Source: Medicines & Healthcare Products Regulatory Agency (GB) Revision Year: 2018 Publisher: Fannin (UK) Ltd., DCC Vital, Westminster Industrial Estate, Repton Road, Measham, Swadlincote, Derbyshire, DE12 7DT, England
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 official guidance on the appropriate use of antimicrobial agents.
For oral use.
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.
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.
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.
As children may be less likely or unable to report ocular toxicity, particular caution may be warranted (see Section 4.4).
Dosage as for adults. However, patients with decreased renal function may need to have the dosage adjusted as determined by blood levels of ethambutol.
Gastrointestinal disturbances, vomiting, fever, headache, anorexia, dizziness, hallucinations and/or visual disturbances.
There is no specific antidote, but gastric lavage should be employed if necessary.
3 years.
Do not store above 25°C.
Al/PVC/PVDC blisters. Pack size of 56 tablets. PP tablet containers. Pack size of 56 tablets.
None.
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