Pantoprazole Sodium 40 mg Tablet, Delayed Release
🆔 Identity & classification
Where does this data come from?
🏷️ RxNorm drug class
This medicine belongs to the Proton Pump Inhibitor class.
Where does this data come from?
🏭 Manufacturer & labeler
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🩺 Clinical
Pantoprazole is used to treat damage from gastroesophageal reflux disease (GERD), a condition in which backward flow of acid from the stomach causes heartburn and possible injury of the esophagus (the tube between the throat and stomach) in adults and children 5 years of age and older. Pantoprazole is used to allow the esophagus to heal and prevent further damage to the esophagus in adults with GERD. It is also used to treat conditions where the stomach produces too much acid, such as Zollinger-Ellison syndrome in adults. Pantoprazole is in a class of medications called proton-pump inhibitors....
Read the full MedlinePlus article ↗- Pantoprazole shuts down the pumps in your stomach that produce acid. Most people notice relief from heartburn and related symptoms within a few days of starting it, but the full he...
- What exactly does pantoprazole do, and how quickly will I feel better?
- It depends on the form you're taking. If you're on the delayed-release tablet, you can take it with or without food — meals just delay it a bit but don't affect how much gets absor...
- Does it matter when I take pantoprazole — with food or without?
Patient education
Supplement & herbal interactions
Pantoprazole may be associated with lower levels of 9 nutrients — worth a chat with your pharmacist, not a cause for alarm.
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Ask a licensed pharmacist directly — free, answered by our team.
💊 What it looks like
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🧪 Inactive Ingredients / Excipients
Inactive ingredients, also called excipients, are components of the drug product other than the active ingredient. They may include fillers, dyes, coatings, preservatives, flavors, or other formulation ingredients.
💡 Tap an ingredient (hover on desktop) to see what it is and why it’s used.
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UNII 2S7830E561
Crospovidone is a synthetic polymer derived from povidone. It acts as a disintegrant, helping the tablet or capsule break apart quickly in the stomach so the active ingredient can be absorbed.
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UNII XM0M87F357
A dark iron oxide compound that gives medicines their black or dark color. It's used as a colorant in tablets and capsules to help identify the product and make it visually distinctive.
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UNII R8WTH25YS2
Glyceryl dibehenate is a wax-like substance made from behenate fatty acids and glycerol. It functions as a binder and release-control agent in tablets and capsules, helping hold ingredients together and regulate how quickly the medicine dissolves and releases in your body.
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UNII 3NXW29V3WO
Hypromellose is a plant-based thickener made from cellulose. It's used in medicines as a binder to hold ingredients together, a coating for tablets, and a thickener for liquids.
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UNII EWQ57Q8I5X
Lactose monohydrate is a natural sugar derived from milk. It serves as a filler and binder in tablets and capsules, helping create the proper size, texture, and consistency of the medicine.
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UNII 74G4R6TH13
A synthetic polymer made by combining two plastic-like chemicals. It forms a coating on tablets or capsules that dissolves at a specific point in the digestive tract, controlling where and when the medicine releases.
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UNII 7SEV7J4R1U
A powder made from a naturally occurring mineral. In medicines, talc works as a glidant and anti-caking agent, helping tablets and capsules flow smoothly during manufacturing and preventing clumping.
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UNII 15FIX9V2JP
Titanium dioxide is a bright white mineral powder commonly used as a colorant and opacifying agent. It makes pills and tablets white or lighter in color and helps make coatings non-transparent.
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UNII 8Z96QXD6UM
Triethyl citrate is a clear liquid derived from citric acid. It acts as a plasticizer and solvent in tablet coatings and film formulations, helping the coating remain flexible and adhere properly to the medicine.
9 inactive ingredients listed in the exact product block matched to this NDC.
Where does this data come from?
ingredient classCode="IACT" elements from the exact product block matched by this NDC. Label-section narrative from DailyMed / the openFDA label index is shown separately when available.Inactive ingredient FAQ
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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 ea | Per package |
|---|---|---|
| Retail pharmacies payNADAC · weekly | $0.035 | $1.76 / 50 tablet |
| Medicaid paysCMS SDUD · 12 mo | $0.2805 | $14.03 / 50 tablet |
| Medicare drug plans payPart D · Q2 2026 | $0.1305 | $6.53 / 50 tablet |
Where does this data come from?
🔁 Therapeutic equivalents
| Product | Labeler | Pack | NADAC/unit | TE | Status | Price vs. this |
|---|---|---|---|---|---|---|
| Pantoprazole Sodium 40 mg 00378-6689-10 | Mylan | 1000 tablets | $0.035 | AB | Availability likely | — |
| Pantoprazole Sodium 40 mg 00904-6870-45 | Major | 1 tablet | $0.035 | AB | Availability likely | — |
| Pantoprazole Sodium 40 mg 13668-0429-05 | Torrent | 500 tablets | $0.035 | AB | Availability likely | — |
| Pantoprazole Sodium 40 mg 31722-0713-10 | Camber | 1000 tablets | $0.035 | AB | Availability likely | — |
| Pantoprazole Sodium 40 mg 35573-0428-80 | Burel | 10 tablets | $0.035 | AB | Availability likely | — |
| Pantoprazole Sodium 40 mgthis 50268-0639-15 | AvPAK | 1 tablet | $0.035 | AB | Availability likely | — |
| Pantoprazole Sodium 40 mg 51079-0051-20 | Mylan | 1 tablet | $0.035 | AB | Availability likely | — |
| Pantoprazole Sodium 40 mg 60687-0736-01 | American | 1 tablet | $0.035 | AB | Availability likely | — |
| Pantoprazole Sodium 40 mg 62135-0534-08 | Chartwell | 450 tablets | $0.035 | AB | Availability likely | — |
| Pantoprazole Sodium 40 mg 62175-0617-43 | Lannett | 1000 tablets | $0.035 | AB | Availability likely | — |
| Pantoprazole Sodium 40 mg 64980-0677-09 | Rising | 90 tablets | $0.035 | AB | Availability likely | — |
| pantoprazole sodium 40 mg 70010-0191-09 | Granules | 90 tablets | $0.035 | AB | Availability likely | — |
| Pantoprazole sodium delayed-release 40 mg 70756-0019-12 | Lifestar | 1000 tablets | $0.035 | — | Availability likely | — |
| Pantoprazole 40 mg 72603-0178-01 | NorthStar | 90 tablets | $0.035 | AB | Availability likely | — |
| Pantoprazole Sodium 40 mg 72603-0746-01 | NorthStar | 500 tablets | $0.035 | AB | Availability likely | — |
| Pantoprazole Sodium 40 mg 82009-0011-90 | Quallent | 90 tablets | $0.035 | AB | Availability likely | — |
| Protonix Delayed-Release 40 mg 00008-0841-81 | Wyeth | 90 tablets | $14.215 | AB | Availability likely | +40259% |
| Pantoprazole Sodium 40 mg 00615-7629-05 | NCS | 15 tablets | — | AB | FDA listed | — |
| Pantoprazole Sodium 40 mg 00904-6474-45 | Major | 1 tablet | — | AB | Discontinued | — |
| Pantoprazole Sodium 40 mg 42708-0104-30 | QPharma | 30 tablets | — | AB | FDA listed | — |
| Pantoprazole Sodium 40 mg 42708-0180-30 | QPharma | 30 tablets | — | AB | FDA listed | — |
| Pantoprazole Sodium 40 mg 42708-0185-30 | QPharma | 30 tablets | — | AB | FDA listed | — |
| Pantoprazole Sodium 40 mg 43353-0027-30 | Aphena | 30 tablets | — | AB | FDA listed | — |
| Pantoprazole Sodium 40 mg 48433-0081-20 | Safecor | 1 tablet | — | AB | FDA listed | — |
| Pantoprazole Sodium 40 mg 50090-5378-00 | A-S | 30 tablets | — | AB | FDA listed | — |
| Pantoprazole Sodium 40 mg 50090-5379-00 | A-S | 90 tablets | — | AB | FDA listed | — |
| Pantoprazole Sodium 40 mg 50090-5794-00 | A-S | 30 tablets | — | AB | FDA listed | — |
| Pantoprazole Sodium 40 mg 50090-7512-00 | A-S | 90 tablets | — | AB | FDA listed | — |
| Pantoprazole Sodium 40 mg 51407-0613-10 | Golden | 1000 tablets | — | AB | FDA listed | — |
| Pantoprazole Sodium 40 mg 51655-0797-52 | Northwind | 30 tablets | — | AB | FDA listed | — |
| Pantoprazole 40 mg 55111-0333-01 | Dr. | 100 tablets | — | — | FDA listed | — |
| Pantoprazole Sodium 40 mg 55154-4165-00 | Cardinal | 1 tablet | — | AB | FDA listed | — |
| Pantoprazole Sodium 40 mg 55154-4382-00 | Cardinal | 1 tablet | — | AB | FDA listed | — |
| Pantoprazole Sodium 40 mg 55154-7634-00 | Cardinal | 1 tablet | — | AB | FDA listed | — |
| Pantoprazole Sodium 40 mg 60760-0679-30 | St. | 30 tablets | — | AB | FDA listed | — |
| Pantoprazole Sodium 40 mg 63187-0654-30 | Proficient | 30 tablets | — | AB | FDA listed | — |
| Pantoprazole Sodium 40 mg 63187-0938-30 | Proficient | 30 tablets | — | AB | FDA listed | — |
| Pantoprazole Sodium 40 mg 63187-0974-30 | Proficient | 30 tablets | — | AB | FDA listed | — |
| Pantoprazole Sodium 40 mg 65162-0637-03 | Amneal | 30 tablets | — | AB | FDA listed | — |
| Pantoprazole Sodium 40 mg 65862-0560-10 | Aurobindo | 10 tablets | — | AB | FDA listed | — |
| Pantoprazole Sodium 40 mg 67046-0536-03 | Coupler | 30 tablets | — | AB | FDA listed | — |
| Pantoprazole Sodium 40 mg 68071-1963-03 | NuCare | 30 tablets | — | AB | FDA listed | — |
| Pantoprazole Sodium 40 mg 68071-2215-03 | NuCare | 30 tablets | — | AB | FDA listed | — |
| Pantoprazole 40 mg 68071-3524-03 | NuCare | 30 tablets | — | AB | FDA listed | — |
| Pantoprazole 40 mg 68071-3995-09 | NuCare | 90 tablets | — | AB | FDA listed | — |
| Pantoprazole Sodium 40 mg 68071-4864-09 | NuCare | 90 tablets | — | AB | FDA listed | — |
| Pantoprazole Sodium 40 mg 68071-4895-09 | NuCare | 90 tablets | — | AB | FDA listed | — |
| Pantoprazole Sodium 40 mg 68071-4917-04 | NuCare | 14 tablets | — | AB | FDA listed | — |
| Pantoprazole Sodium 40 mg 68788-8644-01 | Preferred | 100 tablets | — | AB | FDA listed | — |
| Pantoprazole Sodium 40 mg 70518-0860-00 | REMEDYREPACK | 90 tablets | — | AB | FDA listed | — |
| Pantoprazole Sodium 40 mg 70518-1298-01 | REMEDYREPACK | 1 tablet | — | AB | FDA listed | — |
| Pantoprazole Sodium 40 mg 71335-0310-01 | Bryant | 90 tablets | — | AB | FDA listed | — |
| Pantoprazole Sodium 40 mg 71335-0551-01 | Bryant | 90 tablets | — | AB | FDA listed | — |
| Pantoprazole Sodium 40 mg 71335-1429-01 | Bryant | 90 tablets | — | AB | FDA listed | — |
| Pantoprazole Sodium 40 mg 71610-0653-30 | Aphena | 30 tablets | — | AB | FDA listed | — |
| Pantoprazole Sodium 40 mg 72162-1746-03 | Bryant | 30 tablets | — | AB | FDA listed | — |
| Pantoprazole Sodium DR 40 mg 72189-0514-90 | Direct_Rx | 90 tablets | — | AB | FDA listed | — |
| Pantoprazole Sodium 40 mg 72789-0086-30 | PD-Rx | 30 tablets | — | AB | FDA listed | — |
| Pantoprazole Sodium 40 mg 72789-0268-30 | PD-Rx | 30 tablets | — | AB | FDA listed | — |
| Pantoprazole Sodium 40 mg 72865-0230-10 | XLCare | 1000 tablets | — | AB | FDA listed | — |
| Pantoprazole Sodium 40 mg 76420-0669-10 | Asclemed | 10 tablets | — | AB | FDA listed | — |
| Pantoprazole Sodium 40 mg 76420-0674-01 | Asclemed | 100 tablets | — | AB | FDA listed | — |
| Pantoprazole Sodium 40 mg 76420-0806-10 | Asclemed | 10 tablets | — | AB | FDA listed | — |
| Pantoprazole Sodium DR 40 mg 80425-0133-01 | Advanced | 30 tablets | — | AB | FDA listed | — |
| Pantoprazole Sodium DR 40 mg 80425-0162-01 | Advanced | 30 tablets | — | AB | FDA listed | — |
| Pantoprazole Sodium 40 mg 85534-0061-00 | HAWAII | 10 tablets | — | AB | FDA listed | — |
| Pantoprazole Sodium 40 mg 87441-0066-01 | Unit | 30 tablets | — | AB | FDA listed | — |
| Pantoprazole Sodium 40 mg 67296-1812-07 | Redpharm | 14 tablets | — | AB | Discontinued | — |
Where does this data come from?
⏳ Availability & generic status
This product is an FDA-approved generic. Other versions of the same drug are listed under Therapeutic equivalents, least expensive first.
Where does this data come from?
🗺️ Medicaid utilization & spend
📊 Medicare Part D spend CMS · PART D · 2026 (Q1)
🔬 Reported adverse events (FAERS)
Top reported reactions
Age at onset
Reporter sex
Serious outcomes
Where does this data come from?
📦 Packaging — all sizes for this product
| Package NDC | Description | Marketing start | Status |
|---|---|---|---|
| 50268-0639-15 You're viewing this | 50 BLISTER PACK in 1 BOX (50268-639-15) / 1 TABLET, DELAYED RELEASE in 1 BLISTER PACK (50268-639-11) | 2015-02-19 | Active |
📄 Full prescribing information FDA SPL
🎯 Indications and Usage ▾
1 INDICATIONS AND USAGE Pantoprazole Sodium Delayed-Release Tablets, USP are indicated for: Pantoprazole is a proton pump inhibitor (PPI) indicated for the following: Short-Term Treatment of Erosive Esophagitis Associated with Gastroesophageal Reflux Disease (GERD) ( 1.1 ) Maintenance of Healing of Erosive Esophagitis ( 1.2 ) Pathological Hypersecretory Conditions Including Zollinger-Ellison (ZE) Syndrome ( 1.3 )
1.1Short-Term Treatment of Erosive Esophagitis Associated With Gastroesophageal Reflux Disease (GERD) Pantoprazole is indicated in adults and pediatric patients five years of age and older for the short-term treatment (up to 8 weeks) in the healing and symptomatic relief of erosive esophagitis (EE). For those adult patients who have not healed after 8 weeks of treatment, an additional 8-week course of Pantoprazole may be considered. Safety of treatment beyond 8 weeks in pediatric patients has not been established.
1.2Maintenance of Healing of Erosive Esophagitis Pantoprazole is indicated for maintenance of healing of EE and reduction in relapse rates of daytime and nighttime heartburn symptoms in adult patients with GERD. Controlled studies did not extend beyond 12 months.
1.3Pathological Hypersecretory Conditions Including Zollinger-Ellison (ZE) Syndrome Pantoprazole is indicated for the long-term treatment of pathological hypersecretory conditions, including Zollinger-Ellison (ZE) Syndrome.
⏱️ Dosage and Administration ▾
2 DOSAGE AND ADMINISTRATION Indication Dose Frequency Short-Term Treatment of Erosive Esophagitis Associated With GERD ( 2.1 ) Adults 40 mg Once Daily for up to 8 wks Children (5 years and older) ≥ 15 kg to < 40 kg 20 mg Once Daily for up to 8 wks ≥ 40 kg 40 mg Maintenance of Healing of Erosive Esophagitis ( 2.1 ) Adults 40 mg Once Daily Controlled studies did not extend beyond 12 months Pathological Hypersecretory Conditions Including Zollinger-Ellison Syndrome ( 2.1 ) Adults 40 mg Twice Daily See full prescribing information for administration instructions
2.1Recommended Dosing Schedule Pantoprazole is supplied as delayed-release tablets. The recommended dosages are outlined in Table 1. Table 1: Recommended Dosing Schedule for Pantoprazole Indication Dose Frequency Short-Term Treatment of Erosive Esophagitis Associated With GERD Adults 40 mg Once daily for up to 8 weeks For adult patients who have not healed after 8 weeks of treatment, an additional 8-week course of Pantoprazole may be considered.
Children (5 years and older) ≥ 15 kg to < 40 kg 20 mg Once daily for up to 8 weeks ≥ 40 kg 40 mg Maintenance of Healing of Erosive Esophagitis Adults 40 mg Once daily Controlled studies did not extend beyond 12 months Pathological Hypersecretory Conditions Including Zollinger-Ellison Syndrome Adults 40 mg Twice daily Dosage regimens should be adjusted to individual patient needs and should continue for as long as clinically indicated. Doses up to 240 mg daily have been administered.
2.2Administration Instructions Directions for method of administration for each dosage form are presented in Table 2. Table 2: Administration Instructions Formulation Route Instructions Do not split, chew, or crush Pantoprazole Sodium Delayed-Release Tablets. Delayed-Release Tablets Oral Swallowed whole, with or without food Take a missed dose as soon as possible.
If it is almost time for the next dose, skip the missed dose and take the next dose at the regular scheduled time. Do not take 2 doses at the same time. Pantoprazole Sodium Delayed-Release Tablets Swallow Pantoprazole Sodium Delayed-Release Tablets whole, with or without food in the stomach.
For patients unable to swallow a 40 mg tablet, two 20 mg tablets may be taken. Concomitant administration of antacids does not affect the absorption of Pantoprazole Sodium Delayed-Release Tablets.
💊 Dosage Forms and Strengths ▾
3 DOSAGE FORMS AND STRENGTHS Delayed-Release Tablets: 40 mg, white oval biconvex tablets debossed with "17" on one side 20 mg, white oval biconvex tablets imprinted in black ink with "KU" on one side and "180" on the other side Delayed-Release Tablets: 20 mg and 40 mg ( 3 )
⛔ Contraindications ▾
4 CONTRAINDICATIONS Pantoprazole is contraindicated in patients with known hypersensitivity to any component of the formulation or any substituted benzimidazole. Hypersensitivity reactions may include anaphylaxis, anaphylactic shock, angioedema, bronchospasm, acute interstitial nephritis, and urticaria [see Adverse Reactions ( 6 )]. Proton pump inhibitors (PPIs), including Pantoprazole, are contraindicated with patients receiving rilpivirine-containing products [see Drug Interactions ( 7 )].
Patients with known hypersensitivity to any component of the formulation or to substituted benzimidazoles ( 4 ) Patients receiving rilpivirine-containing products ( 4 , 7 )
⚠️ Warnings and Cautions ▾
5 WARNINGS AND PRECAUTIONS Gastric Malignancy: In adults, symptomatic response does not preclude presence of gastric malignancy. Consider additional follow-up and diagnostic testing. ( 5.1 ) Acute Interstitial Nephritis: Observed in patients taking PPIs.
( 5.2 ) Clostridium difficile- Associated Diarrhea: PPI therapy may be associated with increased risk of Clostridium difficile -associated diarrhea. ( 5.3 ) 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. ( 5.4 ) Cutaneous and Systemic Lupus Erythematosus: Mostly cutaneous; new onset or exacerbation of existing disease; discontinue Pantoprazole and refer to specialist for evaluation.
( 5.5 ) Cyanocobalamin (Vitamin B-12) Deficiency: Daily long-term use (e.g., longer than 3 years) may lead to malabsorption or a deficiency of cyanocobalamin. ( 5.6 ) Hypomagnesemia: Reported rarely with prolonged treatment with PPIs. ( 5.7 ) Fundic Gland Polyps: Risk increases with long-term use, especially beyond one year.
Use the shortest duration of therapy. ( 5.9 )
5.1Presence of Gastric Malignancy In adults, symptomatic response to therapy with Pantoprazole 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 PPI. In older patients, also consider an endoscopy.
5.2Acute Interstitial Nephritis Acute interstitial nephritis has been observed in patients taking PPIs including Pantoprazole. Acute interstitial nephritis may occur at any point during PPI therapy and is generally attributed to an idiopathic hypersensitivity reaction. Discontinue Pantoprazole if acute interstitial nephritis develops [see Contraindications ( 4 )].
5.3Clostridium difficile- Associated Diarrhea Published observational studies suggest that PPI therapy like Pantoprazole may be associated with an increased risk of Clostridium difficile associated diarrhea, especially in hospitalized patients. This diagnosis should be considered for diarrhea that does not improve [see Adverse Reactions ( 6.2 )]. Patients should use the lowest dose and shortest duration of PPI therapy appropriate to the condition being treated.
5.4Bone Fracture Several published observational studies suggest that PPI therapy may be associated with an increased risk for osteoporosis-related fractures of the hip, wrist, or spine. The risk of fracture was increased in patients who received high-dose, defined as multiple daily doses, and long-term PPI therapy (a year or longer). Patients should use the lowest dose and shortest duration of PPI therapy appropriate to the condition being treated.
Patients at risk for osteoporosis-related fractures should be managed according to established treatment guidelines [see Dosage and Administration ( 2 ), Adverse Reactions ( 6.2 )].
5.5Cutaneous and Systemic Lupus Erythematosus Cutaneous lupus erythematosus (CLE) and systemic lupus erythematosus (SLE) have been reported in patients taking PPIs, including pantoprazole sodium. These events have occurred as both new onset and an exacerbation of existing autoimmune disease. The majority of PPI-induced lupus erythematous cases were CLE.
The most common form of CLE reported in patients treated with PPIs was subacute CLE (SCLE) and occurred within weeks to years after continuous drug therapy in patients ranging from infants to the elderly. Generally, histological findings were observed without organ involvement. Systemic lupus erythematosus (SLE) is less commonly reported than CLE in patients receiving PPIs.
PPI associated SLE is usually milder than non-drug induced SLE. Onset of SLE typically occurred within days to years after initiating treatment primarily in patients ranging from young adults to the elderly. The majority of patients presented with rash; however, arthralgia and cytopenia were…
🤒 Adverse Reactions ▾
6 ADVERSE REACTIONS The following serious adverse reactions are described below and elsewhere in labeling: Acute Interstitial Nephritis [see Warnings and Precautions ( 5.2 )] Clostridium difficile- Associated Diarrhea [see Warnings and Precautions ( 5.3 )] Bone Fracture [see Warnings and Precautions ( 5.4 )] Cutaneous and Systemic Lupus Erythematosus [see Warnings and Precautions ( 5.5 )] Cyanocobalamin (Vitamin B-12) Deficiency [see Warnings and Precautions ( 5.6 )] Hypomagnesemia [see Warnings and Precautions ( 5.7 )] Fundic Gland Polyps [see Warnings and Precautions ( 5.9 )] Most common adverse reactions are: For adult use (>2%): headache, diarrhea, nausea, abdominal pain, vomiting, flatulence, dizziness, and arthralgia.
( 6.1 ) For pediatric use (>4%): URI, headache, fever, diarrhea, vomiting, rash, and abdominal pain. ( 6.1 ) To report SUSPECTED ADVERSE REACTIONS, contact AvKARE at 1-855-361-3993 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 clinical practice. Adults Safety in nine randomized comparative US clinical trials in patients with GERD included 1,473 patients on oral Pantoprazole (20 mg or 40 mg), 299 patients on an H 2 -receptor antagonist, 46 patients on another PPI, and 82 patients on placebo.
The most frequently occurring adverse reactions are listed in Table 3. Table 3: Adverse Reactions Reported in Clinical Trials of Adult Patients with GERD at a Frequency of > 2% Pantoprazole (n=1473) % Comparators (n=345) % Placebo (n=82) % Headache 12.2 12.8
8.5Diarrhea 8.8 9.6
4.9Nausea 7.0 5.2
9.8Abdominal pain 6.2 4.1
6.1Vomiting 4.3 3.5
2.4Flatulence 3.9 2.9
3.7Dizziness 3.0 2.9
1.2Arthralgia 2.8 1.4
1.2Additional adverse reactions that were reported for Pantoprazole in clinical trials with a frequency of ≤ 2% are listed below by body system: Body as a Whole: allergic reaction, pyrexia, photosensitivity reaction, facial edema Gastrointestinal: constipation, dry mouth, hepatitis Hematologic: leukopenia, thrombocytopenia Metabolic/Nutritional: elevated CK (creatine kinase), generalized edema, elevated triglycerides, liver enzymes elevated Musculoskeletal: myalgia Nervous: depression, vertigo Skin and Appendages: urticaria, rash, pruritus Special Senses: blurred vision Pediatric Patients Safety of Pantoprazole in the treatment of EE associated with GERD was evaluated in pediatric patients ages 1 year through 16 years in three clinical trials.
Safety trials involved pediatric patients with EE; however, as EE is uncommon in the pediatric population, 249 pediatric patients with endoscopically-proven or symptomatic GERD were also evaluated. All adult adverse reactions to Pantoprazole are considered relevant to pediatric patients. In patients ages 1 year through 16 years, the most commonly reported (> 4%) adverse reactions include: URI, headache, fever, diarrhea, vomiting, rash, and abdominal pain.
For safety information in patients less than 1 year of age see Use in Specific Populations ( 8.4 ) . Additional adverse reactions that were reported for Pantoprazole in pediatric patients in clinical trials with a frequency of ≤ 4% are listed below by body system: Body as a Whole: allergic reaction, facial edema Gastrointestinal: constipation, flatulence, nausea Metabolic/Nutritional: elevated triglycerides, elevated liver enzymes, elevated CK (creatine kinase) Musculoskeletal: arthralgia, myalgia Nervous: dizziness, vertigo Skin and Appendages: urticaria The following adverse reactions seen in adults in clinical trials were not reported in pediatric patients in clinical trials, but are considered relevant to pediatric patients: photosensitivity reaction, dry mouth, hepatitis, thrombocytopenia, generalized edema, depression, pruritus, leu…
🔄 Drug Interactions ▾
7 DRUG INTERACTIONS Table 4 includes drugs with clinically important drug interactions and interaction with diagnostics when administered concomitantly with Pantoprazole and instructions for preventing or managing them. Consult the labeling of concomitantly used drugs to obtain further information about interactions with PPIs. Table 4: Clinically Relevant Interactions Affecting Drugs Co-Administered with Pantoprazole and Interactions 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 Pantoprazole may reduce antiviral effect and promote the development of drug resistance. Increased exposure of other antiretroviral drugs (e.g., saquinavir) when used concomitantly with Pantoprazole may increase toxicity of the antiretroviral drugs .
There are other antiretroviral drugs which do not result in clinically relevant interactions with pantoprazole sodium. Intervention: Rilpivirine-containing products: Concomitant use with Pantoprazole is contraindicated [see Contraindications ( 4 )]. See prescribing information.
Atazanavir: See prescribing information for atazanavir for dosing information. Nelfinavir: Avoid concomitant use with Pantoprazole. See prescribing information for nelfinavir.
Saquinavir: See the prescribing information for saquinavir and monitor for potential saquinavir toxicities. Other antiretrovirals: See prescribing information. Warfarin Clinical Impact: Increased INR and prothrombin time in patients receiving PPIs, including pantoprazole, and warfarin concomitantly.
Increases in INR and prothrombin time may lead to abnormal bleeding and even death. Intervention: Monitor INR and prothrombin time. Dose adjustment of warfarin may be needed to maintain target INR range.
See prescribing information for warfarin. Clopidogrel Clinical Impact: Concomitant administration of pantoprazole and clopidogrel in healthy subjects had no clinically important effect on exposure to the active metabolite of clopidogrel or clopidorgrel-induced platelet inhibition [see Clinical Pharmacology ( 12.3 )]. Intervention: No dose adjustment of clopidogrel is necessary when administered with an approved does of Pantoprazole.
Methotrexate Clinical Impact: Concomitant use of PPIs 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 ( 5.12 )]. Intervention: A temporary withdrawal of Pantoprazole may be considered in some patients receiving high-dose methotrexate.
Drugs Dependent on Gastric pH for Absorption (e.g., iron salts, erlotinib, dasatinib, nilotinib, mycophenolate mofetil, ketoconazole/itraconazole) Clinical Impact: Pantoprazole can reduce the absorption of other drugs due to its effect on reducing intragastric acidity. Intervention: Mycophenolate mofetil (MMF): Co-administration of pantoprazole sodium in healthy subjects and in transplant patients receiving MMF has been reported to reduce the exposure to the active metabolite, mycophenolic acid (MPA), possibly due to a decrease in MMF solubility at an increased gastric pH [see Clinical Pharmacology ( 12.3 )].
The clinical relevance of reduced MPA exposure on organ rejection has not been established in transplant patients receiving Pantoprazole and MMF. Use Pantoprazole with caution in transplant patients receiving MMF. See the prescribing information for other drugs dependent on gastric pH for absorption.
Interactions with Investigation of Neuroendocrine Tumors Clinical Impact: CgA levels increase secondary PPI-induced decreases in gastric acidity. The increased CgA level may…
👥 Use in Specific Populations ▾
8 USE IN SPECIFIC POPULATIONS Pregnancy: Based on animal data, may cause fetal harm. ( 8.1 )
8.2Lactation Risk Summary Pantoprazole has been detected in breast milk of a nursing mother after a single 40 mg oral dose of pantoprazole. There were no effects on the breastfed infant (see Data). There are no data on pantoprazole effects on milk production.
The developmental and health benefits of breastfeeding should be considered along with the mother’s clinical need for Pantoprazole and any potential adverse effects on the breastfed child from pantoprazole or from the underlying maternal condition. Data The breast milk of a 42-year-old woman receiving 40 mg of oral pantoprazole, at 10 months postpartum, was studied for 24 hours, to demonstrate low levels of pantoprazole present in the breast milk. Pantoprazole was detectable in milk only 2 and 4 hours after the dose with milk levels of approximately 36 mcg/L and 24 mcg/L, respectively.
A milk-to-plasma ratio of 0.022 was observed at 2 hours after drug administration. Pantoprazole was not detectable (<10 mcg/L) in milk at 6, 8 and 24 hours after the dose. The relative dose to the infant was estimated to be 7.3 mcg of pantoprazole, which is equivalent to 0.14% of the weight-adjusted maternal dose.
No adverse events in the infant were reported by the mother.
8.3Nursing Mothers Pantoprazole and its metabolites are excreted in the milk of rats. Pantoprazole excretion in human milk has been detected in a study of a single nursing mother after a single 40 mg oral dose of pantoprazole sodium. The clinical relevance of this finding is not known.
Many drugs which are excreted in human milk have a potential for serious adverse reactions in nursing infants. Based on the potential for tumorigenicity shown for pantoprazole sodium in rodent carcinogenicity studies, a decision should be made whether to discontinue nursing or to discontinue the drug, taking into account the benefit of the drug to the mother.
8.4Pediatric Use The safety and effectiveness of Pantoprazole for short-term treatment (up to eight weeks) of EE associated with GERD have been established in pediatric patients 1 year through 16 years of age. Effectiveness for EE has not been demonstrated in patients less than 1 year of age. In addition, for patients less than 5 years of age, there is no appropriate dosage strength in an age-appropriate formulation available.
Therefore, Pantoprazole is indicated for the short-term treatment of EE associated with GERD for patients 5 years and older. The safety and effectiveness of Pantoprazole for pediatric uses other than EE have not been established. 1 year through 16 years of age Use of Pantoprazole in pediatric patients 1 year through 16 years of age for short-term treatment (up to eight weeks) of EE associated with GERD is supported by: a) extrapolation of results from adequate and well-controlled studies that supported the approval of Pantoprazole for treatment of EE associated with GERD in adults, and b) safety, effectiveness, and pharmacokinetic studies performed in pediatric patients [see Clinical Studies ( 14.1 ), Clinical Pharmacology ( 12.3 )].
Safety of Pantoprazole in the treatment of EE associated with GERD in pediatric patients 1 through 16 years of age was evaluated in three multicenter, randomized, double-blind, parallel-treatment studies, involving 249 pediatric patients, including 8 with EE (4 patients ages 1 year to 5 years and 4 patients 5 years to 11 years). The children ages 1 year to 5 years with endoscopically diagnosed EE (defined as an endoscopic Hetzel-Dent score ≥ 2) were treated once daily for 8 weeks with one of two dose levels of Pantoprazole (approximating 0.6 mg/kg or 1.2 mg/kg).
All 4 of these patients with EE were healed (Hetzel-Dent score of 0 or 1) at 8 weeks. Because EE is uncommon in the pediatric population, predominantly pediatric patients with endoscopically-proven or symptomatic GERD were also included in these studies. Patients were treated with…
🤰 Pregnancy ▾
8.1 Pregnancy
🧒 Pediatric Use ▾
8.4Pediatric Use The safety and effectiveness of Pantoprazole for short-term treatment (up to eight weeks) of EE associated with GERD have been established in pediatric patients 1 year through 16 years of age. Effectiveness for EE has not been demonstrated in patients less than 1 year of age. In addition, for patients less than 5 years of age, there is no appropriate dosage strength in an age-appropriate formulation available.
Therefore, Pantoprazole is indicated for the short-term treatment of EE associated with GERD for patients 5 years and older. The safety and effectiveness of Pantoprazole for pediatric uses other than EE have not been established. 1 year through 16 years of age Use of Pantoprazole in pediatric patients 1 year through 16 years of age for short-term treatment (up to eight weeks) of EE associated with GERD is supported by: a) extrapolation of results from adequate and well-controlled studies that supported the approval of Pantoprazole for treatment of EE associated with GERD in adults, and b) safety, effectiveness, and pharmacokinetic studies performed in pediatric patients [see Clinical Studies ( 14.1 ), Clinical Pharmacology ( 12.3 )].
Safety of Pantoprazole in the treatment of EE associated with GERD in pediatric patients 1 through 16 years of age was evaluated in three multicenter, randomized, double-blind, parallel-treatment studies, involving 249 pediatric patients, including 8 with EE (4 patients ages 1 year to 5 years and 4 patients 5 years to 11 years). The children ages 1 year to 5 years with endoscopically diagnosed EE (defined as an endoscopic Hetzel-Dent score ≥ 2) were treated once daily for 8 weeks with one of two dose levels of Pantoprazole (approximating 0.6 mg/kg or 1.2 mg/kg).
All 4 of these patients with EE were healed (Hetzel-Dent score of 0 or 1) at 8 weeks. Because EE is uncommon in the pediatric population, predominantly pediatric patients with endoscopically-proven or symptomatic GERD were also included in these studies. Patients were treated with a range of doses of Pantoprazole once daily for 8 weeks.
For safety findings see Adverse Reactions ( 6.1 ) . Because these pediatric trials had no placebo, active comparator, or evidence of a dose response, the trials were inconclusive regarding the clinical benefit of Pantoprazole for symptomatic GERD in the pediatric population. The effectiveness of Pantoprazole for treating symptomatic GERD in pediatric patients has not been established.
Although the data from the clinical trials support use of Pantoprazole for the short-term treatment of EE associated with GERD in pediatric patients 1 year through 5 years, there is no commercially available dosage formulation appropriate for patients less than 5 years of age [see Dosage and Administration ( 2 )]. In a population pharmacokinetic analysis, clearance values in the children 1 to 5 years old with endoscopically proven GERD had a median value of
2.4L/h. Following a 1.2 mg/kg equivalent dose (15 mg for ≤ 12.5 kg and 20 mg for > 12.5 to < 25 kg), the plasma concentrations of pantoprazole were highly variable and the median time to peak plasma concentration was 3 to 6 hours. The estimated AUC for patients 1 to 5 years old was 37% higher than for adults receiving a single 40 mg tablet, with a geometric mean AUC value of 6.8 mcg•hr/mL.
Neonates to less than one year of age Pantoprazole was not found to be effective in a multicenter, randomized, double-blind, placebo-controlled, treatment-withdrawal study of 129 pediatric patients 1 through 11 months of age. Patients were enrolled if they had symptomatic GERD based on medical history and had not responded to non-pharmacologic interventions for GERD for two weeks. Patients received Pantoprazole daily for four weeks in an open-label phase, then patients were randomized in equal proportion to receive Pantoprazole treatment or placebo for the subsequent four weeks in a double-blind manner.
Efficacy was assessed by observing the time from randomizatio…
🧓 Geriatric Use ▾
8.5Geriatric Use In short-term US clinical trials, EE healing rates in the 107 elderly patients (≥ 65 years old) treated with Pantoprazole were similar to those found in patients under the age of 65. The incidence rates of adverse reactions and laboratory abnormalities in patients aged 65 years and older were similar to those associated with patients younger than 65 years of age.
🆘 Overdosage ▾
10 OVERDOSAGE Experience in patients taking very high doses of Pantoprazole (greater than 240 mg) is limited. Spontaneous post-marketing reports of overdose are generally within the known safety profile of Pantoprazole. Pantoprazole is not removed by hemodialysis.
In case of overdosage, treatment should be symptomatic and supportive. Single oral doses of pantoprazole at 709 mg/kg, 798 mg/kg, and 887 mg/kg were lethal to mice, rats, and dogs, respectively. The symptoms of acute toxicity were hypoactivity, ataxia, hunched sitting, limb-splay, lateral position, segregation, absence of ear reflex, and tremor.
If overexposure to Pantoprazole occurs, call your Poison Control Center at 1-800-222-1222 for current information on the management of poisoning or overdosage.
🧬 Clinical Pharmacology ▾
12 CLINICAL PHARMACOLOGY
12.1Mechanism of Action Pantoprazole is a PPI that suppresses the final step in gastric acid production by covalently binding to the (H + , K + )-ATPase enzyme system at the secretory surface of the gastric parietal cell. This effect leads to inhibition of both basal and stimulated gastric acid secretion, irrespective of the stimulus. The binding to the (H + , K + )-ATPase results in a duration of antisecretory effect that persists longer than 24 hours for all doses tested (20 mg to 120 mg).
12.2Pharmacodynamics Antisecretory Activity Under maximal acid stimulatory conditions using pentagastrin, a dose-dependent decrease in gastric acid output occurs after a single dose of oral (20-80 mg) pantoprazole in healthy subjects. Pantoprazole given once daily results in increasing inhibition of gastric acid secretion. Following the initial oral dose of 40 mg pantoprazole, a 51% mean inhibition was achieved by 2.5 hours.
With once-a-day dosing for 7 days, the mean inhibition was increased to 85%. Pantoprazole suppressed acid secretion in excess of 95% in half of the subjects. Acid secretion had returned to normal within a week after the last dose of pantoprazole; there was no evidence of rebound hypersecretion.
In a series of dose-response studies, pantoprazole, at oral doses ranging from 20 to 120 mg, caused dose-related increases in median basal gastric pH and in the percent of time gastric pH was > 3 and > 4. Treatment with 40 mg of pantoprazole produced significantly greater increases in gastric pH than the 20 mg dose. Doses higher than 40 mg (60, 80, 120 mg) did not result in further significant increases in median gastric pH.
The effects of pantoprazole on median pH from one double-blind crossover study are shown in Table 5. Table 5: Effect of Single Daily Doses of Oral Pantoprazole on Intragastric pH Median pH on day 7 Time Placebo 20 mg 40 mg 80 mg 8 a.m. - 8 a.m. (24 hours) 1.3
2.9 Significantly different from placebo
3.8Significantly different from 20 mg 3.9 8 a.m. - 10 p.m. (Daytime) 1.6 3.2 4.4 4.8 10 p.m. - 8 a.m. (Nighttime) 1.2 2.1 3.0
2.6Serum Gastrin Effects Fasting serum gastrin levels were assessed in two double-blind studies of the acute healing of EE in which 682 patients with gastroesophageal reflux disease (GERD) received 10, 20, or 40 mg of Pantoprazole for up to 8 weeks. At 4 weeks of treatment there was an increase in mean gastrin levels of 7%, 35%, and 72% over pretreatment values in the 10, 20, and 40 mg treatment groups, respectively. A similar increase in serum gastrin levels was noted at the 8-week visit with mean increases of 3%, 26%, and 84% for the three pantoprazole dose groups.
Median serum gastrin levels remained within normal limits during maintenance therapy with Pantoprazole Sodium Delayed-Release Tablets. In long-term international studies involving over 800 patients, a 2- to 3-fold mean increase from the pretreatment fasting serum gastrin level was observed in the initial months of treatment with pantoprazole at doses of 40 mg per day during GERD maintenance studies and 40 mg or higher per day in patients with refractory GERD. Fasting serum gastrin levels generally remained at approximately 2 to 3 times baseline for up to 4 years of periodic follow-up in clinical trials.
Following short-term treatment with Pantoprazole, elevated gastrin levels return to normal by at least 3 months. Enterochromaffin-Like (ECL) Cell Effects In 39 patients treated with oral pantoprazole 40 mg to 240 mg daily (majority receiving 40 mg to 80 mg) for up to 5 years, there was a moderate increase in ECL-cell density, starting after the first year of use, which appeared to plateau after 4 years. In a nonclinical study in Sprague-Dawley rats, lifetime exposure (24 months) to pantoprazole at doses of 0.5 to 200 mg/kg/day resulted in dose-related increases in gastric ECL cell proliferation and gastric neuroendocrine (NE)-cell tumors.
Gastric NE-cell tumors in rats may result from chronic elevat…
🧬 Mechanism of Action ▾
12.1Mechanism of Action Pantoprazole is a PPI that suppresses the final step in gastric acid production by covalently binding to the (H + , K + )-ATPase enzyme system at the secretory surface of the gastric parietal cell. This effect leads to inhibition of both basal and stimulated gastric acid secretion, irrespective of the stimulus. The binding to the (H + , K + )-ATPase results in a duration of antisecretory effect that persists longer than 24 hours for all doses tested (20 mg to 120 mg).
📦 How Supplied / Storage and Handling ▾
16 HOW SUPPLIED/STORAGE AND HANDLING How Supplied Pantoprazole Sodium Delayed-Release Tablets, USP are supplied as 40 mg white, oval biconvex delayed-release tablets debossed with "17" on one side and are available as follows: NDC 50268-639-15 (10 tablets per card, 5 cards per carton) Pantoprazole Sodium Delayed-Release Tablets, USP are supplied as 20 mg white, oval biconvex delayed-release tablets imprinted in black ink with "KU" on one side and "180" on the other side and are available as follows: NDC 50268-639-15 (10 tablets per card, 5 cards per carton) Dispensed in Unit Dose Package.
For Institutional Use Only. Storage Store Pantoprazole Sodium Delayed-Release Tablets, USP 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].
📦 Storage and Handling ▾
Storage Store Pantoprazole Sodium Delayed-Release Tablets, USP 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].
📋 Description ▾
11 DESCRIPTION The active ingredient in Pantoprazole Sodium Delayed-Release Tablets, USP is a substituted benzimidazole, sodium 5-(difluoromethoxy)-2-[[(3,4-dimethoxy-2-pyridinyl)methyl] sulfinyl]-1 H -benzimidazole sesquihydrate, a compound that inhibits gastric acid secretion. Its empirical formula is C 16 H 14 F 2 N 3 NaO 4 S ×
1.5H 2 O, with a molecular weight of 432.4. The structural formula is: Pantoprazole sodium sesquihydrate is a white to off-white crystalline powder and is racemic. Pantoprazole has weakly basic and acidic properties.
Pantoprazole sodium sesquihydrate is freely soluble in water, very slightly soluble in phosphate buffer at pH 7.4, and practically insoluble in n-hexane. The stability of the compound in aqueous solution is pH-dependent. The rate of degradation increases with decreasing pH.
At ambient temperature, the degradation half-life is approximately 2.8 hours at pH 5 and approximately 220 hours at pH 7.8. Pantoprazole is supplied as a delayed-release tablet, available in two strengths (20 mg and 40 mg). Each Pantoprazole Sodium Delayed-Release Tablet contains 45.1 mg or 22.55 mg of pantoprazole sodium sesquihydrate (equivalent to 40 mg or 20 mg pantoprazole, respectively) with the following inactive ingredients: crospovidone, glyceryl dibehenate, hypromellose, lactose monohydrate, methacrylic acid copolymer dispersion, talc, titanium dioxide, and triethyl citrate.
The 20 mg tablet also contains black iron oxide, isopropyl alcohol, and propylene glycol. Pantoprazole Sodium Delayed-Release Tablets (40 mg and 20 mg) complies with USP dissolution test 4. Chemical Structure
💬 Information for Patients ▾
17 PATIENT COUNSELING INFORMATION Advise the patient to read the FDA-approved patient labeling (Medication Guide). Gastric Malignancy Advise patients to return to their healthcare provider if they have a suboptimal response or an early symptomatic relapse [see Warnings and Precautions ( 5.1 )]. Acute Interstitial Nephritis Advise patients to call their healthcare provider immediately if they experience signs and/or symptoms associated with acute interstitial nephritis [see Warnings and Precautions ( 5.2 )].
Clostridium difficile -Associated Diarrhea Advise patients to immediately call their healthcare provider if they experience diarrhea that does not improve [see Warnings and Precautions ( 5.3 )]. Bone Fracture Advise patients to report any fractures, especially of the hip, wrist or spine, to their healthcare provider [see Warnings and Precautions ( 5.4 )]. Cutaneous and Systemic Lupus Erythematosus Advise patients to immediately call their healthcare provider for any new or worsening of symptoms associated with cutaneous or systemic lupus erythematosus [see Warnings and Precautions ( 5.5 )].
Cyanocobalamin (Vitamin B-12) Deficiency Advise patients to report any clinical symptoms that may be associated with cyancobalamin deficiency to their healthcare provider if they have been receiving Pantoprazole for longer than 3 years [see Warnings and Precautions ( 5.6 )]. Hypomagnesemia Advise patients to report any clinical symptoms that may be associated with hypomagnesemia to their healthcare provider, if they have been receiving Pantoprazole for at least 3 months [see Warnings and Precautions ( 5.7 )]. Drug Interactions Instruct patients to inform their healthcare provider of any other medications they are currently taking, including rilpivirine-containing products [see Contraindications ( 4 )] digoxin [see Warnings and Precautions ( 5.7 )] and high dose methotrexate [see Warnings and Precautions ( 5.12 )] .
Pregnancy Advise a pregnant woman of the potential risk to a fetus. Advise females of reproductive potential to inform their healthcare provider of a known or suspected pregnancy [see Use in Specific Populations ( 8.1 )]. Administration Do not split, crush, or chew Pantoprazole Sodium Delayed-Release Tablets.
Swallow Pantoprazole Sodium Delayed-Release Tablets whole, with or without food in the stomach. Concomitant administration of antacids does not affect the absorption of Pantoprazole Sodium Delayed-Release Tablets. Take a missed dose as soon as possible.
If it is almost time for the next dose, skip the missed dose and take the next dose at the regular scheduled time. Do not take 2 doses at the same time. This product’s label may have been updated.
For current full prescribing information, call 1-855-361-3993. Manufactured for: AvKARE Pulaski, TN 38478 Mfg. Rev.
05/19 AV Rev. 01/20 (P) AvPAK
💬 Medication Guide ▾
MEDICATION GUIDE Pantoprazole (pan-TOE-pruh-zole) Sodium Delayed-Release Tablets, USP What is the most important information I should know about Pantoprazole? You should take Pantoprazole exactly as prescribed, at the lowest dose possible and for the shortest time needed. Pantoprazole may help your acid-related symptoms, but you could still have serious stomach problems.
Talk with your doctor. Pantoprazole can cause serious side effects, including: A type of kidney problem (acute interstitial nephritis) . Some people who take proton pump inhibitor (PPI) medicines, including Pantoprazole, may develop a kidney problem called acute interstitial nephritis that can happen at any time during treatment with Pantoprazole.
Call your doctor right away if you have a decrease in the amount that you urinate or if you have blood in your urine. 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 for a long period of time (a year or longer).
Tell your doctor if you have a 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 Pantoprazole, 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.
Pantoprazole can have other serious side effects. See “ What are the possible side effects of Pantoprazole?” What is Pantoprazole? A prescription medicine called a proton pump inhibitor (PPI) used to reduce the amount of acid in your stomach.
In adults, Pantoprazole is used for: 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 8 weeks of Pantoprazole 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 Pantoprazole is safe and effective when used longer than 12 months for this purpose. the long-term treatment of conditions where your stomach makes too much acid.
This includes a rare condition called Zollinger-Ellison Syndrome. In children 5 years of age and older, Pantoprazole is used for: up to 8 weeks for the healing and symptom relief of EE. It is not known if Pantoprazole is safe if used longer than 8 weeks in children.
Pantoprazole is not for use in children under 5 years of age. It is not known if Pantoprazole is safe and effective in children for treatement other than EE. Do not take Pantoprazole if you are: allergic to pantoprazole sodium or any of the other PPI medicine, or any of the ingredients in Pantoprazole.
See the end of this Medication Guide for a complete list of ingredients in Pantoprazole. are taking a medicine that contains rilpivirine (EDURANT, COMPLERA, ODEFSEY) used to treat HIV-1 (Human Immunodeficiency Virus). Before taking Pantoprazole, tell your doctor about all of your medical conditions, including if you: have low magnesium levels in your blood. are pregnant or plan to become pregnant. Pantoprazole may harm your unborn baby.
Tell your doctor if you become pregnant or think you may be pregnant during treatment with Pantoprazole. are breastfeeding or plan to breastfeed. Pantoprazole can pass into your breast milk. You and your doctor should decide if you will take Pantoprazole or breastfeed.
You should not do both. Talk with your doctor about the best way to feed your baby if you tak…