Prescription Drug Information: Lansoprazole

LANSOPRAZOLE- lansoprazole capsule, delayed release
Aidarex Pharmaceuticals LLC

1 INDICATIONS AND USAGE

1.1 Short-Term Treatment of Active Duodenal Ulcer

Lansoprazole delayed-release capsules 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 capsules /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)]

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 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. 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 capsules 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 capsules 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 capsules 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 capsules 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 capsules is 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 capsules is 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 capsules for 8 weeks (5 to10%), 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 capsules may be considered. [See Clinical Studies (14)]

1.8 Maintenance of Healing of Erosive Esophagitis (EE)

Lansoprazole delayed-release capsules 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 capsules are indicated for the long-term treatment of pathological hypersecretory conditions, including Zollinger-Ellison syndrome. [See Clinical Studies (14)]

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 Dose

Indication Recommended Dose Frequency
*
Controlled studies did not extend beyond indicated duration.
For patients who do not heal with lansoprazole delayed-release capsules 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 capsules may be considered.
§
The lansoprazole delayed-release capsules dose was increased (up to 30 mg twice daily) in some pediatric patients after 2 or more weeks of treatment if they remained symptomatic. For pediatric patients unable to swallow an intact capsule please see Administration Options.
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 4 years.
Duodenal Ulcers
Short-Term Treatment 15 mg Once daily for 4 weeks
Maintenance of Healed 15 mg Once daily
H. pylori Eradication to Reduce the Risk of Duodenal Ulcer Recurrence *
Triple Therapy:
Lansoprazole delayed-release capsules 30 mg Twice daily (q12h) for 10 or 14 days
Amoxicillin 1 gram Twice daily (q12h) for 10 or 14 days
Clarithromycin 500 mg Twice daily (q12h) for 10 or 14 days
Dual Therapy:
Lansoprazole delayed-release capsules 30 mg Three times daily (q8h) for 14 days
Amoxicillin 1 gram Three times daily (q8h) 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
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 §
(12 to 17 years of age)Short-Term Treatment of Symptomatic GERD
Nonerosive GERD 15 mg Once daily for up to 8 weeks
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

Patients should be instructed that if a dose is missed, it should be taken as soon as possible. However, if the next scheduled dose is due, the patient should not take the missed dose, and should be instructed to take the next dose on time. Patients should be instructed not to take 2 doses at one time to make up for a missed dose.

2.2 Special Populations

Renal impairment patients and geriatric patients do not require dosage adjustment. However, consider dose adjustment in patients with severe liver impairment. [See Use in Specific Populations (8.5, 8.6 and 8.7]

2.3 Important Administration Information

Administration Options

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