Source: Health Products and Food Branch (CA) Revision Year: 2019
ETIBI (ethambutol) is indicated in combination with other antituberculosis medications in the treatment of all forms of tuberculosis, including tuberculous meningitis, caused by Mycobacterium tuberculosis.
In retreatment cases, ETIBI should be given together with at least one other second line drug for which bacterial susceptibility has been indicated by appropriate in vitro studies and which has not been administered previously to the patient.
To reduce the development of drug-resistant bacteria and maintain the effectiveness of ETIBI Tablets and other antibacterial drugs, ETIBI Tablets should be used only to treat infections that are proven or strongly suspected to be caused by susceptible bacteria. When culture and susceptibility information are available, they should be considered in selecting or modifying antibacterial therapy. In the absence of such data, local epidemiology and susceptibility patterns may contribute to the empiric selection of therapy.
ETIBI (ethambutol) may be taken with food if gastrointestinal irritation occurs. Since daily administration in divided doses may not result in therapeutic serum concentrations, it is recommended that ETIBI be administered only in a single daily dose if feasible. Since bacterial resistance may develop rapidly when ethambutol is administered alone, it should only be administered concurrently with other antituberculosis medications.
Usual adult and adolescent dose: - Tuberculosis – for the initial treatment of patients who have not received previous therapy with antituberculosis agents, the usual dosage of ETIBI is 15 mg/kg once daily. In patients who have received previous antituberculosis therapy, the usual dosage is 25 mg/kg daily for 60 days or until bacteriologic smears and cultures become negative, followed by 15 mg/kg daily.
Alternatively, when ETIBI is used in combination with other antituberculosis agents and these drugs are administered twice weekly, the usual adult dose is 50 mg/kg up to 2.5 grams twice weekly. In a three times weekly administration regimen with other antituberculosis agents, the dosage of ETIBI is 25-30 mg/kg to a maximum of 2.5 grams.
Usual pediatric dose: Children 13 years of age and over – see usual adult and adolescent dose. Children up to 13 years of age – Dosage has not been established. However, ETIBI should be considered for all children with organisms resistant to other medications, and in whom susceptibility to ethambutol has been demonstrated or is likely. ETIBI is generally not recommended in children whose visual acuity cannot be monitored (younger than 6 years of age).
Dosage in Renal Impairment: in patients with impaired renal function, doses and/or frequency of administration of ETIBI should be modified in response to the degree of renal impairment.
Usually ETIBI (ethambutol) is well tolerated. However, optical disturbances, as noted above, are reversible when the drug is discontinued. This may require a period of weeks to months. Any unusual sign or symptom should be investigated thoroughly and the drug discontinued if the condition persists.
Keep away from light, moisture, and excessive heat. Store in well-closed container at controlled room temperature (15-30°C).
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