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PROTONIX® (pantoprazole sodium)
If you provide additional keywords, you may be able to browse through our database of Scientific Response Documents.
Our scientific content is evidence-based, scientifically balanced and non-promotional. It undergoes rigorous internal medical review and is updated regularly to reflect new information.
PROTONIX® Quick Finder
Highlights
Indications and Usage
1 INDICATIONS AND USAGE
PROTONIX For Delayed-Release Oral Suspension and PROTONIX Delayed-Release Tablets are indicated for:
1.1 Short-Term Treatment of Erosive...
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Dosage and Administration
2 DOSAGE AND ADMINISTRATION
2.1 Recommended Dosing Schedule
PROTONIX is supplied as delayed-release granules in packets for preparation of oral suspensions or as...
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Dosage Forms and Strengths
3 DOSAGE FORMS AND STRENGTHS
Delayed-Release Tablets:
- •
- 40 mg pantoprazole, yellow oval biconvex tablets imprinted with PROTONIX (brown ink) on one side
- •
- 20 mg pantoprazole, yellow oval...
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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...
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Warnings and Precautions
5 WARNINGS AND PRECAUTIONS
5.1 Presence of Gastric Malignancy
In adults, symptomatic response to therapy with PROTONIX does not preclude the presence of gastric...
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Adverse Reactions
6 ADVERSE REACTIONS
The following serious adverse reactions are described below and elsewhere in labeling:
- •
- Acute Tubulointerstitial Nephritis [see Warnings and...
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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.
...
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Use in Specific Populations
8 USE IN SPECIFIC POPULATIONS
8.1 Pregnancy
Risk Summary
Available data from...
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Overdosage
10 OVERDOSAGE
Experience in patients taking very high doses of PROTONIX (greater than 240 mg) is limited. Spontaneous post-marketing reports of overdose are generally within the known safety profile of PROTONIX.
...
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Description
11 DESCRIPTION
The active ingredient in PROTONIX (pantoprazole sodium) For Delayed-Release Oral Suspension and PROTONIX (pantoprazole sodium) Delayed-Release Tablets, a PPI, is a substituted benzimidazole, sodium 5-(...
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Clinical Pharmacology
12 CLINICAL PHARMACOLOGY
12.1 Mechanism of Action
Pantoprazole is a PPI that suppresses the final step in gastric acid production by covalently binding to the (H...
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Nonclinical Toxicology
13 NONCLINICAL TOXICOLOGY
13.1 Carcinogenesis, Mutagenesis, Impairment of Fertility
In a 24-month carcinogenicity study, Sprague-Dawley rats were treated orally with...
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Clinical Studies
14 CLINICAL STUDIES
PROTONIX Delayed-Release Tablets were used in the following clinical trials.
14.1 Erosive Esophagitis (EE) Associated with Gastroesophageal Reflux...
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How Supplied/Storage and Handling
16 HOW SUPPLIED/STORAGE AND HANDLING
How Supplied
PROTONIX (pantoprazole sodium) Delayed-Release Tablets are supplied as yellow, oval...
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Instructions For Use
Instructions for Use
Instructions for Use
PROTONIX (pro-TAH-nix)
(pantoprazole sodium)
for delayed-release oral suspension
PROTONIX for delayed-release oral suspension (PROTONIX for oral suspension):...
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Other
This product's label may have been updated. For the most recent prescribing information, please visit www.pfizer.com.
For Medical...
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Report Adverse Event
To report an adverse event related to a Pfizer product and you are not part of a clinical trial* for this product, click the link below to submit your information: Pfizer Safety Reporting Site
*If you are involved in a clinical trial for either product, adverse events should be reported to your coordinating study site.
If you cannot use the above website to report an adverse event related to a Pfizer product, please call Pfizer Medical Information at (800) 438-1985.
You may also contact the U.S. Food and Drug Administration (FDA) directly to report adverse events or product quality concerns either online at www.fda.gov/medwatchor by calling
(800)-332-1088.
(800)-332-1088.