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Nexium I.V.

Generic Name: esomeprazole magnesium injection
Date of Approval: March 31, 2005
Company: AstraZeneca
Treatment for: Gastroesophageal Reflux Disease (GERD)

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FDA approves Nexium I.V.

The FDA has approved Nexium I.V., a new administration formulation for the prescription proton pump inhibitor esomeprazole magnesium.

Nexium I.V. is now approved as an intravenous infusion or injection for the short-term treatment (up to 10 days) of gastroesophageal reflux disease (GERD) patients, with a history of erosive esophagitis, who are unable to take capsules. Nexium I.V. for injection is administered once daily as either a 10 to 30 minute intravenous infusion or by intravenous injection (no less than 3 minutes). Nexium I.V. treatment is given for up to 10 days and does not require an in-line filter.

About Nexium I.V. for injection

The approval of Nexium I.V. was based, in part, on the findings of four multi-centre, open-label, two-period crossover studies. These studies compared the pharmacodynamic efficacy of Nexium I.V (the intravenous formulation) with Nexium delayed-release capsules at corresponding doses of 20 mg and 40 mg in GERD patients with or without a history of erosive esophagitis. They demonstrated that, after 10 days of once-daily administration, Nexium I.V. 20 mg and 40 mg are similar in their ability to suppress acid to the corresponding oral dosage form of Nexium.

There were no relevant changes in acid suppression when switching between intravenous and oral dosage forms.

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About Nexium delayed-release capsules

Nexium (delayed release capsules) is indicated for treating frequent, persistent heartburn and other symptoms associated with acid reflux disease. The drug was recently approved for reducing the risk of gastric (stomach) ulcers developing among at risk patients on continuous NSAID therapy. It also is approved for healing erosive esophagitis. Studies show that up to 94 percent of patients were healed with Nexium. Most erosions heal in 4 to 8 weeks.

Dosage and Administration

The recommended adult dose of Nexium I.V is either 20 or 40 mg given once daily by intravenous injection (no less than 3 minutes) or intravenous infusion (10 to 30 minutes). Nexium I.V. 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 soon as the patient is able to resume treatment with Nexium Delayed-Release Capsules. Safety and efficacy of Nexium I.V. for Injection as a treatment of GERD patients with a history of erosive esophagitis for more than 10 days have not been demonstrated.