PANTOPRAZOLE SODIUM injection, powder, lyophilized, for solution

Држава: Сједињене Америчке Државе

Језик: Енглески

Извор: NLM (National Library of Medicine)

Активни састојак:

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

Доступно од:

Hikma Pharmaceuticals USA Inc.

INN (Међународно име):

PANTOPRAZOLE SODIUM

Састав:

PANTOPRAZOLE 40 mg

Пут администрације:

INTRAVENOUS

Тип рецептора:

PRESCRIPTION DRUG

Терапеутске индикације:

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 (5.3), Adverse Reactions (6)] . •     Proton pump inhibitors (PPIs), including Pantoprazole Sodium for Injection, are contraindicated in patients

Резиме производа:

How Supplied Pantoprazole Sodium for Injection is supplied in a single-dose vial as a white to off-white sterile lyophilized powder for reconstitution containing 40 mg of pantoprazole. Pantoprazole Sodium for Injection is available as follows: NDC Number S trength P ac kage Size 0143-9284-10 40 mg pantoprazole 10 vials Store 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.

Статус ауторизације:

New Drug Application

Карактеристике производа

PANTOPRAZOLE SODIUM- PANTOPRAZOLE SODIUM INJECTION, POWDER,
LYOPHILIZED,
FOR SOLUTION
HIKMA PHARMACEUTICALS USA INC.
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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 administered once daily by
intravenous infusion for 7 to 10
days.
Pathological Hypersecretory Conditions, Including ZE Syndrome (2.3):
• The recommended adult dosage is 80 mg administered every 12 hours
by intravenous infusion. See the
full prescribing information for information on how to adjust dosing
for individual patient needs.
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 lyophilized powder in a single-dose
vial for reconstitution (3)
CONTRAINDICATIONS
• Patients with 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