Lansoprazole

LANSOPRAZOLE- lansoprazole capsule, delayed release
Major Pharmaceuticals

1 INDICATIONS AND USAGE

1.1 Treatment of Active Duodenal Ulcer

Lansoprazole delayed-release capsules are indicated in adults 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 delayed-release capsules/amoxicillin/clarithromycin

Lansoprazole delayed-release capsules in combination with amoxicillin plus clarithromycin as triple therapy is indicated in adults 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 delayed-release capsules /amoxicillin

Lansoprazole delayed-release capsules in combination with amoxicillin as dual therapy is indicated in adults 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.

1.3 Maintenance of Healed Duodenal Ulcers

Lansoprazole delayed-release capsules are indicated in adults to maintain healing of duodenal ulcers. Controlled studies do not extend beyond 12 months. [see Clinical Studies (14.3)].

1.4 Short-Term Treatment of Active Benign Gastric Ulcer

Lansoprazole delayed-release capsules are indicated in adults for short-term treatment (up to eight weeks) for healing and symptom relief of active benign gastric ulcer [see Clinical Studies (14.4)].

1.5 Healing of NSAID-Associated Gastric Ulcer

Lansoprazole delayed-release capsules are indicated in adults for the treatment of NSAID-associated gastric ulcer in patients who continue NSAID use. Controlled studies did not extend beyond eight weeks [see Clinical Studies (14.5)].

1.6 Risk Reduction of NSAID-Associated Gastric Ulcer

Lansoprazole delayed-release capsules are indicated in adults 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 (14.6)].

1.7 Treatment of Symptomatic Gastroesophageal Reflux Disease (GERD)

Lansoprazole delayed-release capsules are indicated for short-term treatment in adults and pediatric patients 12 to 17 years of age (up to eight weeks) and pediatric patients one to 11 years of age (up to 12 weeks) for the treatment of heartburn and other symptoms associated with GERD [see Clinical Studies (14.7)].

1.8 Treatment of Erosive Esophagitis (EE)

Lansoprazole delayed-release capsules are indicated for short-term treatment in adults and pediatric patients 12 to 17 years of age (up to eight weeks) and pediatric patients one to 11 years of age (up to 12 weeks) for healing and symptom relief of all grades of EE.

For adults who do not heal with lansoprazole delayed-release capsules for eight weeks (5 to 10%), it may be helpful to give an additional eight weeks of treatment. If there is a recurrence of erosive esophagitis an additional eight week course of lansoprazole delayed-release capsules may be considered [see Clinical Studies (14.8)].

1.9 Maintenance of Healing of EE

Lansoprazole delayed-release capsules are indicated in adults to maintain healing of EE. Controlled studies did not extend beyond 12 months [see Clinical Studies (14.9)].

1.10 Pathological Hypersecretory Conditions Including Zollinger-Ellison Syndrome (ZES)

Lansoprazole delayed-release capsules are indicated in adults for the long-term treatment of pathological hypersecretory conditions, including Zollinger-Ellison syndrome [see Clinical Studies (14.10)].

2 DOSAGE AND ADMINISTRATION

Lansoprazole is available as a capsule, and is available in 15 mg and 30 mg strengths. Directions for use specific to the route and available methods of administration is presented below. Lansoprazole delayed-release capsules should be taken before eating. Lansoprazole delayed-release capsule products SHOULD NOT BE CRUSHED OR CHEWED. In the clinical trials, antacids were used concomitantly with lansoprazole delayed-release capsules.

2.1 Recommended Adult Dosage by Indication

Indication

Recommended Dose

Frequency

Duodenal Ulcers Short-Term Treatment Maintenance of Healed

15 mg 15 mg

Once daily for 4 weeks Once daily

Eradication of H. pylori to Reduce the Risk of Duodenal Ulcer Recurrence * Triple Therapy: Lansoprazole delayed-release capsules Amoxicillin Clarithromycin Dual Therapy: Lansoprazole delayed-release capsules Amoxicillin

30 mg 1 gram 500 mg 30 mg 1 gram

Twice daily for 10 or 14 days Twice daily for 10 or 14 days Twice daily for 10 or 14 days Three times daily for 14 days Three times daily for 14 days

Benign Gastric Ulcer Short-Term Treatment

30 mg

Once daily for up to 8 weeks

NSAID-Associated Gastric Ulcer Healing Risk Reduction

30 mg 15 mg

Once daily for 8 weeks Once daily for up to 12 weeks

Gastroesophageal Reflux Disease (GERD) Short-Term Treatment of Symptomatic GERD Short -Term Treatment of Erosive Esophagitis

15 mg 30 mg

Once daily for up to 8 weeks Once daily for up to 8 weeks

Maintenance of Healing of Erosive Esophagitis Pathological Hypersecretory Conditions Including Zollinger-Ellison Syndrome

15 mg 60 mg

Once daily Once daily§

* Please refer to amoxicillin and clarithromycin full prescribing information for Contraindications and Warnings and Precautions sections, and for information regarding dosing in elderly and renally-impaired patients.

Controlled studies did not extend beyond indicated duration.

For patients who do not heal with lansoprazole delayed-release capsules for eight weeks (5 to 10%), it may be helpful to give an additional eight weeks of treatment. If there is a recurrence of erosive esophagitis, an additional eight week course of lansoprazole delayed-release capsules may be considered.

§ Varies with individual patient. Recommended adult starting dose is 60 mg once daily. Doses should be adjusted to individual patient needs and should continue for as long as clinically indicated. Dosages up to 90 mg twice daily have been administered. Daily dose of greater than 120 mg should be administered in divided doses. Some patients with Zollinger-Ellison syndrome have been treated continuously with lansoprazole delayed-release capsules for more than four years.

Controlled studies did not extend beyond 12 months

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