देश: संयुक्त राज्य
भाषा: अंग्रेज़ी
स्रोत: NLM (National Library of Medicine)
PANTOPRAZOLE SODIUM (UNII: 6871619Q5X) (PANTOPRAZOLE - UNII:D8TST4O562)
St Marys Medical Park Pharmacy
PANTOPRAZOLE SODIUM
PANTOPRAZOLE 20 mg
PRESCRIPTION DRUG
Abbreviated New Drug Application
PANTOPRAZOLE SODIUM- PANTOPRAZOLE SODIUM TABLET, DELAYED RELEASE ST MARYS MEDICAL PARK PHARMACY ---------- HIGHLIGHTS OF PRESCRIBING INFORMATION THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE PANTOPRAZOLE SODIUM DELAYED-RELEASE TABLETS, USP SAFELY AND EFFECTIVELY. SEE FULL PRESCRIBING INFORMATION FOR PANTOPRAZOLE SODIUM DELAYED-RELEASE TABLETS, USP. PANTOPRAZOLE SODIUM DELAYED-RELEASE TABLETS, USP INITIAL U.S. APPROVAL: 2000 RECENT MAJOR CHANGES Indications and Usage, Pediatric (1) 11/2009 Dosage and Administration, Pediatric (2) 11/2009 Contraindications (4) 11/2009 Warnings and Precautions, Bone Fracture (5.4) 09/2010 INDICATIONS AND USAGE (1) Pantoprazole sodium delayed-release tablet is a proton pump inhibitor indicated for the following: (1) 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) (1) DOSAGE AND ADMINISTRATION INDIC ATIO N DO SE FREQUENCY See full prescribing information for administration instructions SHORT-TERM TREATMENT OF EROSIVE ESOPHAGITIS ASSOCIATED WITH GERD ( 2.1 ) Adults 40 mg Once Daily for up to 8 wks 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 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) (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) Bone Fracture Long-term and multiple daily dose PPI therapy may be associated with an increased risk for osteoporosis-related fractures of the hip, wrist or spine. (5) (5) ADVERSE REACTIONS The most frequently occurring adverse reactions are as follows: (6) पूरा दस्तावेज़ पढ़ें