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

Ország: Egyesült Államok

Nyelv: angol

Forrás: NLM (National Library of Medicine)

Aktív összetevők:

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

Beszerezhető a:

Cardinal Health 107, LLC

Az alkalmazás módja:

INTRAVENOUS

Recept típusa:

PRESCRIPTION DRUG

Terápiás javallatok:

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

Termék összefoglaló:

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: Available overbagged with 5 vials per bag, NDC 55154-4225-5. 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.

Engedélyezési státusz:

New Drug Application

Termékjellemzők

PROTONIX I.V.- PANTOPRAZOLE SODIUM INJECTION, POWDER, FOR SOLUTION
CARDINAL HEALTH 107, LLC
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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
Warnings and Precautions, Fundic Gland Polyps (5.11)
06/2018
INDICATIONS AND USAGE
PROTONIX is a proton pump inhibitor (PPI) indicated in adults for the
following:
•
•
DOSAGE AND ADMINISTRATION
GERD Associated with EE (2.1)
•
Pathological Hypersecretion Conditions, Including ZE Syndrome (2.3):
•
Administration (2.2, 2.4):
•
•
•
DOSAGE FORMS AND STRENGTHS
•
CONTRAINDICATIONS
•
•
WARNINGS AND PRECAUTIONS
•
•
•
•
•
•
®
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