Forthyron 600 Microgram Tablets for Dogs

Summary of Product characteristics

                                Issued: November 2011
AN: 01161/2010
Page 1 of 5
SUMMARY OF PRODUCT CHARACTERISTICS
1.
NAME OF THE VETERINARY MEDICINAL PRODUCT
Forthyron 600 microgram tablets for dogs
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
ONE TABLET CONTAINS:
600
microgram
levothyroxine
sodium
per
tablet
equivalent
to
583
microgram
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
The tablets may be divided into halves or quarters.
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.
Do not use in cases of known hypersensitivity to levothyroxine sodium
4.4.
SPECIAL WARNINGS FOR EACH TARGET SPECIES
The diagnosis hypothyroidism should be confirmed with appropriate
tests.
4.5.
SPECIAL PRECAUTIONS FOR USE
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 in
dogs with cardiac disease, diabetes mellitus and renal or
                                
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