MYAMBUTOL tablets 100mg

Country: Australia

Language: English

Source: Department of Health (Therapeutic Goods Administration)

Active ingredient:

ethambutol hydrochloride, Quantity: 100 mg

Available from:

Aspen Pharma Pty Ltd

Pharmaceutical form:

Tablet, film coated

Composition:

Excipient Ingredients: sorbitol solution (70 per cent) (non-crystallising); sucrose; Gelatin; stearic acid; magnesium stearate; quinoline yellow; purified water; purified talc; Shellac; industrial methylated spirit; povidone; acetylated monoglycerides

Administration route:

Oral

Units in package:

56 tablets

Prescription type:

(S4) Prescription Only Medicine

Therapeutic indications:

INDICATIONS AS AT 04 JAN 2002 : Oral Administation : MYAMBUTOL 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, tuberculois meningitis, tuberculosis of bones and joints, genitourinary tuberculosis, tuberculous of the shin and tuberculous eye diseases. It should not be used as the sole antituberculosis drug, but should be used in conjuction 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 - MYAMBUTOL, isoniazid, rifampicin and streptomycin - for the first 2-4 mo

Product summary:

Visual Identification: Yellow tablets, glossy, round, standard biconvex, 5/16" diameter.; Container Type: Bottle; Container Material: LDPE; Container Life Time: 5 Years; Container Temperature: Store below 25 degrees Celsius; Container Closure: Child resistant closure

Authorization status:

Registered

Authorization date:

1994-02-16

Patient Information leaflet

MYAMBUTOL- Consumer Medicine Information
Page 1 of 3
MYAMBUTOL
®
_Ethambutol tablets _
CONSUMER MEDICINE INFORMATION (CMI)
WHAT IS IN THIS LEAFLET
This leaflet answers some common
questions about MYAMBUTOL. It
does not contain all the available
information. It does not take the
place of talking to your doctor or
pharmacist.
All medicines have risks and
benefits. Your doctor has weighed
the risks of you taking MYAMBUTOL
against the benefits this medicine is
expected to have for you.
IF YOU HAVE ANY QUESTIONS ABOUT
TAKING THIS MEDICINE, ASK YOUR
DOCTOR OR PHARMACIST.
KEEP THIS LEAFLET.
You may need to read it again.
WHAT MYAMBUTOL IS
USED FOR
The name of your medicine is
MYAMBUTOL. It contains the
active ingredient ethambutol.
MYAMBUTOL is an antibiotic which
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). Importantly, MYAMBUTOL
will not cure any other bacterial, viral
or fungal diseases.
Your doctor may have prescribed
MYAMBUTOL for another purpose.
ASK YOUR DOCTOR IF YOU HAVE ANY
QUESTIONS ABOUT WHY IT HAS BEEN
PRESCRIBED FOR YOU.
This medicine is available only with
a doctor's prescription.
MYAMBUTOL is not addictive.
BEFORE YOU TAKE IT
_ _
_WHEN YOU MUST NOT TAKE IT: _
DO NOT TAKE MYAMBUTOL IF:

YOU HAVE EVER HAD AN ALLERGIC
REACTION TO ETHAMBUTOL, OR ANY
OF THE INGREDIENTS LISTED AT THE
END OF THIS LEAFLET
Some of the symptoms of an allergic
reaction to a ethambutol may
include rash, itching or hives on the
skin, swelling of the face, lips,
tongue or other parts of the body,
shortness of breath, wheezing or
troubled breathing.

THE EXPIRY DATE (EXP) PRINTED
ON THE PACK HAS PASSED.
It may have no effect at all, or worse,
an entirely unexpected effect, if you
take it after the expiry date.

THE PACKAGING IS TORN OR
SHOWS SIGNS OF TAMPERING. IF
THIS IS THE CASE, TAKE THE
TABLETS BACK TO YOUR
PHARMACIST.
_BEFORE YOU START TO TAKE IT _
YOU SHOULD NOTIFY YOUR DOCTOR IF
YOU HAVE OR HAVE HAD ANY EYE
PROBLE

Summary of Product characteristics

1
AUSTRALIAN PRODUCT INFORMATION
MYAMBUTOL (ETHAMBUTOL HYDROCHLORIDE) TABLETS
1
NAME OF THE MEDICINE
Ethambutol hydrochloride
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
MYAMBUTOL 100 MG TABLETS: each tablet contains ethambutol
hydrochloride equivalent to
100 mg ethambutol.
MYAMBUTOL 400 MG TABLETS: each tablet contains ethambutol
hydrochloride equivalent to
400 mg ethambutol.
For the full list of excipients, see Section 6.1 List of excipients.
3
PHARMACEUTICAL FORM
MYAMBUTOL ethambutol hydrochloride tablets 100 mg 56’s's, are yellow
tablets, glossy, round,
standard biconvex, 5/16" diameter.
MYAMBUTOL ethambutol hydrochloride tablets 400 mg, 56’s are white to
off-white smooth
round, biconvex, film coated tablets plain on both the sides.
4
CLINICAL PARTICULARS
4.1
T
HERAPEUTIC INDICATIONS
Oral Administration:
MYAMBUTOL 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 - MYAMBUTOL,
isoniazid, rifampicin and streptomycin - for the first 2-4 months: for
example,
MYAMBUTOL plus isoniazid plus rifampicin
or
MYAMBUTOL plus isoniazid plus streptomycin
then continuing with a two drug regimen such as
MYAMBUTOL plus isoniazid
or
MYAMBUTOL plus rifampicin.
2
In patients who have received previous antit