PROTONIX DELAYED-RELEASE- pantoprazole 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:

Physicians Total Care, Inc.

INN (International Name):

PANTOPRAZOLE SODIUM

Composition:

PANTOPRAZOLE 20 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 benzimidazo

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: PROTONIX (pantoprazole sodium) Delayed-Release Tablets are supplied as 20 mg yellow oval biconvex delayed-release tablets imprinted with P20 (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 DELAYED-RELEASE- PANTOPRAZOLE SODIUM TABLET, DELAYED RELEASE
PHYSICIANS TOTAL CARE, INC.
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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
Warnings and Precautions, Hypomagnesemia (5.5) 05/2011
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
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
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
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)
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 occurr