Drugplain

Protonix Delayed-Release 40 mg/1

PANTOPRAZOLE SODIUM · GRANULE, DELAYED RELEASE · Wyeth Pharmaceuticals LLC, a subsidiary of Pfizer Inc.

No Recall History
Plain English

Protonix (pantoprazole) is a prescription medication that reduces stomach acid and is used to treat conditions like acid reflux and ulcers. It comes as delayed-release granules that you take by mouth.

Key Facts

Brand Name
Protonix Delayed-Release
Generic Name
PANTOPRAZOLE SODIUM
NDC Code (Product)
0008-0844
Manufacturer
Wyeth Pharmaceuticals LLC, a subsidiary of Pfizer Inc.
Strength
40 mg/1
Dosage Form
GRANULE, DELAYED RELEASE
Route
ORAL
Marketing Status
Application #
NDA022020
Marketing Start
02/29/2008

Recall History

No Recall History

Side Effects Reported to FDA

FDA FAERS database · These are reported events, not confirmed side effects

chronic kidney disease24,461 reports
acute kidney injury13,784 reports
fatigue11,135 reports
renal failure10,851 reports
nausea10,254 reports
pain9,635 reports
dyspnoea9,263 reports
diarrhoea9,159 reports
drug ineffective8,621 reports
headache7,981 reports

Full Prescribing Information

Source: FDA Drug Label (SPL)For healthcare professionals

Indications & Usage

1 INDICATIONS AND USAGE PROTONIX For Delayed-Release Oral Suspension and PROTONIX Delayed-Release Tablets are indicated for: PROTONIX 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) PROTONIX 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 PROTONIX may be considered. Safety of treatment beyond 8 weeks in pediatric patients has not been established. 1.2 Maintenance of Healing of Erosive Esophagitis PROTONIX is indicated for maintenance of healing of EE and reduction in relapse rates of daytime and nighttime heartburn symptoms in adult patients with GERD. Controlled studies did not…

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) ≥ 15 kg to < 40 kg 20 mg Once Daily for up to 8 wks ≥ 40 kg 40 mg Maintenance of Healing of Erosive Esophagitis ( 2.1 ) Adults 40 mg Once Daily Controlled studies did not extend beyond 12 months Pathological Hypersecretory Conditions Including Zollinger-Ellison Syndrome ( 2.1 ) Adults 40 mg Twice Daily See full prescribing information for administration instructions 2.1 Recommended Dosing Schedule PROTONIX is supplied as delayed-release granules in packets for preparation of oral suspensions or as delayed-release tablets. The recommended dosages are outlined in Table 1. Table 1: Recommended Dosing Schedule for PROTONIX Indication Dose Frequency Short-Term Treatment of Erosive Esophagitis Associated With GERD Adults 40 mg Once daily for up to 8 weeks For adult patients who have not healed after 8 weeks of treatment, an additional 8-week course of PROTONIX may be considered. Children (5 years and older) ≥ 15 kg to < 40 kg 20 mg Once daily for up to 8 weeks ≥ 40 kg 40 mg Maintenance of Healin…

Contraindications

4 CONTRAINDICATIONS • PROTONIX 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 PROTONIX, 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 PROTONIX 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 PROTONIX 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 PROTONIX is …

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 Pfizer Inc at 1-800-438-1985 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch . 6.1 Clinical Trials Experience The adverse reaction profiles for PROTONIX (pantoprazole sodium) For Delayed-Releas…

Frequently Asked Questions

What is Protonix Delayed-Release used for?

Protonix (pantoprazole) is a prescription medication that reduces stomach acid and is used to treat conditions like acid reflux and ulcers. It comes as delayed-release granules that you take by mouth.

Is Protonix Delayed-Release a controlled substance?

Protonix Delayed-Release is not classified as a controlled substance by the DEA.

What is the generic name for Protonix Delayed-Release?

The generic name for Protonix Delayed-Release is PANTOPRAZOLE SODIUM. There are 10 other brand versions of PANTOPRAZOLE SODIUM.

What is the NDC code for Protonix Delayed-Release 40 mg/1?

The NDC (National Drug Code) for Protonix Delayed-Release 40 mg/1 is 0008-0844, listed by Wyeth Pharmaceuticals LLC, a subsidiary of Pfizer Inc..

Product NDC

0008-0844

Package NDC

0008-0844-02

Other Protonix Delayed-Release Dosages

Other Pantoprazole Brands

See all →

Not medical advice. Always consult your doctor or pharmacist before making any medication decisions.

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