Pantoprazole Sodium
Tablet, Delayed Release · Oral, Intravenous
Uses
Pantoprazole Sodium for Injection is a proton pump inhibitor (PPI) indicated in adults for the following:
• Short-term treatment (7 to 10 days) of gastroesophageal reflux disease (GERD) associated with a history of erosive esophagitis (EE). ( 1.1 )
• Pathological hypersecretion conditions, including Zollinger-Ellison (ZE) syndrome. ( 1.2 ) 1.1 Gastroesophageal Reflux Disease Associated with a History of Erosive Esophagitis Pantoprazole Sodium for Injection is indicated for short-term treatment (7 to 10 days) of adult patients with gastroesophageal reflux disease (GERD) and a history of erosive esophagitis (EE). Safety and efficacy of Pantoprazole Sodium for Injection as a treatment of patients with GERD and a history of EE for more than 10 days have not been demonstrated. 1.2 Pathological Hypersecretion Including Zollinger-Ellison Syndrome Pantoprazole Sodium for Injection is indicated for the treatment of pathological hypersecretory conditions including Zollinger-Ellison (ZE) Syndrome in adults.
Dosage and administration
Associated with EE ( 2.1 ) :
• The recommended adult dosage is 40 mg administered once daily by intravenous infusion for 7 to 10 days. P ath olog ica l Hypersecretory Conditions, Including ZE Syndrome ( 2.3 ):
• The recommended adult dosage is 80 mg administered every 12 hours by intravenous infusion. See the full prescribing information for information on how to adjust dosing for individual patient needs. A d ministration ( 2.2 , 2.4 ) :
• Only for intravenous infusion.
• The intravenous infusion can be administered over 2 minutes or 15 minutes.
• For information on how to prepare and administer for each indication, see the full prescribing information. 2.1 Dosage for Gastroesophageal Reflux Disease Associated With a History of Erosive Esophagitis The recommended adult dosage of Pantoprazole Sodium for Injection is 40 mg given once daily by intravenous infusion for 7 to 10 days. Discontinue treatment with Pantoprazole Sodium for Injection as soon as the patient is able to receive treatment with pantoprazole sodium delayed-release tablets or oral suspension. Data on the safe and effective dosing for conditions other than those described [see Indications and Usage (1) ] such as life-threatening upper gastrointestinal bleeds, are not available. Pantoprazole Sodium for Injection 40 mg once daily does not raise gastric pH to levels sufficient to contribute to the treatment of such life-threatening conditions. 2.2 Preparation and Administration Instructions for Gastroesophageal Reflux Disease Associated with a History of Erosive Esophagitis For intravenous infusion only. F ifteen Minute Infusion 1. Reconstitute Pantoprazole Sodium for Injection with 10 mL of 0.9% Sodium Chloride Injection, USP 2. Further dilute with 100 mL of 5% Dextrose Injection, USP, 0.9% Sodium Chloride Injection, USP, or Lactated Ringer's Injection, USP, to a final concentration of approximately 0.4 mg/mL. 3. Inspect the diluted Pantoprazole Sodium for Injection solution visually for particulate matter and discoloration prior to and during administration. 4. Administer intravenously over a period of approximately 15 minutes at a rate of approximately 7 mL/minute. Storage The reconstituted solution may be stored for up to 6 hours at room temperature prior to further dilution. The diluted solution may be stored at room temperature and must be used within 24 hours from the time of initial reconstitution. Both the reconstituted solution and the diluted solution do not need to be protected from light. Do not freeze either the reconstituted or diluted solutions. Two Minute Infusion 1. Reconstitute Pantoprazole Sodium for Injection with 10 mL of 0.9% Sodium Chloride Injection, USP, to a final concentration of approximately 4 mg/mL. 2. Inspect the diluted Pantoprazole Sodium for Injection solution visually for particulate matter and discoloration prior to and during administration. 3. Administer intravenously over a period of at least 2 minutes. Storage The reconstituted solution may be stored for up to 24 hours at room temperature prior to intravenous infusion and does not need to be protected from light. Do not freeze either the reconstituted or diluted solutions. 2.3 Dosage for Pathological Hypersecretion Including Zollinger-Ellison Syndrome The recommended adult dosage of Pantoprazole Sodium for Injection is 80 mg intravenously every 12 hours. The frequency of dosing can be adjusted to individual patient needs based on acid output measurements. In those patients who need a higher dosage, 80 mg intravenously every 8 hours is expected to maintain acid output below 10 mEq/h. Daily doses higher than 240 mg or administered for more than 6 days have not been studied [see Clinical Studies (14.2) ] . Transition from oral to intravenous and from intravenous to oral formulations of gastric acid inhibitors should be performed in such a manner to ensure continuity of effect of suppression of acid secretion. Patients with ZE Syndrome may be vulnerable to serious clinical complications of increased acid production even after a short period of loss of effective inhibition. 2.4 Preparation and Administration Instructions for Pathological Hypersecretion Including Zollinger-Ellison Syndrome For intravenous infusion only. Fifteen Minute Infusion 1. Reconstitute each vial of Pantoprazole Sodium for Injection with 10 mL of 0.9% Sodium Chloride Injection, USP. 2. Combine the contents of the two vials and further dilute with 80 mL of 5% Dextrose Injection, USP, 0.9% Sodium Chloride Injection, USP, or Lactated Ringer's Injection, USP, to a total volume of 100 mL with a final concentration of approximately 0.8 mg/mL. 3. Inspect the diluted Pantoprazole Sodium for Injection solution visually for particulate matter and discoloration prior to and during administration. 4. Administer intravenously over a period of approximately 15 minutes at a rate of approximately 7 mL/minute. Storage The reconstituted solution may be stored for up to 6 hours at room temperature prior to further dilution. The diluted solution may be stored at room temperature and must be used within 24 hours from the time of initial reconstitution. Both the reconstituted solution and the diluted solution do not need to be protected from light. Do not freeze either the reconstituted or diluted solutions. Two Minute Infusion 1. Reconstitute Pantoprazole Sodium for Injection with 10 mL of 0.9% Sodium Chloride Injection, USP, per vial to a final concentration of approximately 4 mg/mL. 2. Inspect the reconstituted Pantoprazole Sodium for Injection solution visually for particulate matter and discoloration prior to and during administration. 3. Administer the total volume from both vials intravenously over a period of at least 2 minutes. Storage The reconstituted solution may be stored for up to 24 hours at room temperature prior to intravenous infusion and does not need to be protected from light. Do not freeze the reconstituted solution.
Dosage forms and strengths
For Injection: 40 mg pantoprazole white to off-white lyophilized powder in a single-dose vial for reconstitution. For Injection: 40 mg pantoprazole lyophilized powder in a single-dose vial for reconstitution ( 3 )
Contraindications
• Pantoprazole Sodium for Injection is contraindicated in patients with known hypersensitivity reactions including anaphylaxis to the formulation or any substituted benzimidazole. Hypersensitivity reactions may include anaphylaxis, anaphylactic shock, angioedema, bronchospasm, acute tubulointerstitial nephritis, and urticaria [see Warnings and Precautions (5.3) , Adverse Reactions (6) ] .
• Proton pump inhibitors (PPIs), including Pantoprazole Sodium for Injection, are contraindicated in 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 precautions
• Gastric Malignancy : In adults, symptomatic response to therapy with Pantoprazole Sodium for Injection does not preclude the presence of gastric malignancy. Consider additional follow-up and diagnostic testing. ( 5.1 )
• Injection Site Reactions : Thrombophlebitis is associated with intravenous use. ( 5.2 )
• Acute Tubulointerstitial Nephritis : Discontinue treatment and evaluate patients. ( 5.3 )
• Clostridium difficile -Associated Diarrhea : PPI therapy may be associated with increased risk. ( 5.4 )
• Bone Fracture : Long-term and multiple daily dose PPI therapy may be associated with an increased risk for osteoporosis-related fractures of the hip, wrist or spine. ( 5.5 )
• Severe Cutaneous Adverse Reactions : Discontinue at the first signs or symptoms of severe cutaneous adverse reactions or other signs of hypersensitivity and consider further evaluation. ( 5.6 )
• Cutaneous and Systemic Lupus Erythematosus : Mostly cutaneous; new onset or exacerbation of existing disease; discontinue Pantoprazole Sodium for Injection and refer to specialist for evaluation. ( 5.7 )
• Hepatic Effects : Elevations of transaminases observed. ( 5.8 )
• Hypomagnesemia and Mineral Metabolism : Reported rarely with prolonged treatment with PPIs. ( 5.9 )
• Fundic Gland Polyps : Risk increases with long-term use, especially beyond one year. Use the shortest duration of therapy. ( 5.10 ) 5.1 Presence of Gastric Malignancy In adults, symptomatic response to therapy with Pantoprazole Sodium for Injection 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 Injection Site Reactions Thrombophlebitis was associated with the administration of another intravenous pantoprazole sodium product. 5.3 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 Sodium for Injection and evaluate patients with suspected acute TIN [see Contraindications (4) ] . 5.4 Clostridium difficile -Associated Diarrhea Published observational studies suggest that PPI therapy like Pantoprazole Sodium for Injection 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. 5.5 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 (2.2 , 2.4) and Adverse Reactions (6) ] . 5.6 Severe Cutaneous Adverse Reactions Severe cutaneous adverse reactions, including Stevens-Johnson syndrome (SJS) and toxic epidermal necrolysis (TEN), drug reaction with eosinophilia and systemic symptoms (DRESS), and acute generalized exanthematous pustulosis (AGEP) have been reported in association with the use of PPIs [see Adverse Reactions (6.2) ] . Discontinue Pantoprazole Sodium for Injection at the first signs or symptoms of severe cutaneous adverse reactions or other signs of hypersensitivity and consider further evaluation. 5.7 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 Sodium for Injection, 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. 5.8 Hepatic Effects Mild, transient transaminase elevations have been observed in clinical studies.
Side effects
The following serious adverse reactions are described below and elsewhere in labeling:
• Injection Site Reactions [see Warnings and Precautions (5.2) ]
• Acute Tubulointerstitial Nephritis [see Warnings and Precautions (5.3) ]
• C lostridium difficile- Associated Diarrhea [see Warnings and Precautions (5.4) ]
• Bone Fracture [see Warnings and Precautions (5.5) ]
• Severe Cutaneous Adverse Reactions [See Warnings and Precautions (5.6) ]
• Cutaneous and Systemic Lupus Erythematosus [see Warnings and Precautions (5.7) ]
• Hepatic Effects [see Warnings and Precautions (5.8) ]
• Hypomagnesemia and Mineral Metabolism [see Warnings and Precautions (5.9) ]
• Fundic Gland Polyps [see Warnings and Precautions (5.10) ] Most common adverse reactions (>2%) are: headache, diarrhea, nausea, abdominal pain, vomiting, flatulence, dizziness, and arthralgia. ( 6.1 ) To report SUSPECTED ADVERSE REACTIONS, contact Hikma Pharmaceuticals USA Inc. at 1-877-845-0689 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch . 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. The safety of Pantoprazole Sodium for Injection has been established from adequate and well-controlled studies of another intravenous pantoprazole sodium product [see Clinical Studies (14) ] . Below is a display of the adverse reactions of pantoprazole sodium in these adequate and well-controlled studies. Gastroesophageal Reflux Disease (GERD) 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 1. The number of patients treated in comparative studies with intravenous pantoprazole sodium is limited; however, the adverse reactions seen were similar to those seen in the oral studies. Thrombophlebitis was the only new adverse reaction identified with intravenous pantoprazole sodium. T able 1: Adverse Reactions Reported in Clinical Trials of Adult Patients with GERD at a Frequency of >2% O ral Pantoprazole Sodium ( n=1473) % C o m parators ( n=345) % P lacebo ( n=82) % Headache 12.2 12.8 8.5 Diarrhea 8.8 9.6 4.9 Nausea 7 5.2 9.8 Abdominal pain 6.2 4.1 6.1 Vomiting 4.3 3.5 2.4 Flatulence 3.9 2.9 3.7 Dizziness 3 2.9 1.2 Arthralgia 2.8 1.4 1.2 Additional adverse reactions that were reported for oral pantoprazole sodium in US clinical trials with a frequency of 2% or less are listed below by body system: Body as a Whole: allergic reaction, fever, photosensitivity reaction, facial edema, thrombophlebitis (intravenous only) Gastrointestinal: constipation, dry mouth, hepatitis Hematologic: leukopenia (reported in ex-US clinical trials only), thrombocytopenia Me tabolic/Nutritional: elevated CPK (creatine phosphokinase), generalized edema, elevated triglycerides, liver function tests abnormal M usculoskeletal: myalgia N e rvous: depression, vertigo Skin and Appendages: urticaria, rash, pruritus Special Senses: blurred vision Z ollinger-Ellison Syndrome In clinical studies of Zollinger-Ellison Syndrome, adverse reactions reported in 35 patients administered oral pantoprazole doses of 80 mg to 240 mg per 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 other pantoprazole sodium products. 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: General Disorders and Administration Conditions: asthenia, fatigue, malaise I mmune System Disorders: anaphylaxis (including anaphylactic shock), systemic lupus erythematosus I nvestigations: weight changes Skin and Subcutaneous Tissue Disorders: severe dermatologic reactions (some fatal), including erythema multiforme, SJS/TEN, DRESS, AGEP [see Warnings and Precautions (5.6) ] , and angioedema (Quincke's edema) and cutaneous lupus erythematosus Musculoskeletal Disorders: rhabdomyolysis, bone fracture Renal and Genitourinary Disorders: interstitial nephritis, erectile dysfunction Hepatobiliary Disorders: hepatocellular damage leading to jaundice and hepatic failure Psychiatric Disorder: hallucinations, confusion, insomnia, somnolence Metabolism and Nutritional Disorders: hypomagnesemia, hypocalcemia, hypokalemia [see Warnings and Precautions (5.9) ] , hyponatremia Infections and Infestations: Clostridium difficile- associated diarrhea Hematologic: pancytopenia, agranulocytosis N e rvous: ageusia, dysgeusia Gastrointestinal Disorders: fundic gland polyps
Drug interactions
Table 2 includes drugs with clinically important drug interactions and interaction with diagnostics when administered concomitantly with Pantoprazole Sodium for Injection and instructions for preventing or managing them. Consult the labeling of concomitantly used drugs to obtain further information about interactions with PPIs. T able 2: Clinically Relevant Interactions Affecting Drugs Co-Administered with P antoprazole Sodium for Injection and Interaction with Diagnostics Antiretrovirals C linical 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 [see Clinical Pharmacology (12.3 )] .
• There are other antiretroviral drugs which do not result in clinically relevant interactions with pantoprazole. I ntervention: R ilpivirine-containing products: Concomitant use with Pantoprazole Sodium for Injection is contraindicated [see Contraindications (4) ] . See prescribing information. Atazanavir: See prescribing information for atazanavir for dosing information. Nelfinavir: Avoid concomitant use with Pantoprazole Sodium for Injection. See prescribing information for nelfinavir. S a quinavir: See the prescribing information for saquinavir and for monitoring of potential saquinavir-related toxicities. Other antiretrovirals: See prescribing information for specific antiretroviral drugs. Warfarin C linical 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. I ntervention: Monitor INR and prothrombin time and adjust the dose of warfarin, if needed, to maintain the target INR range. See prescribing information for warfarin. Clopidogrel C linical Impact: Concomitant administration of pantoprazole and clopidogrel in healthy subjects had no clinically important effect on exposure to the active metabolite of clopidogrel-induced platelet inhibition [see Clinical Pharmacology (12.3) ]. I ntervention: No dose adjustment of clopidogrel is necessary when administered with an approved dose of Pantoprazole Sodium for Injection. Met h otrexate C linical 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 (5.13) ]. I ntervention: A temporary withdrawal of Pantoprazole Sodium for Injection may be considered in some patients receiving high-dose methotrexate. Drugs Dependent on Gastric pH for Absorption (e.g., iron salts, erlotinib, dasatinib, n ilotinib, mycophenoloate mofetil, ketoconazole/itraconazole) C linical Impact: Pantoprazole can reduce the absorption of other drugs due to its effect on reducing intragastric acidity I ntervention: 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 Sodium for Injection and MMF. Use Pantoprazole Sodium for Injection with caution in transplant patients receiving MMF [see Clinical Pharmacology (12.3) ] . See the prescribing information for other drugs dependent on gastric pH for absorption. Interactions with Investigations of Neuroendocrine Tumors C linical 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 (5.11) , Clinical Pharmacology (12.2) ] . I ntervention: Temporarily stop Pantoprazole Sodium for Injection 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. F alse Positive Urine Tests for THC C linical Impact: There have been reports of false positive urine screening tests for tetrahydrocannabinol (THC) in patients receiving PPIs, including pantoprazole sodium [see Warnings and Precautions (5.12 )] . I ntervention: An alternative confirmatory method should be considered to verify positive results. See full prescribing information for a list of clinically important drug interactions. ( 7 )
Use in specific populations
Pregnancy: Based on animal data, may cause fetal harm. ( 8.1 ) 8.1 Pregnancy R isk Summary Available data from published observational studies did not demonstrate an association of major malformations or other adverse pregnancy outcomes with pantoprazole (see Data ) . In animal reproduction studies, no evidence of adverse development outcomes was observed with pantoprazole. Reproduction studies have been performed in rats at intravenous doses up to 20 mg/kg/day (4 times the recommended human dose) and rabbits at intravenous doses up to 15 mg/kg/day (6 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. Data Human Data Available 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 intravenous pantoprazole doses up to 20 mg/kg/day (4 times the recommended human dose based on body surface area) and rabbits at intravenous doses up to 15 mg/kg/day (6 times the recommended human dose based on body surface area) with administration of pantoprazole sodium during organogenesis in pregnant animals and 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 R isk Summary The limited data from a single case reports the presence of pantoprazole in human breast milk. 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.
Pregnancy
8.1 Pregnancy R isk Summary Available data from published observational studies did not demonstrate an association of major malformations or other adverse pregnancy outcomes with pantoprazole (see Data ) . In animal reproduction studies, no evidence of adverse development outcomes was observed with pantoprazole. Reproduction studies have been performed in rats at intravenous doses up to 20 mg/kg/day (4 times the recommended human dose) and rabbits at intravenous doses up to 15 mg/kg/day (6 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. Data Human Data Available 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 intravenous pantoprazole doses up to 20 mg/kg/day (4 times the recommended human dose based on body surface area) and rabbits at intravenous doses up to 15 mg/kg/day (6 times the recommended human dose based on body surface area) with administration of pantoprazole sodium during organogenesis in pregnant animals and 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.
Pediatric use
8.4 Pediatric Use The safety and effectiveness of Pantoprazole Sodium for Injection have not been established in pediatric patients. Animal Toxicity Data In a pre- and post-natal development study in rats, the pups were administered oral doses of pantoprazole at 5, 15, and 30 mg/kg/day on postnatal day (PND 4) through PND 21, in addition to lactational exposure through milk. 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 and higher doses. Changes in bone parameters were partially reversible following a recovery period [see Use in Specific Populations (8.1) ] . In neonatal/juvenile animals (rats and dogs) toxicities were similar to those observed in adult animals including gastric alterations, decreases in red cell mass, increases in lipids, enzyme induction and hepatocellular hypertrophy. An increased incidence of eosinophilic chief cells in adult and neonatal/juvenile rats, and atrophy of chief cells in adult rats and in neonatal/juvenile dogs, was observed in the fundic mucosa of stomachs in repeated-dose studies. Full to partial recovery of these effects were noted in animals of both age groups following a recovery period.
Geriatric use
8.5 Geriatric Use Of 286 patients in clinical studies of intravenous pantoprazole sodium in patients with GERD and a history of EE, 86 (43%) were 65 years of age and over. No overall differences in safety or effectiveness were observed between these subjects and younger subjects, and other reported clinical experience with oral pantoprazole sodium has not identified differences in responses between the elderly and younger patients, but greater sensitivity of some older individuals cannot be ruled out.
Overdosage
Experience in patients taking very high doses of pantoprazole (greater than 240 mg) is limited. Adverse reactions seen in spontaneous reports of overdose generally reflect the known safety profile of pantoprazole. Pantoprazole is not removed by hemodialysis. In case of overdose, treatment should be symptomatic and supportive. Single intravenous doses of pantoprazole at 378, 230, and 266 mg/kg (38, 46, and 177 times the recommended human dose based on body surface area) 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.
Description
The active ingredient in Pantoprazole Sodium for Injection, a PPI, is a substituted benzimidazole, sodium 5-(difluoromethoxy)-2-[[(3,4-dimethoxy-2-pyridyl)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
• 1.5 H 2 O, with a molecular weight of 432.37. The structural formula is: Pantoprazole sodium is a white to off-white crystalline powder and is racemic. Pantoprazole sodium 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. The reconstituted solution of Pantoprazole Sodium for Injection is in the pH range 9.5 to 11.5. Pantoprazole Sodium for Injection is supplied for intravenous administration as a sterile lyophilized powder in a single-dose clear glass vial fitted with a rubber stopper and crimp seal. Each vial contains 40 mg pantoprazole (equivalent to 45.1 mg of pantoprazole sodium), and sodium hydroxide to adjust pH. structure
Mechanism of action
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).
How supplied
How Supplied Pantoprazole Sodium for Injection is supplied in a single-dose vial as a white to off-white sterile lyophilized powder for reconstitution containing 40 mg of pantoprazole. Pantoprazole Sodium for Injection is available as follows: NDC Number S trength P ac kage Size 72572-553-10 40 mg pantoprazole 10 vials S torage and Handling Store at 20° to 25°C (68° to 77°F); excursions permitted to 15° to 30°C (59° to 86°F) [see USP Controlled Room Temperature]. Protect from light.
Patient information
Adverse Reactions Advise patients to report to their healthcare provider if they experience any signs or symptoms consistent with:
• Injection Site Reactions [see Warnings and Precautions (5.2) ]
• Acute Tubulointerstitial Nephritis [see Warnings and Precautions (5.3) ]
• C lostridium difficile- Associated Diarrhea [see Warnings and Precautions (5.4) ]
• Bone Fracture [see Warnings and Precautions (5.5) ]
• Severe Cutaneous Adverse Reactions [see Warnings and Precautions (5.6) ]
• Cutaneous and Systemic Lupus Erythematosus [see Warnings and Precautions (5.7) ]
• Hepatic Effects [see Warnings and Precautions (5.8) ]
• Hypomagnesemia and Mineral Metabolism [see Warnings and Precautions (5.9) ] Drug Interactions Advise patients to report to their healthcare provider before they start treatment with any of the following:
• Rilpivirine-containing products [see Contraindications (4) ]
• High-dose methotrexate [see Warnings and Precautions (5.13) ] P re g n a ncy Advise a pregnant woman of the potential risk to a fetus. Advise females of reproductive potential to inform their prescriber of a known or suspected pregnancy [see Use in Specific Populations (8.1) ]. Distributed by Civica, Inc. Lehi, Utah 84043 Manufactured by HIKMA FARMACÊUTICA (PORTUGAL), S.A. Estrada do Rio da Mó, 8, 8A e 8B – Fervença – 2705-906 Terrugem SNT, PORTUGAL PIN676-CIV/1 Revised: October 2024
Label text from the FDA structured product label by Civica, Inc. (revised Oct 31, 2024). Long sections are shortened; the complete label is on DailyMed.
Active ingredients
- Pantoprazole Sodium in 142 products
Pantoprazole Sodium NDC products (142)
| NDC | Strength & form | Labeler | Type |
|---|---|---|---|
| 50090-5361 | Pantoprazole Sodium 20 mg/1 Tablet, Delayed Release | A-S Medication Solutions | ANDA |
| 50090-5378 | Pantoprazole Sodium 40 mg/1 Tablet, Delayed Release | A-S Medication Solutions | ANDA |
| 50090-5379 | Pantoprazole Sodium 40 mg/1 Tablet, Delayed Release | A-S Medication Solutions | ANDA |
| 50090-7512 | Pantoprazole Sodium 40 mg/1 Tablet, Delayed Release | A-S Medication Solutions | ANDA |
| 50090-5794 | Pantoprazole Sodium 40 mg/1 Tablet, Delayed Release | A-S Medication Solutions | ANDA |
| 50090-5793 | Pantoprazole Sodium 20 mg/1 Tablet, Delayed Release | A-S Medication Solutions | ANDA |
| 80425-0406 | Pantoprazole Sodium 20 mg/1 Tablet, Delayed Release | Advanced Rx of Tennessee, LLC | ANDA |
| 80425-0085 | Pantoprazole Sodium 20 mg/1 Tablet, Delayed Release | Advanced Rx of Tennessee, LLC | ANDA |
| 80425-0162 | Pantoprazole Sodium 40 mg/1 Tablet, Delayed Release | Advanced Rx Pharmacy of Tennessee, LLC | ANDA |
| 80425-0133 | Pantoprazole Sodium 40 mg/1 Tablet, Delayed Release | Advanced Rx Pharmacy of Tennessee, LLC | ANDA |
| 80425-0179 | Pantoprazole Sodium 20 mg/1 Tablet, Delayed Release | Advanced Rx Pharmacy of Tennessee, LLC | ANDA |
| 80425-0278 | Pantoprazole Sodium 20 mg/1 Tablet, Delayed Release | Advanced Rx Pharmacy of Tennessee, LLC | ANDA |
| 27241-256 | Pantoprazole Sodium 40 mg/1 For Suspension | Ajanta Pharma USA Inc. | ANDA |
| 62332-071 | Pantoprazole Sodium 40 mg/10mL Powder, For Solution | Alembic Pharmaceuticals Inc. | ANDA |
| 46708-071 | Pantoprazole Sodium 40 mg/10mL Powder, For Solution | Alembic Pharmaceuticals Limited | ANDA |
| 60687-767 | Pantoprazole Sodium 40 mg/1 For Suspension | American Health Packaging | ANDA |
| 60687-725 | Pantoprazole Sodium 20 mg/1 Tablet, Delayed Release | American Health Packaging | ANDA |
| 60687-736 | Pantoprazole Sodium 40 mg/1 Tablet, Delayed Release | American Health Packaging | ANDA |
| 65162-636 | Pantoprazole Sodium 20 mg/1 Tablet, Delayed Release | Amneal Pharmaceuticals LLC | ANDA |
| 65162-637 | Pantoprazole Sodium 40 mg/1 Tablet, Delayed Release | Amneal Pharmaceuticals LLC | ANDA |
| 71610-653 | Pantoprazole Sodium 40 mg/1 Tablet, Delayed Release | Aphena Pharma Solutions - Tennessee, LLC | ANDA |
| 71610-659 | Pantoprazole Sodium 20 mg/1 Tablet, Delayed Release | Aphena Pharma Solutions - Tennessee, LLC | ANDA |
| 43353-027 | Pantoprazole Sodium 40 mg/1 Tablet, Delayed Release | Aphena Pharma Solutions - Tennessee, LLC | ANDA |
| 76420-669 | Pantoprazole Sodium 40 mg/1 Tablet, Delayed Release | Asclemed USA, Inc. | ANDA |
| 76420-668 | Pantoprazole Sodium 20 mg/1 Tablet, Delayed Release | Asclemed USA, Inc. | ANDA |
| 76420-806 | Pantoprazole Sodium 40 mg/1 Tablet, Delayed Release | Asclemed USA, Inc. | ANDA |
| 76420-805 | Pantoprazole Sodium 20 mg/1 Tablet, Delayed Release | Asclemed USA, Inc. | ANDA |
| 76420-674 | Pantoprazole Sodium 40 mg/1 Tablet, Delayed Release | Asclemed USA, Inc. | ANDA |
| 76420-671 | Pantoprazole Sodium 20 mg/1 Tablet, Delayed Release | Asclemed USA, Inc. | ANDA |
| 65862-560 | Pantoprazole Sodium 40 mg/1 Tablet, Delayed Release | Aurobindo Pharma Limited | ANDA |
| 59651-671 | Pantoprazole Sodium 40 mg/1 Granule, Delayed Release | Aurobindo Pharma Limited | ANDA |
| 65862-559 | Pantoprazole Sodium 20 mg/1 Tablet, Delayed Release | Aurobindo Pharma Limited | ANDA |
| 50268-639 | Pantoprazole Sodium 40 mg/1 Tablet, Delayed Release | AvPAK | ANDA |
| 50268-727 | Pantoprazole Sodium 40 mg/1 Tablet, Delayed Release | AvPAK | ANDA |
| 50268-585 | Pantoprazole Sodium 20 mg/1 Tablet, Delayed Release | AvPAK | ANDA |
| 71839-122 | Pantoprazole Sodium 40 mg/10mL Injection, Powder, For Solution | BE Pharmaceuticals Inc. | ANDA |
| 71335-0551 | Pantoprazole Sodium 40 mg/1 Tablet, Delayed Release | Bryant Ranch Prepack | ANDA |
| 71335-0291 | Pantoprazole Sodium 20 mg/1 Tablet, Delayed Release | Bryant Ranch Prepack | ANDA |
| 71335-1165 | Pantoprazole Sodium 20 mg/1 Tablet, Delayed Release | Bryant Ranch Prepack | ANDA |
| 71335-1429 | Pantoprazole Sodium 40 mg/1 Tablet, Delayed Release | Bryant Ranch Prepack | ANDA |
| 71335-1572 | Pantoprazole Sodium 20 mg/1 Tablet, Delayed Release | Bryant Ranch Prepack | ANDA |
| 71335-0310 | Pantoprazole Sodium 40 mg/1 Tablet, Delayed Release | Bryant Ranch Prepack | ANDA |
| 72162-1746 | Pantoprazole Sodium 40 mg/1 Tablet, Delayed Release | Bryant Ranch Prepack | ANDA |
| 35573-428 | Pantoprazole Sodium 40 mg/1 Tablet, Delayed Release | Burel Pharmaceuticals, LLC | ANDA |
| 31722-712 | Pantoprazole Sodium 20 mg/1 Tablet, Delayed Release | Camber Pharmaceuticals, Inc. | ANDA |
| 31722-032 | Pantoprazole Sodium 40 mg/1 Granule, Delayed Release | Camber Pharmaceuticals, Inc. | ANDA |
| 31722-204 | Pantoprazole Sodium 40 mg/1 Injection, Powder, For Solution | Camber Pharmaceuticals, Inc. | ANDA |
| 31722-713 | Pantoprazole Sodium 40 mg/1 Tablet, Delayed Release | Camber Pharmaceuticals, Inc. | ANDA |
| 55154-8336 | Pantoprazole Sodium 40 mg/1 Injection, Powder, For Solution | Cardinal Health 107, LLC | ANDA |
| 55154-7634 | Pantoprazole Sodium 40 mg/1 Tablet, Delayed Release | Cardinal Health 107, LLC | ANDA |
| 55154-4382 | Pantoprazole Sodium 40 mg/1 Tablet, Delayed Release | Cardinal Health 107, LLC | ANDA |
| 55154-4346 | Pantoprazole Sodium 20 mg/1 Tablet, Delayed Release | Cardinal Health 107, LLC | ANDA |
| 55154-4165 | Pantoprazole Sodium 40 mg/1 Tablet, Delayed Release | Cardinal Health 107, LLC | ANDA |
| 55154-2645 | Pantoprazole Sodium 20 mg/1 Tablet, Delayed Release | Cardinal Health 107, LLC | ANDA |
| 55154-0289 | Pantoprazole Sodium 40 mg/1 Tablet, Delayed Release | Cardinal Health 107, LLC | ANDA |
| 62135-533 | Pantoprazole Sodium 20 mg/1 Tablet, Delayed Release | Chartwell RX, LLC | ANDA |
| 62135-534 | Pantoprazole Sodium 40 mg/1 Tablet, Delayed Release | Chartwell RX, LLC | ANDA |
| 67046-0536 | Pantoprazole Sodium 40 mg/1 Tablet, Delayed Release | Coupler LLC | ANDA |
| 67046-0347 | Pantoprazole Sodium 20 mg/1 Tablet, Delayed Release | Coupler LLC | ANDA |
| 73043-020 | Pantoprazole Sodium 40 mg/10mL Injection, Powder, For Solution | Devatis Inc. | ANDA |
| 72189-112 | Pantoprazole Sodium 20 mg/1 Tablet, Delayed Release | DIRECT RX | ANDA |
| 42799-952 | Pantoprazole Sodium 40 mg/1 Granule, Delayed Release | Edenbridge Pharmaceuticals LLC. | ANDA |
| 55150-202 | Pantoprazole Sodium 40 mg/1 Injection, Powder, For Solution | Eugia US LLC | ANDA |
| 65219-385 | Pantoprazole Sodium 40 mg/10mL Injection, Powder, Lyophilized, For Solution | Fresenius Kabi USA, LLC | ANDA |
| 68083-493 | Pantoprazole Sodium 40 mg/10mL Injection, Powder, Lyophilized, For Solution | Gland Pharma Limited | ANDA |
| 51407-613 | Pantoprazole Sodium 40 mg/1 Tablet, Delayed Release | Golden State Medical Supply, Inc. | ANDA |
| 51407-612 | Pantoprazole Sodium 20 mg/1 Tablet, Delayed Release | Golden State Medical Supply, Inc. | ANDA |
| 70010-190 | Pantoprazole Sodium 20 mg/1 Tablet, Delayed Release | Granules Pharmaceuticals Inc. | ANDA |
| 70010-191 | Pantoprazole Sodium 40 mg/1 Tablet, Delayed Release | Granules Pharmaceuticals Inc. | ANDA |
| 85534-0061 | Pantoprazole Sodium 40 mg/1 Tablet, Delayed Release | HAWAII REPACK, INC. | ANDA |
| 85534-0062 | Pantoprazole Sodium 20 mg/1 Tablet, Delayed Release | HAWAII REPACK, INC. | ANDA |
| 85534-0027 | Pantoprazole Sodium 20 mg/1 Tablet, Delayed Release | HAWAII REPACK, INC. | ANDA |
| 85534-0028 | Pantoprazole Sodium 40 mg/1 Tablet, Delayed Release | HAWAII REPACK, INC. | ANDA |
| 62175-617 | Pantoprazole Sodium 40 mg/1 Tablet, Delayed Release | Lannett Company, Inc. | ANDA |
| 62175-618 | Pantoprazole Sodium 20 mg/1 Tablet, Delayed Release | Lannett Company, Inc. | ANDA |
| 0904-6870 | Pantoprazole Sodium 40 mg/1 Tablet, Delayed Release | Major Pharmaceuticals | ANDA |
| 0904-7458 | Pantoprazole Sodium 20 mg/1 Tablet, Delayed Release | Major Pharmaceuticals | ANDA |
| 0904-6474 | Pantoprazole Sodium 40 mg/1 Tablet, Delayed Release | Major Pharmaceuticals | ANDA |
| 71288-600 | Pantoprazole Sodium 40 mg/10mL Injection, Powder, For Solution | Meitheal Pharmaceuticals Inc. | ANDA |
| 51079-051 | Pantoprazole Sodium 40 mg/1 Tablet, Delayed Release | Mylan Institutional Inc. | ANDA |
| 0378-6688 | Pantoprazole Sodium 20 mg/1 Tablet, Delayed Release | Mylan Pharmaceuticals Inc. | ANDA |
| 0378-6689 | Pantoprazole Sodium 40 mg/1 Tablet, Delayed Release | Mylan Pharmaceuticals Inc. | ANDA |
| 0615-8113 | Pantoprazole Sodium 20 mg/1 Tablet, Delayed Release | NCS HealthCare of KY, LLC dba Vangard Labs | ANDA |
| 0615-7629 | Pantoprazole Sodium 40 mg/1 Tablet, Delayed Release | NCS HealthCare of KY, LLC dba Vangard Labs | ANDA |
| 72603-128 | Pantoprazole Sodium 40 mg/10mL Injection, Powder, For Solution | Northstar Rx LLC | ANDA |
| 72603-746 | Pantoprazole Sodium 40 mg/1 Tablet, Delayed Release | NorthStar Rx LLC | ANDA |
| 72603-317 | Pantoprazole Sodium 40 mg/1 Granule, Delayed Release | NorthStar RxLLC | ANDA |
| 51655-797 | Pantoprazole Sodium 40 mg/1 Tablet, Delayed Release | Northwind Health Company, LLC | ANDA |
| 51655-744 | Pantoprazole Sodium 20 mg/1 Tablet, Delayed Release | Northwind Health Company, LLC | ANDA |
| 51655-075 | Pantoprazole Sodium 20 mg/1 Tablet, Delayed Release | Northwind Health Company, LLC | ANDA |
| 72205-180 | Pantoprazole Sodium 40 mg/10mL Injection, Powder, For Solution | Novadoz Pharmaceuticals LLC | ANDA |
| 68071-1963 | Pantoprazole Sodium 40 mg/1 Tablet, Delayed Release | NuCare Pharmaceuticals, Inc. | ANDA |
| 68071-2215 | Pantoprazole Sodium 40 mg/1 Tablet, Delayed Release | NuCare Pharmaceuticals,Inc. | ANDA |
| 68071-5053 | Pantoprazole Sodium 20 mg/1 Tablet, Delayed Release | NuCare Pharmaceuticals,Inc. | ANDA |
| 68071-2285 | Pantoprazole Sodium 20 mg/1 Tablet, Delayed Release | NuCare Pharmaceuticals,Inc. | ANDA |
| 68071-4864 | Pantoprazole Sodium 40 mg/1 Tablet, Delayed Release | NuCare Pharmaceuticals,Inc. | ANDA |
| 68071-4895 | Pantoprazole Sodium 40 mg/1 Tablet, Delayed Release | NuCare Pharmaceuticals,Inc. | ANDA |
| 68071-4917 | Pantoprazole Sodium 40 mg/1 Tablet, Delayed Release | NuCare Pharmaceuticals,Inc. | ANDA |
| 72789-086 | Pantoprazole Sodium 40 mg/1 Tablet, Delayed Release | PD-Rx Pharmaceuticals, Inc. | ANDA |
| 72789-268 | Pantoprazole Sodium 40 mg/1 Tablet, Delayed Release | PD-Rx Pharmaceuticals, Inc. | ANDA |
| 85509-1636 | Pantoprazole Sodium 20 mg/1 Tablet, Delayed Release | PHOENIX RX LLC | ANDA |
| 66794-258 | Pantoprazole Sodium 40 mg/10mL Injection, Powder, For Solution | Piramal Critical Care | ANDA |
| 68788-8644 | Pantoprazole Sodium 40 mg/1 Tablet, Delayed Release | Preferred Pharmaceuticals Inc. | ANDA |
| 63187-974 | Pantoprazole Sodium 40 mg/1 Tablet, Delayed Release | Proficient Rx LP | ANDA |
| 63187-654 | Pantoprazole Sodium 40 mg/1 Tablet, Delayed Release | Proficient Rx LP | ANDA |
| 63187-831 | Pantoprazole Sodium 20 mg/1 Tablet, Delayed Release | Proficient Rx LP | ANDA |
| 63187-837 | Pantoprazole Sodium 20 mg/1 Tablet, Delayed Release | Proficient Rx LP | ANDA |
| 63187-938 | Pantoprazole Sodium 40 mg/1 Tablet, Delayed Release | Proficient Rx LP | ANDA |
| 42708-185 | Pantoprazole Sodium 40 mg/1 Tablet, Delayed Release | QPharma Inc | ANDA |
| 42708-180 | Pantoprazole Sodium 40 mg/1 Tablet, Delayed Release | QPharma Inc | ANDA |
| 42708-104 | Pantoprazole Sodium 40 mg/1 Tablet, Delayed Release | QPharma Inc | ANDA |
| 83008-034 | Pantoprazole Sodium 20 mg/1 Tablet, Delayed Release | Quality Care Products, LLC | ANDA |
| 82009-011 | Pantoprazole Sodium 40 mg/1 Tablet, Delayed Release | Quallent Pharmaceuticals Health LLC | ANDA |
| 82009-010 | Pantoprazole Sodium 20 mg/1 Tablet, Delayed Release | Quallent Pharmaceuticals Health LLC | ANDA |
| 67296-1812 | Pantoprazole Sodium 40 mg/1 Tablet, Delayed Release | Redpharm Drug | ANDA |
| 70518-1298 | Pantoprazole Sodium 40 mg/1 Tablet, Delayed Release | REMEDYREPACK INC. | ANDA |
| 70518-0860 | Pantoprazole Sodium 40 mg/1 Tablet, Delayed Release | REMEDYREPACK INC. | ANDA |
| 70518-1788 | Pantoprazole Sodium 20 mg/1 Tablet, Delayed Release | REMEDYREPACK INC. | ANDA |
| 64980-677 | Pantoprazole Sodium 40 mg/1 Tablet, Delayed Release | Rising Pharma Holdings, Inc. | ANDA |
| 64980-676 | Pantoprazole Sodium 20 mg/1 Tablet, Delayed Release | Rising Pharma Holdings, Inc. | ANDA |
| 48433-081 | Pantoprazole Sodium 40 mg/1 Tablet, Delayed Release | Safecor Health LLC | ANDA |
| 25021-751 | Pantoprazole Sodium 40 mg/10mL Injection, Powder, Lyophilized, For Solution | Sagent Pharmaceuticals | ANDA |
| 0781-3480 | Pantoprazole Sodium 40 mg/10mL Injection, Powder, For Solution | Sandoz Inc | ANDA |
| 85766-224 | Pantoprazole Sodium 20 mg/1 Tablet, Delayed Release | Sportpharm LLC | ANDA |
| 85766-225 | Pantoprazole Sodium 40 mg/1 Tablet, Delayed Release | Sportpharm LLC | ANDA |
| 60760-679 | Pantoprazole Sodium 40 mg/1 Tablet, Delayed Release | St. Mary's Medical Park Pharmacy | ANDA |
| 70095-024 | Pantoprazole Sodium 40 mg/10mL Injection, Powder, Lyophilized, For Solution | Sun Pharmaceutical Industries Limited | ANDA |
| 62756-071 | Pantoprazole Sodium 40 mg/1 Granule, Delayed Release | Sun Pharmaceutical Industries, Inc. | ANDA |
| 62756-129 | Pantoprazole Sodium 40 mg/10mL Injection, Powder, Lyophilized, For Solution | Sun Pharmaceutical Industries, Inc. | ANDA |
| 13668-429 | Pantoprazole Sodium 40 mg/1 Tablet, Delayed Release | Torrent Pharmaceuticals Limited | ANDA |
| 13668-096 | Pantoprazole Sodium 20 mg/1 Tablet, Delayed Release | Torrent Pharmaceuticals Limited | ANDA |
| 87441-065 | Pantoprazole Sodium 20 mg/1 Tablet, Delayed Release | Unit Dose Solutions, Inc. | ANDA |
| 87441-066 | Pantoprazole Sodium 40 mg/1 Tablet, Delayed Release | Unit Dose Solutions, Inc. | ANDA |
| 72865-230 | Pantoprazole Sodium 40 mg/1 Tablet, Delayed Release | XLCare Pharmaceuticals Inc. | ANDA |
| 72865-229 | Pantoprazole Sodium 20 mg/1 Tablet, Delayed Release | XLCare Pharmaceuticals Inc. | ANDA |
| 0338-9648 | Pantoprazole Sodium 80 mg/100mL Injection, Solution | Baxter Healthcare Company | NDA |
| 0338-9646 | Pantoprazole Sodium 40 mg/50mL Injection, Solution | Baxter Healthcare Company | NDA |
| 0338-9644 | Pantoprazole Sodium 40 mg/100mL Injection, Solution | Baxter Healthcare Company | NDA |
| 55154-7477 | Pantoprazole Sodium 40 mg/1 Injection, Powder, Lyophilized, For Solution | Cardinal Health 107, LLC | NDA |
| 72572-553 | Pantoprazole Sodium 40 mg/1 Injection, Powder, Lyophilized, For Solution | Civica, Inc. | NDA |
| 0143-9300 | Pantoprazole Sodium 40 mg/1 Injection, Powder, Lyophilized, For Solution | Hikma Pharmaceuticals USA Inc. | NDA |
| 0143-9284 | Pantoprazole Sodium 40 mg/1 Injection, Powder, Lyophilized, For Solution | Hikma Pharmaceuticals USA Inc. | NDA |
Pantoprazole Sodium recalls
- D-0812-2026 Sep 9, 2026 · Class II · Ongoing
CGMP Deviations - D-0484-2026 Apr 29, 2026 · Class II · Ongoing
Discoloration: Firm received five (5) complaints stating that, "Tablets discolored darker than normal and have lighter-colored spots." - D-1148-2023 Sep 20, 2023 · Class II · Terminated
Lack of Assurance of Sterility: Powder discoloration due to small crack in some vials. - D-0530-2023 Apr 19, 2023 · Class II · Ongoing
CGMP Deviations: Discoloration - D-0068-2023 Nov 30, 2022 · Class II · Terminated
Discoloration - D-0852-2022 May 11, 2022 · Class II · Terminated
CGMP deviations: tablets cracking - D-0506-2021 Jun 2, 2021 · Class II · Terminated
CGMP Deviations: Intermittent exposure to temperature excursion during storage. - D-0251-2021 Feb 17, 2021 · Class III · Terminated
Failed Impurity/Degradation Specifications - D-0340-2018 Feb 14, 2018 · Class I · Terminated
Presence of Particulate Matter: One vial from a lot of Pantoprazole Sodium for Injection (40 mg) contained a piece of glass - D-0470-2017 Feb 15, 2017 · Class III · Terminated
Discoloration: Some vials were found to contain powder with a yellowish-brownish appearance.
Frequently asked questions
What is Pantoprazole Sodium used for?
Pantoprazole Sodium for Injection is a proton pump inhibitor (PPI) indicated in adults for the following: • Short-term treatment (7 to 10 days) of gastroesophageal reflux disease (GERD) associated with a history of erosive esophagitis (EE). ( 1.1 ) • Pathological hypersecretion conditions, including Zollinger-Ellison (ZE) syndrome. ( 1.2 ) 1.1 Gastroesophageal Reflux Disease Associated with a…
What are the side effects of Pantoprazole Sodium?
The following serious adverse reactions are described below and elsewhere in labeling: • Injection Site Reactions [see Warnings and Precautions (5.2) ] • Acute Tubulointerstitial Nephritis [see Warnings and Precautions (5.3) ] • C lostridium difficile- Associated Diarrhea [see Warnings and Precautions (5.4) ] • Bone Fracture [see Warnings and Precautions (5.5) ] • Severe Cutaneous Adverse… See the full label for the complete list.
Who makes Pantoprazole Sodium?
Pantoprazole Sodium is listed by 65 labelers in the FDA NDC directory, including A-S Medication Solutions, Advanced Rx of Tennessee, LLC, Advanced Rx Pharmacy of Tennessee, LLC, Ajanta Pharma USA Inc..
Has Pantoprazole Sodium been recalled?
The FDA enforcement database lists 10 recalls for Pantoprazole Sodium, most recently D-0812-2026 (class ii): CGMP Deviations