Combutol
✅ Treats Tuberculosis
✅ Kills Bacteria
✅ Prevents Disease Spread
✅ Prescribed Antibiotic
✅ Oral Medication Option
Combutol contains Ethambutol.
✓ Medisch beoordeeld door Morgan Ellis — Apotheekonderzoeker · 8 jaar ervaring · Laatst beoordeeld: mei 2026
⚡ Quick Answer — What is Combutol?
Combutol bevat ethambutol hydrochloride (200 mg / 400 mg / 800 mg tablets) from a WHO-GMP certified manufacturer (made by Lupin) — a bacteriostatic anti-tuberculous antibiotic that disrupts mycobacterial cell-wall arabinogalactan synthesis. Combutol’s job in active TB is to be the “E” in the 4-drug RIPE regimen during the first 2-month intensive phase — it prevents the emergence of resistance to the bactericidal companion drugs (rifampicin, isoniazid, pyrazinamide). Standard adult dose: 15 mg/kg once daily (typically 800 mg for > 55 kg). The defining toxicity is dosisafhankelijke optische neuritis — loss of visual acuity and red-green colour discrimination, usually reversible if the drug is stopped at the first symptom but potentially permanent if it is not. Baseline ophthalmology assessment + monthly visual checks are mandatory, and the dose must be reduced in renal impairment.
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What Combutol (Ethambutol) Is
Combutol is the Lupin brand of ethambutol hydrochloride, a synthetic bacteriostatic anti-tuberculous agent introduced in 1961 and on the WHO Model List of Essential Medicines. Each tablet contains 200 mg, 400 mg, or 800 mg of ethambutol HCl. It is one of the four first-line agents used in the standard short-course regimen for drug-susceptible tuberculosis — the “E” in RIPE — and is also a core agent for Mycobacterium avium complex (MAC) infection.
How Combutol Works (Mechanism)
Ethambutol inhibits arabinosyl transferase III (encoded by the embB gene), an enzyme essential for the synthesis of arabinogalactan and lipoarabinomannan — key polysaccharide components of the mycobacterial cell wall. Without these polysaccharides the cell wall is structurally weakened, mycolic acid attachment fails, and the bacteria become more susceptible to other antibiotics. Ethambutol is bacteriostatic on its own at the doses used clinically; its main contribution to a combination regimen is to prevent the emergence of resistance to the bactericidal partner drugs (rifampicin, isoniazid).
Indications — What Combutol Treats
1. Active tuberculosis (combination therapy)
Ethambutol is part of the WHO 4-drug RIPE regimen during the first 2 months of treatment for new pulmonary or extrapulmonary tuberculosis caused by M. tuberculosis. Once drug-susceptibility testing confirms full sensitivity to rifampicin and isoniazid, ethambutol can sometimes be dropped before the end of the intensive phase — but in routine practice it is given for the full 2 months.
| Fase | Duur | Drugs |
|---|---|---|
| Intensive | 2 months | Rifampicine + Isoniazide + Pyrazinamide + Ethambutol |
| Continuation | 4 months | Rifampicin + Isoniazid |
2. Mycobacterium avium complex (MAC)
MAC infection — both disseminated disease in advanced HIV (CD4 generally < 50) and chronic pulmonary disease in non-HIV patients with bronchiectasis — is treated with macrolide-anchored regimens. The standard combination is clarithromycin or azithromycin + ethambutol, often with rifabutin for severe disease. Ethambutol’s role here mirrors its role in TB: it prevents macrolide resistance.
3. Other non-tuberculous mycobacteria
Ethambutol is included in regimens for M. kansasii (with rifampicin and isoniazid), M. xenopi, and certain other slow-growing non-tuberculous mycobacteria. Treatment of these infections is specialist-led and varies by isolate susceptibility.
Dosering
| Indicatie | Adult dose (daily) | Opmerkingen |
|---|---|---|
| Active TB — intensive phase | 15 mg/kg once daily • 38–55 kg → 800 mg • > 55 kg → 1200 mg (rounded; some guidelines cap at 1600 mg) | Continue for 2 months as part of RIPE |
| Active TB — intermittent (3 doses/week) | 25–30 mg/kg per dose | Only under directly observed therapy |
| MAC pulmonary disease | 15 mg/kg once daily | Combined with macrolide; treatment 12–18 months minimum |
| MAC disseminated disease in HIV | 15 mg/kg once daily | Combined with clarithromycin/azithromycin ± rifabutin |
| Paediatric (TB) | 20 mg/kg once daily | Avoid or use cautiously where the child cannot report visual symptoms |
Aanpassing van de nierdosis
| Creatinine clearance | Dose adjustment |
|---|---|
| > 50 mL/min | Standard 15 mg/kg once daily |
| 30–50 mL/min | 15 mg/kg every 24–36 hours |
| 10–30 mL/min | 15 mg/kg every 48 hours |
| Hemodialyse | 15–25 mg/kg three times a week, dose na dialysis |
Take Combutol once daily, with or without food — whichever causes less nausea. Separate from aluminium-containing antacids by at least 4 hours.
Verplichte monitoring
Additional monitoring: baseline and periodic liver-function tests (ethambutol itself is mildly hepatotoxic but the partner drugs are more so), urea/creatinine, serum uric acid in patients with a history of gout, and full blood count. Sputum culture conversion at 2 months is the main efficacy marker for active TB.
Bijwerkingen
Most clinically important:
- Optic neuritis (see red-box warning above) — dose-dependent; reversible if caught early; permanent if ignored
- Hyperuricaemia — ethambutol reduces renal urate excretion; can precipitate gout flare in susceptible patients
- Peripheral neuropathy — rare; numbness or tingling in hands or feet
Common but mild:
- Nausea, anorexia, abdominal discomfort — usually self-limiting
- Hoofdpijn, duizeligheid
- Mild rash
Zeldzaam maar belangrijk:
- Hepatitis (rare with ethambutol alone; more common when combined with rifampicin + isoniazid + pyrazinamide)
- Thrombocytopenia, eosinophilia, leukopenia
- Hypersensitivity rash, fever; rare anaphylaxis
- Confusion, disorientation, hallucinations — very rare
Geneesmiddelinteracties
Ethambutol has a relatively quiet interaction profile compared with the other first-line TB drugs.
- Aluminium-containing antacids reduce ethambutol absorption substantially — separate doses by at least 4 hours.
- Disulfiram may worsen ethambutol-related neurotoxicity (avoid).
- No clinically meaningful CYP-induction or CYP-inhibition interactions.
The serious drug interactions in a TB regimen come from the partner drugs (especially rifampicin) — review every concurrent medication when starting any TB regimen, even if you are mainly worried about ethambutol.
Contra-indicaties en voorzorgsmaatregelen
- Known hypersensitivity to ethambutol
- Pre-existing optic neuritis (relative contraindication — specialist review)
- Inability to report visual symptoms reliably (very young children, severe cognitive impairment, unconscious patients) — relative contraindication
Use with caution in: significant renal impairment (dose-adjust as above), gout, diabetic retinopathy or other pre-existing eye disease (baseline ophthalmology review recommended), elderly patients.
Pregnancy, Breastfeeding, and Children
Ethambutol is part of the standard WHO TB regimen used in pregnancy. It is well tolerated and not associated with foetal optic toxicity. Compatible with breastfeeding (small amounts in milk). In children, ethambutol can be used at 20 mg/kg/day if the child can reliably report visual symptoms; otherwise the paediatric TB team will weigh the regimen-resistance benefit against the inability to monitor for optic neuritis.
Opslag
Store at 15–30 °C in the original blister, protected from moisture, heat, and direct sunlight. Keep out of reach of children. Dispose of unused or expired tablets through a pharmacy take-back scheme.
Veelgestelde vragen
Can I treat active tuberculosis with Combutol alone?
No. Ethambutol is a bacteriostatic agent — it slows mycobacterial growth but does not sterilise the infection. Active TB requires combination chemotherapy: rifampicin + isoniazid + pyrazinamide + ethambutol for the first 2 months (intensive phase), then rifampicin + isoniazid for 4 more months (continuation phase). Ethambutol’s job in the regimen is to prevent the bacteria from becoming resistant to the bactericidal partner drugs.
What visual symptoms should make me stop Combutol immediately?
Any new visual change. The classic warning signs are: blurred vision, dimming of central vision, difficulty distinguishing red from green (a cup of tea may look brown rather than red-brown), a dark spot in the centre of vision (central scotoma), or eye pain on movement. Stop the drug and contact your physician the same day — do niet wait for the next clinic appointment. Early stopping is usually followed by full or near-full recovery; continuing in the face of symptoms can leave permanent vision loss.
What eye tests do I need before and during ethambutol therapy?
Before starting: visual-acuity test (Snellen chart) and red-green colour vision (Ishihara plates) for each eye separately. Document the baseline. Repeat the same tests at least monthly throughout treatment; an ophthalmologist review is recommended if any baseline visual abnormality is present, in older adults, in renal impairment, or when the dose exceeds 15 mg/kg.
Why does my dose need to change if I have kidney problems?
Ethambutol is cleared mainly by the kidneys (about 80% renal excretion of unchanged drug). In renal impairment the drug accumulates, the blood concentration rises, and so does the risk of optic neuritis. Standard adjustments: creatinine clearance 30–50 mL/min → 15 mg/kg every 24–36 hours; CrCl 10–30 mL/min → every 48 hours; on haemodialysis → standard dose three times a week given na dialysis. Always recheck creatinine before starting and during therapy.
Can children take ethambutol?
Yes, but with care. Older children (those who can reliably report visual changes — usually around school age and above) tolerate ethambutol well at 20 mg/kg/day. In very young children who cannot describe visual symptoms, many guidelines either avoid ethambutol or use it short-term only when the regimen requires it. The decision is always individualised by the paediatric TB team.
Is Combutol safe in pregnancy and breastfeeding?
Yes. Ethambutol crosses the placenta but is not associated with foetal optic toxicity and has been used safely in pregnant women with active TB for decades. It is part of the standard WHO regimen in pregnancy. Small amounts pass into breast milk but breastfeeding can continue.
Does food affect how Combutol is absorbed?
Mildly. Food can slow and slightly reduce absorption but the difference is small enough that ethambutol can be taken with or without food — pick whichever causes least nausea and stick to it. Aluminium-containing antacids reduce absorption substantially — separate any antacid by at least 4 hours from your Combutol dose.
What is Mycobacterium avium complex (MAC) and why is ethambutol used for it?
MAC is a group of slow-growing non-tuberculous mycobacteria that cause disseminated infection in advanced HIV (CD4 typically < 50) and chronic lung disease in older adults with bronchiectasis. The standard MAC regimen is clarithromycin or azithromycin + ethambutol ± rifabutin. Ethambutol prevents macrolide resistance — the same anti-resistance role it plays in TB.
Can I drink alcohol while on ethambutol?
Ethambutol itself has minimal hepatotoxicity and does not interact strongly with alcohol. However, the companion drugs in TB therapy (rifampicin, isoniazid, pyrazinamide) are all hepatotoxic and alcohol substantially raises the risk of treatment-related liver injury. While on combination TB therapy, avoid alcohol or limit it strictly — the most common reason TB regimens have to be interrupted is hepatitis.
How is Combutol stored?
Store at 15–30 °C in the original blister, protected from moisture, heat, and direct sunlight. Tablets are stable in normal household conditions. Keep out of reach of children — ethambutol overdose can cause severe optic neuritis. Dispose of unused or expired tablets through a pharmacy take-back scheme.
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