PANTOPRAZOLE SODIUM injection, powder, lyophilized, for solution

국가: 미국

언어: 영어

출처: NLM (National Library of Medicine)

유효 성분:

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

제공처:

Hikma Pharmaceuticals USA Inc.

INN (국제 이름):

PANTOPRAZOLE SODIUM

구성:

PANTOPRAZOLE 40 mg

관리 경로:

INTRAVENOUS

처방전 유형:

PRESCRIPTION DRUG

치료 징후:

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

제품 요약:

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.

승인 상태:

New Drug Application

제품 특성 요약

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