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 |
---|---|---|
| ||
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.
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