Lansoprazole

LANSOPRAZOLE- lansoprazole capsule, delayed release
Xiromed LLC

1 INDICATIONS AND USAGE

1.1 Treatment 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.

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 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 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 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

2.1 Recommended Adult Dosage by Indication

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 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 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

* 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 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 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 for more than four years.
# Controlled studies did not extend beyond 12 months

2.2 Recommended Pediatric Dosage by Indication

Pediatric Patients 1 to 11 Years of AgeIn clinical studies, Lansoprazole delayed-release capsules was not administered beyond 12 weeks in 1 to 11 year olds. It is not known if Lansoprazole delayed-release capsules 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
Pediatric (1 to 11 years of age)
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
Pediatric (12 to 17 years of age)
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

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