In open studies of 136 patients with pathological hypersecretory conditions, such as Zollinger-Ellison (ZE) syndrome with or without multiple endocrine adenomas, PRILOSEC 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) ]. PRILOSEC 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 PRILOSEC. 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 PRILOSEC 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 PRILOSEC [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 PRILOSEC 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.
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.
PRILOSEC delayed-release capsules, 10 mg, are opaque, hard gelatin, apricot and amethyst colored capsules, coded 606 on cap and PRILOSEC 10 on the body. They are supplied as follows:
NDC 0186-0606-31 unit of use bottles of 30
PRILOSEC delayed-release capsules, 20 mg, are opaque, hard gelatin, amethyst colored capsules, coded 742 on cap and PRILOSEC 20 on body. They are supplied as follows:
NDC 0186-0742-31 unit of use bottles of 30
NDC 0186-0742-82 bottles of 1000
PRILOSEC delayed-release capsules, 40 mg, are opaque, hard gelatin, apricot and amethyst colored capsules, coded 743 on cap and PRILOSEC 40 on the body. They are supplied as follows:
NDC 0186-0743-31 unit of use bottles of 30
NDC 0186-0743-68 bottles of 100
PRILOSEC for delayed-release oral suspension, 2.5 mg or 10 mg, is supplied as a unit dose packet containing a fine yellow powder, consisting of white to brownish omeprazole granules and pale yellow inactive granules. PRILOSEC unit dose packets are supplied as follows:
NDC 0186-0625–01 unit dose packages of 30: 2.5 mg packets
NDC 0186-0610–01 unit dose packages of 30: 10 mg packets
Store PRILOSEC delayed-release capsules in a tight container protected from light and moisture. Store between 15°C and 30°C (59°F and 86°F).
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.]
Advise the patient to read the FDA-approved patient labeling (Medication Guide and Instructions for Use).
Advise patients to report to their healthcare provider if they experience any signs or symptoms consistent with:
- Hypersensitivity reactions [see Contraindications (4)].
- Acute Interstitial Nephritis [see Warnings and Precautions (5.2)].
- Clostridium difficile Associated Diarrhea [see Warnings and Precautions (5.3)].
- Bone Fracture [see Warnings and Precautions (5.4)].
- Cutaneous and Systemic Lupus Erythematosus [see Warnings and Precautions (5.5)].
- Cyanocobalamin (Vitamin B-12) Deficiency [see Warnings and Precautions (5.7)].
- Hypomagnesemia [see Warnings and Precautions (5.8)].
Advise patients to report to their healthcare provider if they start treatment with clopidogrel, St. John’s Wort or rifampin; or, if they take high-dose methotrexate [see Warnings and Precautions (5.6, 5.9,5.11)].
- Take PRILOSEC before meals.
- Antacids may be used concomitantly with PRILOSEC.
- Missed doses: If a dose is missed, administer as soon as possible. However, if the next scheduled dose is due, do not take the missed dose, and take the next dose on time. Do not take two doses at one time to make up for a missed dose.
PRILOSEC Delayed-Release Capsules
- Swallow PRILOSEC delayed-release capsules whole; do not chew.
- For patients unable to swallow an intact capsule, PRILOSEC delayed-release capsules can be opened and administered in applesauce, as described in the Medication Guide.
PRILOSEC For Delayed-Release Oral Suspension
- PRILOSEC for delayed-release oral suspension is intended to be prepared in water and administered orally or via a nasogastric (NG) or gastric tube, as described in the Medication Guide.
PRILOSEC is a trademark of the AstraZeneca group of companies.
Manufactured for: AstraZeneca Pharmaceuticals LP, Wilmington, DE 19850
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