Get an alert when a recall is issued.
There is currently no warning information available for this product. We apologize for any inconvenience.
There is currently no manufacturer warning information available for this drug.
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)].
The active ingredient in Lansoprazole Delayed-Release Orally Disintegrating Tablets is lansoprazole, a substituted benzimidazole, 2-[[[3-methyl-4-(2,2,2-trifluoroethoxy)-2-pyridyl] methyl] sulfinyl] benzimidazole, a compound that inhibits gastric acid secretion. Its empirical formula is C16H14F3N3O2S with a molecular weight of 369.37. Lansoprazole has the following structure:
Lansoprazole is a white to brownish-white odorless crystalline powder which melts with decomposition at approximately 166°C. Lansoprazole is freely soluble in dimethylformamide; soluble in methanol; sparingly soluble in ethanol; slightly soluble in ethyl acetate, dichloromethane and acetonitrile; very slightly soluble in ether; and practically insoluble in hexane and water.
Lansoprazole is stable when exposed to light for up to two months. The rate of degradation of the compound in aqueous solution increases with decreasing pH. The degradation half-life of the drug substance in aqueous solution at 25°C is approximately 0.5 hour at pH 5.0 and approximately 18 hours at pH 7.0.
Lansoprazole is supplied as delayed-release orally disintegrating tablets for oral administration.
Lansoprazole delayed-release orally disintegrating tablets are available in two dosage strengths: 15 mg and 30 mg of lansoprazole per tablet. Each delayed-release orally disintegrating tablet contains enteric-coated microgranules consisting of 15 mg or 30 mg of lansoprazole (active ingredient) and the following inactive ingredients: mannitol, methacrylic acid, hydroxypropyl cellulose, lactose monohydrate-microcrystalline cellulose sphere, triethyl citrate, crospovidone, polyacrylate, magnesium carbonate, aspartame1, glyceryl monostearate, hypromellose, magnesium stearate, citric acid, titanium dioxide, talc, artificial strawberry flavor, polyethylene glycol, polysorbate 80 and ferric oxide.
1Phenylketonurics: Contains Phenylalanine 2.5 mg per 15 mg Tablet and 5.1 mg per 30 mg Tablet.