Tamiflu

Product manufactured by Remedyrepack Inc.

Application Nr Approved Date Route Status External Links
NDA021087 2007-07-02 Oral RX Google , Wikipedia , PubMed , DailyMed , Raw OpenFDA , ECHA , ToxNet , JECFA , FAO , 21 CFR

Indications and Purposes

1 Indications And Usage Tamiflu Is An Influenza Neuraminidase Inhibitor (nai) Indicated For: Treatment Of Acute, Uncomplicated Influenza A And B In Patients 2 Weeks Of Age And Older Who Have Been Symptomatic For No More Than 48 Hours. ( 1.1) Prophylaxis Of Influenza A And B In Patients 1 Year And Older. ( 1.2) Limitations Of Use: Not A Substitute For Annual Influenza Vaccination. ( 1.3) Consider Available Information On Influenza Drug Susceptibility Patterns And Treatment Effects When Deciding Whether To Use. ( 1.3) Not Recommended For Patients With End-Stage Renal Disease Not Undergoing Dialysis. ( 1.3) 1.1 Treatment Of Influenza Tamiflu Is Indicated For The Treatment Of Acute, Uncomplicated Illness Due To Influenza A And B Infection In Patients 2 Weeks Of Age And Older Who Have Been Symptomatic For No More Than 48 Hours. 1.2 Prophylaxis Of Influenza Tamiflu Is Indicated For The Prophylaxis Of Influenza A And B In Patients 1 Year And Older. 1.3 Limitations Of Use Tamiflu Is Not A Substitute For Early Influenza Vaccination On An Annual Basis As Recommended By The Centers For Disease Control And Prevention Advisory Committee On Immunization Practices. Influenza Viruses Change Over Time. Emergence Of Resistance Substitutions Could Decrease Drug Effectiveness. Other Factors (for Example, Changes In Viral Virulence) Might Also Diminish Clinical Benefit Of Antiviral Drugs. Prescribers Should Consider Available Information On Influenza Drug Susceptibility Patterns And Treatment Effects When Deciding Whether To Use Tamiflu [see Microbiology (12.4)] . Tamiflu Is Not Recommended For Patients With End-Stage Renal Disease Not Undergoing Dialysis [see Dosage And Administration (2.4) And Use In Specific Populations (8.6)].

All Formulated Excipients (7 Total)

Name Structure Kind Function Status
1. Povidone K30 POVIDONE K30 Unresolved
2. Ferric Oxide Red FERRIC OXIDE RED Molecular
3. Titanium Dioxide TITANIUM DIOXIDE Unresolved DYE-Dye
4. Gelatin GELATIN Unresolved
5. Saccharin Sodium SACCHARIN SODIUM Molecular
6. Sodium Benzoate SODIUM BENZOATE Molecular
7. Sorbitol SORBITOL Molecular MISC-Miscellaneous GRAS-Generally recognized as safe.

Active Ingredients ( 1 Total)

Name Structure ZINC ID(s)
1. Oseltamivir Phosphate OSELTAMIVIR PHOSPHATE ZINC3929508

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