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).

Weight-Dose Table
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 120NDC 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
(click image for full-size original)

Ethambutol Hydrochloride Tablets, USP 400 mg Tablets

ETHAMBUTOL ethambutol hydrochloride tablet, film coated
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:54868-6219(NDC:61748-014)
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
ETHAMBUTOL HYDROCHLORIDE (ETHAMBUTOL) ETHAMBUTOL HYDROCHLORIDE 400 mg
Inactive Ingredients
Ingredient Name Strength
SILICON DIOXIDE
STARCH, CORN
CROSCARMELLOSE SODIUM
DOCUSATE SODIUM
LACTOSE MONOHYDRATE
MAGNESIUM STEARATE
POVIDONE K30
STEARIC ACID
RAW SUGAR
POLYETHYLENE GLYCOL
POLYSORBATE 80
TITANIUM DIOXIDE
HYPROMELLOSE 2208 (15000 MPA.S)
Product Characteristics
Color white (White) Score 2 pieces
Shape ROUND (Round) Size 13mm
Flavor Imprint Code VP;14
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:54868-6219-0 120 TABLET, FILM COATED (TABLET) in 1 BOTTLE, PLASTIC None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA075095 12/20/2010
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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