País: Estados Unidos
Idioma: inglés
Fuente: NLM (National Library of Medicine)
PANTOPRAZOLE SODIUM (UNII: 6871619Q5X) (PANTOPRAZOLE - UNII:D8TST4O562)
Rebel Distributors Corp
PANTOPRAZOLE SODIUM
PANTOPRAZOLE 40 mg
ORAL
PRESCRIPTION DRUG
Pantoprazole sodium delayed-release tablets are indicated for: Pantoprazole sodium delayed-release tablets are indicated in adults for the short-term treatment (up to 8 weeks) in the healing and symptomatic relief of erosive esophagitis. For those adult patients who have not healed after 8 weeks of treatment, an additional 8 week course of pantoprazole sodium delayed-release tablets may be considered. Safety of treatment beyond 8 weeks in pediatric patients has not been established. Pediatric indication and usage information in pediatric patients ages five years and older with erosive esophagitis associated with GERD is approved for Wyeth Pharmaceuticals Inc.’s pantoprazole sodium delayed-release tablets. However, due to Wyeth Pharmaceuticals Inc.’s marketing exclusivity rights, this drug product is not labeled with that pediatric information. Pantoprazole sodium delayed-release tablets are indicated for maintenance of healing of erosive esophagitis and reduction in relapse rates of daytime and nighttime hear
How Supplied Pantoprazole sodium NDC 21695-771-30 delayed-release tablets USP are available as: 40 mg - yellow, oval shaped tablets imprinted with black ink on one side of the tablet “93/12” and blank on the other side. They are available in bottles of 30. Storage Store at 20° to 25°C (68° to 77°F) [See USP Controlled Room Temperature]. Dispense in a tight, light-resistant container as defined in the USP, with a child-resistant closure (as required).
Abbreviated New Drug Application
PANTOPRAZOLE SODIUM- PANTOPRAZOLE SODIUM TABLET, DELAYED RELEASE REBEL DISTRIBUTORS CORP ---------- 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 FOR ORAL USE 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 Pantoprazole sodium delayed-release tablets are 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 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) 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) ADVERSE REACTIONS The most frequently occurring adverse reactions are as follows: For adult use (> 2%) a Leer el documento completo