País: Regne Unit
Idioma: anglès
Font: MHRA (Medicines & Healthcare Products Regulatory Agency)
Ethambutol hydrochloride
DE Pharmaceuticals
J04AK02
Ethambutol hydrochloride
400mg
Oral tablet
Oral
No Controlled Drug Status
Valid as a prescribable product
BNF: 05010900
By reporting side effects you can help provide more information on the safety of this medicine. Play or Apple App Store. Intrapharm Laboratories Ltd., The Courtyard Barns, Choke Lane, Maidenhead, Berks SL6 6PT, UK Intrapharm Laboratories Ltd., The Courtyard Barns, Choke Lane, Maidenhead, Berks SL6 6PT, UK 280.00 mm 150.00 mm Llegiu el document complet
SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Ethambutol 400 mg Tablets 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Each film coated tablet contains 400mg Ethambutol Hydrochloride. For a full list of excipients see section 6.1. 3 PHARMACEUTICAL FORM Film coated tablet. Smooth, grey, circular, biconvex film coated tablet, plain on both sides. 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS The primary treatment and re-treatment of tuberculosis and for prophylaxis in cases of inactive tuberculosis or large-tuberculinpositive reaction. Ethambutol should only be used in conjunction with other anti-tuberculous drugs to which the patient’s organisms are susceptible. Consideration should be given to official guidance on the appropriate use of antibacterial agents 4.2 POSOLOGY AND METHOD OF ADMINISTRATION _Route of administration_: Oral _Posology: _ Recommended Dosage The dosage of ethambutol must be adjusted according to the body weight of the patient. This drug should not be used as a sole anti-tuberculosis agent, but should be given with at least one other antituberculosis drug to avoid development of resistant strains. The usual daily dosage is 15-25mg/kg body weight given as a single dose. _ _ _ADULTS _ For primary treatment and prophylaxis: Ethambutol should be administered in a single daily dose of 15mg/kg, concomitant drugs being maintained at their recommended dosage levels. For re-treatment: For the first 60 days of treatment, ethambutol should be administered in a single daily dose of 25mg/kg. Thereafter the dosage should be reduced to 15mg/kg, concomitant drugs being maintained at their recommended dosage levels. _ _ _CHILDREN _ For primary treatment and re-treatment: For the first 60 days of treatment, a single daily oral dose of 25mg/kg. Thereafter the dosage should be reduced to 15mg/kg, concomitant drugs being maintained at their recommended dosage levels._ _ For prophylaxis: A single daily oral dose of 15mg/kg, concomitant drugs being used at their recommended dosage levels As ch Llegiu el document complet