ELTROXIN levothyroxine sodium 88 microgram tablet bottle
Country: Australia
Language: English
Source: Department of Health (Therapeutic Goods Administration)
Patient Information leaflet
(PIL)
07-12-2015
Summary of Product characteristics
(SPC)
12-10-2017
Public Assessment Report
(PAR)
20-05-2019
Active ingredient:
levothyroxine sodium, Quantity: 88 microgram
Available from:
Aspen Pharmacare Australia Pty Ltd
INN (International Name):
levothyroxine sodium
Pharmaceutical form:
Tablet
Composition:
Excipient Ingredients: colloidal anhydrous silica; maize starch; magnesium stearate; purified talc; microcrystalline cellulose
Administration route:
Oral
Units in package:
100, 200
Prescription type:
(S4) Prescription Only Medicine
Therapeutic indications:
ELTROXIN is indicated for the management of demonstrated thyroid hormone deficiency.,ELTROXIN is also used to suppress thyrotropin (TSH) for the management of TSH-responsive tumours of the thyroid.
Product summary:
Visual Identification: Round, white coloured, flat, bevelled tablets debossed with "88" on one side and "L07" on the other side; Container Type: Bottle; Container Material: HDPE; Container Life Time: 24 Months; Container Temperature: Store below 25 degrees Celsius; Container Closure: Child resistant closure
Authorization status:
Licence status A
Authorization date:
2014-05-19
Patient Information leaflet
ELTROXIN- Consumer Medicine Information
Page 1 of 4
ELTROXIN
®
_thyroxine sodium _
CONSUMER MEDICINE INFORMATION (CMI)
WHAT IS IN THIS
LEAFLET
This leaflet answers some
common questions about
Eltroxin 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
Eltroxin 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
Eltroxin. It is available in
tablets of six different
strengths: 25 micrograms
(scored), 50 micrograms, 75
micrograms, 100 micrograms,
125 micrograms and 200
micrograms.
The active ingredient is called
_thyroxine sodium._
WHAT IS IT USED FOR
_ _
_Thyroxine sodium_ is a thyroid
hormone. It is used as
replacement therapy in the
treatment of thyroid hormone
deficiency.
Eltroxin 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. Eltroxin replaces the
shortage of thyroid hormones.
USE ELTROXIN ONLY AS
DIRECTED.
Your doctor may have
prescribed Eltroxin 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.
Eltroxin tablets are only
available with a doctor’s
prescription.
BEFORE YOU TAKE IT
_
Read the complete document
Summary of Product characteristics
ELTROXIN - Product Information
Page 1 of 10
PRODUCT INFORMATION
ELTROXIN
NAME OF DRUG
ELTROXIN TABLETS
contain
LEVOTHYROXINE SODIUM 25 µG, 50 µG, 75 µG, 88 µG, 100 µG, 112
µG, 125 µG, 137 µG, 150 µG, 175 µG OR 200 µG.
Levothyroxine sodium, is a monosodium salt of the
_levo_
isomer of thyroxine, the principal
secretion of the thyroid gland. It has the following chemical
structure:
I
HO
I
O
I
O-
O
NH
2
I
Na+
It has the molecular formula C
15
H
10
I
4
NNaO
4
and a molecular weight of 798.86.
DESCRIPTION
Levothyroxine
sodium
is
almost
white
to
pale
brownish-yellow,
odourless,
tasteless,
hygroscopic, amorphous or crystalline powder. On exposure to light, it
may acquire a slight
pink colour. It is very slightly soluble in water and alcohol, however
it is insoluble in acetone,
chloroform and ether. It dissolves in aqueous solutions of alkali
hydroxides and in hot
solutions of alkali carbonates.
_EXCIPIENTS: _
ELTROXIN
tablets
contain
the
following
excipients:
microcrystalline
cellulose
,
pregelatinised maize starch, purified talc–, colloidal anhydrous
silica and magnesium stearate.
ELTROXIN is not bioequivalent on a same-dose basis with
EUTROXSIG/OROXINE. If a
decision is made to switch a patient from EUTROXSIG/OROXINE to
ELTROXIN, then
prescribers should have a plan for monitoring TSH. Prescribers should
be aware that dose
adjustment may be required.
Prescribers should tell their patients not to interchange ELTROXIN and
EUTROXSIG/OROXINE unless a decision has been made to switch products,
and there is
a plan for monitoring TSH levels and review of dose.
ELTROXIN - Product Information
Page 2 of 10
PHARMACOLOGY
ACTIONS:
ELTROXIN
is used as thyroid replacement therapy for the treatment of
hypothyroidism. The
principal pharmacological effect of thyroid hormones is to increase
the metabolic rate of body
tissues.
Thyroid
hormones
are
also
involved
in
the
regulation
of
cell
growth
and
differentiation. Thyroxine is the major component of normal secretions
of the thyroid gland;
therefore it is the essential determi
Read the complete document
