Nexium - Indications & Dosage

(Page 2)

No dosage adjustment is necessary. (See CLINICAL PHARMACOLOGY, Pharmacokinetics.)

Hepatic Insufficiency:

No dosage adjustment is necessary in patients with mild to moderate liver impairment (Child Pugh Classes A and B). For patients with severe liver impairment (Child Pugh Class C), a dose of 20 mg of NEXIUM should not be exceeded (See CLINICAL PHARMACOLOGY, Pharmacokinetics.)

Gender:

No dosage adjustment is necessary. (See CLINICAL PHARMACOLOGY, Pharmacokinetics.)

HOW SUPPLIED

NEXIUM Delayed-Release Capsules, 20 mg, are opaque, hard gelatin, amethyst colored capsules with two radial bars in yellow on the cap and 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 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

Storage Store at 25° C (77° F); excursions permitted to 15Ð 30° C (59Ð 86° F).

[See USP Controlled Room Temperature]. Keep container tightly closed. Dispense in a tight container if the product package is subdivided.

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.

NEXIUM is a trademark of the AstraZeneca group ©AstraZeneca 2003

Manufactured for: AstraZeneca LP

Wilmington, DE 19850 By: AstraZeneca AB

Södertälje, Sweden

Product of France

620514-04 9346604

Rev. 03/ 03

Nexium ® (esomeprazole magnesium) Delayed-Release Capsules Nexium ® (esomeprazole magnesium) Delayed-Release Capsules Nexium ® (esomeprazole magnesium) Delayed-Release Capsules