দেশ: মার্কিন যুক্তরাষ্ট্র
ভাষা: ইংরেজি
সূত্র: NLM (National Library of Medicine)
PANTOPRAZOLE SODIUM (UNII: 6871619Q5X) (PANTOPRAZOLE - UNII:D8TST4O562)
Cardinal Health
INTRAVENOUS
PRESCRIPTION DRUG
PROTONIX I.V. 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. Safety and efficacy of PROTONIX I.V. for Injection as a treatment of patients with GERD and a history of erosive esophagitis for more than 10 days have not been demonstrated. PROTONIX I.V. for Injection is indicated for the treatment of pathological hypersecretory conditions including Zollinger-Ellison Syndrome in adults. PROTONIX is contraindicated in patients with known hypersensitivity reactions including anaphylaxis to the formulation [see Warnings and Precautions (5.2)] or any substituted benzimidazole. Hypersensitivity reactions may include anaphylaxis, anaphylactic shock, angioedema, bronchospasm, acute interstitial nephritis, and urticaria [see Adverse Reactions (6) ]. Teratogenic Effects Reproduction studies have been performed in rats at intravenous doses up to 20 mg/kg/day (4 times the recommended human dose based on
PROTONIX I.V. (pantoprazole sodium) for Injection is supplied as a freeze-dried powder containing 40 mg of pantoprazole per vial. PROTONIX I.V. for Injection is available as follows: NDC 0008-0941-02 – Package of 10. Each vial (NDC 0008-0941-01) contains PROTONIX I.V. for Injection (each vial containing 40 mg pantoprazole). NDC 0008-0941-03 – Package of 25. Each vial (NDC 0008-0941-01) contains PROTONIX I.V. for Injection (each vial containing 40 mg pantoprazole). Store PROTONIX I.V. for Injection vials at 20° - 25°C (68° - 77°F); excursions permitted to 15°- 30°C (59° - 86°F) [see USP Controlled Room Temperature] . Protect from light. The reconstituted product should not be frozen.
New Drug Application
PROTONIX I.V.- PANTOPRAZOLE SODIUM INJECTION, POWDER, FOR SOLUTION CARDINAL HEALTH ---------- 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 Contraindications (4) 1/2015 Warnings and Precautions, Acute Interstitial Nephritis (5.5) 1/2015 INDICATIONS AND USAGE PROTONIX is a proton pump inhibitor indicated for the following: • • DOSAGE AND ADMINISTRATION • DOSAGE FORMS AND STRENGTHS • CONTRAINDICATIONS Known hypersensitivity to any component of the formulation or to substituted benzimidazoles (4) WARNINGS AND PRECAUTIONS • • • • • • • • ADVERSE REACTIONS The most frequently occurring adverse reactions are as follows: • TO REPORT SUSPECTED ADVERSE REACTIONS, CONTACT PFIZER INC. AT 1-800-438-1985 OR FDA AT 1-800-FDA- 1088 OR WWW.FDA.GOV/MEDWATCH. DRUG INTERACTIONS • • • • ® Short-term Treatment (7 to 10 days) of Gastroesophageal Reflux Disease (GERD) Associated With a History of Erosive Esophagitis (1.1) Pathological Hypersecretion Conditions Including Zollinger-Ellison Syndrome (1.2) The recommended adult dose is 40 mg pantoprazole given once daily by intravenous infusion for 7 to 10 days. (2.1) PROTONIX I.V. (pantoprazole sodium) for Injection: 40 mg pantoprazole (3) Symptomatic response to therapy with pantoprazole does not preclude the presence of gastric malignancy (5.1) Anaphylaxis has been reported with use of intravenous pantoprazole (5.2) Thrombophlebitis is associated with the administration of intravenous pantoprazole (5.3) Zinc supplementation should be considered in patients treated with PROTONIX I.V. for Injection who are prone to zinc deficiency. Caution should be used when other EDTA containing products are also co-administered intravenously (5.4) Acute interstitial nephritis has been observed in patients সম্পূর্ণ নথি পড়ুন