Country: United States
Language: English
Source: NLM (National Library of Medicine)
PANTOPRAZOLE SODIUM (UNII: 6871619Q5X) (PANTOPRAZOLE - UNII:D8TST4O562)
Wyeth Pharmaceuticals LLC, a subsidiary of Pfizer Inc.
PANTOPRAZOLE SODIUM
PANTOPRAZOLE 40 mg in 10 mL
INTRAVENOUS
PRESCRIPTION DRUG
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. - PROTONIX I.V. 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 PROTONIX I.V., are contraindicated in patients receiving rilpivirine-containing products [see Drug Interactions (7)] . Risk Summary Available data fro
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: 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.
New Drug Application
PROTONIX I.V.- PANTOPRAZOLE SODIUM INJECTION, POWDER, FOR SOLUTION WYETH PHARMACEUTICALS LLC, A SUBSIDIARY OF PFIZER INC. ---------- 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, Severe Cutaneous Adverse Reactions (5.7) 03/2022 Hypomagnesemia and Mineral Metabolism (5.10) 03/2022 INDICATIONS AND USAGE PROTONIX 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 PROTONIX I.V. does not preclude the presence of gastric malignancy Read the complete document