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Protonix

[pantoprazole sodium]


Indications & Dosage
INDICATIONS AND USAGE

Short-Term Treatment of Erosive Esophagitis Associated With Gastroesophageal Reflux Disease (GERD) PROTONIX (pantoprazole sodium) Delayed-Release Tablets are indicated for the short-term treatment (up to 8 weeks) in the healing and symptomatic relief of erosive esophagitis. For those patients who have not healed after 8 weeks of treatment, an additional 8 week course of PROTONIX may be considered.

Maintenance of Healing of Erosive Esophagitis

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PROTONIX Delayed-Release Tablets are indicated for maintenance of healing of erosive esophagitis and reduction in relapse rates of daytime and nighttime heartburn symptoms in patients with gastroesophageal reflux disease (GERD). Controlled studies did not extend beyond 12 months.

Pathological Hypersecretory Conditions Including Zollinger-Ellison Syndrome

PROTONIX Delayed-Release Tablets are indicated for the long-term treatment of pathological hypersecretory conditions, including Zollinger-Ellison syndrome.

DOSAGE AND ADMINISTRATION

Treatment of Erosive Esophagitis

The recommended adult oral dose is 40 mg given once daily for up to 8 weeks. For those patients who have not healed after 8 weeks of treatment, an additional 8-week course of PROTONIX may be considered. (See INDICATIONS AND USAGE.)

Maintenance of Healing of Erosive Esophagitis

The recommended adult oral dose is one PROTONIX 40 mg Delayed-Release Tablet, taken daily. (See Clinical Studies.) Pathological Hypersecretory Conditions Including Zollinger-Ellison Syndrome The dosage of PROTONIX in patients with pathological hypersecretory conditions varies with the individual patient. The recommended adult starting dose is 40 mg twice daily. Dosage regimens should be adjusted to individual patient needs and should continue for as long as clinically indicated. Doses up to 240 mg daily have been administered. Some patients have been treated continuously with PROTONIX for more than 2 years.

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