OROXINE levothyroxine sodium 200 microgram tablet blister pack

Χώρα: Αυστραλία

Γλώσσα: Αγγλικά

Πηγή: Department of Health (Therapeutic Goods Administration)

Δραστική ουσία:

levothyroxine sodium, Quantity: 0.2 mg

Διαθέσιμο από:

Aspen Pharma Pty Ltd

INN (Διεθνής Όνομα):

levothyroxine sodium

Φαρμακοτεχνική μορφή:

Tablet, uncoated

Σύνθεση:

Excipient Ingredients: dextrin; magnesium stearate; lactose monohydrate; maize starch

Οδός χορήγησης:

Oral

Μονάδες σε πακέτο:

200, 150 tablets

Τρόπος διάθεσης:

(S4) Prescription Only Medicine

Θεραπευτικές ενδείξεις:

OROXINE is indicated for the management of demonstrated thyroid hormone deficiency.,OROXINE is also used to suppress thyrotropin (TSH) for the management of TSH-responsive tumours of the thyroid.

Περίληψη προϊόντος:

Visual Identification: White, biconvex, round tablet, scored and marked "200" on one side , plain on the other side; Container Type: Blister Pack; Container Material: Al/Al; Container Life Time: 18 Months; Container Temperature: Store at 2 to 8 degrees Celsius

Καθεστώς αδειοδότησης:

Licence status A

Ημερομηνία της άδειας:

2006-05-17

Φύλλο οδηγιών χρήσης

OROXINE- Consumer Medicine Information
Page 1 of 4
OROXINE
®
_levothyroxine sodium _
CONSUMER MEDICINE INFORMATION (CMI)
WHAT IS IN THIS
LEAFLET
This leaflet answers some
common questions about
Oroxine tablets.
It does not contain all the
available information about the
medicine.
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
Oroxine against the benefits he
or she expects it will have.
IF YOU HAVE ANY CONCERNS
ABOUT TAKING THIS MEDICINE,
ASK YOUR DOCTOR OR
PHARMACIST.
KEEP THIS LEAFLET WITH THE
MEDICINE.
You may need to read it again.
The name of your medicine is
Oroxine. It is available in
tablets of four different
strengths: 50 micrograms, 75
micrograms, 100 microgram
and 200 microgram.
The active ingredient is called
_levothyroxine sodium._
WHAT IS IT USED FOR
_ _
_Levothyroxine sodium_ is a
thyroid hormone. It is used as
replacement therapy in the
treatment of thyroid hormone
deficiency.
Oroxine is used to treat:
1. Thyroid hormone deficiency
also known as Hypothyroidism
Hypothyroidism is a disease in
which the thyroid gland is
underactive and does not
produce enough thyroxine, a
hormone, which is important
for controlling your
metabolism. Symptoms of
hypothyroidism include
tiredness, muscle weakness,
and cramps, feeling the cold, a
slow heart rate, dry and flaky
skin, hair loss, a deep husky
voice and weight gain.
2. TSH-responsive tumours
(certain tumours of the thyroid
gland) of the thyroid
For these conditions to be
treated, patients need a supply
of thyroid hormones in their
body. Oroxine replaces the
shortage of thyroid hormones.
USE OROXINE ONLY AS
DIRECTED.
Your doctor may have
prescribed Oroxine for another
condition.
ASK YOUR DOCTOR IF YOU HAVE
ANY QUESTIONS ABOUT WHY THE
MEDICINE HAS BEEN
PRESCRIBED FOR YOU.
Ask your doctor if you have
any concerns about taking it.
Oroxine tablets are only
available with a doctor’s
prescription.
BEFORE YOU TAKE IT
_ _
_WHEN YOU MUST NOT TAKE IT _
DO NOT TA

Αρχείο Π.Χ.Π.

1
AUSTRALIAN PRODUCT INFORMATION – OROXINE
(LEVOTHYROXINE SODIUM) TABLETS
1
NAME OF THE MEDICINE
Levothyroxine sodium
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
OROXINE tablets are available in four strengths and contain
levothyroxine sodium 50, 75,
100 or 200 micrograms as the active ingredient. They also contain the
following excipients:
maize starch, lactose monohydrate, dextrin and magnesium stearate.
3
PHARMACEUTICAL FORM
White, biconvex, round tablets.
4
CLINICAL PARTICULARS
4.1
T
HERAPEUTIC INDICATIONS
OROXINE is indicated for the management of demonstrated thyroid
hormone deficiency.
OROXINE is also used to suppress thyrotropin (TSH) for the management
of TSH-
responsive tumours of the thyroid.
4.2
D
OSE AND METHOD OF ADMINISTRATION
Thyroxine is best taken as a single daily dose first thing in the
morning. It should be taken with
water and on an empty stomach, and at least 30 minutes and preferably
60 minutes before the
intake of any food or other medications. Thyroxine is best ingested in
the fasting state, as food
will impair absorption.
The dose should be individualised on the basis of clinical response
and biochemical tests.
Regular monitoring of TSH and thyroxine is recommended when starting
therapy or changing
the dose.
ADULTS
INITIAL DOSE
Commence with thyroxine 50 to 100 micrograms daily. Increase the daily
dose by 25 to 50
micrograms according to response at not less than 4-weekly intervals,
up to 100 to 200
micrograms daily.
In patients aged 60 years and over and in those with ischaemic heart
disease, thyroxine therapy
should normally be initiated with low doses (25 or 50 μg/day).
Wherever possible, whole tablets should be taken (e.g. if the dose
required is 150
µ
g then 1 x
100
µ
g tablet and 1 x 50
µ
g tablet should be taken, rather than 1½ x 100
µ
g tablets).
2
When there is no contraindication to full thyroxine replacement, a TSH
level of about 1 mU/L
with a serum thyroxine level in the high-normal range, usually
indicates optimal therapy.
MAINTENANCE DOSES
ADULTS:
100 to 200 µg per