Zegerid with Magnesium Hydroxide (Omeprazole / Sodium Bicarbonate / Magnesium Hydroxide) - Indications and Dosage

INDICATIONS AND USAGE

Duodenal Ulcer

ZEGERID with Magnesium Hydroxide 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.

Gastric Ulcer

ZEGERID with Magnesium Hydroxide is indicated for short-term treatment (4-8 weeks) of active benign gastric ulcer. (See CLINICAL PHARMACOLOGY, Clinical Studies, Gastric Ulcer.)

Treatment of Gastroesophageal Reflux Disease (GERD)

Symptomatic GERD

ZEGERID with Magnesium Hydroxide is indicated for the treatment of heartburn and other symptoms associated with GERD.

Erosive Esophagitis

ZEGERID with Magnesium Hydroxide 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 with Magnesium Hydroxide 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 (eg, heartburn), additional 4-8 week courses of omeprazole may be considered.

Maintenance of Healing of Erosive Esophagitis

ZEGERID with Magnesium Hydroxide is indicated to maintain healing of erosive esophagitis. Controlled studies do not extend beyond 12 months.

DOSAGE AND ADMINISTRATION

ZEGERID with Magnesium Hydroxide (omeprazole/sodium bicarbonate/magnesium hydroxide) is available as chewable tablets in 20 mg and 40 mg strengths for adult use. Directions for use for each indication are summarized in Table 13.

Because ZEGERID chewable tablets contain magnesium hydroxide, the chewable tablets should not be substituted for other dosage forms (eg, ZEGERID Powder for Oral Suspension or ZEGERID Capsules).

Since both the 20-mg and 40-mg chewable tablets contain the same amount of sodium bicarbonate (600 mg) and magnesium hydroxide (700 mg), two 20-mg chewable tablets are not equivalent to one 40-mg chewable tablet; therefore, two 20-mg chewable tablets should not be substituted for one 40-mg chewable tablet.

ZEGERID with Magnesium Hydroxide should be taken on an empty stomach at least one hour before a meal.

Table 13: Recommended Doses of ZEGERID® with Magnesium Hydroxide by Indication for Adults 18 Years and Older

Indication	Recommended Dose	Frequency
* Most patients heal within 4 weeks. Some patients may require an additional 4 weeks of therapy.
** For additional information, see CLINICAL PHARMACOLOGY, Clinical Studies section
+ For additional information, see INDICATIONS AND USAGE section
Short-Term Treatment of Active Duodenal Ulcer	20 mg	Once daily for 4 weeks*,+
Benign Gastric Ulcer	40 mg	Once daily for 4-8 weeks **,+
Gastroesophageal Reflux Disease (GERD)
Symptomatic GERD    (with no esophageal erosions)	20 mg	Once daily for up to 4 weeks+
Erosive Esophagitis	20 mg	Once daily for 4-8 weeks+
Maintenance of Healing of Erosive Esophagitis	20 mg	Once daily**

Administration of Chewable Tablets

ZEGERID with Magnesium Hydroxide chewable tablets should be chewed and swallowed with water. DO NOT SWALLOW WHOLE. DO NOT USE OTHER LIQUIDS. DO NOT SUBSTITUTE FOR OTHER ZEGERID DOSAGE FORMS.

HOW SUPPLIED

ZEGERID with Magnesium Hydroxide 20-mg Chewable Tablets: Each pink, 18 mm in diameter, round tablet, inscribed with the number “2031” on one side and the Santarus logo on the other side, contains 20 mg omeprazole and 600 mg sodium bicarbonate plus 700 mg magnesium hydroxide.

NDC 68012-152-30 Bottles of 30 chewable tablets

ZEGERID with Magnesium Hydroxide 40-mg Chewable Tablets: Each pink, 18 mm in diameter, round tablet, inscribed with the number “4031” on one side and the Santarus logo on the other side, contains 40 mg omeprazole and 600 mg sodium bicarbonate plus 700 mg magnesium hydroxide.

NDC 68012-154-30 Bottles of 30 chewable tablets

Storage

Store at 25°C (77°F); excursions permitted to 15 - 30°C (59 - 86°F). [See USP Controlled Room Temperature]. Do not store this product at temperatures above 30°C (86°F).

Rx Only