Ethambutol 100mg tablets

Land: Storbritannia

Språk: engelsk

Kilde: MHRA (Medicines & Healthcare Products Regulatory Agency)

Aktiv ingrediens:

Ethambutol hydrochloride

Tilgjengelig fra:

DE Pharmaceuticals

ATC-kode:

J04AK02

INN (International Name):

Ethambutol hydrochloride

Dosering :

100mg

Legemiddelform:

Oral tablet

Administreringsrute:

Oral

Klasse:

No Controlled Drug Status

Resept typen:

Valid as a prescribable product

Produkt oppsummering:

BNF: 05010900

Informasjon til brukeren

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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
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145.00 mm
277.50 mm

Preparatomtale

SUMMARY OF PRODUCT CHARACTERISTICS
1
NAME OF THE MEDICINAL PRODUCT
Ethambutol 100 mg Tablets
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each film coated tablet contains 100mg Ethambutol Hydrochloride.
For a full list of excipients see section 6.1.
3
PHARMACEUTICAL FORM
Film coated tablet.
Smooth, yellow, 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 chil