PANTOPRAZOLE SODIUM injection, powder, for solution

País: Estados Unidos

Idioma: inglés

Fuente: NLM (National Library of Medicine)

Ingredientes activos:

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

Disponible desde:

Eugia US LLC

Designación común internacional (DCI):

PANTOPRAZOLE SODIUM

Composición:

PANTOPRAZOLE 40 mg

Vía de administración:

INTRAVENOUS

tipo de receta:

PRESCRIPTION DRUG

indicaciones terapéuticas:

Pantoprazole sodium 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 (EE). Safety and efficacy of pantoprazole sodium for injection as a treatment of patients with GERD and a history of EE for more than 10 days have not been demonstrated. Pantoprazole sodium for injection is indicated for the treatment of pathological hypersecretory conditions including Zollinger-Ellison (ZE) Syndrome in adults. - Pantoprazole sodium for injection is contraindicated in patients with known hypersensitivity reactions including anaphylaxis to the formulation or any substituted benzimidazole. Hypersensitivity reactions may include anaphylaxis, anaphylactic shock, angioedema, bronchospasm, acute tubulointerstitial nephritis, and urticaria [see Warnings and Precautions (5.2, 5.4), Adverse Reactions (6)] . - Proton pump inhibitors (PPIs), including  pantoprazole sodium for injection, are contraindicated in pa

Resumen del producto:

Pantoprazole sodium for injection is supplied in a single-dose vial as a sterile, freeze-dried, white to off-white, porous cake or powder for reconstitution containing 40 mg of pantoprazole. Pantoprazole sodium for injection is available as follows: 40 mg per vial:       Single-dose Vials in a carton of 10                                               NDC 55150-202-10       Single-dose Vials in a carton of 25                                               NDC 55150-202-25 Storage and Handling Store at 20° to 25°C (68° to 77°F) [see USP Controlled Room Temperature].     Protect from light. The vial stopper is not made with natural rubber latex.

Estado de Autorización:

Abbreviated New Drug Application

Ficha técnica

PANTOPRAZOLE SODIUM - PANTOPRAZOLE SODIUM INJECTION, POWDER, FOR
SOLUTION
EUGIA US LLC
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HIGHLIGHTS OF PRESCRIBING INFORMATION
THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE
PANTOPRAZOLE SODIUM
FOR INJECTION SAFELY AND EFFECTIVELY. SEE FULL PRESCRIBING INFORMATION
FOR PANTOPRAZOLE
SODIUM FOR INJECTION.
PANTOPRAZOLE SODIUM FOR INJECTION, FOR INTRAVENOUS USE
INITIAL U.S. APPROVAL: 2000
INDICATIONS AND USAGE
Pantoprazole sodium for injection is a proton pump inhibitor (PPI)
indicated in adults for the following:
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)
DOSAGE AND ADMINISTRATION
GERD Associated with EE (2.1)
The recommended adult dosage is 40 mg given once daily by intravenous
infusion for 7 to 10 days.
(2.1)
Pathological Hypersecretion Conditions, Including ZE Syndrome (2.3):
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.
Administration (2.2, 2.4):
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.
DOSAGE FORMS AND STRENGTHS
For Injection: 40 mg pantoprazole freeze-dried powder in a single-dose
vial for reconstitution. (3)
CONTRAINDICATIONS
Patients with a known hypersensitivity to any component of the
formulation or to substituted
benzimidazoles. (4)
Patients receiving rilpivirine-containing products. (4, 7)
WARNINGS AND PRECAUTIONS
Gastric Malignancy: In adults, symptomatic response to therapy with
pantoprazole sodium for injection
does not preclude the presence of gastric malignancy. Consider
additional follow-up and diagnostic
testing. (5.1)
Injection Site Reactions: Thrombophlebitis is associ