EUTROXSIG levothyroxine sodium 50 microgram tablet blister pack

Country: Australia

Language: English

Source: Department of Health (Therapeutic Goods Administration)

Active ingredient:

levothyroxine sodium, Quantity: 0.05 mg

Available from:

Aspen Pharma Pty Ltd

INN (International Name):

levothyroxine sodium

Pharmaceutical form:

Tablet, uncoated

Composition:

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

Administration route:

Oral

Units in package:

150 tablets, 200

Prescription type:

(S4) Prescription Only Medicine

Therapeutic 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.

Product summary:

Visual Identification: White, biconvex, round tablet, scored and marked "50" 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

Authorization status:

Registered

Authorization date:

2006-05-17

Patient Information leaflet

EUTROXSIG - Consumer Medicine Information
Page 1 of 4
EUTROXSIG
®
_levothyroxine sodium tablets _
CONSUMER MEDICINE INFORMATION (CMI)
WHAT IS IN THIS LEAFLET
This leaflet answers some
common questions about
EUTROXSIG 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
EUTROXSIG against the benefits
they expect it will have.
ASK YOUR DOCTOR OR PHARMACIST
IF YOU HAVE ANY CONCERNS ABOUT
TAKING THIS MEDICINE.
KEEP THIS LEAFLET WITH THE
MEDICINE.
You may need to read it again.
WHAT IS EUTROXSIG
USED FOR
_ _
EUTROXSIG is available in
tablets of four different strengths:
50 micrograms, 75 micrograms,
100 micrograms and 200
micrograms.
The active ingredient in
EUTROXSIG is levothyroxine
sodium, which is a thyroid
hormone. It is used as
replacement therapy in the
treatment of thyroid hormone
deficiency.
EUTROXSIG 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.
EUTROXSIG replaces the
shortage of thyroid hormones.
USE EUTROXSIG ONLY AS
DIRECTED.
Your doctor may have prescribed
the medicine for another
condition.
ASK YOUR DOCTOR IF YOU HAVE ANY
QUESTIONS ABOUT WHY IT HAS
BEEN PRESCRIBED FOR YOU.
This medicine is only available
with a doctor’s prescription.
BEFORE YOU TAKE IT
_ _
_WHEN YOU MUST NOT TAKE IT _
DO NOT TAKE EUTROXSIG IF YOU
ARE ALLERGIC TO:
•
levothyroxine sodium or any
other thyroid h

Summary of Product characteristics

1
AUSTRALIAN PRODUCT INFORMATION – EUTROXSIG
(LEVOTHYROXINE SODIUM) TABLETS
1
NAME OF THE MEDICINE
Levothyroxine sodium
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
EUTROXSIG 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
EUTROXSIG is indicated for the management of demonstrated thyroid
hormone deficiency.
EUTROXSIG 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