PANTOPRAZOLE SODIUM tablet, delayed release

País: Estats Units

Idioma: anglès

Font: NLM (National Library of Medicine)

ingredients actius:

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

Disponible des:

WOCKHARDT LIMITED

Designació comuna internacional (DCI):

PANTOPRAZOLE SODIUM

Composición:

PANTOPRAZOLE SODIUM 20 mg

Vía de administración:

ORAL

tipo de receta:

PRESCRIPTION DRUG

indicaciones terapéuticas:

Pantoprazole and its metabolites are excreted in the milk of rats. Pantoprazole excretion in human milk has been detected in a study of a single nursing mother after a single 40 mg oral dose. The clinical relevance of this finding is not known. Many drugs which are excreted in human milk have a potential for serious adverse reactions in nursing infants. Based on the potential for tumorigenicity shown for pantoprazole in rodent carcinogenicity studies, a decision should be made whether to discontinue nursing or to discontinue the drug, taking into account the benefit of the drug to the mother. The effectiveness of pantoprazole sodium delayed-release tablets for treating symptomatic GERD in pediatric patients has not been established. Information describing use in pediatric patients 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 produc

Resumen del producto:

How Supplied Pantoprazole sodium delayed-release tablets, USP are supplied as 20 mg yellow colored, biconvex oval shaped tablets plain on one side and imprinted with “W433” (brown ink) on other side. HDPE bottle of 30 tablets.............................NDC 64679-433-01 HDPE bottle of 90 tablets.............................NDC 64679-433-04 HDPE bottle of 1000 tablets.........................NDC 64679-433-02 Unit dose packages of 100 tablets…..........NDC 64679-433-03 HDPE bottle of 100 tablets...........................NDC 64679-433-05 Pantoprazole sodium delayed-release tablets, USP are supplied as 40 mg yellow colored, biconvex oval shaped tablets plain on one side and imprinted with “W434” (brown ink) on other side. HDPE bottle of 30 tablets............................NDC 64679-434-01 HDPE bottle of 90 tablets............................NDC 64679-434-04 HDPE bottle of 1000 tablets........................NDC 64679-434-02 Unit dose packages of 100 tablets.............NDC 64679-434-03 HDPE bottle of 100 tablets..........................NDC 64679-434-05 Storage Store at 20°-25°C (68°-77°F); [See USP Controlled Room Temperature].

Estat d'Autorització:

Abbreviated New Drug Application

Fitxa tècnica

PANTOPRAZOLE SODIUM - PANTOPRAZOLE SODIUM TABLET, DELAYED RELEASE
WOCKHARDT LIMITED
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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
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 tablet 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
INDICATION
DOSE
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)
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%) are headache, di