Ethambutol Hydrochloride

Indications

INDICATIONS AND USAGE 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.

Dosage and administration (summary)

DOSAGE AND ADMINISTRATION Ethambutol hydrochloride should not be used alone, in initial treatment or in retreatment. Ethambutol hydrochloride should be administered on a once every 24-hour basis only. Absorption is not significantly altered by administration with food. Therapy, in general, should be continued until bacteriological conversion has become permanent and maximal clinical improvement has occurred. Ethambutol hydrochloride is not recommended for use in pediatric patients under 13 years of age since safe conditions for use have not been established.

Contraindications

CONTRAINDICATIONS Ethambutol hydrochloride is contraindicated in patients who are known to be hypersensitive to this drug. It is also contraindicated in patients with known optic neuritis unless clinical judgment determines that it may be used. Ethambutol hydrochloride is contraindicated in patients who are unable to appreciate and report visual side effects or changes in vision (e.g., young children, unconscious patients).

Warnings and precautions

WARNINGS Ethambutol hydrochloride 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 PRECAUTIONS and ADVERSE REACTIONS ). Liver toxicities including fatalities have been reported (See ADVERSE REACTIONS ). Baseline and periodic assessment of hepatic function should be performed.

Pregnancy

Pregnancy Teratogenic Effects: Pregnancy Category C There are no adequate and well-controlled studies in pregnant women. There are reports of ophthalmic abnormalities occurring in infants born to women on antituberculous therapy that included ethambutol hydrochloride.

Storage and supply

HOW SUPPLIED Ethambutol Hydrochloride Tablets USP, 100 mg: round, white, film-coated tablets, debossed “VP” on one side and “11” on the other side. • NDC 42806-101-01 Bottles of 100 tablets Ethambutol Hydrochloride Tablets USP, 400 mg: round, white, film-coated tablets, debossed “VP” on one side and “1” to the left of bisect, and “4” to the right o…

Source: Ethambutol Hydrochloride (Ethambutol Hydrochloride) — US FDA prescribing information, 2023-11-08, DailyMed. Summarised and shortened; the full label governs. Iranian registration, indications and labelling may differ.