PROTONIX I.V.- pantoprazole sodium injection, powder, for solution

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

PANTOPRAZOLE SODIUM (UNII: 6871619Q5X) (PANTOPRAZOLE - UNII:D8TST4O562)

Available from:

Cardinal Health

Administration route:

INTRAVENOUS

Prescription type:

PRESCRIPTION DRUG

Therapeutic indications:

PROTONIX I.V. for Injection is indicated for short-term treatment (7 to 10 days) of adult patients with gastroesophageal reflux disease (GERD) and a history of erosive esophagitis. Safety and efficacy of PROTONIX I.V. for Injection as a treatment of patients with GERD and a history of erosive esophagitis for more than 10 days have not been demonstrated. PROTONIX I.V. for Injection is indicated for the treatment of pathological hypersecretory conditions including Zollinger-Ellison Syndrome in adults. PROTONIX is contraindicated in patients with known hypersensitivity reactions including anaphylaxis to the formulation [see Warnings and Precautions (5.2)] or any substituted benzimidazole. Hypersensitivity reactions may include anaphylaxis, anaphylactic shock, angioedema, bronchospasm, acute interstitial nephritis, and urticaria [see Adverse Reactions (6) ]. Teratogenic Effects Reproduction studies have been performed in rats at intravenous doses up to 20 mg/kg/day (4 times the recommended human dose based on

Product summary:

PROTONIX I.V. (pantoprazole sodium) for Injection is supplied as a freeze-dried powder containing 40 mg of pantoprazole per vial. PROTONIX I.V. for Injection is available as follows: NDC 0008-0941-02 – Package of 10. Each vial (NDC 0008-0941-01) contains PROTONIX I.V. for Injection (each vial containing 40 mg pantoprazole). NDC 0008-0941-03 – Package of 25. Each vial (NDC 0008-0941-01) contains PROTONIX I.V. for Injection (each vial containing 40 mg pantoprazole). Store PROTONIX I.V. for Injection vials at 20° - 25°C (68° - 77°F); excursions permitted to 15°- 30°C (59° - 86°F) [see USP Controlled Room Temperature] . Protect from light. The reconstituted product should not be frozen.

Authorization status:

New Drug Application

Summary of Product characteristics

PROTONIX I.V.- PANTOPRAZOLE SODIUM INJECTION, POWDER, FOR SOLUTION
CARDINAL HEALTH
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HIGHLIGHTS OF PRESCRIBING INFORMATION
THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE
PROTONIX I.V. SAFELY AND EFFECTIVELY. SEE
FULL PRESCRIBING INFORMATION FOR PROTONIX I.V.
PROTONIX I.V. (PANTOPRAZOLE SODIUM) FOR INJECTION, FOR INTRAVENOUS USE
INITIAL U.S. APPROVAL: 2000
RECENT MAJOR CHANGES
Contraindications (4)
1/2015
Warnings and Precautions, Acute Interstitial Nephritis (5.5)
1/2015
INDICATIONS AND USAGE
PROTONIX is a proton pump inhibitor indicated for the following:
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DOSAGE AND ADMINISTRATION
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DOSAGE FORMS AND STRENGTHS
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CONTRAINDICATIONS
Known hypersensitivity to any component of the formulation or to
substituted benzimidazoles (4)
WARNINGS AND PRECAUTIONS
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ADVERSE REACTIONS
The most frequently occurring adverse reactions are as follows:
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TO REPORT SUSPECTED ADVERSE REACTIONS, CONTACT PFIZER INC. AT
1-800-438-1985 OR FDA AT 1-800-FDA-
1088 OR WWW.FDA.GOV/MEDWATCH.
DRUG INTERACTIONS
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®
Short-term Treatment (7 to 10 days) of Gastroesophageal Reflux Disease
(GERD) Associated With a History of
Erosive Esophagitis (1.1)
Pathological Hypersecretion Conditions Including Zollinger-Ellison
Syndrome (1.2)
The recommended adult dose is 40 mg pantoprazole given once daily by
intravenous infusion for 7 to 10 days. (2.1)
PROTONIX I.V. (pantoprazole sodium) for Injection: 40 mg pantoprazole
(3)
Symptomatic response to therapy with pantoprazole does not preclude
the presence of gastric malignancy (5.1)
Anaphylaxis has been reported with use of intravenous pantoprazole
(5.2)
Thrombophlebitis is associated with the administration of intravenous
pantoprazole (5.3)
Zinc supplementation should be considered in patients treated with
PROTONIX I.V. for Injection who are prone to
zinc deficiency. Caution should be used when other EDTA containing
products are also co-administered
intravenously (5.4)
Acute interstitial nephritis has been observed in patients