Země: Spojené státy
Jazyk: angličtina
Zdroj: NLM (National Library of Medicine)
PANTOPRAZOLE SODIUM (UNII: 6871619Q5X) (PANTOPRAZOLE - UNII:D8TST4O562)
Lake Erie Medical DBA Quality Care Products LLC
PANTOPRAZOLE SODIUM
PANTOPRAZOLE 20 mg
PRESCRIPTION DRUG
New Drug Application
PANTOPRAZOLE SODIUM DELAYED-RELEASE- PANTOPRAZOLE SODIUM TABLET, DELAYED RELEASE LAKE ERIE MEDICAL DBA QUALITY CARE PRODUCTS LLC ---------- HIGHLIGHTS OF PRESCRIBING INFORMATION THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE PANTOPRAZOLE SODIUM DELAYED-RELEASE TABLETS SAFELY AND EFFECTIVELY. SEE FULL PRESCRIBING INFORMATION FOR PANTOPRAZOLE SODIUM DELAYED-RELEASE T ABLE TS. PANTOPRAZOLE SODIUM DELAYED-RELEASE TABLETS INITIAL U.S. APPROVAL: 2000 RECENT MAJOR CHANGES Dosage and Administration, Recommended Dosing Schedule (2.1) 1/2015 Contraindications (4) 1/2015 Warnings and Precautions, Acute Interstitial Nephritis (5.3) 1/2015 INDICATIONS AND USAGE Pantoprazole sodium is a proton pump inhibitor indicated for the following: Short-Term Treatment of Erosive Esophagitis Associated with Gastroesophageal Reflux Disease (GERD) (1.1) Maintenance of Healing of Erosive Esophagitis (1.2) Pathological Hypersecretory Conditions Including Zollinger-Ellison Syndrome (1.3) DOSAGE AND ADMINISTRATION INDIC ATIO N DO SE FREQUENCY * SHORT-TERM TREATMENT OF EROSIVE ESOPHAGITIS ASSOCIATED WITH GERD (2.1) Adults 40 mg Once Daily for up to 8 wks Children (5 years and older) ≥ 15 kg to < 40 kg 20 mg Once Daily for up to 8 wks ≥ 40 kg 40 mg MAINTENANCE OF HEALING OF EROSIVE ESOPHAGITIS (2.1) Adults 40 mg Once Daily PATHOLOGICAL HYPERSECRETORY CONDITIONS INCLUDING ZOLLINGER-ELLISON SYNDROME (2.1) Adults 40 mg Twice Daily See full prescribing information for administration instructions DOSAGE FORMS AND STRENGTHS Delayed-Release Tablets, 20 mg and 40 mg (3) CONTRAINDICATIONS Known hypersensitivity to any component of the formulation or to substituted benzimidazoles (4) WARNINGS AND PRECAUTIONS Symptomatic response does not preclude presence of gastric malignancy (5.1) Atrophic gastritis has been noted with long-term therapy (5.2) Acute interstitial nephritis has been observed in patients taking PPIs. (5.3) Cyanocobalamin (vitamin B-12) Deficiency: Daily long-term use (e.g., longer than 3 years) may lead to malabsorptio Přečtěte si celý dokument