Pantoprazole Sodium (Page 8 of 10)

14.2 Long-Term Maintenance of Healing of Erosive Esophagitis

Two independent, multicenter, randomized, double-blind, comparator-controlled trials of identical design were conducted in adult GERD patients with endoscopically confirmed healed EE to demonstrate efficacy of pantoprazole sodium delayed-release tablets in long-term maintenance of healing. The two US studies enrolled 386 and 404 patients, respectively, to receive either 10 mg, 20 mg, or 40 mg of pantoprazole sodium delayed-release tablets once daily or 150 mg of ranitidine twice daily. As demonstrated in Table 10, pantoprazole sodium delayed-release tablets 40 mg and 20 mg were significantly superior to ranitidine at every timepoint with respect to the maintenance of healing. In addition, pantoprazole sodium delayed-release tablet 40 mg was superior to all other treatments studied.

Table 10: Long-Term Maintenance of Healing of Erosive Gastroesophageal Reflux Disease (GERD Maintenance): Percentage of Patients Who Remained Healed

* (p < 0.05 vs. ranitidine)

# (p < 0.05 vs. pantoprazole sodium delayed-release tablets 20 mg)

Pantoprazole Sodium Delayed-Release Tablets 20 mg daily Pantoprazole Sodium Delayed-Release Tablets 40 mg daily Ranitidine 150 mg twice daily
Study 1 n = 75 n = 74 n = 75
Month 1 91* 99* 68
Month 3 82* 93*# 54
Month 6 76* 90*# 44
Month 12 70* 86*# 35
Study 2 n = 74 n = 88 n = 84
Month 1 89* 92*# 62
Month 3 78* 91*# 47
Month 6 72* 88*# 39
Month 12 72* 83* 37

Note: Pantoprazole sodium delayed-release tablet 10 mg was superior (p < 0.05) to ranitidine in Study 2, but not Study 1.

Pantoprazole sodium delayed-release tablet 40 mg was superior to ranitidine in reducing the number of daytime and nighttime heartburn episodes from the first through the twelfth month of treatment. Pantoprazole sodium delayed-release tablet 20 mg, administered once daily, was also effective in reducing episodes of daytime and nighttime heartburn in one trial, as presented in Table 11.

Table 11: Number of Episodes of Heartburn (mean ± SD)

* (p < 0.001 vs. ranitidine, combined data from the two US studies)

Pantoprazole Sodium Delayed-Release Tablet 40 mg daily Ranitidine 150 mg twice daily
Month 1 Daytime 5.1 ± 1.6* 18.3 ± 1.6
Nighttime 3.9 ± 1.1* 11.9 ± 1.1
Month 12 Daytime 2.9 ± 1.5* 17.5 ± 1.5
Nighttime 2.5 ± 1.2* 13.8 ± 1.3

14.3 Pathological Hypersecretory Conditions Including Zollinger-Ellison Syndrome

In a multicenter, open-label trial of 35 patients with pathological hypersecretory conditions, such as Zollinger-Ellison Syndrome, with or without multiple endocrine neoplasia-type I, pantoprazole sodium delayed-release tablets successfully controlled gastric acid secretion. Doses ranging from 80 mg daily to 240 mg daily maintained gastric acid output below 10 mEq/h in patients without prior acid-reducing surgery and below 5 mEq/h in patients with prior acid-reducing surgery.

Doses were initially titrated to the individual patient needs, and adjusted in some patients based on the clinical response with time [ see Dosage and Administration ( 2) .]. Pantoprazole sodium delayed-release tablet was well tolerated at these dose levels for prolonged periods (greater than 2 years in some patients).

16 HOW SUPPLIED/STORAGE AND HANDLING

How Supplied

Pantoprazole sodium delayed-release tablets, USP are supplied as yellow colored, biconvex oval shaped tablets plain on one side and imprinted with “W433” (brown ink) on other side containing 20 mg and are available as follows:

HDPE bottle of 30 tablets NDC 64679-433-01

HDPE bottle of 90 tablets NDC 64679-433-04

HDPE bottle of 1000 tablets NDC 64679-433-02

Unit dose packages of 100 tablets NDC 64679-433-03

HDPE bottle of 100 tablets NDC 64679-433-05

Pantoprazole sodium delayed-release tablets, USP are supplied as yellow colored, biconvex oval shaped tablets plain on one side and imprinted with “W434” (brown ink) on other side containing 40 mg and are available as follows:

HDPE bottle of 30 tablets NDC 64679-434-01

HDPE bottle of 90 tablets NDC 64679-434-04

HDPE bottle of 1000 tablets NDC 64679-434-02

Unit dose packages of 100 tablets NDC 64679-434-03

HDPE bottle of 100 tablets NDC 64679-434-05

Storage

Store at 20°-25°C (68°-77°F); [See USP Controlled Room Temperature].

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