Zegerid (Omeprazole) - Indications and Dosage

INDICATIONS AND USAGE

DUODENAL ULCER

ZEGERID™ is indicated for short-term treatment of active duodenal ulcer. Most patients heal within four weeks. Some patients may require an additional four weeks of therapy.

TREATMENT OF GASTROESOPHAGEAL REFLUX DISEASE (GERD)

Symptomatic GERD

ZEGERID™, is indicated for the treatment of heartburn and other symptoms associated with GERD.

Erosive Esophagitis

ZEGERID™, is indicated for the short-term treatment (4-8 weeks) of erosive esophagitis which has been diagnosed by endoscopy. (See CLINICAL PHARMACOLOGY, Clinical Studies.)

The efficacy of ZEGERID™ used for longer than 8 weeks in these patients has not been established. In the rare instance of a patient not responding to 8 weeks of treatment, it may be helpful to give up to an additional 4 weeks of treatment. If there is recurrence of erosive esophagitis or GERD symptoms (e.g. heartburn), additional 4-8 week courses of omeprazole may be considered.

MAINTENANCE OF HEALING OF EROSIVE ESOPHAGITIS

ZEGERID™ Powder for Oral Suspension is indicated to maintain healing of erosive esophagitis.

Controlled studies do not extend beyond 12 months.

DOSAGE AND ADMINISTRATION

SHORT-TERM TREATMENT OF ACTIVE DUODENAL ULCER

The recommended adult oral dose of omeprazole, is 20 mg once daily. Most patients heal within four weeks. Some patients may require an additional four weeks of therapy. (See INDICATIONS AND USAGE.)

GASTROESOPHAGEAL REFLUX DISEASE (GERD)

The recommended adult oral dose for the treatment of patients with symptomatic GERD and no esophageal lesions is 20 mg daily for up to 4 weeks. The recommended adult oral dose for the treatment of patients with erosive esophagitis and accompanying symptoms due to GERD is 20 mg daily for 4 to 8 weeks. (See INDICATIONS AND USAGE.)

MAINTENANCE OF HEALING OF EROSIVE ESOPHAGITIS

The recommended adult oral dose is 20 mg daily. (See CLINICAL PHARMACOLOGY, Clinical Studies.)

PREPARATION AND ADMINISTRATION OF SUSPENSION

ZEGERID™ should be taken on an empty stomach 1 hour before a meal.

ZEGERID™ is supplied as unit dose packets containing an immediate-release formulation of omeprazole 20 mg.

Directions for use: Empty packet contents into a small cup containing 2 tablespoons of WATER. DO NOT USE OTHER LIQUIDS OR FOODS. Stir well and drink immediately. Refill cup with water and drink.

HOW SUPPLIED

ZEGERID™ is a white, flavored powder packaged in individual 20 mg dose packets. It is supplied as follows:

NDC 68012-052-30 Cartons of 30: 20 mg unit dose packets

Storage

Store ZEGERID™ in its original individual packets. Store at 25°C (68 - 77°F): excursions permitted to 15 - 30°C (59 - 86°F). [see USP Controlled Room Temperature]

ZEGERID™ is a trademark of Santarus, Inc.

Manufactured for: Santarus, Inc., San Diego, CA 92130

By: Patheon Inc., Whitby, Ontario L1N 5Z5