Overview
Lansoprazole marketed under the brand Prevacid, is a proton pump inhibitor (PPI) and is structurally classified as a substituted benzimidazole. It reduces gastric acid secretion by targeting gastric H,K-ATPase pumps and is thus effective at promoting healing in ulcerative diseases, and treating gastroesophageal reflux disease (GERD) along with other pathologies caused by excessive acid secretion.
Indication
Lansoprazole is used to reduce gastric acid secretion and is approved for short term treatment of active gastric ulcers, active duodenal ulcers, erosive reflux oesophagitis, symptomatic gastroesophageal reflux disease, and non-steroidal anti-inflammatory drug (NSAID) induced gastric and duodenal ulcers. It may be used in the maintenance and healing of several gastric conditions including duodenal ulcers, NSAID related gastric ulcers, and erosive esophagitis. Lansoprazole prevents recurrence of gastric ulcers in patients who have a documented history of gastric ulcers who also use NSAIDs chronically. Predictably, it is also useful in the management of hypersecretory conditions including Zollinger-Ellison syndrome. Lansoprazole is effective at eradicating H. pylori when used in conjunction with amoxicillin and clarithromycin (triple therapy) or with amoxicillin alone (dual therapy).
Associated Conditions
- Duodenal Ulcer
- Erosive Esophagitis
- Helicobacter Pylori Infection
- Symptomatic Gastroesophageal Reflux Disease (sGERD)
- Ulcer Healing
- Zollinger-Ellison Syndrome
- Active Duodenal ulcer
- Develop NSAID-induced gastric ulcers
- Hypersecretory conditions
- Maintenance of healing Erosive esophagitis
Research Report
Lansoprazole: A Comprehensive Pharmacological and Clinical Review
1. Introduction and Overview
Lansoprazole is a widely utilized pharmaceutical agent belonging to the class of proton pump inhibitors (PPIs). It is primarily prescribed for the management of conditions related to excessive gastric acid secretion.
- Generic Name: Lansoprazole [1]
- Brand Names: Lansoprazole is marketed under various brand names globally, with Prevacid® being one of the most recognized. Other common names include Prevacid 24HR (an over-the-counter formulation), Prevacid SoluTab (an orally disintegrating tablet), and Prevacid OTC.[1] During its development, it was also known by the code AG 1749.[1] The availability of multiple brand names, including over-the-counter (OTC) options, reflects its extensive clinical use and established profile for certain indications. However, this also necessitates careful patient education to prevent inadvertent duplication of therapy or inappropriate self-medication if a patient is also prescribed a PPI.
- DrugBank ID: DB00448 [1]
- CAS Number: 103577-45-3 [1]
- Chemical Type: Lansoprazole is a small molecule drug [User Query]. Structurally, it is classified as a substituted benzimidazole.[1] It exists as a racemic 1:1 mixture of its two enantiomers, dexlansoprazole (the R-enantiomer) and levolansoprazole (the S-enantiomer).[1] The benzimidazole core is a common structural feature among many PPIs, which may imply shared mechanistic properties and, theoretically, a potential for cross-reactivity in hypersensitivity reactions, although specific data on lansoprazole cross-reactivity were not detailed in the provided materials. The existence of dexlansoprazole as a separately marketed, enantiomerically pure drug suggests potential pharmacokinetic or pharmacodynamic distinctions from the racemic mixture.
- Brief Summary of Use and Therapeutic Class: As a proton pump inhibitor, lansoprazole effectively reduces the production of stoma
Clinical Trials
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Title | Posted | Study ID | Phase | Status | Sponsor |
---|---|---|---|---|---|
2015/09/22 | N/A | Completed | Canadian Network for Observational Drug Effect Studies, CNODES | ||
2015/03/17 | Phase 3 | Completed | |||
2015/03/17 | Phase 3 | Completed | |||
2015/01/08 | Phase 1 | Completed | |||
2014/10/29 | Phase 4 | UNKNOWN | McGill University Health Centre/Research Institute of the McGill University Health Centre | ||
2014/09/29 | Phase 4 | Completed | |||
2014/06/26 | Phase 4 | Completed | Shanghai Jiao Tong University School of Medicine | ||
2014/06/26 | Phase 4 | Completed | Shanghai Jiao Tong University School of Medicine | ||
2014/06/23 | N/A | Completed | |||
2014/05/30 | N/A | Completed |
FDA Drug Approvals
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Approved Product | Manufacturer | NDC Code | Route | Strength | Effective Date |
---|---|---|---|---|---|
Dr.Reddy's Laboratories Ltd. | 55111-399 | ORAL | 30 mg in 1 1 | 3/21/2022 | |
Zydus Pharmaceuticals USA Inc. | 68382-771 | ORAL | 15 mg in 1 1 | 8/22/2022 | |
Camber Pharmaceuticals, Inc. | 31722-571 | ORAL | 30 mg in 1 1 | 7/24/2020 | |
Ascend Laboratories, LLC | 67877-274 | ORAL | 15 mg in 1 1 | 7/29/2022 | |
Teva Pharmaceuticals USA, Inc. | 0093-7351 | ORAL | 30 mg in 1 1 | 3/31/2022 | |
Bryant Ranch Prepack | 63629-2340 | ORAL | 30 mg in 1 1 | 1/5/2021 | |
Advanced Rx Pharmacy of Tennessee, LLC | 80425-0148 | ORAL | 15 mg in 1 1 | 11/17/2022 | |
Rising Pharma Holdings, Inc. | 16571-698 | ORAL | 30 mg in 1 1 | 10/13/2023 | |
A-S Medication Solutions | 50090-4596 | ORAL | 15 mg in 1 1 | 10/14/2020 | |
NuCare Pharmaceuticals,Inc. | 68071-2734 | ORAL | 15 mg in 1 1 | 5/25/2022 |
EMA Drug Approvals
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HSA Drug Approvals
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NMPA Drug Approvals
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PPB Drug Approvals
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TGA Drug Approvals
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Health Canada Drug Approvals
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CIMA AEMPS Drug Approvals
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Approved Product | Company | Registration Number | Pharmaceutical Form | Prescription Type | Status |
---|---|---|---|---|---|
LANSOPRAZOL DISTRIQUIMICA 30 MG CAPSULAS DURAS GASTRORRESISTENTES EFG | 83144 | CÁPSULA DURA GASTRORRESISTENTE | Medicamento Sujeto A Prescripción Médica | Not Commercialized | |
DOSTAB FLAS 30 MG COMPRIMIDOS BUCODISPERSABLES | Laboratorios Salvat S.A. | 78396 | COMPRIMIDO BUCODISPERSABLE | Medicamento Sujeto A Prescripción Médica | Not Commercialized |
OPIREN 30 MG CAPSULAS | 36286-00-00IP | CÁPSULA DURA GASTRORRESISTENTE | Medicamento Sujeto A Prescripción Médica | Commercialized | |
PROCESOL 30 MG CAPSULAS DURAS GASTRORRESISTENTES EFG | 86448 | CÁPSULA DURA GASTRORRESISTENTE | Medicamento Sujeto A Prescripción Médica | Not Commercialized | |
LANSOPRAZOL FLAS SANDOZ 30 MG COMPRIMIDOS BUCODISPERSABLES EFG | Sandoz Farmaceutica S.A. | 78839 | COMPRIMIDO BUCODISPERSABLE | Medicamento Sujeto A Prescripción Médica | Not Commercialized |
LANSOPRAZOL TEVA-RATIOPHARM 15 mg CAPSULAS DURAS GASTRORRESISTENTES EFG | Teva Pharma S.L.U. | 66147 | CÁPSULA DURA GASTRORRESISTENTE | Medicamento Sujeto A Prescripción Médica | Commercialized |
OPIREN FLAS 30 MG COMPRIMIDOS BUCODISPERSABLES | Takeda France S.A.S. | 3400939239989IP2 | COMPRIMIDO BUCODISPERSABLE | Medicamento Sujeto A Prescripción Médica | Not Commercialized |
LANSOPRAZOL MABO 30 mg CAPSULAS DURAS GASTRORRESISTENTES EFG | Mabo Farma S.A. | 66224 | CÁPSULA DURA GASTRORRESISTENTE | Medicamento Sujeto A Prescripción Médica | Commercialized |
LANSOPRAZOL ALMUS 15 mg CAPSULAS DURAS GASTRORRESISTENTES EFG | Almus Farmaceutica S.A.U. | 70761 | CÁPSULA DURA GASTRORRESISTENTE | Medicamento Sujeto A Prescripción Médica | Commercialized |
LANSOPRAZOL CINFAMED 30 mg CAPSULAS GASTRORRESISTENTES EFG | Laboratorios Cinfa S.A. | 66350 | CÁPSULA DURA GASTRORRESISTENTE | Medicamento Sujeto A Prescripción Médica | Commercialized |
Philippines FDA Drug Approvals
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Saudi SFDA Drug Approvals
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Malaysia NPRA Drug Approvals
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UK EMC Drug Information
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