Prilosec (Page 12 of 14)

14.6 Maintenance of Healing of EE due to Acid-Mediated GERD

In a U.S. double-blind, randomized, multicenter, placebo controlled study, two dose regimens of omeprazole magnesium delayed-release capsules were studied in patients with endoscopically confirmed healed esophagitis. Results to determine maintenance of healing of EE are shown below.

Life Table Analysis
*
(p < 0.01) omeprazole magnesium delayed-release capsules 20 mg once daily versus omeprazole magnesium delayed-release capsules 20 mg 3 consecutive days per week or placebo.

omeprazole magnesium delayed-release capsules

20 mg once daily

(n = 138)

omeprazole magnesium delayed-release capsules

20 mg 3 days per week

(n = 137)

Placebo

(n = 131)

Percent in endoscopic remission at 6 months

70*

34

11

In an international multicenter double-blind study, omeprazole magnesium delayed-release capsules 20 mg daily and 10 mg daily were compared with ranitidine 150 mg twice daily in patients with endoscopically confirmed healed esophagitis. The table below provides the results of this study for maintenance of healing of EE.

Life Table Analysis
*
(p = 0.01) omeprazole magnesium delayed-release capsules 20 mg once daily versus omeprazole magnesium delayed-release capsules 10 mg once daily or Ranitidine.
(p = 0.03) omeprazole magnesium delayed-release capsules 10 mg once daily versus Ranitidine.

omeprazole magnesium delayed-release capsules

20 mg once daily

(n = 131)

omeprazole magnesium delayed-release capsules

10 mg once daily

(n = 133)

Ranitidine

150 mg twice daily

(n = 128)

Percent in endoscopic remission at 12 months

77*

58

46

In patients who initially had grades 3 or 4 erosive esophagitis, for maintenance after healing 20 mg daily of omeprazole magnesium delayed-release capsules was effective, while 10 mg did not demonstrate effectiveness.

14.7 Pathological Hypersecretory Conditions

In open studies of 136 patients with pathological hypersecretory conditions, such as Zollinger-Ellison (ZE) syndrome with or without multiple endocrine adenomas, omeprazole magnesium delayed-release capsules significantly inhibited gastric acid secretion and controlled associated symptoms of diarrhea, anorexia, and pain. Doses ranging from 20 mg every other day to 360 mg per day maintained basal acid secretion below 10 mEq/hr in patients without prior gastric surgery, and below 5 mEq/hr in patients with prior gastric surgery.

Initial doses were titrated to the individual patient need, and adjustments were necessary with time in some patients [see Dosage and Administration (2)]. Omeprazole magnesium delayed-release capsules was well tolerated at these high dose levels for prolonged periods (> 5 years in some patients). In most ZE patients, serum gastrin levels were not modified by omeprazole magnesium delayed-release capsules. However, in some patients serum gastrin increased to levels greater than those present prior to initiation of omeprazole therapy. At least 11 patients with ZE syndrome on long-term treatment with omeprazole magnesium delayed-release capsules developed gastric carcinoids. These findings are believed to be a manifestation of the underlying condition, which is known to be associated with such tumors, rather than the result of the administration of omeprazole magnesium delayed-release capsules [see Adverse Reactions (6)].

14.8 Pediatric Studies for the Treatment of Symptomatic GERD, Treatment of EE due to Acid-Mediated GERD, and Maintenance of Healing of EE due to Acid-Mediated GERD

Treatment of Symptomatic GERD

The effectiveness of omeprazole magnesium delayed-release capsules for the treatment of symptomatic GERD in pediatric patients 1 to 16 years of age is based in part on data obtained from 125 pediatric patients in two uncontrolled clinical studies.

The first study enrolled 12 pediatric patients 1 to 2 years of age with a history of clinically diagnosed GERD. Patients were administered a single dose of omeprazole (0.5 mg/kg, 1 mg/kg, or 1.5 mg/kg) for 8 weeks as an open capsule in 8.4% sodium bicarbonate solution. Seventy-five percent (9/12) of the patients had vomiting/regurgitation episodes decreased from baseline by at least 50%.

The second study enrolled 113 pediatric patients 2 to 16 years of age with a history of symptoms suggestive of symptomatic GERD. Patients were administered a single dose of omeprazole (10 mg or 20 mg, based on body weight) for 4 weeks either as an intact capsule or as an open capsule in applesauce. Successful response was defined as no moderate or severe episodes of either pain-related symptoms or vomiting/regurgitation during the last 4 days of treatment. Results showed success rates of 60% (9/15; 10 mg omeprazole) and 59% (58/98; 20 mg omeprazole), respectively.

Treatment of EE due to Acid-Mediated GERD

In an uncontrolled, open-label dose-titration study, for the treatment of EE in pediatric patients 1 to 16 years of age, required doses that ranged from 0.7 to 3.5 mg/kg/day (80 mg/day). Doses were initiated at 0.7 mg/kg/day. Doses were increased in increments of 0.7 mg/kg/day (if intraesophageal pH showed a pH of < 4 for less than 6% of a 24-hour study). After titration, patients remained on treatment for 3 months. Forty-four percent of the patients were healed on a dose of 0.7 mg/kg body weight; most of the remaining patients were healed with 1.4 mg/kg after an additional 3 months’ treatment. EE was healed in 51 of 57 (90%) children who completed the first course of treatment in the healing phase of the study. In addition, after 3 months of treatment, 33% of the children had no overall symptoms, 57% had mild reflux symptoms, and 40% had less frequent regurgitation/vomiting.

Maintenance of Healing of EE due to Acid-Mediated GERD

In an uncontrolled, open-label study of maintenance of healing of EE in 46 pediatric patients 1 to 16 years of age, 54% of patients required half the healing dose. The remaining patients increased the healing dose (0.7 to a maximum of 2.8 mg/kg/day) either for the entire maintenance period, or returned to half the dose before completion. Of the 46 patients who entered the maintenance phase, 19 (41%) had no relapse during follow-up (range 4 to 25 months). In addition, maintenance therapy in EE patients resulted in 63% of patients having no overall symptoms.

15 REFERENCES

1.
Clinical and Laboratory Standards Institute (CLSI). Methods for Dilution Antimicrobial Susceptibility Tests for Bacteria That Grow Aerobically; Approved Standard —Tenth Edition. CLSI Document M07-A10, Clinical and Laboratory Standards Institute, 950 West Valley Road, Suite 2500, Wayne, Pennsylvania, 19087, USA 2015.

16 HOW SUPPLIED/STORAGE AND HANDLING

PRILOSEC (omeprazole magnesium) for delayed-release oral suspension, 2.5 mg or 10 mg omeprazole, is supplied as a unit dose packet containing a fine yellow powder, consisting of white to brownish omeprazole magnesium granules and pale yellow inactive granules. PRILOSEC unit dose packets are supplied as follows:

NDC 70515-625–01 unit dose packages of 30: 2.5 mg packets

NDC 70515-610–01 unit dose packages of 30: 10 mg packets

Storage

Store PRILOSEC for delayed-release oral suspension at 25°C (77°F); excursions permitted to 15 – 30°C (59 – 86°F). [See USP Controlled Room Temperature.]

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