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Questions & Answers
Side Effects & Adverse Reactions
Ethambutol hydrochloride tablets may produce decreases in visual acuity which appear to be due to optic neuritis. This effect may be related to dose and duration of treatment. This effect is generally reversible when administration of the drug is discontinued promptly. However, irreversible blindness has been reported. (See PRECAUTIONSand ADVERSE REACTIONS).
Liver toxicities including fatalities have been reported (See ADVERSE REACTIONS). Baseline and periodic assessment of hepatic function should be performed.
There is currently no legal information available for this drug.
FDA Safety Alerts
There are currently no FDA safety alerts available for this drug.
There is currently no manufacturer warning information available for this drug.
FDA Labeling Changes
There are currently no FDA labeling changes available for this drug.
Ethambutol hydrochloride tablets 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 freguently used regimens have been the following:
- Ethambutol Hydrochloride Tablets plus isoniazid
- Ethambutol Hydrochloride Tablets 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 tablets 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 tablets 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.
There is currently no drug history available for this drug.
Ethambutol hydrochloride is an oral chemotherapeutic agent which is specifically effective against actively growing microorganisms of the genus Mycobacterium, including M. tuberculosis. Ethambutol hydrochloride is a white, crystalline powder. The structural formula is:
Each tablet, for oral administration, contains 100 mg or 400 mg ethambutol hydrochloride.
In addition, each tablet contains the following inactive ingredients: Colloidal Silicon Dioxide, Corn Starch, Croscarmellose Sodium, Docusate Sodium, Lactose Monohydrate, Magnesium Stearate, Polyvinyl Pyrrolidone, Stearic Acid, Sugar. Film Coating and Polishing contains: Hydroxypropyl Methylcellulose, Polyethylene Glycol, Polysorbate 80, Titanium Dioxide.