Liothyronine 20microgram powder for solution for injection vials

Country: United Kingdom

Language: English

Source: MHRA (Medicines & Healthcare Products Regulatory Agency)

Active ingredient:

Liothyronine sodium

Available from:

Advanz Pharma

ATC code:

H03AA02

INN (International Name):

Liothyronine sodium

Dosage:

20microgram

Pharmaceutical form:

Powder for solution for injection

Administration route:

Intravenous

Class:

No Controlled Drug Status

Prescription type:

Valid as a prescribable product

Product summary:

BNF: 06020100; GTIN: 5099602996069

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 Liothyronine Sodium injection is and what it is used for
2. Before you are given Liothyronine Sodium injection
3. How Liothyronine Sodium injection is given
4. Possible side effects
5. How to store Liothyronine Sodium injection
6. Further information
1. WHAT LIOTHYRONINE SODIUM INJECTION IS
AND WHAT IT IS USED FOR
Liothyronine
Sodium
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.
Liothyronine Sodium 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 LIOTHYRONINE SODIUM
INJECTION
YOU SHOULD NOT RECEIVE LIOTHYRONINE SODIUM INJECTION IF:
• you know that you are allergic to liothyronine sodium or any
of the other ingredients of Liothyronine Sodium 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 LIOTHYRONINE SODIUM INJECTION IF YOU:
• suffer from diabetes. The dosage of your diabetic treatment
may need to be altered
• have heart failure (e.g. suggested by symptoms like swelling
of
the
ankles,
breathlessness
etc.)
or
have
high
blood
pressure
• are an elderly patient with history of hypo

Summary of Product characteristics

OBJECT 1
LIOTHYRONINE SODIUM 20 MICROGRAMS INJECTION
Summary of Product Characteristics Updated 14-Dec-2015 | Concordia
International - formerly AMCo
1. Name of the medicinal product
Liothyronine Sodium 20 micrograms Powder for Solution for Injection
2. Qualitative and quantitative composition
Each vial contains 20 micrograms liothyronine sodium
For excipients, see 6.1
3. Pharmaceutical form
Intravenous injection
Packed as a freeze dried white plug, in a glass vial for
reconstitution with 1 or 2ml water for injection.
4. Clinical particulars
4.1 Therapeutic indications
Liothyronine Sodium Injection 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 of 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.
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 elderl