Lansoprazole: Package Insert and Label Information

LANSOPRAZOLE- lansoprazole tablet, orally disintegrating, delayed release
Mylan Pharmaceuticals Inc.

1 INDICATIONS AND USAGE

1.1 Treatment of Active Duodenal Ulcer

Lansoprazole delayed-release orally disintegrating tablets 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 Orally Disintegrating Tablets/Amoxicillin/Clarithromycin

Lansoprazole delayed-release orally disintegrating tablets in combination with amoxicillin plus clarithromycin as triple therapy are 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 Orally Disintegrating Tablets/Amoxicillin

Lansoprazole delayed-release orally disintegrating tablets in combination with amoxicillin as dual therapy are 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 orally disintegrating tablets 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 Treatment of Active Benign Gastric Ulcer

Lansoprazole delayed-release orally disintegrating tablets 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 orally disintegrating tablets 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 orally disintegrating tablets 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 orally disintegrating tablets 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 orally disintegrating tablets 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 orally disintegrating tablets 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 orally disintegrating tablets may be considered [see Clinical Studies (14.8)].

1.9 Maintenance of Healing of EE

Lansoprazole delayed-release orally disintegrating tablets 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 orally disintegrating tablets 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

2.1 Recommended Adult Dosage by Indication

*
Please refer to the amoxicillin and clarithromycin full prescribing information, 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 orally disintegrating tablets 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 orally disintegrating tablets may be considered.
§
Controlled studies did not extend beyond 12 months.
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 orally disintegrating tablets for more than four years.

Indication

Recommended Dose

Frequency

Duodenal Ulcers

Short-Term Treatment

15 mg

Once daily for 4 weeks

Maintenance of Healed

15 mg

Once daily

Eradication of H. pylori to Reduce the Risk of Duodenal Ulcer Recurrence *

Triple Therapy:

Lansoprazole Delayed-Release Orally Disintegrating Tablets

30 mg

Twice daily for 10 or 14 days

Amoxicillin

1 gram

Twice daily for 10 or 14 days

Clarithromycin

500 mg

Twice daily for 10 or 14 days

Dual Therapy:

Lansoprazole Delayed-Release Orally Disintegrating Tablets

30 mg

Three times daily for 14 days

Amoxicillin

1 gram

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

30 mg

Once daily for 8 weeks

Risk Reduction

15 mg

Once daily for up to 12 weeks

Gastroesophageal Reflux Disease (GERD)

Short-Term Treatment of Symptomatic GERD

15 mg

Once daily for up to 8 weeks

Short-Term Treatment of Erosive Esophagitis

30 mg

Once daily for up to 8 weeks

Maintenance of Healing of Erosive Esophagitis

15 mg

Once daily §

Pathological Hypersecretory Conditions Including Zollinger-Ellison Syndrome

60 mg

Once daily

2.2 Recommended Pediatric Dosage by Indication

Pediatric Patients 1 to 11 Years of Age

In clinical studies, lansoprazole delayed-release orally disintegrating tablets were not administered beyond 12 weeks in 1 to 11 year olds. It is not known if lansoprazole delayed-release orally disintegrating tablets are safe and effective if used longer than the recommended duration. Do not exceed the recommended dose and duration of use in pediatric patients as outlined below [see Use in Specific Populations (8.4)].

Indication

Recommended Dose

Frequency

Short-Term Treatment of Symptomatic GERD and Short-Term Treatment of Erosive Esophagitis

≤ 30 kg

15 mg

Once daily for up to 12 weeks

> 30 kg

30 mg

Once daily for up to 12 weeks

Pediatric Patients 12 to 17 Years of Age

Indication

Recommended Dose

Frequency

Short-Term Treatment of Symptomatic GERD

Non-erosive GERD

15 mg

Once daily for up to 8 weeks

Erosive Esophagitis

30 mg

Once daily for up to 8 weeks

2.3 Hepatic Impairment

The recommended dosage is 15 mg orally daily in patients with severe liver impairment (Child-Pugh C) [see Use in Specific Populations (8.6)].

2.4 Important Administration Information

Take lansoprazole delayed-release orally disintegrating tablets before meals.
Do not crush or chew lansoprazole delayed-release orally disintegrating tablets.
Take lansoprazole delayed-release orally disintegrating tablets at least 30 minutes prior to sucralfate [see Drug Interactions (7)].
Antacids may be used concomitantly with lansoprazole delayed-release orally disintegrating tablets.
Missed doses: If a dose is missed, administer as soon as possible. However, if the next scheduled dose is due, do not take the missed dose, and take the next dose on time. Do not take two doses at one time to make up for a missed dose.

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