PANTOPRAZOLE SODIUM DELAYED RELEASE- pantoprazole sodium tablet

Country: Сједињене Америчке Државе

Језик: Енглески

Извор: NLM (National Library of Medicine)

Активни састојак:

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

Доступно од:

New Horizon Rx Group, LLC

INN (Међународно име):

PANTOPRAZOLE SODIUM

Састав:

PANTOPRAZOLE 40 mg

Пут администрације:

ORAL

Тип рецептора:

PRESCRIPTION DRUG

Терапеутске индикације:

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

Резиме производа:

How Supplied Pantoprazole sodium delayed-release tablets, USP are supplied as 40 mg yellow, round, biconvex, delayed-release tablets imprinted with ‘124’ (black ink) on one side and are available as follows: NDC 58517-420-30    Bottles of 30’s with Child Resistant Caps Storage Store pantoprazole sodium delayed-release tablets at 20° to 25°C (68° to 77°F); excursions permitted between 15° and 30°C (59° and 86°F).  [See USP Controlled Room Temperature.]  Product should be stored and dispensed in the original container.

Статус ауторизације:

Abbreviated New Drug Application

Карактеристике производа

PANTOPRAZOLE SODIUM DELAYED RELEASE- PANTOPRAZOLE SODIUM TABLET
NEW HORIZON RX GROUP, LLC
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HIGHLIGHTS OF PRESCRIBING INFORMATION
THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE
PANTOPRAZOLE SODIUM SAFELY AND
EFFECTIVELY. SEE FULL PRESCRIBING INFORMATION FOR PANTOPRAZOLE SODIUM.
PANTOPRAZOLE SODIUM (PANTOPRAZOLE SODIUM) TABLET FOR ORAL USE.
INITIAL U.S. APPROVAL: 2007
RECENT MAJOR CHANGES
Warnings and Precautions, Concomitant use of Pantoprazole with
Methotrexate (5.8) 05/2012
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
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, 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. (5.4)
Hypomagnesemia has been reported rarely with prolonged treatment with
PPIs (5.5)
ADVERSE REACTIONS
The most frequently occurring adverse reactions are as follows:
For adult use (>2%) are headache, diarrhea, nausea, abdominal pain,
vomiting, flatulence, di