Lansoprazole

LANSOPRAZOLE — lansoprazole capsule, delayed release
Actavis Inc

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

2.1 Recommended Dose

* 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 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.
Indication Recommended Dose Frequency
Duodenal Ulcers Short-Term Treatment Maintenance of Healed15 mg15 mgOnce daily for 4 weeksOnce daily
H. pylori Eradication to Reduce the Risk of Duodenal Ulcer Recurrence *
Triple Therapy:
Lansoprazole delayed-release capsules 30 mgTwice daily (q12h) for 10 or 14 days
Amoxicillin1 gramTwice daily (q12h) for 10 or 14 days
Clarithromycin500 mgTwice daily (q12h) for 10 or 14 days
Dual Therapy:
Lansoprazole delayed-release capsules30 mgThree times daily (q8h) for 14 days
Amoxicillin1 gramThree times daily (q8h) for 14 days
Benign Gastric Ulcer
Short-Term Treatment30 mgOnce daily for up to 8 weeks
NSAID-associated Gastric Ulcer
Healing30 mgOnce daily for 8 weeks
Risk Reduction 15 mgOnce daily for up to 12 weeks
Gastroesophageal Reflux Disease (GERD)
Short-Term Treatment of Symptomatic GERD15 mgOnce daily for up to 8 weeks
Short-Term Treatment of Erosive Esophagitis30 mgOnce 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 kg15 mgOnce daily for up to 12 weeks§
> 30 kg30 mgOnce daily for up to 12 weeks§
(12 to 17 years of age)Short-Term Treatment of Symptomatic GERD
Nonerosive GERD15 mgOnce daily for up to 8 weeks
Erosive Esophagitis30 mgOnce daily for up to 8 weeks
Maintenance of Healing of Erosive Esophagitis15 mgOnce daily
Pathological Hypersecretory Conditions Including Zollinger-Ellison Syndrome60 mgOnce 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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