ersecretory conditions, such as Zollinger-Ellison Syndrome, NEXIUM significantly inhibited gastric acid secretion. Initial dose was 40 mg twice daily in 19/21 patients and 80 mg twice daily in 2/21 patients. Total daily doses ranging from 80 mg to 240 mg for 12 months maintained gastric acid output below the target levels of 10 mEq/h in patients without prior gastric acid-reducing surgery and below 5 mEq/hr in patients with prior gastric acid-reducing surgery. At the Month 12 final visit, 18/20 (90%) patients had Basal Acid Output (BAO) under satisfactory control (median BAO = 0.17 mmol/hr). Of the 18 patients eva luated with a starting dose of 40 mg twice daily, 13 (72%) had their BAO controlled with the original dosing regimen at the final visit.
Table 14
Adequate Acid Suppression at Final Visit by Dose Regimen
NEXIUM dose at the Month 12 visit
BAO under adequate control at the Month 12 visit (N=20)*
40 mg twice daily
13/15
80 mg twice daily
4/4
80 mg three times daily
1/1
15 REFERENCES
1. National Committee for Clinical Laboratory Standards. Methods for Dilution Antimicrobial Susceptibility Tests for Bacteria That Grow Aerobically. Fifth Edition: Approved Standard NCCLS Document M7-A5, Vol. 20, no. 2, NCCLS, Wayne, PA, January 2000.
16 HOW SUPPLIED/STORAGE AND HANDLING
NEXIUM Delayed-Release Capsules, 20 mg, are opaque, hard gelatin, amethyst colored capsules with two radial bars in yellow on the cap and NEXIUM 20 mg in yellow on the body. They are supplied as follows:
NDC 0186-5020-31 unit of use bottles of 30
NDC 0186-5022-28 unit dose packages of 100
NDC 0186-5020-54 bottles of 90
NDC 0186-5020-82 bottles of 1000
NEXIUM Delayed-Release Capsules, 40 mg, are opaque, hard gelatin, amethyst colored capsules with three radial bars in yellow on the cap and NEXIUM 40 mg in yellow on the body. They are supplied as follows:
NDC 0186-5040-31 unit of use bottles of 30
NDC 0186-5042-28 unit dose packages of 100
NDC 0186-5040-54 bottles of 90
NDC 0186-5040-82 bottles of 1000
NDC 0186-5040-35 unit of use bottles of 30
NDC 0186-5042-25 unit dose packages of 100
NDC 0186-5040-55 bottles of 90
NDC 0186-5040-85 bottles of 1000
NEXIUM For Delayed-Release Oral Suspension is supplied as a unit dose packet containing a fine yellow powder, consisting of white to pale brownish esomeprazole granules and pale yellow inactive granules. NEXIUM unit dose packets are supplied as follows:
NDC 0186-4010–01 unit dose packages of 30: 10 mg packets
NDC 0186-4020–01 unit dose packages of 30: 20 mg packets
NDC 0186-4040–01 unit dose packages of 30: 40 mg packets
Store at 25°C (77°F); excursions permitted to 15 to 30°C (59 to 86°F). [See USP Controlled Room Temperature]. Keep NEXIUM Delayed-Release Capsules container tightly closed. Dispense in a tight container if the NEXIUM Delayed-Release Capsules product package is subdivided.
NEXIUM and the color purple as applied to the capsule are registered trademarks of the AstraZeneca group of companies.
©AstraZeneca 2011
17 PATIENT COUNSELING INFORMATION
See FDA-Approved Patient Labeling
• Advise patients to let you know if they are taking, or begin taking, other medications, because NEXIUM can interfere with antiretroviral drugs and drugs that are affected by gastric pH changes [see Dru
