PROTONIX- pantoprazoel 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 SODIUM 40 mg

Administration route:

ORAL

Prescription type:

PRESCRIPTION DRUG

Therapeutic indications:

PROTONIX For Delayed-Release Oral Suspension and PROTONIX Delayed-Release Tablets are indicated for: PROTONIX 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 PROTONIX may be considered. Safety of treatment beyond 8 weeks in pediatric patients has not been established. PROTONIX is 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. PROTONIX is indicated for the long-term treatment of pathological hypersecretory conditions, including Zollinger-Ellison syndrome. PROTONIX is contraindicated in patients with known hypersensitivity to any component of the formulation [see Description ( 11 ) ] or any substituted benzi

Product summary:

How Supplied PROTONIX (pantoprazole sodium) Delayed-Release Tablets are supplied as 40 mg yellow, oval biconvex delayed-release tablets imprinted with PROTONIX (brown ink) on one side and are available as follows: Storage Store PROTONIX For Delayed-Release Oral Suspension and PROTONIX Delayed-Release Tablets at 20° to 25°C (68° to 77°F); excursions permitted to 15° to 30°C (59° to 86°F). [See USP Controlled Room Temperature.]

Authorization status:

New Drug Application

Summary of Product characteristics

PROTONIX- PANTOPRAZOEL 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
PROTONIX SAFELY AND EFFECTIVELY. SEE FULL
PRESCRIBING INFORMATION FOR PROTONIX. PROTONIX (PANTOPRAZOLE SODIUM)
DELAYED-RELEASE TABLETS
PROTONIX (PANTOPRAZOLE SODIUM) FOR DELAYED-RELEASE ORAL SUSPENSION
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
INDICATIONS AND USAGE
PROTONIX 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)
Greater than or equal to 15 kg to less than 40 kg
20 mg Once Daily for up to 8 wks
Greater than or equal to 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
See full prescribing information for administration instructions
DOSAGE FORMS AND STRENGTHS
Delayed-Release Tablets, 20 mg and 40 mg (3)
For Delayed-Release Oral Suspension, 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)
ADVERSE REACTIONS
The most frequently occurring adverse reactions are as follows:
For adult use (>2%) are headache, diarrhea, nausea, abdominal pain,
vomiting, flatulence, dizziness, and arthralgia