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Ethambutol

Generic Medicine Info
Indications and Dosage
Oral
Tuberculosis
Adult: In combination with other antituberculosis agents: For initial treatment in patients who have not received previous antituberculosis therapy: 15 mg/kg once daily. For re-treatment in patients who previously received antituberculosis therapy: Initially, 25 mg/kg once daily for 60 days, then reduce to 15 mg/kg once daily thereafter. Dosage recommendations and treatment regimens may vary among individual products and between countries (refer to specific product or local guidelines).
Child: In combination with other antituberculosis agents: 15-25 mg/kg once daily. Dosage recommendations and treatment regimens may vary among individual products and between countries (refer to specific product or local guidelines).
What are the brands available for Ethambutol in Singapore?
  • Ebutol
  • E-Butol
Renal Impairment
Dose adjustment is needed based on serum ethambutol concentrations.
Administration
Ethambutol May be taken with or without food. May be taken with food to reduce GI discomfort. May crush tab & administer via feeding tubes. Take immediately.
Contraindications
Hypersensitivity. Optic neuritis and poor vision (unless clinical judgment determines that it may be used). Patients who cannot discern and report visual changes (e.g. unconscious patients).
Special Precautions
Patient with ocular disease (e.g. cataract, diabetic retinopathy, recurrent inflammatory eye conditions). Renal and hepatic impairment. Children and elderly. Pregnancy and lactation.
Adverse Reactions
Significant: Unilateral or bilateral optic neuritis, resulting in reduced visual acuity or other vision changes. Rarely, severe cutaneous adverse reactions, including Stevens-Johnson syndrome, toxic epidermal necrolysis, and drug reaction with eosinophilia and systemic symptoms.
Blood and lymphatic system disorders: Rarely, thrombocytopenia.
Gastrointestinal disorders: Nausea, vomiting, abdominal pain.
General disorders and administration site conditions: Fever, malaise.
Hepatobiliary disorders: Jaundice.
Immune system disorders: Rarely, hypersensitivity reactions, including anaphylaxis.
Investigations: Abnormal LFTs.
Metabolism and nutrition disorders: Hyperuricaemia, anorexia. Rarely, acute gout.
Musculoskeletal and connective tissue disorders: Joint pain.
Nervous system disorders: Headache, dizziness, disorientation, peripheral neuropathy.
Psychiatric disorders: Confusion, hallucinations.
Renal and urinary disorders: Rarely, interstitial nephritis.
Respiratory, thoracic and mediastinal disorders: Pulmonary infiltrates.
Skin and subcutaneous tissue disorders: Rash, pruritus, urticaria.
Potentially Fatal: Hepatotoxicity, including hepatitis.
Patient Counseling Information
This drug may cause visual impairment, if affected, do not drive or operate machinery.
Monitoring Parameters
Perform culture and susceptibility tests; consult local institutional recommendations before treatment initiation due to antibiotic resistance risks. Monitor LFTs, renal and haematopoietic tests at baseline and periodically; serum ethambutol concentrations (when clinically indicated). Perform ophthalmic examination, including visual acuity (e.g. Snellen eye chart), finger perimetry, ophthalmoscopy and colour discrimination tests on each eye separately and on both eyes tested together before treatment initiation and periodically thereafter. Assess for signs and symptoms of ocular or CNS changes, neuritis, and skin reactions.
Overdosage
Symptoms: Gastrointestinal disturbances, vomiting, anorexia, headache, dizziness, hallucinations, visual disturbances, and fever.

Management: Symptomatic and supportive treatment. May perform gastric lavage if necessary.
Drug Interactions
May reduce absorption with antacids containing aluminium hydroxide.
Action
Description:
Mechanism of Action: Ethambutol is a bacteriostatic antituberculosis agent active against Mycobacterium tuberculosis and some other mycobacteria, including some strains of M. avium, M. kansasii, M. fortuitum, and M. intracellulare. It blocks arabinosyltransferase, leading to impaired synthesis of the mycobacterial cell wall.
Pharmacokinetics:
Absorption: Absorbed from the gastrointestinal tract (approx 80%). Time to peak plasma concentration: 2-4 hours.
Distribution: Widely distributed in the body (including lungs, kidneys, saliva and erythrocytes); may diffuse into the CSF when meninges are inflamed. Crosses the placenta and enters breast milk. Plasma protein binding: 20-30%.
Metabolism: Metabolised partially in the liver into aldehyde and dicarboxylic acid derivatives (inactive metabolites).
Excretion: Via urine (approx 50% as unchanged drug, 8-15% as metabolites); faeces (approx 20% as unchanged drug). Elimination half-life: 2.5-3.6 hours.
Chemical Structure

Chemical Structure Image
Ethambutol

Source: National Center for Biotechnology Information. PubChem Compound Summary for CID 14052, Ethambutol. https://pubchem.ncbi.nlm.nih.gov/compound/Ethambutol. Accessed Nov. 26, 2024.

Storage
Store between 20-25°C. Protect from light and moisture.
MIMS Class
Anti-TB Agents
ATC Classification
J04AK02 - ethambutol ; Belongs to the class of other drugs used in the systemic treatment of tuberculosis.
References
Brayfield A, Cadart C (eds). Ethambutol Hydrochloride. Martindale: The Complete Drug Reference [online]. London. Pharmaceutical Press. https://www.medicinescomplete.com. Accessed 02/09/2025.

Ethambutol Hydrochloride Tablet (Lupin Pharmaceuticals, Inc.). DailyMed. Source: U.S. National Library of Medicine. https://dailymed.nlm.nih.gov/dailymed. Accessed 02/09/2025.

Ethambutol. Gold Standard Drug Database in ClinicalKey [online]. Elsevier Inc. https://www.clinicalkey.com. Accessed 17/09/2025.

Ethambutol. UpToDate Lexidrug, AHFS DI (Adult and Pediatric) Online. American Society of Health-System Pharmacists, Inc. Waltham, MA. UpToDate, Inc. https://online.lexi.com. Accessed 02/09/2025.

Ethambutol. UpToDate Lexidrug, Lexi-Drugs Multinational Online. Waltham, MA. UpToDate, Inc. https://online.lexi.com. Accessed 02/09/2025.

Joint Formulary Committee. Ethambutol Hydrochloride. British National Formulary [online]. London. BMJ Group and Pharmaceutical Press. https://www.medicinescomplete.com. Accessed 02/09/2025.

Myambutol Tablets 100 mg (Genus Pharmaceuticals Holdings Limited). MHRA. https://products.mhra.gov.uk. Accessed 02/09/2025.

PDR 400 (Unimed Sdn Bhd). National Pharmaceutical Regulatory Agency - Ministry of Health Malaysia. https://www.npra.gov.my. Accessed 02/09/2025.

Disclaimer: This information is independently developed by MIMS based on Ethambutol from various references and is provided for your reference only. Therapeutic uses, prescribing information and product availability may vary between countries. Please refer to MIMS Product Monographs for specific and locally approved prescribing information. Although great effort has been made to ensure content accuracy, MIMS shall not be held responsible or liable for any claims or damages arising from the use or misuse of the information contained herein, its contents or omissions, or otherwise. Copyright © 2025 MIMS. All rights reserved. Powered by MIMS.com
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