Soloxine 0.5 mg Tablet

Ireland - English - HPRA (Health Products Regulatory Authority)

Active ingredient:
Levothyroxine sodium
Available from:
Virbac S.A.
ATC code:
QH03AA01
INN (International Name):
Levothyroxine sodium
Dosage:
0.5 mg/tablet
Pharmaceutical form:
Tablet
Prescription type:
POM: Prescription Only Medicine as defined in relevant national legislation
Therapeutic group:
Dogs
Therapeutic area:
levothyroxine sodium
Therapeutic indications:
Hormone
Authorization status:
Authorised
Authorization number:
VPA10988/069/004
Authorization date:
2007-01-19

Read the complete document

Summary of Product Characteristics

1 NAME OF THE VETERINARY MEDICINAL PRODUCT

Soloxine 0.5 mg Tablet

2 QUALITATIVE AND QUANTITATIVE COMPOSITION

Active Substance

Levothyroxine Sodium

0.50 mg

For a full list of excipients see section 6.1.

3 PHARMACEUTICAL FORM

Small elliptical white tablets.

Scored on the face of each tablet , strength in milligrams to the right and the word SOLOXINE on the reverse.

4 CLINICAL PARTICULARS

4.1 Target Species

Dogs.

4.2 Indications for use, specifying the target species

For the long term treatment of thyroid insufficiency in dogs.

4.3 Contraindications

Do not use in animals with known hypersensitivity to the active ingredient.

Do not use in animals suffering from thyrotoxicosis or uncorrected adrenal insufficiency

4.4 Special warnings for each target species

None.

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4.5 Special precautions for use

Special precaution(s) for use in animals

Appropriate laboratory tests should be conducted to confirm the diagnosis and ensure correct dosage.

Caution should be exercised in the treatment of dogs with clinically significant cardiac disease, hypertension or any

disease rendering the animal susceptible to sharply increased metabolic rate.

In such cases, consideration should be

given to reducing the starting dose, increasing the dose at intervals whilst monitoring all clinical signs. Dogs with

concurrent hypoadrenocorticism should be stabilised witth apprpriate steroid therapy before commencing treatment

with levothyroxine sodium.

The effects of thyroxine therapy are slow in being manifested

Special precautions to be taken by the person administering the veterinary medicinal product to animals

In case of accidental ingestion, seek medical advice immediately and show the doctor the label.

Wash hands after use.

Other precautions

None.

4.6 Adverse reactions (frequency and seriousness)

When administered at an appropriate dose there should not be any adverse effects associated with therapy.

Thyrotoxicosis is very rare, but may develop in dogs receiving high doses or in those with impaired metabolism (i.e.

renal or hepatic insufficiency).

Clinical signs include panting, nervousness, tachycardia, aggressive behaviour, polyuria, polydipsia, polyphagia and

weight loss.

4.7 Use during pregnancy, lactation or lay

Can be used during pregnancy and lactation.

The safety of the product has not been tested in special reproduction studies. However , levothyroxine sodium is an

endogenous hormone and thyroid hormones are essential for the developing foetus. Hypothyroidism during pregnancy

may result in poor foetal and perinatal outcomes.

Therefore, hypothyroid bitches intended to be bred should be

monitored on a regular basis before, during and after pregnancy as the dose of levothyroxine sodium may need to be

adjusted.

4.8 Interaction with other medicinal products and other forms of interaction

In diabetic dogs with concurrent hypothyroidism careful monitoring of diabetic control is recommended once thyroid

treatment commences. Dosages of insulin may need to be increased due to thyroid hormone enhancement of glucose

absorption, glycogenolysis and gluconeogenesis.

4.9 Amounts to be administered and administration route

The commonly prescribed starting dose is 22 µg/kg bodyweight per day.

However, due to individual differences in

absorption and metabolism this is frequently too low and doses of up to 44 µg/kg bodyweight per day may be required.

The dosage should be adjusted for the individual case based on the clinical response of the patient and laboratory

investigations and should be administered daily.

For oral administration.

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4.10 Overdose (symptoms, emergency procedures, antidotes), if necessary

Chronic overdosage will eventually lead to thyrotoxicosis, manifested by: panting, nervousness, tachycardia, aggressive

behaviour, polyuria, polydipsia, polyphagia and weight loss.

4.11 Withdrawal Period(s)

Not applicable

5 PHARMACOLOGICAL or IMMUNOLOGICAL PROPERTIES

Pharmacotherapeutic group: Thyroid Hormones

ATC Vet Code: QH03AA01

5.1 Pharmacodynamic properties

Levothyroxine is a synthetic homologue of the naturally occurring thyroid hormone, thyroxine (T

Levothyroxine is converted to the more biologically active triiodothyronine (T3).

T3 binds via specific receptors

within the plasma membrane, mitochondria and chromatin resulting in changes in DNA transcription and protein

synthesis.

Onset of action is therefore slow.

Thyroid hormones may act on the cellular processes with effects on the

basal metabolic rate, cardiac function and blood flow, lipid and carbohydrate metabolism.

They are essential for the

normal growth and development of the neurological and skeletal systems.

5.2 Pharmacokinetic properties

Time to reach peak serum concentration takes between 2 and 5 hours and the half life of levothyroxine sodium in dogs

following oral administration varies from approximately 6 to 20 hours.

Pharmacokinetic properties, particularly absorption and rate of metabolism, vary markedly between individual dogs,

with variations in maximum serum concentration of up to 3 times.

Therefore it is important to tailor the dose to the

individual dog by regular laboratory and clinical monitoring following commencement of treatment.

Pharmacokinetic trials showed that once daily dosing gave higher peak concentrations than dividing the same dose and

giving twice daily.

6 PHARMACEUTICAL PARTICULARS

6.1 List of excipients

Tartrazine E102

Magnesium Stearate

Maize Starch Pregelatinised

Microcrystalline Cellulose

Lactose Monohydrate

6.2 Incompatibilities

Not applicable

6.3 Shelf-life

Shelf life of the veterinary medicinal product as packaged for sale: 2 years.

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6.4 Special precautions for storage

Do not store above 25°C.

Protect from light.

6.5 Nature and composition of immediate packaging

High-density, brown, polyethylene bottles containing 250 tablets, hermetically sealed and closed with childproof screw

cap.

6.6 Special precautions for the disposal of unused veterinary medicinal products or waste materials

Any unused veterinary medicinal product

or waste materials derived from such veterinary medicinal products should

be disposed of in accordance with local requirements .

7 MARKETING AUTHORISATION HOLDER

Virbac S.A.,

Virbac 1,

1ére Avenue – 2065 m – L.I.D.

06516 Carros Cedex,

France.

8 MARKETING AUTHORISATION NUMBER(S)

VPA 10988/069/002

9 DATE OF THE FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION

Date of first authorisation: 19

January 2007

Date of last renewal: 27

October 2008

10 DATE OF REVISION OF THE TEXT

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