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AstraZeneca Submits sNDA for NEXIUM(R) I.V. for Peptic Ulcer Bleed Indication
Date:5/30/2008

in seven and 30 days.(2) Patients received an I.V. infusion of NEXIUM 80 mg over 30 minutes plus an I.V. infusion of NEXIUM 8 mg/hour for 72 hours, followed by oral NEXIUM 40 mg once daily for 27 days. A control group received an I.V. infusion of placebo for 72 hours followed by the same 27-day period of oral NEXIUM.(2) The study was performed at 91 centers in 16 countries across Europe, Africa and Asia.

About Peptic Ulcer Bleed (PUB)

PUB is a potentially life-threatening event that occurs as a result of peptic ulcer disease. PUB occurs when the ulcer erodes into an underlying blood vessel. The resulting blood loss can be significant as clotting can be impaired in the acidic environment. If after treatment, a peptic ulcer re-bleeds, there is an increased risk of morbidity and mortality(8) and associated healthcare costs.(10 11)

About NEXIUM(R) I.V. (esomeprazole sodium) for Injection

NEXIUM I.V. for Injection is indicated for the short-term treatment (up to 10 days) of GERD adult patients with a history of erosive esophagitis as an alternative to oral therapy in patients when therapy with NEXIUM Delayed-Release Capsules is not possible or appropriate.

When oral therapy is possible or appropriate, intravenous therapy with NEXIUM I.V. for Injection should be discontinued and the therapy should be continued orally.

The recommended adult dose is either 20 or 40 mg esomeprazole given once daily by intravenous injection (no less than 3 minutes) or intravenous infusion (10 to 30 minutes).

NEXIUM I.V. for Injection should not be administered concomitantly with any other medications through the same intravenous site and or tubing. The intravenous line should always be flushed with either 0.9% Sodium Chloride Injection, USP, Lactated Ringer's Injection, USP or 5% Dextrose Injection, USP both prior to and after administration of NEXIUM I.V. for Injection.

Treatment with NEXIUM I.V. for Injection should be discontinued as
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SOURCE AstraZeneca
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