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Ethambutol indications, dose, side effects & concise monograph


Primary treatment of pulmonary and extrapulmonary tuberculosis
Adult: As hydrochloride: Initial 8 wk: 15 mg/kg/day or 30 mg/kg thrice wkly given with isoniazid, rifampicin and pyrazinamide. For patients with history of antimycobacterial therapy: Initial doses: 25 mg/kg/day for 60 days, thereafter reduce to 15 mg/kg/day.
Child: For treatment of drug-resistant tuberculosis: 15-25 mg/kg daily or 50 mg/kg twice wkly. For congenitally acquired tuberculosis: Neonates: 15 mg/kg once daily and ≥1 mth: 15 mg/kg once daily or 30 mg/kg 3 times wkly for 2 mth initial treatment phase.
Renal impairment: Dose reduction may be required.

Special Populations: Reduce dose in patients with renal impairment.
Hypersensitivity; optic neuritis. Lactation.
Warnings / Precautions
Impaired pre-treatment visual acuity, elderly, children. Perform liver, kidney and visual acuity tests regularly. Caution when assessing visual acuity in patients with cataracts, DM, recurrent eye inflammation to make sure that changes are not due to the underlying causes.
Adverse Reactions
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.
Drug Interactions
Absorption delayed or reduced by aluminum hydroxide. Synergistic effect with other antitubercular agents.
See Below for More ethambutol Drug Interactions
Mechanism of Actions
Ethambutol interferes with RNA synthesis, causing suppression of Mycobacteria multiplication. It also has bacteriostatic action against M tuberculosis by acting on rapidly growing pathogens in cavity walls and is also effective in slow-growing pathogens. Has some action against atypical opportunistic Mycobacteria e.g. M kansasii, M avium complex (MAC).
Absorption: 80% is absorbed from the GI tract (oral).
Distribution: Lungs, kidneys, erythrocytes, CSF (in meningitis); crosses the placenta and enters breast milk.
Metabolism: Hepatic: Converted to the aldehyde and dicarboxylic acid derivatives (inactive).
Excretion: Via urine (as unchanged, 8-15% as metabolites), via faeces (20% as unchanged); 3-4 hr (elimination half-life).
Should be taken with food.
Storage Conditions
Oral: Store at 15-25°C.
ATC Classification
J04AK02 - ethambutol ; Belongs to the class of other drugs used in the systemic treatment of tuberculosis.
Oral: Store at 15-25°C.
Available As
  • Ethambutol Hcl IP 1000 mg
  • Ethambutol Hcl 1000 mg
  • Ethambutol 1000 mg
  • Ethambutol 1100 mg
  • Ethambutol 1200 mg
  • Ethambutol 200 mg
  • Ethambutol 267 mg
  • Ethambutol HcI IP 275 mg
  • Ethambutol Hcl 275 mg
  • Ethambutol Hcl IP 275 mg
  • Ethambutol 275 mg
  • Ethambutol IP 400 mg
  • Ethambutol Hcl 400 mg
  • Ethambutol Hcl IP 400 mg
  • Ethambutol 400 mg
  • Ethambutol 550 mg
  • Ethambutol 600 mg
  • Ethambutol 600 mg (2 tab)
  • Ethambutol Hcl IP 800 mg
  • Ethambutol Hcl 800 mg
  • Ethambutol 800 mg
  • Ethambutol 825 mg
  • Ethambutol Hcl IP 825 mg
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