1 INDICATIONS AND USAGE
Lansoprazole is a proton pump inhibitor (PPI). Refer to DOSAGE AND ADMINISTRATION table (below) for indications and usage.
1.1 Short-Term Treatment of Active Duodenal Ulcer
Lansoprazole delayed-release orally disintegrating tablets are indicated for short-term treatment (for 4 weeks) for healing and symptom relief of active duodenal ulcer [see Clinical Studies (14)].
1.2 H. pylori Eradication to Reduce the Risk of Duodenal Ulcer Recurrence
Triple Therapy: Lansoprazole delayed-release orally disintegrating tablets/amoxicillin/clarithromycin
Lansoprazole delayed-release orally disintegrating tablets 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)].
Please refer to the full prescribing information for amoxicillin and clarithromycin.
Dual Therapy: Lansoprazole delayed-release orally disintegrating tablets/amoxicillin
Lansoprazole delayed-release orally disintegrating tablets 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 package insert, MICROBIOLOGY section). Eradication of H. pylori has been shown to reduce the risk of duodenal ulcer recurrence [see Clinical Studies (14)].
Please refer to the full prescribing information for amoxicillin.
1.3 Maintenance of Healed Duodenal Ulcers
Lansoprazole delayed-release orally disintegrating tablets are indicated to maintain healing of duodenal ulcers. Controlled studies do not extend beyond 12 months [see Clinical Studies (14)].
1.4 Short-Term Treatment of Active Benign Gastric Ulcer
Lansoprazole delayed-release orally disintegrating tablets are indicated for short-term treatment (up to 8 weeks) for healing and symptom relief of active benign gastric ulcer [see Clinical Studies (14)].
1.5 Healing of NSAID-Associated Gastric Ulcer
Lansoprazole delayed-release orally disintegrating tablets are indicated for the treatment of NSAID-associated gastric ulcer in patients who continue NSAID use. Controlled studies did not extend beyond 8 weeks [see Clinical Studies (14)].
1.6 Risk Reduction of NSAID-Associated Gastric Ulcer
Lansoprazole delayed-release orally disintegrating tablets are indicated for reducing the risk of NSAID-associated gastric ulcers in patients with a history of a documented gastric ulcer who require the use of an NSAID. Controlled studies did not extend beyond 12 weeks [see Clinical Studies (14)].
1.7 Gastroesophageal Reflux Disease (GERD)
Short-Term Treatment of Symptomatic GERD
Lansoprazole delayed-release orally disintegrating tablets are indicated for the treatment of heartburn and other symptoms associated with GERD [see Clinical Studies (14)].
Short-Term Treatment of Erosive Esophagitis
Lansoprazole delayed-release orally disintegrating tablets are indicated for short-term treatment (up to 8 weeks) for healing and symptom relief of all grades of erosive esophagitis. For patients who do not heal with lansoprazole delayed-release orally disintegrating tablets for 8 weeks (5 to 10%), it may be helpful to give an additional 8 weeks of treatment. If there is a recurrence of erosive esophagitis an additional 8 week course of lansoprazole delayed-release orally disintegrating tablets may be considered [see Clinical Studies (14)].
1.8 Maintenance of Healing of Erosive Esophagitis (EE)
Lansoprazole delayed-release orally disintegrating tablets are indicated to maintain healing of erosive esophagitis. Controlled studies did not extend beyond 12 months [see Clinical Studies (14)].
1.9 Pathological Hypersecretory Conditions Including Zollinger-Ellison Syndrome (ZES)
Lansoprazole delayed-release orally disintegrating tablets are indicated for the long-term treatment of pathological hypersecretory conditions, including Zollinger-Ellison syndrome [see Clinical Studies (14)].