Eubutol Uses

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What is Eubutol?

Eubutol is used to treat tuberculosis (TB). It is used with other medicines for TB. Eubutol may also be used for other problems as determined by your doctor.

To help clear up your tuberculosis (TB) infection completely, you must keep taking Eubutol for the full time of treatment, even if you begin to feel better. This is very important. It is also important that you do not miss any doses.

Eubutol is available only with your doctor's prescription.

Once a medicine has been approved for marketing for a certain use, experience may show that it is also useful for other medical problems. Although this use is not included in product labeling, Eubutol is used in certain patients with the following medical condition:

Eubutol indications

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Primary treatment of pulmonary and extrapulmonary TB.

How should I use Eubutol?

Use Eubutol as directed by your doctor. Check the label on the medicine for exact dosing instructions.

Ask your health care provider any questions you may have about how to use Eubutol.

Uses of Eubutol in details

Use: Labeled Indications

Treatment of pulmonary tuberculosis in conjunction with other antituberculosis agents

Off Label Uses

Mycobacterium avium complex disease

Based on the Department of Health and Human Services (HHS) Guidelines for the Prevention and Treatment of Opportunistic Infections in HIV-Infected Adults and Adolescents, Eubutol, in combination with other appropriate antimycobacterial drugs, is effective and recommended for the treatment and chronic maintenance therapy (secondary prophylaxis) of disseminated MAC disease in HIV-infected patients.

Based on the American Thoracic Society (ATS) and Infectious Diseases Society of America (IDSA) Guideline for the Diagnosis, Treatment, and Prevention of Nontuberculosis Mycobacterial Disease, Eubutol, in combination with other appropriate antimycobacterial drugs, is effective and recommended for the treatment of MAC pulmonary and/or disseminated disease.

Nontuberculous mycobacterial disease (M. kansasii)

Data from a small prospective, single-arm study and a larger retrospective study support the use of Eubutol, in combination with clarithromycin and rifampin, in the treatment of susceptible Mycobacterium kansasii pulmonary disease. Additional trials may be necessary to further define the role of Eubutol in this condition.

Based on the ATS/IDSA Guideline for the Diagnosis, Treatment, and Prevention of Nontuberculous Mycobacterial Diseases Eubutol, in combination with rifampin and isoniazid, is effective and recommended for the treatment of susceptible M. kansasii pulmonary disease

Tuberculous meningitis (drug-susceptible)

Based on the American Thoracic Society (ATS)/Centers for Disease Control and Prevention (CDC)/Infectious Disease Society of America (IDSA) Treatment of Drug-Susceptible Tuberculosis guidelines, Eubutol, in combination with other antitubercular drugs, is effective and recommended for initial treatment of tuberculous meningitis.

Eubutol description

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An antitubercular agent that inhibits the transfer of mycolic acids into the cell wall of the tubercle bacillus. It may also inhibit the synthesis of spermidine in mycobacteria. The action is usually bactericidal, and the drug can penetrate human cell membranes to exert its lethal effect. (From Smith and Reynard, Textbook of Pharmacology, 1992, p863)

Eubutol dosage

Eubutol Dosage

Applies to the following strength(s): 100 mg; 400 mg

The information at Drugs.com is not a substitute for medical advice. Always consult your doctor or pharmacist.

Usual Adult Dose for:

Usual Pediatric Dose for:

Additional dosage information:

Usual Adult Dose for Tuberculosis - Active

Initial treatment: 15 mg/kg orally once a day for 6 to 8 weeks with concurrent isoniazid therapy.

Retreatment: 25 mg/kg orally once a day for 60 days concurrently with at least one other anti-TB drug. After 60 days, decrease dose to 15 mg/kg orally once a day.

As an alternative to single daily dose, a dose of 40 mg/kg orally twice a week or 30 mg/kg orally 3 times a week can be administered. This generally follows 2 weeks of daily therapy. This regimen allows directly observed therapy (DOT).

Usual Adult Dose for Mycobacterium avium-intracellulare - Treatment

900 mg orally once a day. Pulmonary AVI treatment consists of clarithromycin and 2 to 4 other drugs such as Eubutol, rifampin, clofazimine, and/or other agents. The duration of treatment is 18 to 24 months.

Disseminated MAI treatment consists of clarithromycin or azithromycin and 1 to 3 other drugs such as Eubutol, clofazamine, ciprofloxacin, ofloxacin, rifampin, rifabutin, or amikacin. As long as clinical and microbiological response is documented, therapy should be continued for life.

Usual Adult Dose for Mycobacterium avium-intracellulare - Prophylaxis

15 mg/kg orally once a day. Used in combination therapy with clarithromycin or azithromycin. Therapy should be continued for life.

Usual Pediatric Dose for Tuberculosis - Active

Greater than 13 years:

Initial treatment: 15 mg/kg orally once a day for 6 to 8 weeks with concurrent isoniazid therapy.

Retreatment: 25 mg/kg orally once a day for 60 days concurrently with at least one other anti-TB drug. After 60 days, decrease dose to 15 mg/kg orally once a day.

As an alternative to single daily dose, a dose of 40 mg/kg orally twice a week or 30 mg/kg orally 3 times a week can be administered. This generally follows 2 weeks of daily therapy. This regimen allows directly observed therapy (DOT).

Usual Pediatric Dose for Mycobacterium avium-intracellulare - Treatment

Greater than 13 years:

900 mg orally once a day. Pulmonary AVI treatment consists of clarithromycin and 2 to 4 other drugs such as Eubutol, rifampin, clofazimine, and/or other agents. The duration of treatment is 18 to 24 months.

Disseminated MAI treatment consists of clarithromycin or azithromycin and 1 to 3 other drugs such as Eubutol, clofazamine, ciprofloxacin, ofloxacin, rifampin, rifabutin, or amikacin. As long as clinical and microbiological response is documented, therapy should be continued for life.

Usual Pediatric Dose for Mycobacterium avium-intracellulare - Prophylaxis

Greater than 13 years:

15 mg/kg orally once a day. Used in combination therapy with clarithromycin or azithromycin. Therapy should be continued for life.

Renal Dose Adjustments

CrCl less than 10 mL/min: The usual dose may be administered every 48 hours.

CrCl 10 to 50 mL/min: The usual dose may be administered every 24 to 36 hours.

Liver Dose Adjustments

Data not available

Dose Adjustments

Patients with decreased renal function need the dosage reduced as determined by serum levels, since the main path of excretion of this drug is by the kidneys.

Precautions

Eubutol is contraindicated in patients with known optic neuritis unless clinical judgment determines that it may be administered. Eubutol is contraindicated in patients who are unable to appreciate and report visual side effects or changes in vision (e.g., young children, unconscious patients).

Due to the risk of optic neuritis associated with Eubutol, caution should be used when treating patients with preexisting neuritis or other vision defects. Eubutol may produce decreases in visual acuity that appear to be due to optic neuritis. This effect may be related to dosage and duration of treatment. This effect is generally reversible when use of the drug is discontinued promptly. However, irreversible blindness has been observed. Since this drug may have adverse effects on vision, physical examination should include ophthalmoscopy, finger perimetry and testing of color discrimination. In patients with visual defects such as cataracts, recurrent inflammatory conditions of the eye, optic neuritis, and diabetic retinopathy, the evaluation of changes in visual acuity is more difficult, and care should be taken to make sure that variations in vision are not due to the underlying disease conditions. In these patients, consideration should be given to relationship between benefits expected and possible visual deterioration since evaluation of visual changes is difficult. All patients receiving Eubutol should be instructed to report any vision changes or disturbances. Testing of visual acuity should be performed before beginning Eubutol and periodically during drug administration. Monthly visual acuity testing should be done for patients receiving more than 15 mg per kilogram per day.

Liver toxicities including fatalities have been observed. Baseline and periodic assessment of hepatic function should be performed.

Patients with decreased renal function should have the dosage reduced as determined by serum levels of Eubutol, since the main path of excretion of this drug is by the kidneys. Baseline and periodic assessment of renal function should be performed.

Baseline and periodic assessment of hematopoietic function should be performed.

Eubutol may elevate serum uric acid levels and should be used cautiously in patients with preexisting gout. Patients should be monitored for hyperuricemia.

There are limited data on the use of Eubutol in elderly patients. One study of 101 patients, 65 years and older, on multiple drug antituberculosis regimens included 94 patients on Eubutol therapy. No differences in safety or tolerability were reported in these patients compared with that reported in adults in general. Other observed clinical experience has not identified differences in responses between the elderly and younger patients, but greater sensitivity of some older individuals cannot be ruled out.

Dialysis

Eubutol is slightly dialyzable (5% to 20%). The dose should be administered post-dialysis.

Other Comments

Eubutol or streptomycin are used as part of a combination therapy with isoniazid, rifampin, and pyrazinamide. If susceptibility to isoniazid and rifampin is shown, Eubutol may be discontinued.

More about Eubutol

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Related treatment guides

Eubutol interactions

See also:
What other drugs will affect Eubutol?

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Absorption delayed or reduced by aluminum hydroxide. Synergistic effect with other antitubercular agents.

Eubutol side effects

See also:
What are the possible side effects of Eubutol?

Retrobulbar neuritis with a reduction in visual acuity, constriction of visual field, central or peripheral scotoma and green-red colour blindness. Retinal haemorrhage (rare); reduced renal clearance of urates (acute gout); GI disturbances eg, nausea, vomiting, abdominal pain, anorexia; rash, headache, dizziness, confusion, hallucinations, malaise, jaundice; thrombocytopenia; pulmonary infiltrates.

Eubutol contraindications

See also:
What is the most important information I should know about Eubutol?

Hypersensitivity; optic neuritis. Lactation.

Active ingredient matches for Eubutol:

Ethambutol HCl in Vietnam.


Unit description / dosage (Manufacturer)Price, USD
Eubutol 400 mg x 12 Blister x 10 Tablet

List of Eubutol substitutes (brand and generic names):

Combutol 400 400 mg x 10 Blister x 10 Tablet
Confez 3 Kit Kit (Shreya Healthcare P. Ltd.)$ 0.08
Doctor's Ethambutol 400 mg x 100's
E-Butol 400 mg x 500's
Ethambutol 400-SPM 400 mg x 10 Blister x 10 Tablet
Ethambutol 400-SPM 400 mg x 1 Bottle 100 Tablet
Ethambutol Hydrochloride Micro Labs 400 mg x 10 Blister x 10 Tablet
Ethambutol Imexpharm 400 mg x 10 Blister x 12 Tablet
Ethambutol Pharimexco 400 x 10 Blister x 10 Tablet
Ethambutol Pharimexco 400 x 1 Bottle 100 Tablet
Ethambutol Pharimexco 400 x 1 Bottle 200 Tablet
Ethambutol Pharimexco 400 x 1 Bottle 500 Tablet
Ethambutol Pharimexco 400 mg x 10 Blister x 10 Tablet
Ethambutol Pharimexco 400 mg x 1 Bottle 100 Tablet
Ethambutol Pharimexco 400 mg x 1 Bottle 200 Tablet
Ethambutol Pharimexco 400 mg x 1 Bottle 500 Tablet
Hamutol-400 400 mg x 10 Blister x 10 Tablet
Holtresis 400 mg x 100's
Kebitol 800 mg Tablet (Kentreck Labs Pvt Ltd.)$ 0.05
KEBITOL 800MG TABLET 1 strip / 10 tablets each (Kentreck Labs Pvt Ltd.)$ 0.57
Kebitol 800mg Tablet (Kentreck Labs Pvt Ltd.)$ 0.06
Lykabutol 400 mg x 10 Blister x 10 Tablet
Odetol 400 mg x 100's (Medichem)$ 22.13
Tosbutol 800 mg Tablet (Tosc International Pvt Ltd.)$ 0.05
Triambutol 200 mg x 100's$ 5.27

References

  1. DailyMed. "ETHAMBUTOL HYDROCHLORIDE: DailyMed provides trustworthy information about marketed drugs in the United States. DailyMed is the official provider of FDA label information (package inserts).". https://dailymed.nlm.nih.gov/dailyme... (accessed September 17, 2018).
  2. PubChem. "ethambutol". https://pubchem.ncbi.nlm.nih.gov/com... (accessed September 17, 2018).
  3. DrugBank. "ethambutol". http://www.drugbank.ca/drugs/DB00330 (accessed September 17, 2018).

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Information checked by Dr. Sachin Kumar, MD Pharmacology

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