pharmacodynamics is a defining feature of PPIs and explains why once-daily dosing produces sustained acid suppression.
What Should You Know Before Taking Pantoprazol SUN Pharma?
Do not use Pantoprazol SUN Pharma if you are allergic to pantoprazole or any other proton pump inhibitor. Key warnings include increased risk 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 you take.
Before receiving Pantoprazol SUN Pharma, it is essential that your healthcare provider has a complete picture of your medical history, current medications, and any known allergies. Proton pump inhibitors are generally well tolerated, but they carry several important safety considerations that warrant careful evaluation, particularly for patients who will be on therapy for more than a few weeks. The sections below summarise the principal contraindications, warnings, and precautions associated with pantoprazole therapy.
Contraindications
Pantoprazol SUN Pharma 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), this product is contraindicated
- 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 SUN Pharma if any of the following apply:
Liver impairment: Patients with severe hepatic dysfunction require close monitoring, as pantoprazole clearance is substantially reduced. Liver enzyme levels should be checked regularly during treatment. If liver enzymes become elevated, therapy 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 or nelfinavir, you must inform your doctor. Pantoprazole markedly raises gastric pH, which can reduce the absorption and plasma levels of these critical antiretroviral drugs to the point of treatment failure and the emergence of resistant virus. Co-administration is generally not recommended, and alternative acid-suppressing strategies should be considered.
Bone fracture risk: Long-term use of proton pump inhibitors, particularly at high doses and for durations exceeding one year, has been linked in observational studies to a modestly increased risk of hip, wrist, and spine fractures. The absolute risk remains low, but it is particularly relevant for patients with osteoporosis, a family history of fracture, or concomitant corticosteroid therapy. Your doctor may recommend calcium and vitamin D supplementation, weight-bearing exercise, and periodic bone density assessment during extended PPI therapy.
Hypomagnesemia: Use of PPIs for periods exceeding three months — and especially beyond one year — can lead to clinically significant decreases in serum magnesium levels. Symptoms of low magnesium may include fatigue, tetany (involuntary muscle contractions), confusion, delirium, seizures, dizziness, and ventricular arrhythmias. Because low magnesium can in turn depress potassium and calcium levels, the biochemical picture can be complex. If you experience any of these symptoms, contact your healthcare provider immediately. Routine monitoring of serum magnesium is recommended for patients on prolonged therapy or those also taking diuretics or digoxin.
Vitamin B12 deficiency: Gastric acid is required to release vitamin B12 (cyanocobalamin) from dietary proteins. Prolonged acid suppression may therefore impair B12 absorption over time. Symptoms of B12 deficiency include chronic fatigue, paresthesias, glossitis (sore, red tongue), mouth ulcers, muscle weakness, visual disturbances, impaired memory, and depressed mood. Your doctor may check serum B12 levels during long-term treatment, particularly in older adults, vegetarians, vegans, and those with pre-existing borderline levels.
Severe cutaneous reactions: Serious skin reactions have been reported with pantoprazole, including Stevens-Johnson syndrome (SJS), toxic epidermal necrolysis (TEN), drug reaction with eosinophilia and systemic symptoms (DRESS), erythema multiforme, and acute generalized exanthematous pustulosis (AGEP). If you develop a new rash — particularly one that blisters, peels, or involves the mouth, eyes, or genitals — or a rash in sun-exposed areas, stop treatment immediately and seek urgent medical attention.
Subacute cutaneous lupus erythematosus (SCLE): PPIs have been associated with the development of SCLE, a form of lupus that causes a photosensitive skin rash. Symptoms typically appear weeks to months after starting therapy. If lesions develop in sun-exposed areas such as the face, neck, forearms, or upper chest, especially if accompanied by joint pain, contact your doctor.
Chromogranin A (CgA) testing: Pantoprazole raises serum chromogranin A, a biomarker used in the diagnosis and monitoring of neuroendocrine tumors. Elevated CgA during PPI therapy can yield false-positive results. If you are scheduled for a CgA blood test, inform the laboratory that you are taking a proton pump inhibitor; ideally, treatment should be held for at least 14 days before CgA measurement, when clinically appropriate.
Masking of malignancy: Symptomatic relief from pantoprazole does not rule out the presence of a gastric malignancy. If you have alarm features such as unintended weight loss, recurrent vomiting, hematemesis, melena, dysphagia, or iron-deficiency anemia, additional diagnostic work-up (including upper endoscopy) is warranted.
- 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
Clinical data on the use of pantoprazole during pregnancy are limited. Moderate amounts of observational data (from post-marketing registries and cohort studies) have not shown a clear increase in major congenital malformations among women exposed to pantoprazole in the first trimester. Animal reproduction studies have not demonstrated direct harmful effects on embryofetal development at clinically relevant doses. Nonetheless, as with all medications, caution is appropriate during pregnancy.
Pantoprazole has been detected in human breast milk at low concentrations. The decision to use Pantoprazol SUN Pharma during pregnancy or breastfeeding should be made by your physician based on an individual benefit-risk assessment. Both the European Medicines Agency and the U.S. Food and Drug Administration recommend use in pregnancy only when clearly needed. If you are pregnant, breastfeeding, think you may be pregnant, or are planning a pregnancy, discuss this with your healthcare provider before receiving the medication.
Driving and operating machinery
Pantoprazol SUN Pharma 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, refrain from driving or operating machinery until those symptoms have resolved.
Sodium content
This medicine contains less than 1 mmol sodium (23 mg) per vial, making it essentially sodium-free. This is relevant for patients on strictly sodium-restricted diets (for example, some patients with heart failure or advanced kidney disease).
How Does Pantoprazol SUN Pharma Interact with Other Drugs?
Pantoprazol SUN Pharma 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 arise through two principal mechanisms. The first is pH-dependent absorption: drugs that require an acidic gastric environment to dissolve or to be absorbed become less bioavailable when gastric acid is suppressed. The second is cytochrome P450 (CYP) enzyme modulation: pantoprazole is metabolized predominantly by CYP2C19 (with minor contributions from CYP3A4), so drugs that inhibit or induce these enzymes can alter pantoprazole exposure, and pantoprazole itself can modestly affect the metabolism of other CYP substrates.
Compared with some other PPIs (notably omeprazole), pantoprazole has a favourable interaction profile because it causes minimal inhibition of CYP2C19 at therapeutic concentrations. Nevertheless, several clinically significant interactions require attention and occasionally dose modification or substitution.
Major interactions
| Drug | Effect | Recommendation |
|---|---|---|
| Atazanavir (and other HIV protease inhibitors) | Substantially reduced absorption of atazanavir due to increased gastric pH; may lead to virological treatment failure and emergence of HIV resistance | Co-administration is not recommended. Consult HIV specialist for alternative acid-suppression strategies |
| Methotrexate (high-dose) | Pantoprazole may increase methotrexate and hydroxymethotrexate blood levels by inhibiting renal elimination, increasing the risk of methotrexate toxicity | Temporary discontinuation of pantoprazole should be considered during high-dose methotrexate cycles |
| Ketoconazole, Itraconazole, Posaconazole | Reduced absorption of these azole antifungals due to increased gastric pH; potential for treatment failure of serious fungal infections | Avoid co-administration where possible; if unavoidable, monitor antifungal efficacy closely and consider alternative antifungals |
| Erlotinib | Reduced absorption of this oncology agent (an EGFR tyrosine kinase inhibitor) due to increased gastric pH | Avoid co-administration. Discuss alternatives with the treating oncologist |
| Clopidogrel | Potential, though clinically modest, reduction in the antiplatelet activity of clopidogrel via CYP2C19-mediated activation. Pantoprazole is considered among the safer PPIs in this regard | Routine monitoring is sufficient. If acid suppression is essential, pantoprazole is preferred over omeprazole and esomeprazole |
Minor interactions
| Drug | Effect | Recommendation |
|---|---|---|
| Warfarin / Phenprocoumon | Possible alteration of anticoagulant effect; rare case reports of increased INR, abnormal bleeding, or death have been documented | Monitor INR more frequently when starting or stopping pantoprazole |
| Fluvoxamine | Fluvoxamine is a potent CYP2C19 inhibitor and can increase pantoprazole plasma levels several-fold | Dose reduction of pantoprazole should be considered, particularly in patients with hepatic impairment |
| Rifampicin | Rifampicin induces hepatic CYP enzymes, potentially reducing pantoprazole exposure and effectiveness | Monitor acid suppression efficacy; dose adjustment or alternative therapy may be needed |
| St. John's Wort (Hypericum perforatum) | CYP enzyme induction may decrease pantoprazole plasma levels and acid-suppressing efficacy | Avoid concomitant use if possible |
| Digoxin, Ampicillin esters, Iron salts | Absorption of these drugs is partially dependent on gastric pH and may be modestly reduced | Monitor clinical response; dose timing separation is generally not effective with IV pantoprazole |
There have been published reports that proton pump inhibitors may cause false-positive results in urine screening immunoassays for tetrahydrocannabinol (THC). If you are required to undergo workplace or legal drug testing, inform the testing laboratory that you are taking pantoprazole so that confirmatory mass spectrometry testing can be used.
What Is the Correct Dosage of Pantoprazol SUN Pharma?
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 SUN Pharma is always administered by a healthcare professional — a doctor or nurse — as an intravenous injection. The product is reconstituted by adding 10 ml of 0.9% sodium chloride injection to the vial containing the lyophilised powder. The resulting solution may be administered directly or, if preferred, further diluted with 100 ml of 0.9% sodium chloride or 5% glucose solution. Administration is by slow intravenous injection over 2 to 15 minutes. The dose and duration depend 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. Intravenous therapy should continue only until the patient can resume oral intake, at which point they should be transitioned to pantoprazole tablets. Typical total treatment duration (IV plus oral) for reflux esophagitis is 4-8 weeks, for duodenal ulcer 2-4 weeks, and for gastric ulcer 4-8 weeks, depending on response and endoscopic healing.
Zollinger-Ellison syndrome and pathological hypersecretory conditions
Starting dose: 80 mg (two vials) once daily. The dose is then titrated based on basal gastric acid output (the target is usually <10 mEq/hour, or <5 mEq/hour in patients who have undergone previous gastric surgery). If the daily dose exceeds 80 mg, it should be divided into two equal doses given 12 hours apart. A temporary increase to 160 mg (four vials) per day may be used to achieve rapid acid control. Once adequate acid suppression is established, the dose is down-titrated 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 two doses if >80 mg |
| Severe liver impairment | Maximum 20 mg daily | Monitor liver enzymes regularly; discontinue if enzymes rise further |
| Elderly patients (≥65 years) | No routine dose adjustment | Standard dosing applies; monitor for adverse effects, drug interactions, and bone/magnesium status on long-term therapy |
| Renal impairment | No dose adjustment | No clinically relevant accumulation expected; dialysis does not remove pantoprazole |
| Children (<18 years) | Not recommended | Insufficient evidence of efficacy and safety in pediatric patients for this IV formulation |
Missed dose
Because Pantoprazol SUN Pharma is administered by healthcare professionals in a clinical setting, missed doses are unlikely. If a dose is inadvertently skipped, it should be given as soon as the omission is recognised. The next dose should then be administered at the regular scheduled time. Two doses must not be given simultaneously to compensate for a missed dose.
Overdose
Because doses are carefully controlled by healthcare professionals, overdose of intravenous pantoprazole is very unlikely. There are no known specific symptoms of pantoprazole overdose in humans. Doses up to 240 mg administered intravenously over two minutes have been well tolerated in clinical studies. Treatment of any suspected overdose is symptomatic and supportive; there is no specific antidote. Pantoprazole is highly protein-bound and is therefore not readily dialyzable.
What Are the Side Effects of Pantoprazol SUN Pharma?
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 SUN Pharma can cause side effects, although not everybody gets them. The frequency and severity of adverse reactions vary between individuals, and most side effects are mild and transient. The categorisation below uses the standard medical frequency conventions established by the Council for International Organizations of Medical Sciences (CIOMS) and adopted by the European Medicines Agency in Summary of Product Characteristics documents.
- 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 with high body temperature and enlarged lymph nodes (signs of DRESS syndrome)
- Swelling of the tongue, lips, or throat, difficulty swallowing, hives, difficulty breathing, or severe dizziness with rapid heartbeat (signs of anaphylaxis)
- Yellowing of the skin or eyes, dark urine, pale stools, or severe right upper quadrant pain (signs of severe liver injury)
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 upper-abdominal 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 (long-term use)
Rare
- Distortion or complete loss of taste (dysgeusia / ageusia)
- Visual disturbances including blurred vision
- Hives (urticaria)
- Joint pain and muscle pain
- Weight changes
- High body temperature (fever)
- Swelling of extremities (peripheral edema)
- Allergic reactions including anaphylaxis and anaphylactic shock
- Depression and mood changes
- 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 prior history of such symptoms)
- Tingling, prickling, burning sensation, or numbness (paresthesia)
- Skin rash with joint pain
- Microscopic colitis presenting as persistent watery diarrhea
- Decreased sodium, magnesium, calcium, or potassium levels in blood
- Severe liver damage with jaundice or liver failure
- Severe kidney inflammation (tubulointerstitial nephritis)
- Subacute cutaneous lupus erythematosus (photosensitive skin rash)
- Increased risk of Clostridioides difficile-associated diarrhea
- Rhabdomyolysis (severe muscle breakdown) in isolated reports
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 (for example, the MHRA Yellow Card scheme in the UK, the FDA MedWatch program in the US, or your national EMA network contact in the EU). Reporting helps provide more information on the safety of this medicine.
How Should You Store Pantoprazol SUN Pharma?
Store Pantoprazol SUN Pharma 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 until the expiry date. Pantoprazol SUN Pharma, as a lyophilised (freeze-dried) powder, has specific storage requirements that must be followed by hospital pharmacies, ward stock rooms, and any other setting where the product is held before administration.
- Temperature: Store at or below 25°C (77°F). Do not refrigerate or freeze the unreconstituted powder
- Light protection: Keep the vial in its original outer carton, as the active substance 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, however, the product should be used immediately unless the method of preparation excludes the risk of microbial contamination
- Visual inspection: The reconstituted solution should be clear and colourless to slightly yellow. Do not use if you notice visible changes such as cloudiness, colour change, or particulate matter
- Single use only: Each vial is intended for single use. Any unused reconstituted solution should be discarded according to local waste procedures
- Disposal: Do not dispose of medicines in wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer needed. These measures help protect the environment
- Expiry: Do not use Pantoprazol SUN Pharma after the expiry date stated on the carton and vial. The expiry date refers to the last day of that month
What Does Pantoprazol SUN Pharma 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 SUN Pharma has a minimal excipient profile, which reduces the risk of allergic reactions to inactive ingredients. Keeping formulations simple is a principle of good generic parenteral product design. The product is manufactured under the marketing authorisation of Sun Pharmaceutical Industries Europe B.V., based in Hoofddorp, Netherlands, with manufacturing at EU-GMP-certified sites.
Composition
- Active substance: Pantoprazole 40 mg per vial (as pantoprazole sodium sesquihydrate 42.29 mg)
- Excipient: Sodium hydroxide (used only for pH adjustment during manufacture)
Appearance
Pantoprazol SUN Pharma is supplied as a white to almost white lyophilised powder in a clear glass vial sealed with a rubber stopper and aluminium overseal. Before reconstitution, the powder should appear uniform without discoloration or agglomeration.
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. Gently invert the vial until the powder is completely dissolved. The reconstituted solution may be administered directly or after further dilution with 100 ml of 0.9% sodium chloride solution or 5% glucose solution. Glass or plastic containers (polyethylene, polypropylene, or PVC) may be used for dilution. The product must not be reconstituted or mixed with solvents other than those specified. Administration is by slow intravenous injection over 2 to 15 minutes.
Pantoprazol SUN Pharma must not be mixed in the same intravenous line with other drugs, and the line should be flushed with 0.9% sodium chloride before and after administration.
Available pack sizes
Pantoprazol SUN Pharma is available in packs of 1, 5, 10, 20, or 50 vials. Not all pack sizes may be marketed in every country.
Frequently Asked Questions About Pantoprazol SUN Pharma
Pantoprazol SUN Pharma 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 identical in both formulations. The IV form is used only when a patient cannot take oral medication — for example, hospitalised patients who are unable to swallow, 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 of administration. The maximum acid-suppressing effect is typically reached within two to three hours. This rapid onset is one of the advantages of the intravenous route compared with oral tablets, making it particularly useful in acute clinical scenarios such as active gastrointestinal bleeding, severe erosive esophagitis, or critically ill patients at risk of stress-related mucosal disease.
Yes. Pantoprazol SUN Pharma is a generic pantoprazole 40 mg powder for solution for injection. Generic medicines contain the same active substance, strength, dosage form, and route of administration as the reference-listed (originator) product and must demonstrate bioequivalence and equivalent quality standards under European Medicines Agency or equivalent national regulations. You can expect comparable efficacy and safety to other licensed pantoprazole IV products, including originator brands.
Because Pantoprazol SUN Pharma is administered intravenously, it bypasses the gastrointestinal tract entirely, and concurrent use of oral antacids does not affect its absorption or effectiveness. However, if you are taking antacids alongside other oral medications, talk to your doctor, as antacids can interfere with the absorption of certain drugs. If you need urgent acid relief while in hospital, your team will decide which combination is most appropriate.
Pantoprazol SUN Pharma 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, hypomagnesemia, vitamin B12 deficiency, and an increased risk of certain infections such as Clostridioides difficile and community-acquired pneumonia. For patients requiring long-term PPI therapy, regular monitoring and periodic reassessment of the need for continued treatment are recommended in international guidelines, including those from the American Gastroenterological Association (AGA) and the British Society of Gastroenterology (BSG).
No. Pantoprazol SUN Pharma 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, clinicians consider age-appropriate alternatives and formulations such as oral pantoprazole granules or other PPIs licensed for pediatric use, based on national and regional guidelines.
Before receiving Pantoprazol SUN Pharma, tell your doctor if you: have liver problems; are taking HIV medications (especially atazanavir or nelfinavir); 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 or endoscopy; 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 medicines).
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. doi:10.1053/j.gastro.2017.01.031
- 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. doi:10.1136/gutjnl-2022-327745
- European Medicines Agency (EMA). Assessment Report on Proton Pump Inhibitors: Risk of Bone Fractures. Pharmacovigilance Risk Assessment Committee (PRAC). 2022.
- Katz PO, Dunbar KB, Schnoll-Sussman FH, et al. ACG Clinical Guideline for the Diagnosis and Management of Gastroesophageal Reflux Disease. American Journal of Gastroenterology. 2022;117(1):27-56. doi:10.14309/ajg.0000000000001538
- Jensen RT, Cadiot G, Brandi ML, et al. ENETS Consensus Guidelines for the Management of Patients with Digestive Neuroendocrine Neoplasms: Functional Pancreatic Endocrine Tumor Syndromes. Neuroendocrinology. 2012;95(2):98-119. doi:10.1159/000335591
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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