Thyroxanil 600 microgram tablets for dogs and cats

Country: Ireland

Language: English

Source: HPRA (Health Products Regulatory Authority)

Active ingredient:

Levothyroxine sodium

Available from:

Le Vet Beheer B.V.

ATC code:

QH03AA01

INN (International Name):

Levothyroxine sodium

Dosage:

600 microgram(s)

Pharmaceutical form:

Tablet

Prescription type:

POM: Prescription Only Medicine as defined in relevant national legislation

Therapeutic group:

Cats, Dogs

Therapeutic area:

levothyroxine sodium

Therapeutic indications:

Hormone

Authorization status:

Authorised

Authorization date:

2016-06-24

Summary of Product characteristics

Health Products Regulatory Authority
29 January 2021
CRN009XFP
Page 1 of 5
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE VETERINARY MEDICINAL PRODUCT
Thyroxanil 600 microgram tablets for dogs and cats
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each tablet contains:
​
ACTIVE SUBSTANCE:
​
​
Levothyroxine sodium
​
600 µg
​
(equivalent to levothyroxine
​
583 μg)
For the full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Tablet.
White to off white, round and convex tablet with a cross-shaped break
line on one side and the number 600 on the other side.
The tablets can be divided into halves or quarters.
4 CLINICAL PARTICULARS
4.1 TARGET SPECIES
Dogs and cats.
4.2 INDICATIONS FOR USE, SPECIFYING THE TARGET SPECIES
Treatment of primary and secondary hypothyroidism.
4.3 CONTRAINDICATIONS
Do not use in dogs and cats suffering from uncorrected adrenal
insufficiency.
Do not use in cases of known hypersensitivity to levothyroxine sodium
or to any of the excipients.
4.4 SPECIAL WARNINGS FOR EACH TARGET SPECIES
The diagnosis of 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 animals with concurrent hypoadrenocorticism have a
decreased ability to metabolise levothyroxine sodium and
therefore an increased risk of thyrotoxicosis. These animals 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
is recommended (starting with 25% of the normal dose
and increasing by 25% increments every fortnight until optimal
stabilisation is achieved). Gradual introduction of therapy i