MYAMBUTOL SUMMARY
MYAMBUTOL ethambutol hydrochloride is an oral chemotherapeutic agent which is specifically effective against actively growing microorganisms of the genus Mycobacterium, including M. tuberculosis.
MYAMBUTOL 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:
- MYAMBUTOL 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, MYAMBUTOL 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 MYAMBUTOL 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.
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NEWS HIGHLIGHTS
Published Studies Related to Myambutol (Ethambutol)
A prospective, randomized trial examining the efficacy and safety of
clarithromycin in combination with ethambutol, rifabutin, or both for the
treatment of disseminated Mycobacterium avium complex disease in persons with
acquired immunodeficiency syndrome. [2003]
This multicenter, randomized, open-label phase 3 clinical trial compared the
safety and efficacy of 3 clarithromycin-containing combination regimens for the
treatment of disseminated Mycobacterium avium complex (MAC) disease in persons
with acquired immunodeficiency syndrome... Subjects in the C+E+R group had improved
survival, compared with the C+E group (hazard ratio [HR], 0.44; 95% confidence
interval [CI], 0.23-0.83) and the C+R group (HR, 0.49; 95% CI, 0.26-0.92).
Randomized, placebo-controlled trial of rifampin, ethambutol, and ciprofloxacin
for AIDS patients with disseminated Mycobacterium avium complex infection. [1993]
Patients with AIDS and disseminated Mycobacterium avium complex (MAC) infection
received rifampin (600 mg) plus ethambutol (25 mg/kg) plus ciprofloxacin (750 mg)
or matching placebos daily for 8 weeks. Patients were monitored every 2 weeks
clinically and by quantitating MAC colony-forming units (cfu) per milliliter of
blood...
Efficacy of clarithromycin and ethambutol for Mycobacterium avium complex
pulmonary disease. A preliminary study. [2014]
treatment of Mycobacterium avium lung disease... CONCLUSIONS: This preliminary study suggests that treatment with clarithromycin
Clarithromycin vs ciprofloxacin as adjuncts to rifampicin and ethambutol in
treating opportunist mycobacterial lung diseases and an assessment of
Mycobacterium vaccae immunotherapy. [2008]
vaccae vs no immunotherapy was also performed... CONCLUSION: Considering all three species together, there were no differences in
Moxifloxacin versus ethambutol in the first 2 months of treatment for pulmonary
tuberculosis. [2006]
alternate induction regimens... CONCLUSIONS: The addition of moxifloxacin to isoniazid, rifampin, and
Clinical Trials Related to Myambutol (Ethambutol)
Effect of Weight and/or Obesity on Ethambutol Drug Concentrations [Completed]
This study is designed to measure drug concentrations in the blood of healthy volunteers
administered a single dose of ethambutol. Our hypothesis is that volunteers with a body
mass index (BMI) 25-40 kg/m2 will remove ethambutol more quickly from the blood than leaner
volunteers, and those with a BMI > 40 kg/m2 will have even greater clearance than those who
are leaner.
Controlled Comparison of Two Moxifloxacin Containing Treatment Shortening Regimens in Pulmonary Tuberculosis [Completed]
REMoxTB is a study for the "Rapid Evaluation of Moxifloxacin in the treatment of sputum
smear positive tuberculosis". REMoxTB aims to find and evaluate new drugs and regimens that
shorten the duration of tuberculosis therapy.
The purpose of REMoxTB is to evaluate the efficacy, safety and acceptability of two
moxifloxacin-containing treatment combinations to determine whether substituting ethambutol
with moxifloxacin in one combination, and/or substituting isoniazid with moxifloxacin in
another combination, makes it possible to reduce the duration of treatment for TB.
A Study of Rifabutin, Used Alone or With Ethambutol in the Prevention of Mycobacterium Avium Complex (MAC) Bacteremia in Patients With AIDS [Completed]
To optimize Mycobacterium avium Complex (MAC) prophylaxis in AIDS patients by measuring
serum rifabutin levels and adjusting the dose accordingly. To combine rifabutin with
ethambutol to examine the effect of combination therapy in preventing or delaying the
incidence of MAC bacteremia in this patient population.
A Phase II/III Trial of Rifampin, Ciprofloxacin, Clofazimine, Ethambutol, and Amikacin in the Treatment of Disseminated Mycobacterium Avium Infection in HIV-Infected Individuals. [Completed]
To compare the effectiveness and toxicity of two combination drug treatment programs for the
treatment of disseminated Mycobacterium avium infection in HIV seropositive patients. [Per
03/06/92 amendment: to evaluate the efficacy of azithromycin when given in conjunction with
either ethambutol or clofazimine as maintenance therapy.] Disseminated M. avium infection is
the most common systemic bacterial infection complicating AIDS in the United States. The
prognosis of patients with disseminated M. avium is extremely poor, particularly when it
follows other opportunistic infections or is associated with anemia. Test tube studies and
clinical data indicate that the best treatment program may include clofazimine, ethambutol,
a rifamycin derivative, and ciprofloxacin. Test tube and animal studies indicate that
amikacin is a bactericidal (bacteria destroying) drug that works better when used with
ciprofloxacin. Its role in treatment programs is a key issue because of toxicity and because
it must be administered parenterally (by injection or intravenously).
Linezolid Instead of Ethambutol in Treatment of Drug-susceptible Tuberculosis [Recruiting]
The current standard short-course treatment for pulmonary TB requires 6 months to complete.
This long duration of treatment increases the likelihood of side effects while decreasing
patients' adherence to anti-TB drugs. Linezolid showed considerable efficacy against
refractory multidrug-resistant TB. Considering the marked anti-TB effects of linezolid as
well as the possible adverse effects of its long-term use, it is rational to use linezolid
instead of ethambutol for the first 4 weeks of treatment for drug-susceptible pulmonary TB.
Through randomized controlled trial, the investigators will evaluate the hypothesis that the
use of linezolid instead of ethambutol will increase the sputum culture conversion rate by
15% after 2 months of treatment. Patients with TB without resistance to rifampicin will be
randomized to the following three arms at a 1: 1:1 ratio: Arma 1 (control arm), Arm 2
(linezolid for 2 weeks instead of ethambutol), Arm 3 (linezolid for 4 weeks instead of
ethambutol)Primary outcome will be sputum culture conversion rate after 2 months of
treatment (liquid media).
Reports of Suspected Myambutol (Ethambutol) Side Effects
Cytolytic Hepatitis (9),
Hepatitis Fulminant (7),
Confusional State (6),
Convulsion (6),
Diarrhoea (6),
Agitation (5),
Coma (5),
Drug Rash With Eosinophilia and Systemic Symptoms (5),
Eosinophilia (5),
Pyrexia (4), more >>
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Page last updated: 2014-11-30
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