PANTOPRAZOLE SODIUM- pantoprazole tablet, delayed release

Land: Vereinigte Staaten

Sprache: Englisch

Quelle: NLM (National Library of Medicine)

Wirkstoff:

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

Verfügbar ab:

NuCare Pharmaceuticals, Inc.

INN (Internationale Bezeichnung):

PANTOPRAZOLE SODIUM

Zusammensetzung:

PANTOPRAZOLE 20 mg

Verabreichungsweg:

ORAL

Verschreibungstyp:

PRESCRIPTION DRUG

Anwendungsgebiete:

Pantoprazole Sodium Delayed-Release Tablets, USP are indicated for: Pantoprazole Sodium Delayed-Release Tablet, USP is indicated in adults and pediatric patients five years of age and older 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 may be considered. Safety of treatment beyond 8 weeks in pediatric patients has not been established. Pantoprazole Sodium Delayed-Release Tablets, USP are indicated for maintenance of healing of erosive esophagitis and reduction in relapse rates of daytime and nighttime heartburn symptoms in adult patients with GERD. Controlled studies did not extend beyond 12 months. Pantoprazole Sodium Delayed-Release Tablets USP are indicated for the long-term treatment of pathological hypersecretory conditions, including Zollinger-Ellison syndrome. Sodium Delayed-Release Tablets are contraindicated in patient

Produktbesonderheiten:

How Supplied Pantoprazole Sodium Delayed-Release Tablets, USP are supplied as 20 mg yellow to pale yellow, oval, biconvex, delayed-release tablets imprinted H125 on one side with black ink and plain on the other side. They are supplied as follows: Bottles of 30 NDC 68071-3038-3 Bottles of 60 NDC 68071-3038-6 Storage Store pantoprazole sodium delayed-release tablets, USP at 20 to 25°C (68 to 77°F) [see USP Controlled Room Temperature].

Berechtigungsstatus:

Abbreviated New Drug Application

Fachinformation

PANTOPRAZOLE SODIUM- PANTOPRAZOLE TABLET, DELAYED RELEASE
NUCARE PHARMACEUTICALS, INC.
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HIGHLIGHTS OF PRESCRIBING INFORMATION
THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE
PANTOPRAZOLE SODIUM DELAYED-
RELEASE TABLETS SAFELY AND EFFECTIVELY. SEE FULL PRESCRIBING
INFORMATION FOR PANTOPRAZOLE SODIUM
DELAYED-RELEASE TABLETS.
PANTOPRAZOLE SODIUM DELAYED-RELEASE TABLETS, FOR ORAL USE
INITIAL U.S. APPROVAL: 2000
RECENT MAJOR CHANGES
Dosage and Administration, Recommended Dosing Schedule ( 2.1) 12/2014
Contraindications ( 4) 12/2014
Warnings and Precautions, Acute Interstitial Nephritis ( 5.3) 12/2014
INDICATIONS AND USAGE
Pantoprazole sodium delayed-release tablet, USP 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
SHORT-TERM TREATMENT OF EROSIVE ESOPHAGITIS ASSOCIATED WITH GERD (
2.1)
Adults 40 mg Once Daily for up to 8 wks
Children (5 years and older)
≥ 15 kg to < 40 kg 20 mg Once Daily for up to 8 wks
≥ 40 kg 40 mg
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
*Controlled studies did not extend beyond 12 months
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)
• Acute gastritis has been observed in patients taking PPIs. ( 5.3)
• Cyanocobalamin (vitamin B-12) Defici