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Ethambutol (Ethambutol Hydrochloride) - Indications and Dosage

 
 



Indications and Usage:

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 frequently used regimens have been the following:

Ethambutol plus isoniazid

Ethambutol 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 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 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.

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 thirteen years of age since safe conditions for use have not been established.

Initial Treatment:

In patients who have not received previous antituberculous therapy, administer ethambutol hydrochloride 15 mg per kilogram (7 mg per pound) of body weight, as a single oral dose once every 24 hours. In the more recent studies, isoniazid has been administered concurrently in a single, daily, oral dose.

Retreatment:

In patients who have received previous antituberculous therapy, administer ethambutol hydrochloride 25 mg per kilogram (11 mg per pound) of body weight, as a single oral dose once every 24 hours. Concurrently administer at least one other antituberculous drug to which the organisms have been demonstrated to be susceptible by appropriate in vitro tests. Suitable drugs usually consist of those not previously used in the treatment of the patient. After 60 days of ethambutol hydrochloride administration, decrease the dose to 15 mg per kilogram (7 mg per pound) of body weight, and administer as a single oral dose once every 24 hours.

During the period when a patient is on a daily dose of 25 mg/kg, monthly eye examinations are advised.

See Table for easy selection of proper weight-dose tablet(s).

Weight-Dose Table
15 mg/kg (7 mg/lb) Schedule
Weight Range Daily Dose
Pounds Kilograms In mg
Under 85 lbsUnder 37 kg500
85-94.537-43600
95-109.543-50700
110-124.550-57800
125-139.557-64900
140-154.564-711000
155-169.571-791100
170-184.579-841200
185-199.584-901300
200-214.590-971400
215 and OverOver 971500
25 mg/kg (11 mg/lb) Schedule
Under 85 lbsUnder 38 kg900
85-92.538-421000
93-101.542-45.51100
102-109.545.5-501200
110-118.550-541300
119-128.554-581400
129-136.558-621500
137-146.562-671600
147-155.567-711700
156-164.571-751800
165-173.575-791900
174-182.579-832000
183-191.583-872100
192-199.587-912200
200-209.591-952300
210-218.595-992400
219 and OverOver 992500

 

How Supplied:

Ethambutol Hydrochloride Tablets, USP are available as:

400 mg: White, oval-shaped, film-coated, scored, biconvex tablet. Debossed with stylized b on one side and 923/400 on the scored side. Available in bottles of:

100 NDC 0555-0923-02

Dispense with a child-resistant closure in a tight container as defined in the USP.

Store at controlled room temperature 15°-30°C (59°-86°F) [see USP].

MANUFACTURED BY

BARR LABORATORIES, INC.

POMONA, NY 10970

Rev NOVEMBER 2001

BR-923

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