Lansoprazole

Product manufactured by Avkare, Inc.

Application Nr Approved Date Route Status External Links
ANDA077255 2009-11-10 Oral RX Google , Wikipedia , PubMed , DailyMed , Raw OpenFDA , ECHA , ToxNet , JECFA , FAO , 21 CFR

Indications and Purposes

1 Indications And Usage Lansoprazole Is A Proton Pump Inhibitor (ppi) Indicated For: • Short-Term Treatment Of Active Duodenal Ulcer (1.1) • H. Pylori Eradication To Reduce The Risk Of Duodenal Ulcer Recurrence (1.2) • Maintenance Of Healed Duodenal Ulcers (1.3) • Short-Term Treatment Of Active Benign Gastric Ulcer (1.4) • Healing Of Non-Steroidal Anti-Inflammatory Drugs (nsaid)-Associated Gastric Ulcer (1.5) • Risk Reduction Of Nsaid-Associated Gastric Ulcer (1.6) • Gastroesophageal Reflux Disease (gerd) (1.7) • Maintenance Of Healing Of Erosive Esophagitis (ee) (1.8) • Pathological Hypersecretory Conditions Including Zollinger-Ellison Syndrome (zes) (1.9) 1.1 Short-Term Treatment Of Active Duodenal Ulcer Lansoprazole Delayed-Release Capsules Usp 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 Usp/amoxicillin/clarithromycin Lansoprazole Delayed-Release Capsules Usp 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 Usp/amoxicillin Lansoprazole Delayed-Release Capsules Usp 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 Usp 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 Usp 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 Usp 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 Usp 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 Usp 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 Capsules Usp 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 Usp 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 Usp May Be Considered [see Clinical Studies (14)]. 1.8 Maintenance Of Healing Of Erosive Esophagitis (ee) Lansoprazole Delayed-Release Capsules Usp 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 Usp Are Indicated For The Long-Term Treatment Of Pathological Hypersecretory Conditions, Including Zollinger-Ellison Syndrome [see Clinical Studies (14)].

All Formulated Excipients (9 Total)

Name Structure Kind Function Status
1. Ferrosoferric Oxide FERROSOFERRIC OXIDE Molecular
2. Gelatin GELATIN Unresolved
3. Hypromelloses HYPROMELLOSES Unresolved
4. Magnesium Carbonate MAGNESIUM CARBONATE Molecular B&N-Buffer & neutralizing agent FS-Substances permitted as optional ingredient in a standardized food.
5. Propylene Glycol PROPYLENE GLYCOL Molecular MISC-Miscellaneous FS-Substances permitted as optional ingredient in a standardized food.
6. Ferric Oxide Red FERRIC OXIDE RED Molecular
7. Shellac SHELLAC Unresolved
8. Talc TALC Unresolved DYE-Dye GRAS-Generally recognized as safe.
9. Titanium Dioxide TITANIUM DIOXIDE Unresolved DYE-Dye

Active Ingredients ( 1 Total)

Name Structure ZINC ID(s)
1. Lansoprazole LANSOPRAZOLE ZINC599734

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