Pantoprazole Sodium DR 40 mg/1
Pantoprazole Sodium DR · TABLET, DELAYED RELEASE · Direct_Rx
Pantoprazole Sodium DR is a tablet, delayed release containing pantoprazole sodium dr at 40 mg/1, taken oral. Manufactured by Direct_Rx.
Key Facts
- Brand Name
- Pantoprazole Sodium DR
- Generic Name
- Pantoprazole Sodium DR
- NDC Code (Product)
72189-514- Manufacturer
- Direct_Rx
- Strength
- 40 mg/1
- Dosage Form
- TABLET, DELAYED RELEASE
- Route
- ORAL
- Marketing Status
- Application #
- ANDA202882
- Marketing Start
- 09/11/2023
Recall History
Aidapak Services, LLC
Labeling:Label Mixup; PANTOPRAZOLE SODIUM DR Tablet, 20 mg may be potentially mislabeled as FOSINOPRIL SODIUM, Tablet, 20 mg, NDC 60505251102, Pedigree: AD70690_1, EXP: 5/29/2014.
Aidapak Services, LLC
Labeling: Label Mixup: PANTOPRAZOLE SODIUM DR, Tablet, 20 mg may be potentially mislabeled as one of the following drugs: HYOSCYAMINE SULFATE SL, Tablet, 0.125 mg, NDC 00574025001, Pedigree: AD60272_16, EXP: 5/22/2014; MULTIVITAMIN/MULTIMINERAL, Tablet, 0 mg, NDC 65162066810, Pedigree: AD73646_13, EXP: 5/30/2014.
Aidapak Services, LLC
Labeling:Label Mixup; PANTOPRAZOLE SODIUM DR Tablet, 40 mg may be potentially mislabeled as SENNOSIDES, Tablet, 8.6 mg, NDC 60258095001, Pedigree: AD37063_17, EXP: 5/13/2014.
Aidapak Services, LLC
Labeling: Label Mixup; PANTOPRAZOLE SODIUM DR, Tablet, 20 mg may be potentially mislabel as NORTRIPTYLINE HCL, Capsule, 75 mg, NDC 00093081301, Pedigree: W003694, EXP: 6/26/2014.
Aidapak Services, LLC
Labeling:Label Mixup; PANTOPRAZOLE SODIUM DR, Tablet, 20 mg may be potentially mislabeled as DRONEDARONE HCL, Tablet, 400 mg, NDC 00024414260, Pedigree: AD52778_52, EXP: 5/20/2014.
Full Prescribing Information
Indications & Usage
Pantoprazole Sodium Delayed-Release Tablets are indicated for: 1.1 Short-Term Treatment of Erosive Esophagitis Associated With Gastroesophageal Reflux Disease (GERD) Pantoprazole Sodium Delayed-Release Tablet 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 sodium delayed-release tablets 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 Sodium Delayed-Release Tablets are 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 Syndrome Pantoprazole Sodium Delayed-Release Tablets are indicated for the long-term treatment of pathological hypersecretory conditions, including Zollinger-Ellison (ZE) Syndrome.
Dosage & Administration
2.1 Recommended Dosing Schedule Pantoprazole sodium is supplied as delayed-release tablets. The recommended dosages are outlined in Table 1. Table 1: Recommended Dosing Schedule for Pantoprazole Sodium Delayed-Release Tablets Indication Dose Frequency Short-Term Treatment of Erosive Esophagitis Associated With GERD Adults 40 mg Once daily for up to 8 weeks* Children (5 years and older) ≥ 15 kg to < 40 kg ≥ 40 kg 20 mg Once daily for up to 8 weeks 40 mg Maintenance of Healing of Erosive Esophagitis Adults 40 mg Once daily*** Pathological Hypersecretory Conditions Including Zollinger-Ellison Syndrome Adults 40 mg Twice daily ** * For adult patients who have not healed after 8 weeks of treatment, an additional 8-week course of pantoprazole sodium delayed-release tablets may be considered. ** 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. *** Controlled studies did not extend beyond 12 months. 2.2 Administration Instructions Directions for method of administration for each dosage form are presented in Table 2. Table 2: Administration Instructions Formulation Route I…
Contraindications
• Pantoprazole sodium delayed-release tablets are 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 delayed-release tablets, are contraindicated in patients receiving rilpivirine-containing products [see Drug Interactions ( 7)].
Drug Interactions
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 pantoprazol…
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)] • 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)] 6.1 Clinical Trials Experience The adverse reaction profiles for Pantoprazole Sodium For Delayed-Release Oral Suspension and Pantoprazole Sodium Delayed-Release Tablets are similar. 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 patien…
Frequently Asked Questions
What is Pantoprazole Sodium DR used for?
Pantoprazole Sodium DR contains Pantoprazole Sodium DR. It is a tablet, delayed release taken oral. Consult your doctor for specific uses.
Is Pantoprazole Sodium DR a controlled substance?
Pantoprazole Sodium DR is not classified as a controlled substance by the DEA.
What is the generic name for Pantoprazole Sodium DR?
The generic name for Pantoprazole Sodium DR is Pantoprazole Sodium DR. There are no other listed brand versions of Pantoprazole Sodium DR.
What is the NDC code for Pantoprazole Sodium DR 40 mg/1?
The NDC (National Drug Code) for Pantoprazole Sodium DR 40 mg/1 is 72189-514, listed by Direct_Rx.
Not medical advice. Always consult your doctor or pharmacist before making any medication decisions.
Data from openFDA · Public domain (CC0 1.0)