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ETHAMBUTOL LUPIN, ETHAMBUTOL LAPL, ETHAMBUTOL GH (Lupin Australia Pty Limited)

Product name
ETHAMBUTOL LUPIN, ETHAMBUTOL LAPL, ETHAMBUTOL GH
Date registered
Evaluation commenced
Decision date
Approval time
133 (255 working days)
Active ingredients
Ethambutol hydrochloride
Registration type
New generic medicine
Indication

ETHAMBUTOL LUPIN, ETHAMBUTOL LAPL, ETHAMBUTOL GH is indicated for the treatment of pulmonary tuberculosis, as shown by a large number of studies by investigators throughout the world. It has also been used successfully in cases of primary tuberculosis and extrapulmonary forms of tuberculosis, including miliary tuberculosis, tuberculous meningitis, tuberculosis of bones and joints, genitourinary tuberculosis, tuberculosis of the skin and tuberculous eye diseases. It should not be used as the sole antituberculosis drug, but should be used in conjunction with at least one other antituberculosis drug. Selection of the companion drug should be based on clinical experience, considerations of comparative safety and appropriate in vitro susceptibility studies.

In patients who have not received previous antituberculosis therapy, i.e. initial treatment, the most frequently used regimens have included three of the following drugs – ethambutol, isoniazid, rifampicin and streptomycin - for the first 2-4 months. For example:

• ethambutol plus isoniazid plus rifampicin; or

• ethambutol plus isoniazid plus streptomycinthen continuing with a two drug regimen such as ethambutol plus isoniazid; or ethambutol plus rifampicin.

In patients who have received previous antituberculosis therapy, mycobacterial resistance to other drugs used in initial therapy is frequent. Consequently, in such retreatment cases ETHAMBUTOL LUPIN, ETHAMBUTOL LAPL, ETHAMBUTOL GH should be combined with at least one of the second-line drugs not previously administered to the patient and to which bacterial susceptibility has been indicated by appropriate in vitro studies. Antituberculosis drugs used with ethambutol have included cycloserine, ethionamide, pyrazinamide, viomycin and other drugs. Isoniazid, aminosalicylic acid, and streptomycin have also been used in multiple drug regimens. Alternating drug regimens have also been utilised.

Registration process

First generic
First approval of a medicine that contains the same active ingredient as and is bioequivalent to an existing medicine

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