Application Nr Approved Date Route Status External Links
ANDA064150 1998-01-02 Oral RX Google , Wikipedia , PubMed , DailyMed , Raw OpenFDA , ECHA , ToxNet , JECFA , FAO , 21 CFR

Indications and Purposes

Indications And Usage In The Treatment Of Both Tuberculosis And The Meningococcal Carrier State, The Small Number Of Resistant Cells Present Within Large Populations Of Susceptible Cells Can Rapidly Become The Predominant Type. Bacteriologic Cultures Should Be Obtained Before The Start Of Therapy To Confirm The Susceptibility Of The Organism To Rifampin And They Should Be Repeated Throughout Therapy To Monitor The Response To Treatment. Since Resistance Can Emerge Rapidly, Susceptibility Tests Should Be Performed In The Event Of Persistent Positive Cultures During The Course Of Treatment. If Test Results Show Resistance To Rifampin Capsule And The Patient Is Not Responding To Therapy, The Drug Regimen Should Be Modified. Tuberculosis Rifampin Is Indicated In The Treatment Of All Forms Of Tuberculosis. A Three-Drug Regimen Consisting Of Rifampin, Isoniazid, And Pyrazinamide Is Recommended In The Initial Phase Of Short-Course Therapy Which Is Usually Continued For 2 Months. The Advisory Council For The Elimination Of Tuberculosis, The American Thoracic Society, And Centers For Disease Control And Prevention Recommend That Either Streptomycin Or Ethambutol Be Added As A Fourth Drug In A Regimen Containing Isoniazid (inh), Rifampin, And Pyrazinamide For Initial Treatment Of Tuberculosis Unless The Likelihood Of Inh Resistance Is Very Low. The Need For A Fourth Drug Should Be Reassessed When The Results Of Susceptibility Testing Are Known. If Community Rates Of Inh Resistance Are Currently Less Than 4%, An Initial Treatment Regimen With Less Than Four Drugs May Be Considered. Following The Initial Phase, Treatment Should Be Continued With Rifampin And Isoniazid For At Least 4 Months. Treatment Should Be Continued For Longer If The Patient Is Still Sputum Or Culture Positive, If Resistant Organisms Are Present, Or If The Patient Is Hiv Positive. Meningococcal Carriers Rifampin Is Indicated For The Treatment Of Asymptomatic Carriers Of Neisseria Meningitidis To Eliminate Meningococci From The Nasopharynx. Rifampin Is Not Indicated For The Treatment Of Meningococcal Infection Because Of The Possibility Of The Rapid Emergence Of Resistant Organisms. (see Warnings .) Rifampin Should Not Be Used Indiscriminately, And Therefore, Diagnostic Laboratory Procedures, Including Serotyping And Susceptibility Testing, Should Be Performed For Establishment Of The Carrier State And The Correct Treatment. So That The Usefulness Of Rifampin In The Treatment Of Asymptomatic Meningococcal Carriers Is Preserved, The Drug Should Be Used Only When The Risk Of Meningococcal Disease Is High. To Reduce The Development Of Drug-Resistant Bacteria And Maintain The Effectiveness Of Rifampin And Other Antibacterial Drugs, Rifampin Should Be Used Only To Treat Or Prevent Infections That Are Proven Or Strongly Suspected To Be Caused By Susceptible Bacteria. When Culture And Susceptibility Information Are Available, They Should Be Considered In Selecting Or Modifying Antibacterial Therapy. In The Absence Of Such Data, Local Epidemiology And Susceptibility Patterns May Contribute To The Empiric Selection Of Therapy.

All Formulated Excipients (11 Total)

Name Structure Kind Function Status
1. Silicon Dioxide SILICON DIOXIDE Unresolved AC-Anticaking agent , MISC-Miscellaneous , STAB-Stabilizer GRAS-Generally recognized as safe.
2. Starch, Corn STARCH, CORN Unresolved
3. Docusate Sodium DOCUSATE SODIUM Molecular
4. Calcium Stearate CALCIUM STEARATE Molecular AC-Anticaking agent , AF-Antifoaming (or defoaming) agent , MISC-Miscellaneous GRAS-Generally recognized as safe.
5. Gelatin GELATIN Unresolved
6. 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.
7. Cellulose, Microcrystalline CELLULOSE, MICROCRYSTALLINE Unresolved
8. Shellac SHELLAC Unresolved
9. Sodium Benzoate SODIUM BENZOATE Molecular
10. 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.
11. Talc TALC Unresolved DYE-Dye GRAS-Generally recognized as safe.

Active Ingredients ( 1 Total)

Name Structure ZINC ID(s)
1. Rifampin

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