ETHAMBUTOL LUPIN ethambutol hydrochloride 400 mg tablet bottle

Country: Australia

Language: English

Source: Department of Health (Therapeutic Goods Administration)

Active ingredient:

ethambutol hydrochloride, Quantity: 400 mg

Available from:

Lupin Australia Pty Limited

Pharmaceutical form:

Tablet, film coated

Composition:

Excipient Ingredients: maize starch; propylene glycol; hypromellose; colloidal anhydrous silica; purified talc; povidone; magnesium stearate; titanium dioxide; ethylcellulose; polyethylene glycol monomethyl ether

Administration route:

Oral

Units in package:

56 tablets

Prescription type:

(S4) Prescription Only Medicine

Therapeutic indications:

Ethambutol Lupin 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 streptomycin,then 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 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.

Product summary:

Visual Identification: White to off white circular, biconvex film coated tablets plain on both sides; Container Type: Bottle; Container Material: HDPE; Container Life Time: 24 Months; Container Temperature: Store below 30 degrees Celsius; Container Closure: Child resistant closure

Authorization status:

Registered

Authorization date:

2022-07-13

Patient Information leaflet

Ethambutol Lupin v1
1
ETHAMBUTOL LUPIN
CONSUMER MEDICINE INFORMATION (CMI) SUMMARY
The full CMI on the next page has more details. If you are worried
about using this medicine, speak to your doctor or pharmacist.
1.
WHY AM I TAKING ETHAMBUTOL?
Ethambutol Lupin contains the active ingredient ethambutol
hydrochloride. Ethambutol Lupin is used to treat all forms of
tuberculosis (including tuberculosis of the lung, skin, genital tract,
urinary tract, bone and joint, eye and the brain).
For more information, see Section 1. Why am I taking Ethambutol Lupin?
in the full CMI.
2.
WHAT SHOULD I KNOW BEFORE I TAKE ETHAMBUTOL LUPIN?
Do not use if you have ever had an allergic reaction to ethambutol or
any of the ingredients listed at the end of the CMI.
Do not use Ethambutol Lupin if you have sight problems, kidney or
liver problems. TALK TO YOUR DOCTOR IF YOU HAVE ANY OTHER
MEDICAL CONDITIONS, TAKE ANY OTHER MEDICINES, OR ARE PREGNANT OR PLAN
TO BECOME PREGNANT OR ARE BREASTFEEDING.
For more information, see Section 2. What should I know before I take
Ethambutol Lupin?
in the full CMI.
3.
WHAT IF I AM TAKING OTHER MEDICINES?
Some medicines may interfere with Ethambutol Lupin and affect how it
works.
A list of these medicines is in Section 3. What if I am taking other
medicines?
in the full CMI.
4.
HOW DO I TAKE ETHAMBUTOL LUPIN?
•
Ethambutol Lupin tablets should be taken once every 24 hours with or
without food, with a glass of water.
•
The size of the dose to be taken will depend on whether you have
previously received treatment for tuberculosis. It also
depends on your bodyweight. Your doctor will calculate the dose you
need and tell you how many tablets to take each
day.
More instructions can be found in Section 4. How do I take Ethambutol
Lupin? in the full CMI.
5.
WHAT SHOULD I KNOW WHILE TAKING ETHAMBUTOL LUPIN?
THINGS YOU
SHOULD DO
•
Remind any doctor, dentist or pharmacist you visit that you are using
Ethambutol Lupin.
•
If you become pregnant while taking Ethambutol Lupin, tell your doctor
immediately.
THIN

Summary of Product characteristics

AUSTRALIAN PRODUCT INFORMATION – ETHAMBUTOL LUPIN
(ETHAMBUTOL HYDROCHLORIDE) FILM-COATED TABLET
1
NAME OF THE MEDICINE
Ethambutol hydrochloride.
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each tablet contains 400 mg of ethambutol hydrochloride.
For the full list of excipients, see SECTION 6.1 LIST OF EXCIPIENTS.
3
PHARMACEUTICAL FORM
Ethambutol Lupin 400 mg: White to off white circular, biconvex
film-coated tablets, plain on both sides.
4
CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
Ethambutol Lupin 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 streptomycin
then 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
should be combined with at least one of the second-line drugs not
previously administered to the patient
and to which bacterial susceptibility h