NDC 50268-585 Pantoprazole Sodium

Pantoprazole Sodium

NDC Product Code 50268-585

NDC CODE: 50268-585

Proprietary Name: Pantoprazole Sodium What is the Proprietary Name?
The proprietary name also known as the trade name is the name of the product chosen by the medication labeler for marketing purposes.

Non-Proprietary Name: Pantoprazole Sodium What is the Non-Proprietary Name?
The non-proprietary name is sometimes called the generic name. The generic name usually includes the active ingredient(s) of the product.

Drug Use Information

Drug Use Information
The drug use information is a summary and does NOT have all possible information about this product. This information does not assure that this product is safe, effective, or appropriate. This information is not individual medical advice and does not substitute for the advice of a health care professional. Always ask a health care professional for complete information about this product and your specific health needs.

  • Pantoprazole is used to treat certain stomach and esophagus problems (such as acid reflux). It works by decreasing the amount of acid your stomach makes. This medication relieves symptoms such as heartburn, difficulty swallowing, and persistent cough. It helps heal acid damage to the stomach and esophagus, helps prevent ulcers, and may help prevent cancer of the esophagus. Pantoprazole belongs to a class of drugs known as proton pump inhibitors (PPIs).

Product Characteristics

Color(s):
WHITE (C48325)
Shape: OVAL (C48345)
Size(s):
9 MM
Imprint(s):
18
Score: 1

NDC Code Structure

  • 50268 - Avpak

NDC 50268-585-15

Package Description: 50 BLISTER PACK in 1 BOX > 1 TABLET, DELAYED RELEASE in 1 BLISTER PACK (50268-585-11)

NDC Product Information

Pantoprazole Sodium with NDC 50268-585 is a a human prescription drug product labeled by Avpak. The generic name of Pantoprazole Sodium is pantoprazole sodium. The product's dosage form is tablet, delayed release and is administered via oral form.

Labeler Name: Avpak

Dosage Form: Tablet, Delayed Release - A solid dosage form which releases a drug (or drugs) at a time other than promptly after administration. Enteric-coated articles are delayed release dosage forms.

Product Type: Human Prescription Drug What kind of product is this?
Indicates the type of product, such as Human Prescription Drug or Human Over the Counter Drug. This data element matches the “Document Type” field of the Structured Product Listing.

Pantoprazole Sodium Active Ingredient(s)

What is the Active Ingredient(s) List?
This is the active ingredient list. Each ingredient name is the preferred term of the UNII code submitted.

  • PANTOPRAZOLE SODIUM 20 mg/1

Inactive Ingredient(s)

About the Inactive Ingredient(s)
The inactive ingredients are all the component of a medicinal product OTHER than the active ingredient(s). The acronym "UNII" stands for “Unique Ingredient Identifier” and is used to identify each inactive ingredient present in a product.

  • CROSPOVIDONE (UNII: 2S7830E561)
  • GLYCERYL DIBEHENATE (UNII: R8WTH25YS2)
  • HYPROMELLOSE, UNSPECIFIED (UNII: 3NXW29V3WO)
  • LACTOSE MONOHYDRATE (UNII: EWQ57Q8I5X)
  • TALC (UNII: 7SEV7J4R1U)
  • TITANIUM DIOXIDE (UNII: 15FIX9V2JP)
  • TRIETHYL CITRATE (UNII: 8Z96QXD6UM)
  • METHACRYLIC ACID - METHYL METHACRYLATE COPOLYMER (1:1) (UNII: 74G4R6TH13)
  • FERROSOFERRIC OXIDE (UNII: XM0M87F357)
  • ISOPROPYL ALCOHOL (UNII: ND2M416302)
  • PROPYLENE GLYCOL (UNII: 6DC9Q167V3)

Administration Route(s)

What are the Administration Route(s)?
The translation of the route code submitted by the firm, indicating route of administration.

  • Oral - Administration to or by way of the mouth.

Pharmacological Class(es)

What is a Pharmacological Class?
These are the reported pharmacological class categories corresponding to the SubstanceNames listed above.

  • Proton Pump Inhibitor - [EPC] (Established Pharmacologic Class)
  • Proton Pump Inhibitors - [MoA] (Mechanism of Action)

Product Labeler Information

What is the Labeler Name?
Name of Company corresponding to the labeler code segment of the Product NDC.

Labeler Name: Avpak
Labeler Code: 50268
FDA Application Number: ANDA078281 What is the FDA Application Number?
This corresponds to the NDA, ANDA, or BLA number reported by the labeler for products which have the corresponding Marketing Category designated. If the designated Marketing Category is OTC Monograph Final or OTC Monograph Not Final, then the Application number will be the CFR citation corresponding to the appropriate Monograph (e.g. “part 341”). For unapproved drugs, this field will be null.

Marketing Category: ANDA - A product marketed under an approved Abbreviated New Drug Application. What is the Marketing Category?
Product types are broken down into several potential Marketing Categories, such as NDA/ANDA/BLA, OTC Monograph, or Unapproved Drug. One and only one Marketing Category may be chosen for a product, not all marketing categories are available to all product types. Currently, only final marketed product categories are included. The complete list of codes and translations can be found at www.fda.gov/edrls under Structured Product Labeling Resources.

Start Marketing Date: 01-28-2021 What is the Start Marketing Date?
This is the date that the labeler indicates was the start of its marketing of the drug product.

Listing Expiration Date: 12-31-2022 What is the Listing Expiration Date?
This is the date when the listing record will expire if not updated or certified by the product labeler.

Exclude Flag: N What is the NDC Exclude Flag?
This field indicates whether the product has been removed/excluded from the NDC Directory for failure to respond to FDA’s requests for correction to deficient or non-compliant submissions. Values = ‘Y’ or ‘N’.

* Please review the disclaimer below.

Pantoprazole Sodium Product Labeling Information

The product labeling information includes all published material associated to a drug. Product labeling documents include information like generic names, active ingredients, ingredient strength dosage, routes of administration, appearance, usage, warnings, inactive ingredients, etc.

Product Labeling Index

1 Indications And Usage

Pantoprazole Sodium Delayed-Release Tablets, USP are indicated for:

1.1 Short-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.

1.2 Maintenance 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.

1.3 Pathological Hypersecretory Conditions Including Zollinger-Ellison (Ze) Syndrome

Pantoprazole is indicated for the long-term treatment of pathological hypersecretory conditions, including Zollinger-Ellison (ZE) Syndrome.

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.

2.2 Administration 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

3 Dosage Forms And Strengths

  • Delayed-Release Tablets:40 mg, white to off-white, oval-shaped coated tablet, debossed with “17” on one side20 mg, white to off-white, oval-shaped coated tablet, imprinted in black with “18” on one side

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 tubulointerstitial nephritis, and urticaria
  • [see Warnings and Precautions (
  • 5.2),
  • Adverse Reactions (
  • 6)]
  • .
  • Proton pump inhibitors (PPIs), including Pantoprazole, are contraindicated in patients receiving rilpivirine-containing products
  • [see Drug Interactions (
  • 7)]
  • .

5.1 Presence 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.

5.2 Acute Tubulointerstitial Nephritis

Acute tubulointerstitial nephritis (TIN) has been observed in patients taking PPIs and may occur at any point during PPI therapy. Patients may present with varying signs and symptoms from symptomatic hypersensitivity reactions to non-specific symptoms of decreased renal function (e.g., malaise, nausea, anorexia). In reported case series, some patients were diagnosed on biopsy and in the absence of extra-renal manifestations (e.g., fever, rash or arthralgia). Discontinue Pantoprazole and evaluate patients with suspected acute TIN 


[see Contraindications (


4)]


.

5.3 Clostridium 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.

5.4 Bone 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)]


.

5.5 Cutaneous 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 also reported. Avoid administration of PPIs for longer than medically indicated. If signs or symptoms consistent with CLE or SLE are noted in patients receiving Pantoprazole, discontinue the drug and refer the patient to the appropriate specialist for evaluation. Most patients improve with discontinuation of the PPI alone in 4 to 12 weeks. Serological testing (e.g. ANA) may be positive and elevated serological test results may take longer to resolve than clinical manifestations.

5.6 Cyanocobalamin (Vitamin B-12) Deficiency

Generally, daily treatment with any acid-suppressing medications over a long period of time (e.g., longer than 3 years) may lead to malabsorption of cyanocobalamin (Vitamin B-12) caused by hypo- or achlorhydria. Rare reports of cyanocobalamin deficiency occurring with acid-suppressing therapy have been reported in the literature. This diagnosis should be considered if clinical symptoms consistent with cyanocobalamin deficiency are observed.

5.7 Hypomagnesemia

Hypomagnesemia, symptomatic and asymptomatic, has been reported rarely in patients treated with PPIs for at least three months, in most cases after a year of therapy. Serious adverse events include tetany, arrhythmias, and seizures. In most patients, treatment of hypomagnesemia required magnesium replacement and discontinuation of the PPI.For patients expected to be on prolonged treatment or who take PPIs with medications such as digoxin or drugs that may cause hypomagnesemia (e.g., diuretics), health care professionals may consider monitoring magnesium levels prior to initiation of PPI treatment and periodically


[see Adverse Reactions (


6.2)]


.

5.8 Tumorigenicity

Due to the chronic nature of GERD, there may be a potential for prolonged administration of Pantoprazole. In long-term rodent studies, pantoprazole was carcinogenic and caused rare types of gastrointestinal tumors. The relevance of these findings to tumor development in humans is unknown


[see Nonclinical Toxicology (


13.1)]


.

5.9 Fundic Gland Polyps

PPI use is associated with an increased risk of fundic gland polyps that increases with long-term use, especially beyond one year. Most PPI users who developed fundic gland polyps were asymptomatic and fundic gland polyps were identified incidentally on endoscopy. Use the shortest duration of PPI therapy appropriate to the condition being treated.

5.10 Interference With Investigations For Neuroendocrine Tumors

Serum chromogranin A (CgA) levels increase secondary to drug-induced decreases in gastric acidity. The increased CgA level may cause false positive results in diagnostic investigations for neuroendocrine tumors. Healthcare providers should temporarily stop Pantoprazole treatment at least 14 days before assessing CgA levels and consider repeating the test if initial CgA levels are high. If serial tests are performed (e.g. for monitoring), the same commercial laboratory should be used for testing, as reference ranges between tests may vary


[see Clinical Pharmacology (


12.2)]


.

5.11 Interference With Urine Screen For Thc

There have been reports of false-positive urine screening tests for tetrahydrocannabinol (THC) in patients receiving PPIs, including Pantoprazole


[see Drug Interactions (


7)]


.

5.12 Concomitant Use Of Pantoprazole With Methotrexate

Literature suggests that concomitant use of PPIs with methotrexate (primarily at high dose; see methotrexate prescribing information) may elevate and prolong serum levels of methotrexate and/or its metabolite, possibly leading to methotrexate toxicities. In high-dose methotrexate administration, a temporary withdrawal of the PPI may be considered in some patients


[see Drug Interactions (


7)]


.

6 Adverse Reactions

  • The following serious adverse reactions are described below and elsewhere in labeling:Acute Tubulointerstitial Nephritis
  • [see Warnings and Precautions (
  • 5.2)]
  • Clostridium difficile-Associated Diarrhea
  • [see Warnings and Precautions (
  • 5.3)]
  • 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)]

6.1 Clinical 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)


%


Headache12.212.88.5Diarrhea8.89.64.9Nausea7.05.29.8Abdominal pain6.24.16.1Vomiting4.33.52.4Flatulence3.92.93.7Dizziness3.02.91.2Arthralgia2.81.41.2Additional 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, leukopenia, and blurred vision.Zollinger-Ellison (ZE) SyndromeIn clinical studies of ZE Syndrome, adverse reactions reported in 35 patients taking Pantoprazole 80 mg/day to 240 mg/day for up to 2 years were similar to those reported in adult patients with GERD.

6.2 Postmarketing Experience

The following adverse reactions have been identified during postapproval use of Pantoprazole. Because these reactions are reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or establish a causal relationship to drug exposure.These adverse reactions are listed below by body system:Gastrointestinal Disorders: fundic gland polyps
General Disorders and Administration Conditions: asthenia, fatigue, malaise
Hematologic: pancytopenia, agranulocytosis
Hepatobiliary Disorders: hepatocellular damage leading to jaundice and hepatic failure
Immune System Disorders: anaphylaxis (including anaphylactic shock), systemic lupus erythematosus
Infections and Infestations: Clostridium difficile associated diarrhea
Investigations: weight changes
Metabolism and Nutritional Disorders: hyponatremia, hypomagnesemia
Musculoskeletal Disorders: rhabdomyolysis, bone fracture
Nervous: ageusia, dysgeusia
Psychiatric Disorders: hallucination, confusion, insomnia, somnolence
Renal and Urinary Disorders: acute tubulointerstitial nephritis
Skin and Subcutaneous Tissue Disorders: severe dermatologic reactions (some fatal), including erythema multiforme, Stevens-Johnson syndrome, toxic epidermal necrolysis (TEN, some fatal), angioedema (Quincke’s edema) and cutaneous lupus erythematosus
To report SUSPECTED ADVERSE REACTIONS contact AvKARE at 1-855-361-3993; email drugsafety@avkare.com; or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.

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 DiagnosticsAntiretrovirals
  • 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.
  • 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 clopidogrel-induced platelet inhibition
  • [see Clinical Pharmacology (
  • 12.3)]
  • .
  • Intervention:  No dose adjustment of clopidogrel is necessary when administered with an approved dose 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 Investigations of Neuroendocrine Tumors
  • Clinical Impact:CgA levels increase secondary to PPI-induced decreases in gastric acidity. The increased CgA level may cause false positive results in diagnostic investigations for neuroendocrine tumors
  • [see Warnings and Precautions (
  • 5.10), Clinical Pharmacology (
  • 12.2)].
  • Intervention: Temporarily stop Pantoprazole treatment at least 14 days before assessing CgA levels and consider repeating the test if initial CgA levels are high. If serial tests are performed (e.g. for monitoring), the same commercial laboratory should be used for testing, as reference ranges between tests may vary. False Positive Urine Tests for THC
  • Clinical Impact:There have been reports of false positive urine screening tests for tetrahydrocannabinol (THC) in patients receiving PPIs
  • [see Warnings and Precautions (
  • 5.11)]
  • .
  • Intervention: An alternative confirmatory method should be considered to verify positive results.

8.1 Pregnancy

Risk Summary Available data from published observational studies did not demonstrate an association of major malformations or other adverse pregnancy outcomes with pantoprazole. In animal reproduction studies, no evidence of adverse development outcomes was observed with pantoprazole. Reproduction studies have been performed in rats at oral doses up to 450 mg/kg/day (about 88 times the recommended human dose) and rabbits at oral doses up to 40 mg/kg/day (about 16 times the recommended human dose) with administration of pantoprazole during organogenesis in pregnant animals and have revealed no evidence of harm to the fetus due to pantoprazole in this study


(see Data).


A pre- and postnatal development toxicity study in rats with additional endpoints to evaluate the effect on bone development was performed with pantoprazole sodium. Oral pantoprazole doses of 5, 15, and 30 mg/kg/day (approximately 1, 3, and 6 times the human dose of 40 mg/day) were administered to pregnant females from gestation day (GD) 6 through lactation day (LD) 21. Changes in bone morphology were observed in pups exposed to pantoprazole


in utero and through milk during the period of lactation as well as by oral dosing from postnatal day (PND) 4 through PND 21


[see Use in Specific Populations (


8.4)]


. There were no drug-related findings in maternal animals.Advise pregnant women of the potential risk of fetal harm.


The estimated background risk of major birth defects and miscarriage for the indicated population is unknown. All pregnancies have a background risk of birth defect, loss or other adverse outcomes. In the U.S. general population, the estimated background risk of major birth defects and miscarriage in the clinically recognized pregnancies is 2 to 4% and 15 to 20%, respectively.DataHuman DataAvailable data from published observational studies failed to demonstrate an association of adverse pregnancy-related outcomes and pantoprazole use. Methodological limitations of these observational studies cannot definitely establish or exclude any drug-associated risk during pregnancy. In a prospective study by the European Network of Teratology Information Services, outcomes from a group of 53 pregnant women administered median daily doses of 40 mg pantoprazole were compared to a control group of 868 pregnant women who did not take any proton pump inhibitors (PPIs). There was no difference in the rate of major malformations between women exposed to PPIs and the control group, corresponding to a Relative Risk (RR)=0.55, [95% Confidence Interval (CI) 0.08-3.95]. In a population-based retrospective cohort study covering all live births in Denmark from 1996 to 2008, there was no significant increase in major birth defects during analysis of first trimester exposure to pantoprazole in 549 live births. A meta-analysis that compared 1,530 pregnant women exposed to PPIs in at least the first trimester with 133,410 unexposed pregnant women showed no significant increases in risk for congenital malformations or spontaneous abortion with exposure to PPIs (for major malformations OR=1.12 ([95% CI 0.86-1.45] and for spontaneous abortions OR=1.29 [95% CI 0.84-1.97]).Animal Data Reproduction studies have been performed in rats at oral pantoprazole doses up to 450 mg/kg/day (about 88 times the recommended human dose based on body surface area) and in rabbits at oral doses up to 40 mg/kg/day (about 16 times the recommended human dose based on body surface area) with administration of pantoprazole sodium during organogenesis in pregnant animals. The studies have revealed no evidence of impaired fertility or harm to the fetus due to pantoprazole. A pre- and postnatal development toxicity study in rats with additional endpoints to evaluate the effect on bone development was performed with pantoprazole sodium. Oral pantoprazole doses of 5, 15, and 30 mg/kg/day (approximately 1, 3, and 6 times the human dose of 40 mg/day on a body surface area basis) were administered to pregnant females from gestation day (GD) 6 through lactation day (LD) 21. On postnatal day (PND 4) through PND 21, the pups were administered oral doses at 5, 15, and 30 mg/kg/day (approximately 1, 2.3, and 3.2 times the exposure (AUC) in humans at a dose of 40 mg). There were no drug-related findings in maternal animals. During the preweaning dosing phase (PND 4 to 21) of the pups, there were increased mortality and/or moribundity and decreased body weight and body weight gain at 5 mg/kg/day (approximately equal exposures (AUC) in humans receiving the 40 mg dose) and higher doses. On PND 21, decreased mean femur length and weight and changes in femur bone mass and geometry were observed in the offspring at 5 mg/kg/day (approximately equal exposures (AUC) in humans at the 40 mg dose) and higher doses. The femur findings included lower total area, bone mineral content and density, periosteal and endosteal circumference, and cross-sectional moment of inertia. There were no microscopic changes in the distal femur, proximal tibia, or stifle joints. Changes in bone parameters were partially reversible following a recovery period, with findings on PND 70 limited to lower femur metaphysis cortical/subcortical bone mineral density in female pups at 5 mg/kg/day (approximately equal exposures (AUC) in humans at the 40 mg dose) and higher doses.

8.2 Lactation

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.

8.4 Pediatric 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.

8.5 Geriatric 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.

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.

11 Description

The active ingredient in Pantoprazole Sodium Delayed-Release Tablets, USP, a PPI, 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


16H


14F


2N


3NaO


4S x 1.5 H


2O, 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.

12.1 Mechanism 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).

12.3 Pharmacokinetics

Pantoprazole Sodium Delayed-Release Tablets are prepared as enteric-coated tablets so that absorption of pantoprazole begins only after the tablet leaves the stomach. Peak serum concentration (C


max) and area under the serum concentration time curve (AUC) increase in a manner proportional to oral doses from 10 mg to 80 mg. Pantoprazole does not accumulate, and its pharmacokinetics are unaltered with multiple daily dosing. Following oral administration, the serum concentration of pantoprazole declines biexponentially, with a terminal elimination half-life of approximately one hour.


In extensive metabolizers with normal liver function receiving an oral dose of the enteric-coated 40 mg pantoprazole tablet, the peak concentration (C


max) is 2.5 mcg/mL; the time to reach the peak concentration (t


max) is 2.5 h, and the mean total area under the plasma concentration versus time curve (AUC) is 4.8 mcg∙h/mL (range 1.4 to 13.3 mcg∙h/mL).

12.5 Pharmacogenomics

CYP2C19 displays a known genetic polymorphism due to its deficiency in some subpopulations (e.g., approximately 3% of Caucasians and African-Americans and 17% to 23% of Asians are poor metabolizers). Although these subpopulations of pantoprazole poor metabolizers have elimination half-life values of 3.5 to 10 hours in adults, they still have minimal accumulation (23% or less) with once-daily dosing. For adult patients who are CYP2C19 poor metabolizers, no dosage adjustment is needed. Similar to adults, pediatric patients who have the poor metabolizer genotype of CYP2C19 (CYP2C19 *2/*2) exhibited greater than a 6-fold increase in AUC compared to pediatric extensive (CYP2C19 *1/*1) and intermediate (CYP2C19 *1/*x) metabolizers. Poor metabolizers exhibited approximately 10‑fold lower apparent oral clearance compared to extensive metabolizers. For known pediatric poor metabolizers, a dose reduction should be considered.

13.1 Carcinogenesis, Mutagenesis, Impairment Of Fertility

In a 24-month carcinogenicity study, Sprague-Dawley rats were treated orally with pantoprazole doses of 0.5 to 200 mg/kg/day, about 0.1 to 40 times the exposure on a body surface area basis of a 50 kg person dosed with 40 mg/day. In the gastric fundus, treatment with 0.5 to 200 mg/kg/day produced enterochromaffin-like (ECL) cell hyperplasia and benign and malignant neuroendocrine cell tumors in a dose-related manner. In the forestomach, treatment with 50 and 200 mg/kg/day (about 10 and 40 times the recommended human dose on a body surface area basis) produced benign squamous cell papillomas and malignant squamous cell carcinomas. Rare gastrointestinal tumors associated with pantoprazole treatment included an adenocarcinoma of the duodenum with 50 mg/kg/day and benign polyps and adenocarcinomas of the gastric fundus with 200 mg/kg/day. In the liver, treatment with 0.5 to 200 mg/kg/day produced dose-related increases in the incidences of hepatocellular adenomas and carcinomas. In the thyroid gland, treatment with 200 mg/kg/day produced increased incidences of follicular cell adenomas and carcinomas for both male and female rats.In a 24-month carcinogenicity study, Fischer 344 rats were treated orally with doses of 5 to 50 mg/kg/day of pantoprazole, approximately 1 to 10 times the recommended human dose based on body surface area. In the gastric fundus, treatment with 5 to 50 mg/kg/day produced enterochromaffin-like (ECL) cell hyperplasia and benign and malignant neuroendocrine cell tumors. Dose selection for this study may not have been adequate to comprehensively evaluate the carcinogenic potential of pantoprazole.In a 24-month carcinogenicity study, B6C3F1 mice were treated orally with doses of 5 to 150 mg/kg/day of pantoprazole, 0.5 to 15 times the recommended human dose based on body surface area. In the liver, treatment with 150 mg/kg/day produced increased incidences of hepatocellular adenomas and carcinomas in female mice. Treatment with 5 to 150 mg/kg/day also produced gastric-fundic ECL cell hyperplasia.A 26-week p53 +/- transgenic mouse carcinogenicity study was not positive.Pantoprazole was positive in the


in vitro human lymphocyte chromosomal aberration assays, in one of two mouse micronucleus tests for clastogenic effects, and in the


in vitro Chinese hamster ovarian cell/HGPRT forward mutation assay for mutagenic effects. Equivocal results were observed in the


in vivo rat liver DNA covalent binding assay. Pantoprazole was negative in the


in vitro Ames mutation assay, the


in vitro unscheduled DNA synthesis (UDS) assay with rat hepatocytes, the


in vitro AS52/GPT mammalian cell-forward gene mutation assay, the


in vitro thymidine kinase mutation test with mouse lymphoma L5178Y cells, and the


in vivo rat bone marrow cell chromosomal aberration assay.


There were no effects on fertility or reproductive performance when pantoprazole was given at oral doses up to 500 mg/kg/day in male rats (98 times the recommended human dose based on body surface area) and 450 mg/kg/day in female rats (88 times the recommended human dose based on body surface area).

14 Clinical Studies

Pantoprazole Sodium Delayed-Release Tablets were used in the following clinical trials.

14.2 Long-Term Maintenance Of Healing Of Erosive Esophagitis

Two independent, multicenter, randomized, double-blind, comparator-controlled trials of identical design were conducted in adult GERD patients with endoscopically confirmed healed EE to demonstrate efficacy of Pantoprazole in long-term maintenance of healing. The two US studies enrolled 386 and 404 patients, respectively, to receive either 10 mg, 20 mg, or 40 mg of Pantoprazole Sodium Delayed-Release Tablets once daily or 150 mg of ranitidine twice daily. As demonstrated in Table 10, Pantoprazole 40 mg and 20 mg were significantly superior to ranitidine at every timepoint with respect to the maintenance of healing. In addition, Pantoprazole 40 mg was superior to all other treatments studied. Table 10: Long-Term Maintenance of Healing of Erosive Gastroesophageal Reflux Disease (GERD Maintenance): Percentage of Patients Who Remained Healed Note: Pantoprazole 10 mg was superior (p < 0.05) to ranitidine in Study 2, but not Study 1. Pantoprazole


20 mg daily


Pantoprazole


40 mg daily


Ranitidine


150 mg twice daily


 


Study 1 n = 75 n = 74 n = 75 Month 1 91


(p < 0.05 vs. ranitidine) 99


 68 Month 3 82


 93


(p < 0.05 vs. Pantoprazole 20 mg) 54 Month 6 76


 90


 44 Month 12  70


 86


 35         


Study 2 n = 74 n = 88 n = 84 Month 1 89


 92


 62 Month 3  78


 91


 47  Month 6  72


 88


 39  Month 12  72


 83


 37 Pantoprazole 40 mg was superior to ranitidine in reducing the number of daytime and nighttime heartburn episodes from the first through the twelfth month of treatment. Pantoprazole 20 mg, administered once daily, was also effective in reducing episodes of daytime and nighttime heartburn in one trial, as presented in Table 11. Table 11: Number of Episodes of Heartburn (mean ± SD) Pantoprazole


40 mg daily


Ranitidine


150 mg twice daily


 Month 1 Daytime  5.1 ± 1.6


(p < 0.001 vs. ranitidine, combined data from the two US studies) 18.3 ± 1.6  Nighttime 3.9 ± 1.1


 11.9 ± 1.1 Month 12 Daytime 2.9 ± 1.5


 17.5 ± 1.5  Nighttime 2.5 ± 1.2


 13.8 ± 1.3

14.3 Pathological Hypersecretory Conditions Including Zollinger-Ellison Syndrome

In a multicenter, open-label trial of 35 patients with pathological hypersecretory conditions, such as Zollinger-Ellison Syndrome, with or without multiple endocrine neoplasia-type I, Pantoprazole successfully controlled gastric acid secretion. Doses ranging from 80 mg daily to 240 mg daily maintained gastric acid output below 10 mEq/h in patients without prior acid-reducing surgery and below 5 mEq/h in patients with prior acid-reducing surgery. Doses were initially titrated to the individual patient needs, and adjusted in some patients based on the clinical response with time


[see Dosage and Administration (


2)]


. Pantoprazole was well tolerated at these dose levels for prolonged periods (greater than 2 years in some patients).

Other

  • How SuppliedPantoprazole Sodium Delayed-Release Tablets, USP are supplied as 40 mg white to off-white, oval-shaped coated tablet, debossed with "17" on one side.Pantoprazole Sodium Delayed-Release Tablets, USP are supplied as 20 mg white to off-white, oval-shaped coated tablet, imprinted in black with “18” on one side and are available as follows:NDC 50268-585-15 (10 tablets per card, 5 cards per carton).

17 Patient Counseling Information

  • Advise the patient to read the FDA-approved patient labeling (Medication Guide).Gastric MalignancyAdvise 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 Tubulointerstitial NephritisAdvise patients to call their healthcare provider immediately if they experience signs and/or symptoms associated with acute tubulointerstitial nephritis
  • [see
  • Contraindications (
  • 4),
  • Warnings and Precautions (
  • 5.2)]
  • .
  • Clostridium difficile-Associated DiarrheaAdvise 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 InteractionsInstruct 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)]
  • .
  • PregnancyAdvise 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)]
  • .
  • AdministrationDo 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:AvKAREPulaski, TN 38478Mfg. Rev. 12/20AV 01/21 (P)

Medication Guide

  • Pantoprazole (pan toe' pra zole) Sodium Delayed-Release Tablets, USPWhat 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 tubulointerstitial nephritis). Some people who take proton pump inhibitor (PPI) medicines, including Pantoprazole, may develop a kidney problem called acute tubulointerstitial 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 and 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 for 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 treatment other than EE.Do not take Pantoprazole if you are: allergic to pantoprazole sodium, any other PPI medicine, or any of the ingredients in Pantoprazole. See the end of this Medication Guide for a complete list of ingredients.taking a medicine that contains rilpivirine (EDURANT, COMPLERA, ODEFSEY, JULUCA) 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. Talk with your doctor about the best way to feed your baby if you take Pantoprazole.Tell your doctor about all of the medicines you take, including prescription and over-the-counter medicines, vitamins and herbal supplements.
  • Especially tell your doctor if you take methotrexate (Otrexup, Rasuvo, Trexall, XATMEP), digoxin (LANOXIN), or a water pill (diuretic).
  • How should I take Pantoprazole?Take Pantoprazole exactly as prescribed by your doctor.Pantoprazole delayed-release tablets (Pantoprazole tablets):Do not split, chew, or crush Pantoprazole tablets. Swallow Pantoprazole tablets whole, with or without food.Tell your doctor if you are not able to swallow your Pantoprazole tablet.You may use antacids while taking Pantoprazole tablets.If you miss a dose of Pantoprazole, take it as soon as possible. If it is almost time for your next dose, do not take the missed dose. Take the next dose at your regular time. Do not take 2 doses at the same time.If you take too much Pantoprazole, call your doctor or your poison control center at 1-800-222-1222 right away or go to the nearest emergency room.What are the possible side effects of Pantoprazole?Pantoprazole can cause serious side effects, including:See “What is the most important information I should know about Pantoprazole?”Low vitamin B-12 levels in your body can happen in people who have taken Pantoprazole for a long time (more than 3 years). Tell your doctor if you have symptoms of low vitamin B-12 levels, including shortness of breath, lightheadedness, irregular heartbeat, muscle weakness, pale skin, feeling tired, mood changes, and tingling or numbness in the arms and legs.
  • Low magnesium levels in your body can happen in people who have taken Pantoprazole for at least 3 months. Tell your doctor if you have symptoms of low magnesium levels, including seizures, dizziness, irregular heartbeat, jitteriness, muscle aches or weakness, and spasms of hands, feet or voice.
  • Stomach growths (fundic gland polyps). People who take PPI medicines for a long time have an increased risk of developing a certain type of stomach growths called fundic gland polyps, especially after taking PPI medicines for more than 1 year.
  • The most common side effects of Pantoprazole in adults include: headache, diarrhea, nausea, stomach-area (abdominal) pain, vomiting, gas, dizziness, and joint pain.
  • The most common side effects of Pantoprazole in children include: upper respiratory infection, headache, fever, diarrhea, vomiting, rash, and stomach-area (abdominal) pain.
  • These are not all the possible side effects of Pantoprazole. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.
  • How should I store Pantoprazole?Store Pantoprazole at room temperature between 59° to 86°F (15° to 30°C).Keep Pantoprazole and all medicines out of the reach of children.General information about the safe and effective use of Pantoprazole.Medicines are sometimes prescribed for purposes other than those listed in a Medication Guide. Do not use Pantoprazole for a condition for which it was not prescribed. Do not give Pantoprazole to other people, even if they have the same symptoms that you have. It may harm them. You can ask your doctor or pharmacist for information about Pantoprazole that is written for health professionals.What are the ingredients in Pantoprazole?Active ingredient: pantoprazole sodium sesquihydrate
  • Inactive ingredients in Pantoprazole Sodium Delayed-Release Tablets: 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.
  • For more information, call 1-855-361-3993.
  • This Medication Guide has been approved by the U.S. Food and Drug Administration.This product's label may have been updated. For more information, call 1-855-361-3993.Manufactured for:AvKAREPulaski, TN 38478Mfg. Rev. 12/20AV 01/21 (P)All brand names are the trademarks of their respective owners.

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