Lansoprazole

Lansoprazole delayed-release capsules are a proton pump inhibitor (PPI) indicated for the: Treatment of active duodenal ulcer in adults ( 1.1 ) Eradication of H. pylori to reduce the risk of duodenal ulcer recurrence in adults ( 1.2 ) Maintenance of healed duodenal ulcers in adults ( 1.3 ) Treatment of active benign gastric ulcer in adults ( 1.4 ) Healing of nonsteroidal anti-inflammatory drugs (NSAID)-associated gastric ulcer in adults ( 1.5 ) Risk reduction of NSAID-associated gastric ulcer in adults ( 1.6 ) Treatment of symptomatic gastroesophageal reflux disease (GERD) in adults and pediatric patients 1 year of age and older.

( 1.7 ) Treatment of erosive esophagitis (EE) in adults and pediatric patients 1 year of age and older. ( 1.8 ) Maintenance of healing of EE in adults ( 1.9 ) Pathological hypersecretory conditions, including Zollinger-Ellison Syndrome (ZES) in adults ( 1.10 )

1.1Treatment of Active Duodenal Ulcer

Lansoprazole delayed-release capsules are indicated for short-term treatment (for four weeks) for healing and symptom relief of active duodenal ulcer [see Clinical Studies ( 14.1 )].

1.2 Eradication of H. pylori to Reduce the Risk of Duodenal Ulcer Recurrence Triple Therapy: lansoprazole/amoxicillin/clarithromycin Lansoprazole delayed-release capsules in combination with amoxicillin plus clarithromycin as triple therapy is indicated for the treatment of patients with H. pylori infection and duodenal ulcer disease (active or one-year history of a duodenal ulcer) to eradicate H. pylori . Eradication of H. pylori has been shown to reduce the risk of duodenal ulcer recurrence [see Clinical Studies ( 14.2 )].

Please refer to the full prescribing information for amoxicillin and clarithromycin. Dual Therapy: lansoprazole/amoxicillin Lansoprazole delayed-release capsules in combination with amoxicillin as dual therapy is indicated for the treatment of patients with H. pylori infection and duodenal ulcer disease (active or one-year history of a duodenal ulcer) who are either allergic or intolerant to clarithromycin or in whom resistance to clarithromycin is known or suspected (see the clarithromycin prescribing information, MICROBIOLOGY section).

Eradication of H. pylori has been shown to reduce the risk of duodenal ulcer recurrence [see Clinical Studies ( 14.2 )]. Please refer to the full prescribing information for amoxicillin.