Ethambutol appears to inhibit the synthesis of 1 or more metabolites in susceptible bacteria resulting in impairment of cellular metabolism, arrest of multiplication, and cell death. It is active against susceptible bacteria only when they are undergoing cell division.

Ethambutol 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 plus isoniazid
• Ethambutol 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 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 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.

Ethambutol should not be used alone, in initial treatment or in retreatment. Ethambutol 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 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 15 mg/kg 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 25 mg/kg 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 administration, decrease the dose to 15 mg/kg 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.

Renal Impairment: Dose adjustment may be needed as determined by blood levels of ethambutol.

Administration

Should be taken with food.

Ethambutol is contraindicated in patients who are known to be hypersensitive to this drug. It is also contraindicated in patients with known optic neuritis unless clinical judgment determines that it may be used. Ethambutol is contraindicated in patients who are unable to appreciate and report visual side effects or changes in vision

Retrobulbar neuritis with reduction in visual acuity, constriction of visual field, central or peripheral scotoma and green-red colour blindness of 1 or both eyes. Reduced renal clearance of urate and may precipitate acute gout. Confusion, disorientation, hallucinations, headache, dizziness, malaise, jaundice or transient liver dysfunction, peripheral neuropathy, thrombocytopenia, pulmonary infiltrates, eosinophilia and GI disturbances (e.g. nausea, vomiting, anorexia, abdominal pain). Rarely, retinal haemorrhage, hypersensitivity reactions including rashes, pruritus, leucopenia, fever, and joint pains.

Patient with ocular defects (e.g. cataracts, recurrent ocular inflammatory conditions, diabetic neuropathy). Renal impairment. Pregnancy and lactation.

Pregnancy & Lactation

Category C: Either studies in animals have revealed adverse effects on the foetus (teratogenic or embryocidal or other) and there are no controlled studies in women or studies in women and animals are not available. Drugs should be given only if the potential benefit justifies the potential risk to the foetus.