Priftin

Product manufactured by Sanofi-Aventis U.s. Llc

Application Nr Approved Date Route Status External Links
NDA021024 1998-06-22 Oral RX Google , Wikipedia , PubMed , DailyMed , Raw OpenFDA , ECHA , ToxNet , JECFA , FAO , 21 CFR

Indications and Purposes

1 Indications And Usage Priftin Is A Rifamycin Antimycobacterial Drug Indicated In Patients 12 Years Of Age And Older For The Treatment Of Active Pulmonary Tuberculosis (tb) Caused By Mycobacterium Tuberculosis In Combination With One Or More Anti-Tuberculosis (anti-Tb) Drugs To Which The Isolate Is Susceptible. (1.1) Priftin Is Indicated For The Treatment Of Latent Tuberculosis Infection (ltbi) Caused By M. Tuberculosis In Combination With Isoniazid In Patients 2 Years Of Age And Older At High Risk Of Progression To Tb Disease. (1.2) See Limitations Of Use. (1.1, 1.2) 1.1 Active Pulmonary Tuberculosis Priftin® (rifapentine) Is Indicated In Adults And Children 12 Years And Older For The Treatment Of Active Pulmonary Tuberculosis (tb) Caused By Mycobacterium Tuberculosis. Priftin Must Always Be Used In Combination With One Or More Antituberculosis (anti-Tb) Drugs To Which The Isolate Is Susceptible [see Dosage And Administration (2.1) And Clinical Studies (14.1)]. Limitations Of Use Do Not Use Priftin Monotherapy In Either The Initial Or The Continuation Phases Of Active Antituberculous Treatment. Priftin Should Not Be Used Once-Weekly In The Continuation Phase Regimen In Combination With Isoniazid (inh) In Hiv-Infected Patients With Active Pulmonary Tuberculosis Because Of A Higher Rate Of Failure And/or Relapse With Rifampin (rif)-Resistant Organisms [see Warnings And Precautions (5.3) And Clinical Studies (14.1)]. Priftin Has Not Been Studied As Part Of The Initial Phase Treatment Regimen In Hiv- Infected Patients With Active Pulmonary Tuberculosis. 1.2 Latent Tuberculosis Infection Priftin Is Indicated In Adults And Children 2 Years And Older For The Treatment Of Latent Tuberculosis Infection Caused By Mycobacterium Tuberculosis In Patients At High Risk Of Progression To Tuberculosis Disease (including Those In Close Contact With Active Tuberculosis Patients, Recent Conversion To A Positive Tuberculin Skin Test, Hiv-Infected Patients, Or Those With Pulmonary Fibrosis On Radiograph) [see Clinical Studies (14.2)]. Limitations Of Use Active Tuberculosis Disease Should Be Ruled Out Before Initiating Treatment For Latent Tuberculosis Infection. Priftin Must Always Be Used In Combination With Isoniazid As A 12-Week Once-Weekly Regimen For The Treatment Of Latent Tuberculosis Infection. [see Dosage And Administration (2.2) And Clinical Studies (14.2)] Priftin In Combination With Isoniazid Is Not Recommended For Individuals Presumed To Be Exposed To Rifamycin- Or - Isoniazid Resistant M. Tuberculosis.

All Formulated Excipients (2 Total)

Name Structure Kind Function Status
1. Calcium Stearate CALCIUM STEARATE Molecular AC-Anticaking agent , AF-Antifoaming (or defoaming) agent , MISC-Miscellaneous GRAS-Generally recognized as safe.
2. Edetate Disodium Anhydrous EDETATE DISODIUM ANHYDROUS Molecular

Active Ingredients ( 1 Total)

Name Structure ZINC ID(s)
1. Rifapentine RIFAPENTINE ZINC169292536

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