Application Nr Approved Date Route Status External Links
ANDA075095 None Oral None Google , Wikipedia , PubMed , DailyMed , Raw OpenFDA , ECHA , ToxNet , JECFA , FAO , 21 CFR

Indications and Purposes

Indications Ethambutol Hydrochloride Tablets, Usp Are 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, I.e., Initial Treatment, The Most Frequently Used Regimens Have Been The Following: Ethambutol Hydrochloride, Usp Plus Isoniazid Ethambutol Hydrochloride, Usp 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 Hydrochloride 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 Hydrochloride 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 (0 Total)


Active Ingredients ( 1 Total)

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