PROTONIX® Delayed-Release Tablets and PROTONIX® For Delayed-Release Oral Suspension are indicated for:

Short-Term Treatment of Erosive Esophagitis Associated With Gastroesophageal Reflux Disease (GERD)

PROTONIX® is 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 is 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 is indicated for the long-term treatment of pathological hypersecretory conditions, including Zollinger-Ellison syndrome.

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 PROTONIX 40 mg, taken daily (see CLINICAL PHARMACOLOGY, 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 Delayed-Release Tablets.

• PROTONIX For Delayed-Release Oral Suspension should be administered in applesauce or apple juice approximately 30 minutes prior to a meal. See Administration Options subsection below. Patients should be cautioned that PROTONIX Delayed-Release Tablets and PROTONIX For Delayed-Release Oral Suspension should not be split, chewed or crushed.
• PROTONIX For Delayed-Release Oral Suspension should only be administered in apple juice or applesauce, not in water or other liquids, or foods.

Administration Options

PROTONIX For Delayed-Release Oral Suspension - Oral Administration in Applesauce:

• Open packet.
• Sprinkle intact granules on one teaspoonful of applesauce.
• Swallow within 10 minutes of preparation.

PROTONIX For Delayed-Release Oral Suspension - Oral Administration in Apple Juice:

• Open packet.
• Empty intact granules into a small cup containing 5 mL of apple juice (approximately one teaspoonful).
• Stir for 5 seconds and swallow immediately.
• To ensure complete delivery of the dose, rinse the container once or twice with apple juice to remove any remaining granules and swallow immediately.

PROTONIX For Delayed-Release Oral Suspension – Nasogastric Tube Administration

• For patients who have a nasogastric tube in place, PROTONIX For Delayed-Release Oral Suspension can be administered as follows:
• Separate the plunger from the barrel of a 2 ounce (60 mL) catheter tip syringe.
• Connect the catheter tip of the syringe to a 16 French (or larger) nasogastric tube.
• Hold the syringe attached to the tubing as high as possible during application steps to prevent any bending of the tubing in order to provide smooth flow of contents under gravity.
• Empty the contents of the packet into the barrel of the syringe.
• Add 10 mL of apple juice and gently tap and/or shake the barrel of the syringe to help empty the syringe.
• Add an additional 10 mL of apple juice and gently tap and/or shake the barrel of the syringe to help rinse the syringe and the nasogastric tube. Repeat with at least 2 additional 10 mL aliquots of apple juice. No granules should remain in the syringe.
• Make sure the nasogastric tube is not clogged to ensure that patients receive the full dose.

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

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.

They are available as follows:

NDC 0008-0843-81 bottles of 90

PROTONIX® (pantoprazole sodium) For Delayed-Release Oral Suspension contain pale yellowish to dark brownish pantoprazole sodium enteric coated granules in a 40 mg unit dose packet.

They are available as follows:

NDC 0008-0844-02 unit dose carton of 30

Storage

Store PROTONIX® Delayed-Release Tablets and PROTONIX® For Delayed-Release Oral Suspension at 20°-25°C (68 -77°F); excursions permitted to 15°-30°C (59°-86°F). [See USP Controlled Room Temperature.]

This product's label may have been updated. For current package insert and further product information, please visit www.wyeth.com or call our medical communications department toll-free at 1-800-934-5556. Packaged by: Wyeth Pharmaceuticals, Inc.,Philadelphia, PA 19101., under license from Nycomed GmbH, D78467 Konstanz, Germany, FDA revision date: 11/14/2007

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