DrugLib.com — Drug Information Portal

Rx drug information, pharmaceutical research, clinical trials, news, and more

Ethambutol (Ethambutol Hydrochloride) - Indications and Dosage

 
 



INDICATIONS & 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 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.

DOSAGE & ADMINISTRATION

Ethambutol Hydrochloride Tablets should not be used alone, in initial treatment or in retreatment. Ethambutol Hydrochloride Tablets 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 Tablets are not recommended for use in pediatric patients under 13 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 Tablets 15 mg/kg (7 mg/lb) 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 Tablets 25 mg/kg (11 mg/lb) 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 Tablets administration, decrease the dose to 15 mg/kg (7 mg/lb) 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 Table15 mg/kg (7 mg/lb) ScheduleWeight RangeDaily DosePoundsKilogramsIn mgUnder 85 lbs.Under 37 kg50085 - 94.5374360095 - 109.54350700110 - 124.55057800125 - 139.55764900140 - 154.564711000155 - 169.571791100170 - 184.579841200185 - 199.584901300200 - 214.590971400215 and OverOver 97150025 mg/kg (11 mg/lb) ScheduleUnder 85 lbs.Under 38 kg90085 - 92.538 - 42100093 - 101.542 - 45.51100102 - 109.545.5501200110 - 118.55054.1300119 - 128.554581400129 - 136.558621500137 - 146.562671600147 - 155.567711700156 - 164.571751800165 - 173.575791900174 - 182.579832000183 - 191.583872100192 - 199.587912200200 - 209.591952300210 - 218.595992400219 and OverOver 992500

HOW SUPPLIED

Ethambutol Hydrochloride Tablets USP, 100 mg: Film coated white, round, unscored tablets debossed "VP" on one side and "11" on the other side.

  • ●     Bottles of 100 tablets.
Ethambutol Hydrochloride Tablets USP, 400 mg: Film coated, white, round, scored tablets debossed "VP" on one side and "14" on the scored side.
  • ●     Bottles of 60 tablets.
  • ●     Bottles of 90 tablets.
  • ●     Bottles of 100 tablets.
  • ●     Bottles of 1000 tablets.
  • ●     Unit Dose Boxes of 100 tablets.

STORAGE AND HANDLING

Store at 20-25(68-77USP Controlled Room Temperature]. Protect from light and moisture.
Dispense in a tight, light-resistant container as defined in the USP using a child-resistant closure.

-- advertisement -- The American Red Cross
 
Home | About Us | Contact Us | Site usage policy | Privacy policy

All Rights reserved - Copyright DrugLib.com, 2006-2015