Product manufactured by Sanofi-Aventis U.s. Llc

Application Nr Approved Date Route Status External Links
NDA050705 1994-05-31 Oral RX Google , Wikipedia , PubMed , DailyMed , Raw OpenFDA , ECHA , ToxNet , JECFA , FAO , 21 CFR

Indications and Purposes

Indications And Usage Rifater Is Indicated In The Initial Phase Of The Short-Course Treatment Of Pulmonary Tuberculosis. During This Phase, Which Should Last 2 Months, Rifater Should Be Administered On A Daily, Continuous Basis (see Dosage And Administration). Following The Initial Phase And Treatment With Rifater, Treatment Should Be Continued With Rifampin And Isoniazid (e.g., Rifamate) For At Least 4 Months. Treatment Should Be Continued For A Longer Period Of Time If The Patient Is Still Sputum Or Culture Positive, If Resistant Organisms Are Present, Or If The Patient Is Hiv Positive. In The Treatment Of Tuberculosis, The Small Number Of Resistant Cells Present Within Large Populations Of Susceptible Cells Can Rapidly Become The Predominant Type. Since Resistance Can Emerge Rapidly, Susceptibility Tests Should Be Performed In The Event Of Persistent Positive Cultures During The Course Of Treatment. Bacteriologic Smears Or Cultures Should Be Obtained Before The Start Of Therapy To Confirm The Susceptibility Of The Organism To Rifampin, Isoniazid, And Pyrazinamide And They Should Be Repeated Throughout Therapy To Monitor Response To The Treatment. If Test Results Show Resistance To Any Of The Components Of Rifater And The Patient Is Not Responding To Therapy, The Drug Regimen Should Be Modified.

All Formulated Excipients (18 Total)

Name Structure Kind Function Status
1. Povidones POVIDONES Unresolved
2. Calcium Stearate CALCIUM STEARATE Molecular AC-Anticaking agent , AF-Antifoaming (or defoaming) agent , MISC-Miscellaneous GRAS-Generally recognized as safe.
3. Sodium Lauryl Sulfate SODIUM LAURYL SULFATE Molecular AF-Antifoaming (or defoaming) agent , CTG-Component or coating , EMUL-Emulsifier , SANI-Sanitizing agent , SDA-Solubilizing & dispersing agent REG-Food additives for which a petition has been filed and a regulation issued.
4. Sucrose SUCROSE Molecular NUTRS-Nutritive Sweetener GRAS-Generally recognized as safe.
5. Talc TALC Unresolved DYE-Dye GRAS-Generally recognized as safe.
6. Acacia ACACIA Unresolved EMUL-Emulsifier , STAB-Stabilizer FS-Substances permitted as optional ingredient in a standardized food.
7. Titanium Dioxide TITANIUM DIOXIDE Unresolved DYE-Dye
8. Kaolin KAOLIN Molecular
9. Magnesium Carbonate MAGNESIUM CARBONATE Molecular B&N-Buffer & neutralizing agent FS-Substances permitted as optional ingredient in a standardized food.
10. Silicon Dioxide SILICON DIOXIDE Unresolved AC-Anticaking agent , MISC-Miscellaneous , STAB-Stabilizer GRAS-Generally recognized as safe.
11. Aluminum Hydroxide ALUMINUM HYDROXIDE Molecular
12. Ferric Oxide Red FERRIC OXIDE RED Molecular
13. Ferrosoferric Oxide FERROSOFERRIC OXIDE Molecular
14. Carnauba Wax CARNAUBA WAX Unresolved MISC-Miscellaneous GRAS-Generally recognized as safe.
15. White Wax WHITE WAX Unresolved
16. Rosin ROSIN Unresolved REG-Food additives for which a petition has been filed and a regulation issued.
17. Lecithin LECITHIN Unresolved
18. Shellac SHELLAC Unresolved

Active Ingredients ( 3 Total)

Name Structure ZINC ID(s)
1. Isoniazid ISONIAZID ZINC1590
2. Pyrazinamide PYRAZINAMIDE ZINC2005
3. Rifampin