PANTOPRAZOLE SODIUM DELAYED-RELEASE delayed release 40 mg/1
pantoprazole sodium granules · SUSPENSION · Cipla USA Inc.
PANTOPRAZOLE SODIUM DELAYED-RELEASE delayed release is a suspension containing pantoprazole sodium granules at 40 mg/1, taken oral. Manufactured by Cipla USA Inc..
Key Facts
- Brand Name
- PANTOPRAZOLE SODIUM DELAYED-RELEASE delayed release
- Generic Name
- pantoprazole sodium granules
- NDC Code (Product)
69097-531- Manufacturer
- Cipla USA Inc.
- Strength
- 40 mg/1
- Dosage Form
- SUSPENSION
- Route
- ORAL
- Marketing Status
- Application #
- ANDA217458
- Marketing Start
- 04/03/2025
Recall History
No Recall HistorySide Effects Reported to FDA
FDA FAERS database · These are reported events, not confirmed side effects
Full Prescribing Information
Indications & Usage
1 INDICATIONS AND USAGE Pantoprazole sodium for delayed-release oral suspension is indicated for: Pantoprazole sodium is a proton pump inhibitor (PPI) indicated for the following: Short-Term Treatment of Erosive Esophagitis Associated with Gastroesophageal Reflux Disease (GERD) ( 1.1 ) Maintenance of Healing of Erosive Esophagitis ( 1.2 ) Pathological Hypersecretory Conditions Including Zollinger-Ellison (ZE) Syndrome ( 1.3 ) 1.1 Short-Term Treatment of Erosive Esophagitis Associated With Gastroesophageal Reflux Disease (GERD) Pantoprazole sodium for delayed-release oral suspension 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 for delayed-release oral suspension 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 for delayed-release oral suspension is indicated for maintenance of healing of EE and reducti…
Dosage & Administration
2 DOSAGE AND ADMINISTRATION Indication Dose Frequency Short-Term Treatment of Erosive Esophagitis Associated With GERD ( 2.1 ) Adults 40 mg Once Daily for up to 8 wks Children (5 years and older) ≥ 40 kg 40 mg Once Daily for up to 8 wks Maintenance of Healing of Erosive Esophagitis ( 2.1 ) Adults 40 mg Once Daily* Pathological Hypersecretory Conditions Including Zollinger-Ellison Syndrome ( 2.1 ) Adults 40 mg Twice Daily * Controlled studies did not extend beyond 12 months See full prescribing information for administration instructions 2.1 Recommended Dosing Schedule Pantoprazole sodium is supplied as delayed-release granules in packets for preparation of oral suspensions. The recommended dosages are outlined in Table 1. Table 1: Recommended Dosing Schedule for Pantoprazole Sodium for Delayed-Release Oral Suspension 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) ≥ 40 kg 40 mg Once daily for up to 8 weeks Maintenance of Healing of Erosive Esophagitis Adults 40 mg Once Daily*** Pathological Hypersecretory Conditions Including Zollinger-Ellison Syndrome Adults 40 mg Twi…
Contraindications
4 CONTRAINDICATIONS Pantoprazole sodium for delayed-release oral suspension 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 for delayed-release oral suspension, 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 )
Drug Interactions
7 DRUG INTERACTIONS Table 4 includes drugs with clinically important drug interactions and interaction with diagnostics when administered concomitantly with pantoprazole and instructions for preventing or managing them. Consult the labeling of concomitantly used drugs to obtain further information about interactions with PPIs. Table 4: Clinically Relevant Interactions Affecting Drugs Co-Administered with Pantoprazole and Interactions with Diagnostics Antiretrovirals Clinical Impact: The effect of PPIs on antiretroviral drugs is variable. The clinical importance and the mechanisms behind these interactions are not always known. Decreased exposure of some antiretroviral drugs (e.g., rilpivirine atazanavir, and nelfinavir) when used concomitantly with pantoprazole may reduce antiviral effect and promote the development of drug resistance. Increased exposure of other antiretroviral drugs (e.g., saquinavir) when used concomitantly with pantoprazole may increase toxicity of the antiretroviral drugs . There are other antiretroviral drugs which do not result in clinically relevant interactions with pantoprazole. Intervention: Rilpivirine-containing products: Concomitant use with pantoprazo…
Adverse Reactions
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 )] 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 )] Most common adverse reactions are: For adult use (>2%): headache, diarrhea, nausea, abdominal pain, vomiting, flatulence, dizziness, and arthralgia. ( 6.1 ) For pediatric use (>4%): URI, headache, fever, diarrhea, vomiting, rash, and abdominal pain. ( 6.1 ) To report SUSPECTED ADVERSE REACTIONS, contact Cipla Ltd. at 1-866-604-3268 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch . 6.1 Clinical Trials Experience The adverse reaction profiles for pantoprazole sodium for delayed-release oral suspension and p…
Frequently Asked Questions
What is PANTOPRAZOLE SODIUM DELAYED-RELEASE delayed release used for?
PANTOPRAZOLE SODIUM DELAYED-RELEASE delayed release contains pantoprazole sodium granules. It is a suspension taken oral. Consult your doctor for specific uses.
Is PANTOPRAZOLE SODIUM DELAYED-RELEASE delayed release a controlled substance?
PANTOPRAZOLE SODIUM DELAYED-RELEASE delayed release is not classified as a controlled substance by the DEA.
What is the generic name for PANTOPRAZOLE SODIUM DELAYED-RELEASE delayed release?
The generic name for PANTOPRAZOLE SODIUM DELAYED-RELEASE delayed release is pantoprazole sodium granules. There are no other listed brand versions of pantoprazole sodium granules.
What is the NDC code for PANTOPRAZOLE SODIUM DELAYED-RELEASE delayed release 40 mg/1?
The NDC (National Drug Code) for PANTOPRAZOLE SODIUM DELAYED-RELEASE delayed release 40 mg/1 is 69097-531, listed by Cipla USA Inc..
Not medical advice. Always consult your doctor or pharmacist before making any medication decisions.
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