These highlights do not include all the information needed to use PROTONIX safely and effectively. See full prescribing information for PROTONIX. PROTONIX (pantoprazole sodium) delayed-release tablets PROTONIX (pantoprazole sodium) for delayed-release oral suspension Initial U.S. approval: 2000
RECENT MAJOR CHANGES
|
Indications and Usage, Pediatric (1) |
11/2009 |
|
Dosage and Administration, Pediatric (2) |
11/2009 |
|
Contraindications (4) |
11/2009 |
INDICATIONS AND USAGE
PROTONIX is a proton pump inhibitor 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)
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Pathological Hypersecretory Conditions Including Zollinger-Ellison Syndrome (1.3)
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) |
|
|
|
Greater than or equal to 15 kg to less than 40 kg |
20 mg |
Once Daily for up to 8 wks |
|
Greater than or equal to 40 kg |
40 mg |
|
|
Maintenance of Healing of Erosive Esophagitis (2.1) |
|
Adults |
40 mg |
Once Daily |
|
Pathological Hypersecretory Conditions Including Zollinger-Ellison Syndrome (2.1) |
|
Adults |
40 mg |
Twice Daily |
|
|
See full prescribing information for administration instructions
DOSAGE FORMS AND STRENGTHS
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Delayed-Release Tablets, 20 mg and 40 mg (3)
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For Delayed-Release Oral Suspension, 40 mg (3)
CONTRAINDICATIONS
Known hypersensitivity to any component of the formulation or to substituted benzimidazoles (4)
WARNINGS AND PRECAUTIONS
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Symptomatic response does not preclude presence of gastric malignancy (5.1)
-
Atrophic gastritis has been noted with long-term therapy (5.2)
ADVERSE REACTIONS
The most frequently occurring adverse reactions are as follows:
-
For adult use (>2%) are headache, diarrhea, nausea, abdominal pain, vomiting, flatulence, dizziness, and arthralgia. (6)
-
For pediatric use (>4%) are URI, headache, fever, diarrhea, vomiting, rash, and abdominal pain. (6)
To report SUSPECTED ADVERSE REACTIONS, contact Wyeth Pharmaceuticals Inc. at 1-800-934-5556 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch
DRUG INTERACTIONS
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Do not co-administer with atazanavir or nelfinavir (7.1)
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Concomitant warfarin use may require monitoring (7.2)
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May interfere with the absorption of drugs where gastric pH is important for bioavailability (7.3)
-
May produce false-positive urine screen for THC (7.4)
See 17 for PATIENT COUNSELING INFORMATION.
Revised: 8/2010
