Forthyron 200 Microgram Tablet

Summary of Product characteristics

                                Revised: December 2014
AN: 01044/2014
Page 1 of 6
SUMMARY OF PRODUCT CHARACTERISTICS
1.
NAME OF THE VETERINARY MEDICINAL PRODUCT
Forthyron 200 microgram tablet
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
ACTIVE SUBSTANCE:
200µg levothyroxine sodium per tablet equivalent to 194µg
levothyroxine
For a full list of excipients, see section 6.1
3.
PHARMACEUTICAL FORM
Tablet
White to off white round tablets, scored on one side
Tablets divisible into 4 parts
4.
CLINICAL PARTICULARS
4.1.
TARGET SPECIES
Dogs.
4.2.
INDICATIONS FOR USE, SPECIFYING THE TARGET SPECIES
For the treatment of hypothyroidism in dogs.
4.3.
CONTRA-INDICATIONS
Do not use in dogs suffering from uncorrected adrenal insufficiency.
4.4.
SPECIAL WARNINGS FOR EACH TARGET SPECIES
The diagnosis hypothyroidism should be confirmed with appropriate
tests.
Revised: December 2014
AN: 01044/2014
Page 2 of 6
4.5.
SPECIAL PRECAUTIONS FOR USE
i)
Special precautions for use in animals
A sudden increase in demand for oxygen delivery to peripheral tissues,
plus the
chronotropic effects of levothyroxine sodium, may place undue stress
on a poorly
functioning heart, causing decompensation and signs of congestive
heart failure.
Hypothyroid dogs suffering from hypoadrenocorticism have a decreased
ability to
metabolise levothyroxine sodium and therefore an increased risk of
thyrotoxicosis.
Dogs with concurrent hypoadrenocorticism and hypothyroidism should be
stabilised with glucocorticoid and mineralocorticoid treatment prior
to treatment
with levothyroxine sodium to avoid precipitating a hypoadrenocortical
crisis. After
this, thyroid tests should be repeated, then gradual introduction of
levothyroxine
therapy, starting with 25% of the normal dose, increasing by 25%
increments
every fortnight until optimal stabilisation is achieved is
recommended. Gradual
introduction of therapy is also recommended for dogs with other
concurrent
illnesses; particularly diabetes mellitus and renal or hepatic
dysfunction.
ii)
Special precautions to be taken by the person administering the
medi
                                
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