When was nexium approved by the fda




















Alterations in renal function have no effect on esomeprazole's pharmacokinetics, while patients with liver cirrhosis will have a small delay in the time-to-peak plasma concentration 2 vs 1. Mild-to-moderate hepatic dysfunction has no effect on the pharmacokinetics of esomeprazole. This is similar to the previously available PPIs. The most common adverse events reported in the clinical trials were diarrhea, abdominal pain, flatulence, gastritis, nausea, and headache.

Drug interactions reported with omeprazole have included prolonged elimination of diazepam, warfarin, and phenytoin. Isolated reports of changes in elimination have been reported with cyclosporine, disulfiram, and other benzodiazepines.

See Table 3. No drug-drug interactions were found between esomeprazole and phenytoin, R-warfarin, quinidine, amoxicillin, oral contraceptives, and clarithromycin. Esomeprazole may interfere with the elimination of other drugs metabolized by CYP2C Changes in gastric pH can affect the bioavailability of some medications.

Examples of medications where the bioavailability of the medication may be decreased with profound and long-lasting inhibition of gastric acid secretion are ketoconazole and iron salts. See table 4. The recommended dose of esomeprazole is 20 mg or 40 mg once daily for 4 to 8 weeks for the treatment of erosive esophagitis, 20 mg once daily for maintenance of healed erosive esophagitis studies lasted up to 6 months , 20 mg once daily for symptomatic GERD for 4 weeks, and as part of a day triple drug regimen for eradication of H.

The trials included subjects with endoscopically confirmed, healed erosive esophagitis, and they evaluated Nexium 40 mg, 20 mg and 10 mg once-daily over six months of treatment. Subjects remained in remission significantly longer and the number of recurrences of erosive esophagitis was significantly less in subjects treated with Nexium compared to placebo.

Nexium's effectiveness in the resolution of GERD symptoms was evaluated in two multicenter, randomized, double-blind, placebo-controlled trials. These trials were conducted in a total of subjects, and they compared four weeks of treatment with Nexium 20 mg or 40 mg once daily versus placebo. The percentage of subjects who were symptom-free of heartburn was significantly higher in the Nexium groups compared to placebo at all follow-up visits weeks 1, 2 and 4.

In three European symptomatic GERD trials, no significant treatment related differences were observed between Nexium 20 mg and 40 mg and omeprazole 20 mg. Nexium in combination with amoxicillan and clarithromycin was tested in two multicenter, randomized, double-blind trials for the eradication of Helicobacter pylori H. V esomeprazole sodium. Lundbeck Takeda Pharmaceuticals U.

Nexium esomeprazole magnesium , Nexium I. V esomeprazole sodium Profile. Currently Enrolling Trials Show More. Get more clinical research insight with our FREE newsletter sign me up. Sign in or Sign-up. News Feature April 4, I agree to the Terms. I agree to the Privacy Statement. Newsletter Signup. This website uses cookies to ensure you get the best experience on our website.



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