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PROTONIX® IV (pantoprazole sodium for injection)

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PROTONIX® IV Quick Finder

HIGHLIGHTS OF PRESCRIBING INFORMATION

These highlights do not include all the...
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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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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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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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4 CONTRAINDICATIONS

  • 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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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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6 ADVERSE REACTIONS

The following serious adverse reactions are described below and elsewhere in labeling:

  • Hypersensitivity and Severe Skin Reactions [see

    6.1 Clinical...

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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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8 USE IN SPECIFIC POPULATIONS

8.1 Pregnancy

Risk Summary

Available data from...

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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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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]-1H-...

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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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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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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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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 pantoprazole.

PROTONIX I.V....

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17 PATIENT COUNSELING INFORMATION

Adverse Reactions

Advise patients to report to their healthcare provider if they experience any signs or...

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This product's labeling may have been updated. For the most recent prescribing information, please visit www.pfizer.com.

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