Lansoprazole Delayed-release Orally Disintegrating

LANSOPRAZOLE DELAYED-RELEASE ORALLY DISINTEGRATING- lansoprazole tablet, orally disintegrating, delayed release
Prasco Laboratories

1 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/amoxicillin/clarithromycin

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

Lansoprazole delayed-release orally disintegrating tablets in combination with amoxicillin as dual therapy are 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 ulcers 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 for up to 8 weeks [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)].

2 DOSAGE AND ADMINISTRATION

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

2.1 Recommended Dose

Indication Recommended Dose Frequency
*
Please refer to amoxicillin and clarithromycin full prescribing information for CONTRAINDICATIONS and WARNINGS, 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 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 may be considered.
§
The lansoprazole 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.
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 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

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

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.

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