Ethambutol (Page 3 of 3)
DOSAGE AND 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).
15 mg/kg (7 mg/lb) Schedule | |||
Weight Range | Daily Dose | ||
Pounds | Kilograms | In mg | |
Under 85 lbs. | Under 37 kg | 500 | |
85 — 94.5 | 37 – 43 | 600 | |
95 — 109.5 | 43 – 50 | 700 | |
110 — 124.5 | 50 – 57 | 800 | |
125 — 139.5 | 57 – 64 | 900 | |
140 — 154.5 | 64 – 71 | 1000 | |
155 — 169.5 | 71 – 79 | 1100 | |
170 — 184.5 | 79 – 84 | 1200 | |
185 — 199.5 | 84 – 90 | 1300 | |
200 — 214.5 | 90 – 97 | 1400 | |
215 and Over | Over 97 | 1500 | |
25 mg/kg (11 mg/lb) Schedule | |||
Under 85 lbs. | Under 38 kg | 900 | |
85 — 92.5 | 38 — 42 | 1000 | |
93 — 101.5 | 42 — 45.5 | 1100 | |
102 — 109.5 | 45.5 – 50 | 1200 | |
110 — 118.5 | 50 – 54 | .1300 | |
119 — 128.5 | 54 – 58 | 1400 | |
129 — 136.5 | 58 – 62 | 1500 | |
137 — 146.5 | 62 – 67 | 1600 | |
147 — 155.5 | 67 – 71 | 1700 | |
156 — 164.5 | 71 – 75 | 1800 | |
165 — 173.5 | 75 – 79 | 1900 | |
174 — 182.5 | 79 – 83 | 2000 | |
183 — 191.5 | 83 – 87 | 2100 | |
192 — 199.5 | 87 – 91 | 2200 | |
200 — 209.5 | 91 – 95 | 2300 | |
210 — 218.5 | 95 – 99 | 2400 | |
219 and Over | Over 99 | 2500 |
HOW SUPPLIED
Ethambutol Hydrochloride Tablets USP, 400 mg: Film coated, white, round, scored tablets embossed “VP” on one side and “14” on the scored side.Bottles of 120 | NDC 54868-6219-0 |
Store at 20-25°C (68-77°F)[See USP 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.
Manufactured for:
VersaPharm Incorporated
Marietta, GA 30062-2260
Manufactured by:
West-ward Pharmaceutical Corp.
Eatontown. NJ 07724
Revised February 2009
Relabeling and Repackaging by:
Physicians Total Care, Inc.
Tulsa, OK 74146
PRINCIPAL DISPLAY PANEL
Ethambutol Hydrochloride Tablets, USP 400 mg Tablets
ETHAMBUTOL ethambutol hydrochloride tablet, film coated | ||||||||||||||||||||||||||||||
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Labeler — Physicians Total Care, Inc. (194123980) |
Establishment | |||
Name | Address | ID/FEI | Operations |
Physicians Total Care, Inc. | 194123980 | relabel, repack |
Revised: 11/2009 Physicians Total Care, Inc.
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