PANTOPRAZOLE SODIUM tablet delayed release

Šalis: Jungtinės Valstijos

kalba: anglų

Šaltinis: NLM (National Library of Medicine)

Veiklioji medžiaga:

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

Prieinama:

St Marys Medical Park Pharmacy

INN (Tarptautinis Pavadinimas):

PANTOPRAZOLE SODIUM

Sudėtis:

PANTOPRAZOLE 20 mg

Recepto tipas:

PRESCRIPTION DRUG

Autorizacija statusas:

Abbreviated New Drug Application

Prekės savybės

PANTOPRAZOLE SODIUM- PANTOPRAZOLE SODIUM TABLET, DELAYED RELEASE
ST MARYS MEDICAL PARK PHARMACY
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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
(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)