PANTOPRAZOLE SODIUM tablet, delayed release

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

PANTOPRAZOLE SODIUM (UNII: 6871619Q5X) (PANTOPRAZOLE - UNII:D8TST4O562)

Available from:

Rebel Distributors Corp

INN (International Name):

PANTOPRAZOLE SODIUM

Composition:

PANTOPRAZOLE 40 mg

Administration route:

ORAL

Prescription type:

PRESCRIPTION DRUG

Therapeutic indications:

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

Product summary:

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).

Authorization status:

Abbreviated New Drug Application

Summary of Product characteristics

PANTOPRAZOLE SODIUM- PANTOPRAZOLE SODIUM TABLET, DELAYED RELEASE
REBEL DISTRIBUTORS CORP
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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