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PROTONIX®(pantoprazole sodium)

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PROTONIX® Quick Finder

HIGHLIGHTS OF PRESCRIBING INFORMATION

These highlights do not include all the...
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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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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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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 biconvex tablets...
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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,...
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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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6 ADVERSE REACTIONS

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

  • Acute Tubulointerstitial Nephritis [see

    6.1 Clinical Trials Experience

    ...
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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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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 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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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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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

PROTONIX Delayed-Release Tablets were used in the following clinical trials.

14.1 Erosive Esophagitis (EE) Associated with Gastroesophageal Reflux...

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16 HOW SUPPLIED/STORAGE AND HANDLING

How Supplied

PROTONIX (pantoprazole sodium) Delayed-Release Tablets are supplied as yellow, oval...

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MEDICATION GUIDE
PROTONIX (pro-TAH-nix)
(pantoprazole sodium)...
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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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This product's label may have been updated. For current full prescribing information, please visit www.pfizer.com.

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