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:

Wyeth Pharmaceuticals LLC, a subsidiary of Pfizer Inc.

INN (International Name):

PANTOPRAZOLE SODIUM

Composition:

PANTOPRAZOLE 40 mg in 10 mL

Administration route:

INTRAVENOUS

Prescription type:

PRESCRIPTION DRUG

Therapeutic indications:

PROTONIX I.V. is indicated for short-term treatment (7 to 10 days) of adult patients with gastroesophageal reflux disease (GERD) and a history of erosive esophagitis (EE). Safety and efficacy of PROTONIX I.V. as a treatment of patients with GERD and a history of EE for more than 10 days have not been demonstrated. PROTONIX I.V. is indicated for the treatment of pathological hypersecretory conditions including Zollinger-Ellison (ZE) Syndrome in adults. Risk Summary Available data from published observational studies did not demonstrate an association of major malformations or other adverse pregnancy outcomes with pantoprazole. In animal reproduction studies, no evidence of adverse development outcomes was observed with pantoprazole. Reproduction studies have been performed in rats at intravenous doses up to 20 mg/kg/day (4 times the recommended human dose) and rabbits at intravenous doses up to 15 mg/kg/day (6 times the recommended human dose) with administration of pantoprazole during organogenesis in pregnan

Product summary:

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. is available as follows: NDC 0008-0923-51 40 mg/vial pantoprazole Single vial NDC 0008-0923-55 40 mg/vial pantoprazole 10 vials NDC 0008-0923-60 40 mg/vial pantoprazole 25 vials Storage and Handling Store PROTONIX I.V. at 20° to 25°C (68° to 77°F); excursions permitted to 15° to 30°C (59° to 86°F) [see USP Controlled Room Temperature]. Protect from light.

Authorization status:

New Drug Application

Summary of Product characteristics

PROTONIX I.V.- PANTOPRAZOLE SODIUM INJECTION, POWDER, FOR SOLUTION
WYETH PHARMACEUTICALS LLC, A SUBSIDIARY OF PFIZER INC.
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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
INDICATIONS AND USAGE
PROTONIX is a proton pump inhibitor (PPI) indicated in adults for the
following:
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DOSAGE AND ADMINISTRATION
GERD Associated with EE (2.1)
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Pathological Hypersecretion Conditions, Including ZE Syndrome (2.3):
•
Administration (2.2, 2.4):
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•
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DOSAGE FORMS AND STRENGTHS
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CONTRAINDICATIONS
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•
WARNINGS AND PRECAUTIONS
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•
•
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®
Short-term treatment (7 to 10 days) of gastroesophageal reflux disease
(GERD) associated with a
history of Erosive Esophagitis (EE). (1.1)
Pathological hypersecretion conditions including Zollinger-Ellison
(ZE) Syndrome. (1.2)
The recommended adult dosage is 40 mg given once daily by intravenous
infusion for 7 to 10 days.
(2.1)
The recommended adult dosage is 80 mg administered every 12 hours by
intravenous infusion. For
information on how to adjust dosing for individual patient needs, see
the full prescribing information.
Only for intravenous infusion.
The intravenous infusion can be administered over 2 minutes or 15
minutes.
For information on how to prepare and administer for each indication,
see the full prescribing
information.
For Injection: 40 mg pantoprazole freeze-dried powder in a single-dose
vial for reconstitution. (3)
Patients with a known hypersensitivity to any component of the
formulation or to substituted
benzimidazoles. (4)
Patients receiving rilpivirine-containing products. (4,7)
Gastric Malignancy: In adults, symptomatic response to therapy with
PROTONIX I.V. does not preclude
the presence of gastric malignancy. Consider additional follow-up and
diagnostic testing. (5.1)
Injection Sit