Ethambutol Hydrochloride label

Ethambutol Hydrochloride

Ethambutol Hydrochloride Recall

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Side Effects & Adverse Reactions

ETHAMBUTOL 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.

Legal Issues

There is currently no legal information available for this drug.

FDA Safety Alerts

There are currently no FDA safety alerts available for this drug.

Manufacturer Warnings

There is currently no manufacturer warning information available for this drug.

FDA Labeling Changes

There are currently no FDA labeling changes available for this drug.

Uses

ETHAMBUTOL HCI is 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, ie, initial treatment, the most frequently used regimens have been the following:

ETHAMBUTOL HCI plus isoniazid ETHAMBUTOL HCI 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 HCI 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 HCI 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.

History

There is currently no drug history available for this drug.

Other Information

ETHAMBUTOL HYDROCHLORIDE is an oral chemotherapeutic agent which is specifically effective against actively growing microorganisms of the genus Mycobacterium, including M. tuberculosis. The structural formula is:

ETHAMBUTOL HYDROCHLORIDE (HCI) 100 and 400 mg tablets contain the following inactive ingredients: Gelatin, Hydroxypropyl Methylcellulose, Magnesium Stearate, Sodium Lauryl Sulfate, Sorbitol, Stearic Acid, Sucrose, Titanium Dioxide and other ingredients.

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Ethambutol Hydrochloride Recall

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Ethambutol Hydrochloride Manufacturers

Remedyrepack Inc.
No Recall
Ethambutol Hydrochloride | Remedyrepack Inc.

ETHAMBUTOL HCI should not be used alone, in initial treatment or in tretreatment. ETHAMBUTOL HCI 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 HCI 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 HCI 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 HCI 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 HCI administration, decrease the dose to 15 mg/kg (7mg/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
Pounds Kilograms Dose
In mg Under 85 Under 37…………. ……………….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 Under 38............... ……………..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
American Health Packaging
No Recall
Ethambutol Hydrochloride | Rxhomeo Private Limited D.b.a. Rxhomeo, Inc
Adults- Take 4 or 6 Pellets by mouth, three times daily or as suggested by physician. Children 2 years and older- take 1/2 the adult dose.
State Of Florida Doh Central Pharmacy
No Recall
Ethambutol Hydrochloride | State Of Florida Doh Central Pharmacy
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 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
Lupin Pharmaceuticals Inc
No Recall
Ethambutol Hydrochloride | Lupin Pharmaceuticals Inc
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/ 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 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 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
Remedyrepack Inc.
No Recall
Ethambutol Hydrochloride | Remedyrepack Inc.

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
Remedyrepack Inc.
No Recall
Ethambutol Hydrochloride | Remedyrepack Inc.
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
Sti Pharma
No Recall
Ethambutol Hydrochloride | Sti Pharma
ETHAMBUTOL HCI should not be used alone, in initial treatment or in tretreatment. ETHAMBUTOL HCI 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 HCI 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 HCI 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 HCI 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 HCI administration, decrease the dose to 15 mg/kg (7mg/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
Pounds Kilograms Dose
In mg Under 85 Under 37…………. ……………….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 Under 38............... ……………..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
Sti Pharma Llc
No Recall
Ethambutol Hydrochloride | Sti Pharma Llc
ETHAMBUTOL HCI should not be used alone, in initial treatment or in tretreatment. ETHAMBUTOL HCI 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 HCI 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 HCI 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 HCI 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 HCI administration, decrease the dose to 15 mg/kg (7mg/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
Pounds Kilograms Dose
In mg Under 85 Under 37…………. ……………….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 Under 38............... ……………..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
Remedyrepack Inc.
No Recall
Ethambutol Hydrochloride | Remedyrepack Inc.

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.

In patients who have not received previous antituberculous therapy, administer ethambutol hydrochloride 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.

In patients who have received previous antituberculous therapy, administer ethambutol hydrochloride 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 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
Barr Laboratories Inc.
No Recall
Ethambutol Hydrochloride | Barr Laboratories Inc.
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/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 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 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 to 94.5 37 to 43 600 95 to 109.5 43 to 50 700 110 to 124.5 50 to 57 800 125 to 139.5 57 to 64 900 140 to 154.5 64 to 71 1000 155 to 169.5 71 to 79 1100 170 to 184.5 79 to 84 1200 185 to 199.5 84 to 90 1300 200 to 214.5 90 to 97 1400 215 and Over Over 97 1500 25 mg/kg (11 mg/lb) Schedule Under 85 lbs Under 38 kg 900 85 to 92.5 38 to 42 1000 93 to 101.5 42 to 45.5 1100 102 to 109.5 45.5 to 50 1200 110 to 118.5 50 to 54 1300 119 to128.5 54 to 58 1400 129 to 136.5 58 to 62 1500 137 to 146.5 62 to 67 1600 147 to 155.5 67 to 71 1700 156 to 164.5 71 to 75 1800 165 to 173.5 75 to 79 1900 174 to 182.5 79 to 83 2000 183 to 191.5 83 to 87 2100 192 to 199.5 87 to 91 2200 200 to 209.5 91 to 95 2300 210 to 218.5 95 to 99 2400 219 and Over Over 99 2500
Carilion Materials Management
No Recall
Ethambutol Hydrochloride | Carilion Materials Management
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/ 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 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 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/kg (7 mg/lb) of body weight, and administer as a single oral dose once every 24 hours. in-vitro

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