Thyrotab 800 µg Tablets for dogs and cats

Country: Ireland

Language: English

Source: HPRA (Health Products Regulatory Authority)

Active ingredient:

Levothyroxine sodium

Available from:

CP-Pharma Handelsgesellschaft mbH

ATC code:

QH03AA01

INN (International Name):

Levothyroxine sodium

Pharmaceutical form:

Tablet

Prescription type:

POM: Prescription Only Medicine as defined in relevant national legislation

Therapeutic area:

levothyroxine sodium

Authorization date:

2023-12-08

Summary of Product characteristics

1.
NAME OF THE VETERINARY MEDICINAL PRODUCT
Thyrotab 800 microgram Tablets for dogs and cats
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each tablet contains:
ACTIVE SUBSTANCE:
Levothyroxine sodium 800 micrograms (μg)
(equivalent to levothyroxine 778 μg)
EXCIPIENTS:
QUALITATIVE
COMPOSITION OF EXCIPIENTS AND OTHER CONSTITUENTS_ _
Calcium hydrogen phosphate dihydrate
_ _
Croscarmellose sodium
_ _
Cellulose, microcrystalline
_ _
Magnesium stearate
_ _
White to off-white, round and convex tablet with a cross-shaped break
line on one side.
The tablet has an approximately diameter of 11mm.
The tablets can be divided into 2 or 4 equal parts.
3.
CLINICAL INFORMATION
3.1
TARGET SPECIES
Dog and cat.
3.2
INDICATIONS FOR USE FOR EACH TARGET SPECIES
Treatment of primary and secondary hypothyroidism.
3.3
CONTRAINDICATIONS
Do not use in dogs and cats suffering from uncorrected adrenal
insufficiency.
Do not use in cases of hypersensitivity to the active substance or to
any of the excipients.
3.4
SPECIAL WARNINGS
The diagnosis of hypothyroidism should be confirmed with appropriate
tests.
3.5
SPECIAL PRECAUTIONS FOR USE
Special precautions for safe use in the target species:
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 is also
reco