Application Nr Approved Date Route Status External Links
NDA016320 2009-07-01 Oral RX Google , Wikipedia , PubMed , DailyMed , Raw OpenFDA , ECHA , ToxNet , JECFA , FAO , 21 CFR

Indications and Purposes

Indications Ethambutol Hcl Is Indicated For The Treatment Of Pulmonary Tuberculosis. It Should Not Be Used As The Sole Antituberculous Drug, But Should Be Used In Conjunction With At Least One Other Antituberculous Drug. Selection Of The Companion Drug Should Be Based On Clinical Experience, Considerations Of Comparative Safety, And Appropriate In Vitro Susceptibility Studies. In Patients Who Have Not Received Previous Antituberculous Therapy, Ie, Initial Treatment, The Most Frequently Used Regimens Have Been The Following: Ethambutol Hcl Plus Isoniazidethambutol Hcl Plus Isoniazid Plus Streptomycin. In Patients Who Have Received Previous Antituberculous Therapy, Mycobacterial Resistance To Other Drugs Used In Initial Therapy Is Frequent. Consequently, In Such Retreatment Patients, Ethambutol Hcl Should Be Combined With At Least One Of The Second Line Drugs Not Previously Administered To The Patient And To Which Bacterial Susceptibility Has Been Indicated By Appropriate In Vitro Studies. Antituberculous Drugs Used With Ethambutol Hcl Have Included Cycloserine, Ethionamide, Pyrazinamide, Viomycin And Other Drugs. Isoniazid, Aminosalicylic Acid, And Streptomycin Have Also Been Used In Multiple Drug Regimens. Alternating Drug Regimens Have Also Been Utilized.

All Formulated Excipients (7 Total)

Name Structure Kind Function Status
1. Gelatin GELATIN Unresolved
2. Hypromelloses HYPROMELLOSES Unresolved
3. 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.
4. 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.
5. Sorbitol SORBITOL Molecular MISC-Miscellaneous GRAS-Generally recognized as safe.
6. Stearic Acid STEARIC ACID Molecular MISC-Miscellaneous GRAS-Generally recognized as safe.
7. Sucrose SUCROSE Molecular NUTRS-Nutritive Sweetener GRAS-Generally recognized as safe.

Active Ingredients ( 1 Total)

Name Structure ZINC ID(s)
1. Ethambutol Hydrochloride ETHAMBUTOL HYDROCHLORIDE ZINC19364219

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