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PROTONIX® IV (pantoprazole sodium for injection)
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PROTONIX® IV Quick Finder
Highlights
Indications and Usage
1 INDICATIONS AND USAGE
1.1 Gastroesophageal Reflux Disease Associated with a History of Erosive Esophagitis
PROTONIX I.V. is indicated for short-term treatment (7 to...
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Dosage and Administration
2 DOSAGE AND ADMINISTRATION
2.1 Dosage for Gastroesophageal Reflux Disease Associated With a History of Erosive Esophagitis
The recommended adult dosage of PROTONIX I...
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Dosage Forms and Strengths
3 DOSAGE FORMS AND STRENGTHS
For Injection: 40 mg of pantoprazole white to off-white freeze-dried powder in a single-dose vial for reconstitution.
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Contraindications
4 CONTRAINDICATIONS
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- PROTONIX I.V. is contraindicated in patients with known hypersensitivity reactions including anaphylaxis to the formulation or any substituted benzimidazole. Hypersensitivity reactions may include...
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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 I.V. 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:
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- Injection Site Reactions [see Warnings and Precautions (5....
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Drug Interactions
7 DRUG INTERACTIONS
Table 2 includes drugs with clinically important drug interactions and interaction with diagnostics when administered concomitantly with PROTONIX I.V. 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 pantoprazole (greater than 240 mg) is limited. Adverse reactions seen in spontaneous reports of overdose generally reflect the known safety profile of...
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Description
11 DESCRIPTION
The active ingredient in PROTONIX® I.V. (pantoprazole sodium), a PPI, is a substituted benzimidazole, sodium 5-(difluoromethoxy)-2-[[(3,4-dimethoxy-2-pyridinyl)methyl] sulfinyl]-1...
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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
14.1 Gastroesophageal Reflux Disease (GERD) Associated with a History of Erosive Esophagitis
A multicenter, double-blind, two-period placebo-...
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How Supplied/Storage and Handling
16 HOW SUPPLIED/STORAGE AND HANDLING
PROTONIX® I.V. (pantoprazole sodium) is supplied in a single-dose vial as a white to off-white freeze-dried powder for reconstitution containing 40 mg of...
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Medication Guide
17 PATIENT COUNSELING INFORMATION
Adverse Reactions
Advise patients to report to their healthcare provider if they experience any signs...
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