Protonix (Pantoprazole Sodium) - Indications and 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

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.

No dosage adjustment is necessary in patients with renal impairment, hepatic impairment, or for elderly patients. Doses higher than 40 mg/day have not been studied in hepatically-impaired patients. No dosage adjustment is necessary in patients undergoing hemodialysis.

PROTONIX delayed-release Tablets should be swallowed whole, with or without food in the stomach. If patients are unable to swallow a 40 mg tablet, two 20 mg tablets may be taken. Concomitant administration of antacids does not affect the absorption of PROTONIX.

Patients should be cautioned that PROTONIX delayed-release Tablets should not be split, chewed or crushed.

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.

They are available as follows:

NDC 0008-0841-10 bottles of 100

NDC 0008-0841-81 bottles of 90

NDC 0008-0841-91 bottles of 1000

NDC 0008-0841-99 carton of 10 Redipak^® blister strips of 10 tablets each

PROTONIX is supplied as 20 mg yellow oval biconvex delayed-release tablets imprinted with P20 (brown ink) on one side.

They are available as follows:

NDC 0008-0843-81 bottles of 90

Storage

Store PROTONIX^® delayed-release Tablets at 20°-25°C (68°-77°F); excursions permitted to 15°-30°C (59°-86°F).

[See USP Controlled Room Temperature].

U.S. Patent No. 4,758,579

Packaged by Wyeth Laboratories

A Wyeth-Ayerst Company

Philadelphia, PA 19101

under license from

ALTANA Pharma

D78467 Konstanz, Germany

W10438C008

ET01

Rev 06/04