Amitiza

Product manufactured by Bryant Ranch Prepack

Application Nr Approved Date Route Status External Links
NDA021908 2008-04-29 Oral RX Google , Wikipedia , PubMed , DailyMed , Raw OpenFDA , ECHA , ToxNet , JECFA , FAO , 21 CFR

Indications and Purposes

1 Indications And Usage Amitiza Is A Chloride Channel Activator Indicated For: Treatment Of Chronic Idiopathic Constipation In Adults. (1.1) Treatment Of Opioid-Induced Constipation (oic) In Adults With Chronic, Non-Cancer Pain. (1.2) Limitations Of Use: Effectiveness Of Amitiza In The Treatment Of Oic In Patients Taking Diphenylheptane Opioids (e.g., Methadone) Has Not Been Established. (1.2) Treatment Of Irritable Bowel Syndrome With Constipation In Women ≥ 18 Years Old. (1.3) 1.1 Chronic Idiopathic Constipation Amitiza® Is Indicated For The Treatment Of Chronic Idiopathic Constipation In Adults. 1.2 Opioid-Induced Constipation Amitiza Is Indicated For The Treatment Of Opioid-Induced Constipation (oic) In Adults With Chronic Non-Cancer Pain. Limitations Of Use: Effectiveness Of Amitiza In The Treatment Of Opioid-Induced Constipation In Patients Taking Diphenylheptane Opioids (e.g., Methadone) Has Not Been Established. [see Clinical Studies (14.2)] 1.3 Irritable Bowel Syndrome With Constipation Amitiza Is Indicated For The Treatment Of Irritable Bowel Syndrome With Constipation (ibs-C) In Women ≥ 18 Years Old.

All Formulated Excipients (5 Total)

Name Structure Kind Function Status
1. Medium-Chain Triglycerides MEDIUM-CHAIN TRIGLYCERIDES Unresolved
2. Gelatin GELATIN Unresolved
3. Sorbitol SORBITOL Molecular MISC-Miscellaneous GRAS-Generally recognized as safe.
4. Ferric Oxide Red FERRIC OXIDE RED Molecular
5. Titanium Dioxide TITANIUM DIOXIDE Unresolved DYE-Dye

Active Ingredients ( 1 Total)

Name Structure ZINC ID(s)
1. Lubiprostone LUBIPROSTONE ZINC4217732

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