Lansoprazole (Prevacid) Indications and Dosage
- duodenal ulcer
- esophagitis
- gastric ulcer
- gastroesophageal reflux disease (GERD)
- Helicobacter pylori
- NSAID-induced ulcer prophylaxis
- pyrosis (heartburn) †
- Zollinger-Ellison syndrome
† non-FDA-approved indication
Lansoprazole (Prevacid) Indications and Dosage
For the short-term treatment of frequent pyrosis (heartburn) † that occurs >= 2 times per week:
Oral dosage (capsules, disintegrating tablets, or oral suspension):
Adults and the elderly: 15 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 has not been established.
For the short-term treatment of symptomatic non-erosive gastroesophageal reflux disease (GERD):
Oral dosage (capsules, disintegrating tablets, or oral suspension):
Adults, elderly and adolescents: 15 mg PO once daily in the morning at least 30 minutes before a meal, for up to 8 weeks. If the patient has symptomatic erosive or recurrent GERD, initially 30 mg PO once daily in the morning at least 30 minutes before a meal for up to 8 weeks. If healing is incomplete or recurs, a further 8 weeks of therapy can be considered.
Children 1 - 11 years: The FDA-approved initial dosage is 15 - 30 mg PO once daily in the morning at least 30 minutes before a meal for up to 12 weeks (15 mg/day for weight <= 30 kg; 30 mg/day for weight > 30 kg); the dosage was increased (up to 30 mg PO twice daily) in some children who were symptomatic after 2 weeks in trials. Based on published literature, initial starting doses of 1.4 - 1.5 mg/kg/day PO have also been suggested. Individualize dosage to attain clinical goals.
For the treatment of symptomatic erosive GERD, such as erosive esophagitis:
for treatment of active disease:
Oral dosage (capsules, disintegrating tablets, or oral suspension):
Adults, elderly and adolescents: Initially, 30 mg PO once daily in the morning at least 30 minutes before a meal for up to 8 weeks. If healing is incomplete, a further 8 weeks of therapy can be administered. If erosive esophagitis recurs, an additional 8 week course of treatment can be considered.
Children 1 - 11 years: The FDA-approved initial dosage is 15 - 30 mg PO once daily in the morning at least 30 minutes before a meal for up to 12 weeks (15 mg/day for weight <= 30 kg; 30 mg/day for weight > 30 kg); the dosage was increased (up to 30 mg PO twice daily) in some children who were symptomatic after 2 weeks in trials. Based on published literature, initial starting doses of 1.4 - 1.5 mg/kg/day PO have also been suggested. Individualize dosage to attain clinical goals.
for maintenance of remission:
Oral dosage (capsules, disintegrating tablets, or oral suspension):
Adults, elderly and adolescents: The recommended dosage is 15 mg PO once daily in the morning at least 30 minutes before a meal. Controlled studies do not extend beyond 12 months. In one clinical study, 173 patients were randomized to placebo, lansoprazole 15 mg, or lansoprazole 30 mg PO once daily before breakfast for 12 months. Lansoprazole was superior to placebo however there was no difference between the 2 lansoprazole doses.
Children: Safe and effective use has not been established.
for the short-term treatment of erosive esophagitis in patients unable to take oral therapy:
Intravenous infusion dosage:
Adults and the elderly: 30 mg IV once daily given over 30 minutes for up to 7 days (see Administration for dilution and administration methods). Switch to oral therapy when feasible. Oral and IV lansoprazole equally suppress acid production.
Adolescents and children: Safe and effective use has not been established.
For the long-term treatment of pathological hypersecretory conditions, including Zollinger-Ellison syndrome:
Oral dosage (capsules, disintegrating tablets, or oral suspension):
Adults, elderly and adolescents: Initially, 60 mg PO once daily in the morning at least 30 minutes before a meal. Dosage should be individualized and continued for as long as clinically indicated. Some patients with Z-E syndrome have been treated continuously for more than four years. Doses up to 90 mg PO twice daily have been used for this condition. If dosage is > 120 mg/day, give in divided doses.
Children: Safe and effective use has not been established.
For the treatment of active duodenal ulcer or active benign gastric ulcer:
for the short-term treatment of active duodenal ulcer:
Oral dosage (capsules, disintegrating tablets, or oral suspension):
Adults, elderly and adolescents: 15 mg PO once daily in the morning at least 30 minutes before a meal, for up to 4 weeks.
Children: Safe and effective use has not been established.
for maintenance of remission following treatment of active duodenal ulcer:
Oral dosage (capsules, disintegrating tablets, or oral suspension):
Adults, elderly and adolescents: 15 mg PO once daily in the morning at least 30 minutes before a meal. Controlled studies do not extend beyond 12 months.
Children: Safe and effective use has not been established.
for the treatment of active benign gastric ulcer:
Oral dosage (capsules, disintegrating tablets, or oral suspension):
Adults, elderly and adolescents: 30 mg PO once daily in the morning at least 30 minutes before a meal, for up to 8 weeks.
Children: Safe and effective use has not been established.
for triple therapy of Helicobacter pylori-positive duodenal ulcer in combination with clarithromycin and amoxicillin:
Oral dosage (capsules, disintegrating tablets, or oral suspension):
Adults, elderly and adolescents: The FDA-approved dosage is lansoprazole 30 mg PO twice daily, in combination with clarithromycin 500 mg PO twice daily plus amoxicillin 1 g PO twice daily, for 10 - 14 days. The American College of Gastroenterology (ACG) has previously recommended 14 days for triple regimens based on high H. pylori eradication rates.
Children: Safe and effective use has not been established.
for dual therapy of Helicobacter pylori-positive duodenal ulcer in combination with amoxicillin in patients who are intolerant or resistant to clarithromycin:
Oral dosage (capsules, disintegrating tablets, or oral suspension):
Adults, elderly and adolescents: NOTE: More effective triple regimens are available. The FDA-approved dual regimen includes: lanzoprazole 30 mg PO three times daily plus amoxicillin 1 g PO three times daily, given for 14 days. H. pylori eradication rates are lower with this dual regimen (66 - 77%, per-protocol analysis) relative to the 2-week triple regimen containing clarithromycin (85 - 92%, per-protocol analysis).
Children: Safe and effective use has not been established.
For NSAID-induced ulcer prophylaxis or healing:
to treat an NSAID-associated gastric ulcer in patients who continue NSAID use:
Oral dosage (capsules, disintegrating tablets, or oral suspension):
Adults, elderly and adolescents: 30 mg PO once daily in the morning at least 30 minutes before a meal for up to 8 weeks.
Children: Safe and effective use has not been established.
to reduce the risk of NSAID-associated ulcers in patients with a prior documented gastric ulcer, who require NSAID therapy:
Oral dosage (capsules, disintegrating tablets, or oral suspension):
Adults, elderly and adolescents: 15 mg PO once daily in the morning at least 30 minutes before a meal for up to 12 weeks. A higher dosage of 30 mg once daily has been evaluated for risk-reduction of NSAID-induced ulcers in a large multicenter trial; the larger dose yielded no additional benefit compared to the 15 mg dose.
Children: Safe and effective use has not been established.
Maximum Dosage Limits:
Adults: 30 mg/day PO for most indications; 90 mg/day PO for eradication of H. pylori; up to 180 mg/day PO for Zollinger-Ellison syndrome.
Elderly: 30 mg/day PO for most indications; 90 mg/day PO for eradication of H. pylori; up to 180 mg/day PO for Zollinger-Ellison syndrome.
Adolescents: 30 mg/day PO for most indications; 90 mg/day PO for eradication of H. pylori; up to 180 mg/day PO for Zollinger-Ellison syndrome.
Children > 30 kg: 30 mg/day PO for GERD or erosive esophagitis, up to 60 mg/day PO has been used for refractory cases.
Children <= 30 kg: 15 mg/day PO for GERD or erosive esophagitis; occasionally higher dosages used for refractory cases.
Infants: Safe and effective use not established.
Patients with hepatic impairment:
Consider dosage reduction in patients with severe hepatic disease; specific recommendations are not available.
Patients with renal impairment:
No dosage adjustments are needed (manufacturer’s information).
Intermittent hemodialysis:
Lansoprazole is not removed by hemodialysis.
† non-FDA-approved indication
[ Last revised: 8/22/2004 2:03:00 PM ]
References
. Robinson M, Lanza F, Avner D et al. Effective maintenance treatment of reflux esophagitis with low-dose lansoprazole. Ann Intern Med 1996;124:859 - 67.
. Howden CW, Hunt RH. Guidelines for the management of Helicobacter pylori infection. Am J Gastroenterol 1998;93:2330 - 8.
. Faure C, Michaud L, Shaghaghi EK, et al. Lansoprazole in children: pharmacokinetics and efficacy in reflux oesophagitis. Aliment Pharmacol Ther 2001;15:1397 - 402.
. Franco MT, Salvia G, Terrin G, et al. Lansoprazole in the treatment of gastro-oesophageal reflux disease in childhood. Dig Liver Dis 2000;32:660 - 6.
. Freston JW, Pilmer BL, Chiu YL, et al. Evaluation of the pharmacokinetics and pharmacodynamics of intravenous lansoprazole. Aliment Pharmacol Ther. 2004;19:1111 - 22.
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