Complete SPL Sections
1 INDICATIONS AND USAGE
Indications & Usage Section
Pantoprazole sodium delayed-release tablets are indicated for:
2 DOSAGE AND ADMINISTRATION
Dosage & Administration Section
3 DOSAGE FORMS AND STRENGTHS
Dosage Forms & Strengths Section
20 mg pantoprazole, yellow colored, oval shaped, biconvex, enteric-coated tablets imprinted with ‘I’ and ‘51’ with brown ink on one side and plain on other side. 40 mg pantoprazole, yellow colored, oval shaped, biconvex, enteric-coated tablets imprinted with ‘I’ and ‘52’ with brown ink on one side and plain on other side.
4 CONTRAINDICATIONS
Contraindications Section
Pantoprazole sodium 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 sodium, are contraindicated in patients receiving rilpivirine-containing products [see Drug Interactions (7) ] .
5 WARNINGS AND PRECAUTIONS
Warnings And Precautions Section
6 ADVERSE REACTIONS
Adverse Reactions Section
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) ] Severe Cutaneous Adverse Reactions [see Warnings and Precautions (5.5) ] Cutaneous and Systemic Lupus Erythematosus [see Warnings and Precautions (5.6) ] Cyanocobalamin (Vitamin B-12) Deficiency [see Warnings and Precautions (5.7) ] Hypomagnesemia and Mineral Metabolism [see Warnings and Precautions (5.8) ] Fundic Gland Polyps [see Warnings and Precautions (5.10) ]
7 DRUG INTERACTIONS
Drug Interactions Section
Table 4 includes drugs with clinically important drug interactions and interaction with diagnostics when administered concomitantly with pantoprazole sodium 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 Sodium and Interactions with Diagnostics Antiretrovirals Clinical Impact: The effect of PPIs on antiretroviral drugs is variable. The clinical importance and the mechanisms behind these interactions are not always known. Decreased exposure of some antiretroviral drugs (e.g., rilpivirine atazanavir, and nelfinavir) when used concomitantly with pantoprazole may reduce antiviral effect and promote the development of drug resistance. Increased exposure of other antiretroviral drugs (e.g., saquinavir) when used concomitantly with pantoprazole may increase toxicity of the antiretroviral drugs . There are other antiretroviral drugs which do not result in clinically relevant interactions with pantoprazole. Intervention: Rilpivirine-containing products: Concomitant use with pantoprazole sodium are contraindicated [see Contraindications (4) ] . See prescribing information. Atazanavir: See prescribing information for atazanavir for dosing information. Nelfinavir: Avoid concomitant use with pantoprazole sodium. 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 sodium. 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 (5.13) ] . Intervention: A temporary withdrawal of pantoprazole sodium 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 sodium and MMF. Use pantoprazole sodium 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 (5.11) , Clinical Pharmacology (12.2) ] . Intervention: Temporarily stop pantoprazole sodium 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 (5.12) ] . Intervention: An alternative confirmatory method should be considered to verify positive results.
8 USE IN SPECIFIC POPULATIONS
Use In Specific Populations Section
10 OVERDOSAGE
Overdosage Section
Experience in patients taking very high doses of pantoprazole sodium (greater than 240 mg) is limited. Spontaneous post-marketing reports of overdose are generally within the known safety profile of pantoprazole sodium. 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 sodium occurs, call your Poison Control Center at 1-800-222-1222 for current information on the management of poisoning or overdosage.
11 DESCRIPTION
Description Section
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 molecular formula is C 16 H 14 F 2 N 3 NaO 4 S x 1.5 H 2 O, with a molecular weight of 432.4. The structural formula is: Pantoprazole sodium USP is a white to off-white powder and is racemic. Pantoprazole has weakly basic and acidic properties. Pantoprazole sodium USP 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 sodium USP is supplied as a delayed-release tablet, available in two strengths 20 mg pantoprazole (equivalent to 22.56 mg of pantoprazole sodium USP) and 40 mg pantoprazole (equivalent to 45.1 mg of pantoprazole sodium USP). Pantoprazole sodium delayed-release tablets, USP contains the following inactive ingredients: calcium stearate, crospovidone, ferric oxide, hydroxypropyl cellulose, hypromellose, mannitol, methacrylic acid and ethyl acrylate copolymer dispersion, sodium carbonate, and triethyl citrate. The tablets are imprinted with brown ink containing ammonium hydroxide, iron oxide black, iron oxide red, iron oxide yellow, isopropyl alcohol, N-butyl alcohol, propylene glycol, and shellac glaze in ethanol. Pantoprazole sodium delayed-release tablets (40 mg and 20 mg) complies USP dissolution test 3.
12 CLINICAL PHARMACOLOGY
Clinical Pharmacology Section
13 NONCLINICAL TOXICOLOGY
Nonclinical Toxicology Section
14 CLINICAL STUDIES
Clinical Studies Section
Pantoprazole sodium delayed-release tablets were used in the following clinical trials.
16 HOW SUPPLIED/STORAGE AND HANDLING
How Supplied Section
How Supplied Pantoprazole Sodium Delayed-Release Tablets USP, 20 mg are yellow colored, oval shaped, biconvex, enteric-coated tablets imprinted with ‘I’ and ‘51’ with brown ink on one side and plain on other side. Bottles of 90 NDC 65862-559-90 Bottles of 1,000 NDC 65862-559-99 Cartons of 100 (10 x 10) Unit-dose Tablets NDC 65862-559-10 Pantoprazole Sodium Delayed-Release Tablets USP, 40 mg are yellow colored, oval shaped, biconvex, enteric-coated tablets imprinted with ‘I’ and ‘52’ with brown ink on one side and plain on other side. Bottles of 90 NDC 65862-560-90 Bottles of 500 NDC 65862-560-05 Bottles of 1,000 NDC 65862-560-99 Cartons of 100 (10 x 10) Unit-dose Tablets NDC 65862-560-10 Storage Store at 20° to 25°C (68° to 77°F). [See USP Controlled Room Temperature.]
17 PATIENT COUNSELING INFORMATION
Information For Patients Section
Advise the patient to read the FDA-approved patient labeling Medication Guide. Gastric Malignancy Advise patients to return to their healthcare provider if they have a suboptimal response or an early symptomatic relapse [see Warnings and Precautions (5.1) ] . Acute Tubulointerstitial Nephritis Advise 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 Diarrhea Advise patients to immediately call their healthcare provider if they experience diarrhea that does not improve [see Warnings and Precautions (5.3) ] . Bone Fracture Advise patients to report any fractures, especially of the hip, wrist or spine, to their healthcare provider [see Warnings and Precautions (5.4) ] . Severe Cutaneous Adverse Reactions Advise patients to discontinue pantoprazole sodium and immediately call their healthcare provider for further evaluation [see Warnings and Precautions (5.5) ] . 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 (5.6) ] . 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 sodium for longer than 3 years [see Warnings and Precautions (5.7) ] . Hypomagnesemia and Mineral Metabolism Advise patients to report any clinical symptoms that may be associated with hypomagnesemia, hypocalcemia, and/or hypokalemia, to their healthcare provider, if they have been receiving pantoprazole sodium for at least 3 months [see Warnings and Precautions (5.8) ] . Drug Interactions Instruct patients to inform their healthcare provider of any other medications they are currently taking, including rilpivirine-containing products [see Contraindications (4) ], digoxin [see Warnings and Precautions (5.8) ] and high dose methotrexate [see Warnings and Precautions (5.13) ] . Pregnancy Advise a pregnant woman of the potential risk to a fetus. Advise females of reproductive potential to inform their healthcare provider of a known or suspected pregnancy [see Use in Specific Populations (8.1) ] . Administration Do not split, crush, or chew pantoprazole sodium delayed-release tablets. Swallow pantoprazole sodium delayed-release tablets whole, with or without food in the stomach. Concomitant administration of antacids does not affect the absorption of pantoprazole sodium delayed-release tablets. Take a missed dose as soon as possible. If it is almost time for the next dose, skip the missed dose and take the next dose at the regular scheduled time. Do not take 2 doses at the same time. Brands listed are the trademarks of their respective owners. Dispense with Medication Guide available at: www.aurobindousa.com/medication-guides Distributed by: Aurobindo Pharma USA, Inc. 279 Princeton-Hightstown Road East Windsor, NJ 08520 Manufactured by: Aurobindo Pharma Limited Hyderabad-500 032, India Revised: 12/2025
SPL MEDGUIDE SECTION
SPL MEDGUIDE SECTION
Dispense with Medication Guide available at: www.aurobindousa.com/medication-guides MEDICATION GUIDE Pantoprazole Sodium Delayed-Release Tablets, USP (pan toe' pra zole soe' dee um) What is the most important information I should know about pantoprazole sodium delayed-release tablets? You should take pantoprazole sodium delayed-release tablets exactly as prescribed, at the lowest dose possible and for the shortest time needed. Pantoprazole sodium delayed-release tablets may help your acid-related symptoms, but you could still have serious stomach problems. Talk with your doctor. Pantoprazole sodium delayed-release tablets 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 sodium delayed-release tablets, may develop a kidney problem called acute tubulointerstitial nephritis that can happen at any time during treatment with pantoprazole sodium delayed-release tablets. 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 sodium delayed-release tablets, 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. Low magnesium and other mineral levels in your body can happen in people who have taken pantoprazole sodium delayed-release tablets 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. Talk to your doctor about your risk of these serious side effects. Pantoprazole sodium delayed-release tablets can have other serious side effects. See “What are the possible side effects of pantoprazole sodium delayed-release tablets?” What are p antoprazole sodium delayed-release tablets? A prescription medicine called a proton pump inhibitor (PPI) used to reduce the amount of acid in your stomach. In adults, pantoprazole sodium delayed-release tablets are 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 sodium delayed-release tablets 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 sodium delayed-release tablets are 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 sodium delayed-release tablets are used for: up to 8 weeks for the healing and symptom relief of EE. It is not known if pantoprazole sodium delayed-release tablets are safe if used longer than 8 weeks in children. Pantoprazole sodium delayed-release tablets are not for use in children under 5 years of age. It is not known if pantoprazole sodium delayed-release tablets are safe and effective in children for treatment other than EE. Do not take pantoprazole sodium delayed-release tablets if you are: allergic to pantoprazole sodium, any other PPI medicine, or any of the ingredients in pantoprazole sodium delayed-release tablets. 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 sodium delayed-release tablets, tell your doctor about all of your medical conditions, including if you: have low magnesium levels, low calcium levels and low potassium levels in your blood. are pregnant or plan to become pregnant. Pantoprazole sodium delayed-release tablets may harm your unborn baby. Tell your doctor if you become pregnant or think you may be pregnant during treatment with pantoprazole sodium delayed-release tablets. are breastfeeding or plan to breastfeed. Pantoprazole sodium can pass into your breast milk. Talk with your doctor about the best way to feed your baby if you take pantoprazole sodium delayed-release tablets. Tell your doctor about all 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 sodium delayed-release tablets? Take pantoprazole sodium delayed-release tablets exactly as prescribed by your doctor. Do not split, chew, or crush pantoprazole sodium delayed-release tablets. Swallow pantoprazole sodium delayed-release tablets whole, with or without food. Tell your doctor if you are not able to swallow your pantoprazole sodium delayed-release tablet. You may use antacids while taking pantoprazole sodium delayed-release tablets. If you miss a dose of pantoprazole sodium delayed-release tablets, 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 sodium delayed-release tablets, 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 sodium delayed-release tablets? Pantoprazole sodium delayed-release tablets can cause serious side effects, including: See “What is the most important information I should know about pantoprazole sodium delayed-release tablets?” Low vitamin B-12 levels in your body can happen in people who have taken pantoprazole sodium delayed-release tablets 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. 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. Severe skin reactions. Pantoprazole sodium delayed-release tablets can cause rare but severe skin reactions that may affect any part of your body. These serious skin reactions may need to be treated in a hospital and may be life threatening: Skin rash which may have blistering, peeling or bleeding on any part of your skin (including your lips, eyes, mouth, nose, genitals, hands or feet). You may also have fever, chills, body aches, shortness of breath, or enlarged lymph nodes. Stop taking pantoprazole sodium delayed-release tablets and call your doctor right away. These symptoms may be the first sign of a severe skin reaction. The most common side effects of pantoprazole sodium delayed-release tablets in adults include: headache, diarrhea, nausea, stomach-area (ab...
PACKAGE LABEL-PRINCIPAL DISPLAY PANEL - 20 mg (90 Tablets Bottle)
PACKAGE LABEL.PRINCIPAL DISPLAY PANEL
NDC 65862-559-90 Rx only Pantoprazole Sodium Delayed-Release Tablets, USP 20 mg* PHARMACIST: Dispense the Medication Guide provided separately to each patient. AUROBINDO 90 Tablets
PACKAGE LABEL-PRINCIPAL DISPLAY PANEL - 20 mg Blister Carton (10 x 10 Unit-dose)
PACKAGE LABEL.PRINCIPAL DISPLAY PANEL
NDC 65862-559-10 Rx only Pantoprazole Sodium Delayed-Release Tablets, USP 20 mg* PHARMACIST: Dispense the Medication Guide provided separately to each patient. AUROBINDO 100 (10 x 10) Unit-dose Tablets
PACKAGE LABEL-PRINCIPAL DISPLAY PANEL - 40 mg (90 Tablets Bottle)
PACKAGE LABEL.PRINCIPAL DISPLAY PANEL
NDC 65862-560-90 Rx only Pantoprazole Sodium Delayed-Release Tablets, USP 40 mg* PHARMACIST: Dispense the Medication Guide provided separately to each patient. AUROBINDO 90 Tablets
PACKAGE LABEL-PRINCIPAL DISPLAY PANEL - 40 mg Blister Carton (10 x 10 Unit-dose)
PACKAGE LABEL.PRINCIPAL DISPLAY PANEL
NDC 65862-560-10 Rx only Pantoprazole Sodium Delayed-Release Tablets, USP 40 mg* PHARMACIST: Dispense the Medication Guide provided separately to each patient. AUROBINDO 100 (10 x 10) Unit-dose Tablets