Lansoprazole Delayed-release Orally Disintegrating
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Uses
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)].
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.
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)].
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)].
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)].
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)].
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)].
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)].
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)].
History
There is currently no drug history available for this drug.
Other Information
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.
Sources
Lansoprazole Delayed-release Orally Disintegrating Manufacturers
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Prasco Laboratories
![Lansoprazole Delayed-release Orally Disintegrating (Lansoprazole) Tablet, Orally Disintegrating, Delayed Release [Prasco Laboratories]](/wp-content/themes/bootstrap/assets/img/loading2.gif)
Lansoprazole Delayed-release Orally Disintegrating | Prasco Laboratories
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 GERDNonerosive 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 PopulationsRenal 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 InformationAdministration Options
• Lansoprazole delayed-release orally disintegrating tablets should not be broken or cut. • Lansoprazole delayed-release orally disintegrating tablets should not be chewed. o Place the tablet on the tongue and allow it to disintegrate, with or without water, until the particles can be swallowed. o The tablet typically disintegrates in less than 1 minute. o Alternatively, for children or other patients who have difficulty swallowing tablets, lansoprazole delayed-release orally disintegrating tablets can be delivered in two different ways. Oral Syringe For administration via oral syringe, lansoprazole delayed-release orally disintegrating tablets can be administered as follows: • Place a 15 mg tablet in oral syringe and draw up 4 mL of water, or place a 30 mg tablet in oral syringe and draw up 10 mL of water. • Shake gently to allow for a quick dispersal. • After the tablet has dispersed, administer the contents within 15 minutes. • Refill the syringe with approximately 2 mL (5 mL for the 30 mg tablet) of water, shake gently, and administer any remaining contents. Nasogastric Tube (≥8 French) Administration For administration via a nasogastric tube, lansoprazole delayed-release orally disintegrating tablets can be administered as follows: • Place a 15 mg tablet in a syringe and draw up 4 mL of water, or place a 30 mg tablet in a syringe and draw up 10 mL of water. • Shake gently to allow for a quick dispersal. • After the tablet has dispersed, inject through the nasogastric tube into the stomach within 15 minutes. • Refill the syringe with approximately 5 mL of water, shake gently, and flush the nasogastric tube.
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