Triiodothyronine Injection 20µg

Country: Malta

Language: English

Source: Medicines Authority

Active ingredient:

LIOTHYRONINE SODIUM

Available from:

Mercury Pharma Group Limited

ATC code:

H03AA02

INN (International Name):

LIOTHYRONINE SODIUM

Pharmaceutical form:

POWDER FOR SOLUTION FOR INJECTION

Composition:

LIOTHYRONINE SODIUM 20 microgram(s)

Prescription type:

POM

Therapeutic area:

THYROID THERAPY

Authorization status:

Authorised

Authorization date:

2006-03-20

Patient Information leaflet

READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU
HAVE THIS MEDICINE.
Keep this leaflet. You may need to read it again.
If  you  have  any  further  questions,  ask  your  doctor  or
pharmacist.
If any of the side effects become serious, or if you notice any
side effects not listed in this leaflet, please tell your doctor or
pharmacist.
In this leaflet:
1. What Triiodothyronine injection is and what it is used for
2. Before you are given Triiodothyronine injection
3. How Triiodothyronine injection is given
4. Possible side effects
5. How to store Triiodothyronine injection
6. Further information
1. WHAT TRIIODOTHYRONINE INJECTION IS 
AND WHAT IT IS USED FOR
Triiodothyronine injection contains liothyronine sodium which is
a  quick  acting,  naturally  occurring  form  of  the  hormone
thyroxine. 
Thyroxine is normally produced by the thyroid gland in the neck.
It controls many bodily functions, mainly to do with growth and
energy.
Triiodothyronine injection is used to treat severe under activity of
the thyroid gland (myxoedema) when it is not possible to give
thyroid  treatment  by  mouth.  It  may  be  used  with  other
medicines such as steroids.
2. BEFORE YOU ARE GIVEN TRIIODOTHYRONINE
INJECTION
YOU SHOULD NOT RECEIVE TRIIODOTHYRONINE INJECTION IF:
• you know that you are allergic to liothyronine sodium or any
of the other ingredients of Triiodothyronine injection 
(see section 6 of this leaflet)
• you have a disease involving the heart or blood vessels.
• you have pain in the chest (angina pectoris)
• you  have  an  overactive  thyroid  gland  with  raised  levels  of
thyroid hormones (thyrotoxicosis).
Please tell your doctor before you are given this injection if any
of the above applies to you.
TAKE SPECIAL CARE WITH TRIIODOTHYRONI

Summary of Product characteristics

Page 1 of 6
SUMMARY OF PRODUCT CHARACTERISTICS
1
NAME OF THE MEDICINAL PRODUCT
Triiodothyronine 20 micrograms Powder for Solution for Injection
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each vial contains 20mcg liothyronine sodium BP
3.
PHARMACEUTICAL FORM
Sterile Intravenous injection, packed as a freeze-dried white plug, in
a neutral glass ampoule
for reconstitution with 1 or 2ml water for injection.
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
It is indicated for the treatment of myxoedema coma, usually in
conjunction with other
measures including the intravenous injection of a corticosteroid. For
the treatment of less
severe forms of myxoedema and for maintenance therapy, orally
administered liothyronine
should be used.
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
Dosage: 5 to 20 micrograms given by slow intravenous injection, and
repeated at intervals
of 12 hours or less if required. The minimal interval between dosing
is 4 hours.
An initial dose of 50 micrograms intravenously is used by some
physicians, followed by
further intravenous injections of 25 micrograms every 8 hours until
improvement occurs.
The dosage may then be reduced to 25 micrograms intravenously twice
daily.
Method of administration: Usually given by intravenous injection, as
the alkalinity of the
solution may cause irritation of the tissues if given by deep
intramuscular injection. The
solution is prepared by adding 1 or 2ml water for injection to the
ampoule, and shaking
gently until the solution has dissolved.
4.3
CONTRAINDICATIONS
Hypersensitivity to any components of the preparation. Liothyronine
sodium is
contraindicated in patients with cardiovascular disorders or angina of
effort and
thyrotoxicosis.
Page 2 of 6
4.4
SPECIAL WARNINGS AND PRECAUTIONS FOR USE
Liothyronine must be given with extreme caution in myxoedema coma
because too large a
dose can precipitate heart failure, especially in the elderly patients
and those with ischaemic
heart disease.
ECG monitoring can give a useful indication of impending ischemia,
however, cha