Alinia

Product manufactured by Avera Mckennan Hospital

Application Nr Approved Date Route Status External Links
NDA021497 2004-07-21 Oral RX Google , Wikipedia , PubMed , DailyMed , Raw OpenFDA , ECHA , ToxNet , JECFA , FAO , 21 CFR

Indications and Purposes

1 Indications And Usage Diarrhea Caused By Giardia Lamblia Or Cryptosporidium Parvum: Alinia For Oral Suspension (patients 1 Year Of Age And Older) And Alinia Tablets (patients 12 Years And Older) Are Indicated For The Treatment Of Diarrhea Caused By Giardia Lamblia Or Cryptosporidium Parvum. Limitations Of Use Alinia For Oral Suspension And Alinia Tablets Have Not Been Shown To Be Effective For The Treatment Of Diarrhea Caused By Cryptosporidium Parvum In Hiv-Infected Or Immunodeficient Patients [ See Clinical Studies (14.2)] Alinia Is An Antiprotozoal Indicated For The Treatment Of Diarrhea Caused By Giardia Lamblia Or Cryptosporidium Parvum (1). Limitations Of Use: Alinia Has Not Been Shown To Be Effective For The Treatment Of Diarrhea Caused By C. Parvum In Hiv-Infected Or Immunodeficient Patients (1).

All Formulated Excipients (9 Total)

Name Structure Kind Function Status
1. Starch, Corn STARCH, CORN Unresolved
2. Hypromelloses HYPROMELLOSES Unresolved
3. Sucrose SUCROSE Molecular NUTRS-Nutritive Sweetener GRAS-Generally recognized as safe.
4. Talc TALC Unresolved DYE-Dye GRAS-Generally recognized as safe.
5. Magnesium Stearate MAGNESIUM STEARATE Molecular AF-Antifoaming (or defoaming) agent , MISC-Miscellaneous REG-Food additives for which a petition has been filed and a regulation issued.
6. Lecithin, Soybean LECITHIN, SOYBEAN Unresolved
7. Polyvinyl Alcohol POLYVINYL ALCOHOL Unresolved
8. Xanthan Gum XANTHAN GUM Unresolved EMUL-Emulsifier FS-Substances permitted as optional ingredient in a standardized food.
9. Titanium Dioxide TITANIUM DIOXIDE Unresolved DYE-Dye

Active Ingredients ( 1 Total)

Name Structure ZINC ID(s)
1. Nitazoxanide NITAZOXANIDE ZINC3956788

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