Esomeprazole (Nexium) Indications and Dosage
- duodenal ulcer
- esophagitis
- gastroesophageal reflux disease (GERD)
- Helicobacter pylori
- NSAID-induced ulcer prophylaxis
- pyrosis (heartburn) †
† non-FDA-approved indication
Esomeprazole (Nexium) Indications and Dosage
For the short-term treatment of frequent pyrosis (heartburn) † that occurs >= 2 times per week:
Oral dosage:
Adults, including the elderly: 20 mg PO once daily for up to 14 days. Full relief may take 1 - 4 days. If frequent heartburn returns soon after the initial 14-day treatment regimen, patients should contact their health care provider.
Children: Safe and effective use have not been established.
For the treatment of symptomatic gastroesophageal reflux disease (GERD) including erosive esophagitis:
Oral dosage:
Adults, including the elderly: For GERD with no esophageal lesions, 20 mg PO once daily, taken 1 hour before meals, for up to 4 weeks. For erosive esophagitis, 20 - 40 mg PO once daily for 4 - 8 weeks. For no response to initial course or for recurrences, consider an additional 4 - 8 week course. To prevent relapse, chronic maintenance therapy may be necessary; give 20 mg PO once daily. Maintenance studies have not extended beyond 6 months. In one study, 40 mg/day was no more effective than 20 mg/day for maintenance treatment; however, mean time to first recurrence was longer with the 40 mg/day dose (163 days) vs. the 20 mg/day dose (115 days). At month 6, greater than 70% of patients using either dose remained heartburn-free. In a comparative study, the percent of patients with healed esophagitis was significantly greater with esomeprazole 40 mg/day vs. omeprazole 20 mg/day. The incidence of symptomatic relief was higher and relief occurred sooner with esomeprazole 40 mg/day vs. the other treatment groups.
Children: Safe and effective use have not been established.
for the short-term treatment of gastric esophageal reflux (GERD) associated with a history or erosive esophagitis in patients unable to take oral therapy:
Intravenous dosage:
Adults, including the elderly: 20 or 40 mg IV once daily for up to 10 days. The IV formulation is indicated as an alternative to oral therapy for the short-term treatment (up to 10 days) of GERD. Switch to oral therapy when feasible.
Children: Safe and effective use have not been established.
For use in combination with clarithromycin and amoxicillin for the eradication of Helicobacter pylori and to reduce the risk of duodenal ulcer recurrence:
Oral dosage:
Adults, including the elderly: The FDA-approved dosage is esomeprazole 40 mg PO once daily, taken one hour before meals, with clarithromycin (500 mg PO twice daily) and amoxicillin (1 g PO twice daily) for 10 days. In patients who fail therapy, susceptibility testing should be done; resistance will likely be demonstrated. If resistance is found or susceptibility testing is not possible, alternative antimicrobial therapy should be instituted. NOTE: Patients in H. pylori clinical trials had either an active duodenal ulcer or a history of an ulcer. One study notes that after a 7-day course of esomeprazole-based triple therapy, endoscopically confirmed duodenal ulcer healing rates were 91% at 4 weeks. Recommendations on whether esomeprazole needs to be continued for 2 - 4 weeks for active ulcer healing after eradication of H. pylori are not currently available. However, expert opinions generally agree that esomeprazole, like other PPIs, will be continued for several weeks following H. pylori eradication to complete ulcer healing, pending further data.
Children: Safe and effective use have not been established.
For NSAID-induced ulcer prophylaxis (gastric):
Oral dosage:
Adults and the elderly: 20 or 40 mg PO once daily; in clinical trials the 20 and 40 mg dose showed comparable benefits in providing risk reduction. Roughly 95% of patients remained ulcer free for up to 6 months. Studies did not demonstrate significant reduction in the development of NSAID-associated duodenal ulcer due to the low incidence.
Children: Safe and effective use have not been established.
Maximum Dosage Limits:
- Adults: 40 mg/day PO/IV.
- Elderly: 40 mg/day PO/IV.
- Adolescents: Safe and effective use have not been established.
- Children: Safe and effective use have not been established.
Patients with hepatic impairment:
No dosage adjustment is recommended for mild to moderate hepatic impairment. However, in patients with severe hepatic insufficiency (Child Pugh Class C), do not exceed 20 mg/day.
Patients with renal impairment:
No dosage adjustment is necessary.
Intermittent hemodialysis:
No dosage adjustment is necessary. Due to high protein binding, esomeprazole is not expected to be removed by hemodialysis.
[ Last revised: 4/12/2005 10:17:00 AM ]
References
. Kahrilas PJ, Falk GW, Johnson DA. Esomeprazole improves healing and symptom resolution as compared with omeprazole in reflux oesophagitis patients: a randomized controlled trial. Aliment Pharmacol Ther 2000;14:1249 - 58.)
. Johnson DA, Benjamin SB, Vakil NB et al. Esomeprazole once daily for 6 months is effective therapy for maintaining healed erosive esophagitis and for controlling gastroesophageal reflux disease symptoms: a randomized, double-blind, placebo-controlled study of efficacy and safety. Am J Gastroenterol 2001;96:27 - 34.
. Tulassay Z, Kryszewski A, Ditr P et al. 7-day treatment with esomeprazole-based triple therapy eradicates H. pylori (HP) and heals patients with duodenal ulcer (DU) disease. Gastroenterology 2000;118(suppl 2):A502.
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