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ETHAMBUTOL is a brand name for Ethambutol. The medicine, its uses, side effects and dosage are the same regardless of brand.
Used for: For the primary treatment and re-treatment of tuberculosis and for prophylaxis in cases of inactive tuberculosis or large-tuberculin-positive reaction. Ethambutol should only be used in conjunction with other anti-tuberculosis drugs to which the patient’s organisms are susceptible. Consideration should be given to…
Verbatim from this product's MHRA label. Tap a section to expand.
Posolo gy Dosage should be determined according to the body weight of the patient. The usual daily dosage is 15-25mg/kg body weight given as a single dose. Ethambutol should not be used as a sole anti-tuberculosis agent, but should be given with at least one other anti-tuberculosis drug to avoid development of resistant strains.
Adults For primary treatment and prophylaxis:
Ethambutol should be administered in a single daily dose of 15 mg/kg body weight; concomitant drugs should be maintained at their usual recommended dosage.
For re-treatment:
For the first 60 days of treatment, ethambutol should be administered in a single daily dose of 25 mg/kg body weight. Thereafter the dosage should be reduced to 15 mg/kg body weight; concomitant drugs should be maintained at their usual recommended dosage levels.
Paediatric population For primary treatment and re-treatment:
For the first 60 days of treatment, a single daily dose of 25 mg/kg body weight. Thereafter the dosage should be reduced to 15 mg/kg body weight; concomitant drugs being maintained at their usual recommended dosage levels.
For prophylaxis:
A single daily dose of 15 mg/kg body weight; concomitant drugs being maintained at their usual recommended dosage levels. 4). ’ Elderly Dosage as for adults. However, patients with decreased renal function may need to have the dosage adjusted as determined by blood levels of ethambutol.
Method of administration:
Oral use
In this section frequencies of undesirable effects are defined as follows:
Very common ( 1/10); common ( 1/100, < 1/10); uncommon (1/1,000, < 1/100); rare ( 1/10,000, <1/1,000); very rare (< 1/10,000); not known ( frequency cannot be estimated from the available data) SOC LLT Occurrence thrombocytopenia rareBlood and lymphatic system disorders: leukopenia, neutropenia eosinophilia very rare Immune system disorders hypersensitivity, anaphylactoid reactions allergic reactions, anaphylaxis, allergic pneumonitis.
very rare hyperuricaemia. uncommonMetabolism and nutrition disorders gout. very rare Psychiatric disorders mental confusion, hallucination very rare peripheral neuritis, peripheral neuropathy, paraesthesia of the extremities, numbness rare burning pain, weakness (hands and feet), dizziness, headache, disorientation very rare Nervous system disorders tremor unknown retrobulbar neuritis* CommonEye disorders optic neuritis, (decreased visual acuity, loss of vision, scotoma, colour blindness, visual disturbance, visual field defect, eye pain) Uncommon Respiratory, thoracic and mediastinal disorders pneumonitis, pulmonary infiltrates, with or without eosinophilia very rare Gastrointestinal disorders: nausea, vomiting, anorexia, abdominal pain & diarrhoea have been noted in patients on multiple drug anti- tuberculosis therapy including ethambutol although not in test patients receiving ethambutol as sole therapy.
not known Flatulence, metallic taste, loss of appetite, upset stomach Hepatic reactions with hepatitis, jaundice, transient increase in liver enzymes, abnormal liver function test values and very rarely hepatic failure have been reported in patients treated with multiple drug therapy including ethambutol.
Liver function tests should be performed in patients who develop symptoms suggestive of hepatitis or who become generally unwell during treatment. not known1Hepatobiliary disorders: hepatic failure very rare Musculoskeletal and connective tissue disorders joint pains very rare Rash, pruritus, urticaria.
Ocular toxicity:
Ethambutol may produce a unique type of visual impairment which is generally reversible and which appears to be due to optic neuritis and to be related to dose and duration of treatment. Less than 1% of patients undergoing treatment with the higher dose regimen of 25mg/kg/day for two months, and 15mg/kg/day thereafter, have exhibited decrease in visual acuity.
It is recommended that patients undergo a full ophthalmic examination before starting treatment. This should include visual acuity, colour vision, perimetry and ophthalmoscopy. Each eye should be tested separately as ocular toxicity can be unilateral or bilateral.
Routine ophthalmological examination for adults is not thereafter necessary, but patients should be informed of the important of reporting any change in vision. Routine ophthalmological examination may be considered desirable when treating young children.
Any negative effects on vision are generally reversible when administration of the drug is discontinued promptly and recovery of visual acuity has usually occurred over a period of weeks to months after the drug was discontinued. Patients have then received Ethambutol at lower doses without toxicity.
In rare cases, recovery may be delayed for up to one year or more or the effects may be irreversible.
Renal function:
Toxic effects are more common if renal function is impaired.
Hepatic impairment:
Liver function tests should be performed in patients who develop symptoms suggestive of hepatitis or who become generally unwell during treatment.
Skin and subcutaneous tissue disorders:
1. Known optic neuritis and poor vision or retrobulbar neuritis, unless clinical judgement determines that the benefit outweighs the potential risk.
Not medical advice. Always read the patient information leaflet and follow your prescriber or pharmacist.
Other brands of Ethambutol in United Kingdom.
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Rare photosensitive lichenoid eruptions, bullous dermatitis, Stevens Johnson syndrome, epidermal necrolysis. very rare Skin & subcutaneous Tissue disorders drug reaction with eosinophilia and systemic symptoms (DRESS) Not known Renal and urinary disorders: nephrotoxicity including interstitial nephritis.
very rare General disorders and administration site conditions: malaise, pyrexia. very rare * This effect is thought to be dose related, and frequency is dependent on both dose and duration of treatment. It occurs most frequently with doses of 25 mg/kg body weight and after two months of therapy, however optic neuritis has also occurred after only a few days of therapy.
The effect is often reversible upon discontinuation of therapy. To avoid permanent damage visual acuity should be checked regularly during treatment and therapy discontinued immediately when visual disturbances occur. 4). Typical signs include: blurred vision, eye pain, impairment of colour vision (red-green colour blindness), constriction of visual field (central or peripheral scotoma), and any loss in vision.
Recovery of visual acuity has usually occurred over a period of weeks to months after the drug was discontinued, and patients have then received Ethambutol at lower dosage without toxicity. 1Liver function tests should be performed in patients who develop symptoms suggestive of hepatitis or who become generally unwell during treatment.
Reporting of suspected adverse reactions Reporting suspected adverse reactions after authorisation of the medicinal product is important. It allows continued monitoring of the benefit/ risk balance of the medicinal product. uk/yellowcard or search for MHRA Yellow Card in the Google Play or Apple App Store.
Severe cutaneous adverse reactions (SCARs) including Stevens-Johnson syndrome (SJS), toxic epidermal necrolysis (TEN), drug reaction with eosinophilia and systemic symptoms (DRESS), which can be life- threatening or fatal, have been reported post-marketing in association with ethambutol treatment.
At the time of prescription patients should be advised of the signs and symptoms and monitored closely for skin reactions. If signs and symptoms suggestive of these reactions appear, ethambutol should be withdrawn immediately and an alternative treatment considered (as appropriate).
If the patient has developed a serious reaction such as SJS, TEN or DRESS with the use of ethambutol, treatment with ethambutol must not be restarted in this patient at any time. In children, the presentation of a rash can be mistaken for the underlying infection or an alternative infectious process, and physicians should consider the possibility of a reaction to ethambutol in children that develop symptoms of rash and fever during therapy with ethambutol.
Other Warnings:
Consideration should be given to current clinical guidance on the appropriate use of antituberculous drugs. This medicine contains less than 1mmol sodium (23 mg) per 400 mg tablet, that is to say essentially ‘sodium free’.