Application Nr Approved Date Route Status External Links
ANDA089776 1988-06-13 Oral RX Google , Wikipedia , PubMed , DailyMed , Raw OpenFDA , ECHA , ToxNet , JECFA , FAO , 21 CFR

Indications and Purposes

Indications And Usage Isoniazid Tablets, Usp Are Recommended For All Forms Of Tuberculosis In Which Organisms Are Susceptible. However, Active Tuberculosis Must Be Treated With Multiple Concomitant Anti-Tuberculosis Medications To Prevent The Emergence Of Drug Resistance. Single-Drug Treatment Of Active Tuberculosis With Isoniazid Or Any Other Medication, Is Inadequate Therapy. Isoniazid Tablets, Usp Are Recommended As Preventive Therapy For The Following Groups, Regardless Of Age. (note: The Criterion For A Positive Reaction To A Skin Test (in Millimeters Of Induration) For Each Group Is Given In Parenthesis): Persons With Human Immunodeficiency Virus (hiv) Infection (greater Than Or Equal To 5 Mm) And Persons With Risk Factors For Hiv Infection Whose Hiv Infection Status Is Unknown But Who Are Suspected Of Having Hiv Infection. Preventive Therapy May Be Considered For Hiv Infected Persons Who Are Tuberculin-Negative But Belong To Groups In Which The Prevalence Of Tuberculosis Infection Is High. Candidates For Preventive Therapy Who Have Hiv Infection Should Have A Minimum Of 12 Months Of Therapy. Close Contacts Of Persons With Newly Diagnosed Infectious Tuberculosis (greater Than Or Equal To 5 Mm). In Addition, Tuberculin-Negative (less Than 5 Mm) Children And Adolescents Who Have Been Close Contacts Of Infectious Persons Within The Past 3 Months Are Candidates For Preventive Therapy Until A Repeat Tuberculin Skin Test Is Done 12 Weeks After Contact With The Infectious Source. If The Repeat Skin Test Is Positive (greater Than 5 Mm), Therapy Should Be Continued. Recent Converters, As Indicated By A Tuberculin Skin Test (greater Than Or Equal To10 Mm Increase Within A 2-Year Period For Those Less Than 35 Years Old; Greater Than Or Equal To 15 Mm Increase For Those Greater Than Or Equal To 35 Years Of Age). All Infants And Children Younger Than 4 Years Of Age With A Greater Than 10 Mm Skin Test Are Included In This Category. Persons With Abnormal Chest Radiographs That Show Fibrotic Lesions Likely To Represent Old Healed Tuberculosis (greater Than Or Equal To 5 Mm). Candidates For Preventive Therapy Who Have Fibrotic Pulmonary Lesions Consistent With Healed Tuberculosis Or Who Have Pulmonary Silicosis Should Have 12 Months Of Isoniazid Or 4 Months Of Isoniazid And Rifampin, Concomitantly. Intravenous Drug Users Known To Be Hiv-Seronegative (greater Than 10 Mm). Persons With The Following Medical Conditions That Have Been Reported To Increase The Risk Of Tuberculosis (greater Than Or Equal To 10 Mm): Silicosis; Diabetes Mellitus; Prolonged Therapy With Adrenocorticosteroids; Immunosuppressive Therapy; Some Hematologic And Reticuloendothelial Diseases, Such As Leukemia Or Hodgkin's Disease; End-Stage Renal Disease; Clinical Situations Associated With Substantial Rapid Weight Loss Or Chronic Undernutrition (including: Intestinal Bypass Surgery For Obesity, The Postgastrectomy State [with Or Without Weight Loss], Chronic Peptic Ulcer Disease, Chronic Malabsorption Syndromes And Carcinomas Of The Oropharynx And Upper Gastrointestinal Tract That Prevent Adequate Nutritional Intake). Candidates For Preventive Therapy Who Have Fibrotic Pulmonary Lesions Consistent With Healed Tuberculosis Or Who Have Pulmonary Silicosis Should Have 12 Months Of Isoniazid Or 4 Months Of Isoniazid And Rifampin, Concomitantly. Additionally, In The Absence Of Any Of The Above Risk Factors, Persons Under The Age Of 35 With A Tuberculin Skin Test Reaction Of 10 Mm Or More Are Also Appropriate Candidates For Preventive Therapy If They Are A Member Of Any Of The Following High-Incidence Groups: Foreign-Born Persons From High-Prevalence Countries Who Never Received Bcg Vaccine. Medically Underserved Low-Income Populations, Including High-Risk Racial Or Ethnic Minority Populations, Especially Blacks, Hispanics And Native Americans. Residents Of Facilities For Long-Term Care (e.g., Correctional Institutions, Nursing Homes And Mental Institutions). Children Who Are Less Than 4 Years Old Are Candidates For Isoniazid Preventive Therapy If They Have Greater Than 10 Mm Induration From A Ppd Mantoux Tuberculin Skin Test. Finally, Persons Under The Age Of 35 Who A) Have None Of The Above Risk Factors (1 To 6); B) Belong To None Of The High-Incidence Groups; And C) Have A Tuberculin Skin Test Reaction Of 15 Mm Or More, Are Appropriate Candidates For Preventive Therapy. The Risk Of Hepatitis Must Be Weighed Against The Risk Of Tuberculosis In Positive Tuberculin Reactors Over The Age Of 35. However, The Use Of Isoniazid Is Recommended For Those With The Additional Risk Factors Listed Above (1 To 6) And On An Individual Basis In Situations Where There Is Likelihood Of Serious Consequences To Contacts Who May Become Infected.

All Formulated Excipients (3 Total)

Name Structure Kind Function Status
1. Calcium Sulfate, Unspecified Form CALCIUM SULFATE, UNSPECIFIED FORM Molecular
2. Croscarmellose Sodium CROSCARMELLOSE SODIUM Unresolved
3. Povidones POVIDONES Unresolved

Active Ingredients ( 1 Total)

Name Structure ZINC ID(s)
1. Isoniazid ISONIAZID ZINC1590

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