Thyroxyl Tablets for Dogs

Below is the product datasheet. This has been provided by the manufacturer and should always be provided with the medication.

Introduction

Company name: Dechra Veterinary Products Limited
Address: (A business unit of Dechra Pharmaceuticals PLC)
Sansaw Business Park
Hadnall, Shrewsbury
Shropshire SY4 4AS
Telephone: 01939 211200
Fax: 01939 211201
Email: info@dechra-uk.com
Website: www.dechra.com

Presentation

Small elliptical tablets containing Levothyroxine sodium. To the right of the score line on the face of each tablet is the tablet strength in milligrams (e.g. 0.1, 0.2 etc). The tablets are uniformly coloured, each dosage strength being thus uniquely identified:
0.1 mg yellow
0.2 mg orange
0.3 mg green
0.5 mg white
0.8 mg blue

Uses

For the long term treatment of thyroid insufficiency in dogs. L-thyroxine is a synthetic product chemically identical to the naturally occurring thyroid hormone 'T4'. Its effect is slow in onset, but of long duration.

Dosage and administration

The dosage should be adjusted for the individual case based on the response of the patient and laboratory investigations, and should be administered daily. Pharmacokinetic trials demonstrate that once daily dosing gives higher blood levels than dividing the daily dose over the day.
The commonly prescribed dose is 22 µg/kg body weight/day. However, due to individual differences in absorption and metabolism this is frequently too low, and doses of up to 44 µg/kg body weight/day may be required.
Appropriate laboratory tests should be conducted to confirm the diagnosis and ensure correct dosage. For oral administration.

Contraindications, warnings, etc

Do not use in animals with known hypersensitivity to the active ingredient.
Do not use in dogs with thyrotoxicosis or uncorrected adrenal insufficiency.
The effects of thyroxine therapy are slow in being manifested.
Administer with caution to animals with clinically significant heart disease, hypertension or other complications for which a sharply increased metabolic rate might prove hazardous. 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 with appropriate steroid therapy before commencing treatment with levothyroxine sodium.
When administered at an appropriate dose there should not be any adverse effects associated with therapy. Thyrotoxicosis is unusual, 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.
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. Hypothyrodism 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.
In diabetic dogs with concurrent hypothyroidism, careful monitoring of diabetic control is recommended once thyroid hormone treatment commences. Dosages of insulin may need to be increased due to thyroid hormone enhancement of glucose absorption, glycogenolysis and gluconeogenesis.
If you notice any serious effects or other effects not mentioned in the data sheet, please inform your veterinary surgeon.
Special precautions to be taken by the person administering the veterinary medicinal product to animals: Wash hands after use.
In case of accidental ingestion, seek medical advice immediately and show the doctor the data sheet.
General precautions: For animal treatment only.
Keep out of the reach and sight of children.

Pharmaceutical precautions

Do not store above 25°C. Protect from light.
Disposal: Dispose of used packaging in the household refuse. Unused product should be returned to the veterinary surgeon.

Legal category

POM-V

Packaging quantities

Hermetically sealed bottles of 250 tablets.

Further information

To be supplied only on veterinary prescription.
Veterinary medicinal product authorised for use in UK and IE.

Marketing authorisation holder (if different from distributor)

Dechra Limited, Dechra House, Jamage Industrial Estate, Talke Pits, Stoke-on-Trent, Staffordshire, ST7 1XW.

Marketing authorisation numbers

For each strength:
0.1 mg - Vm 10434/4011
0.2 mg - Vm 10434/4012
0.3 mg - Vm 10434/4013
0.5 mg - Vm 10434/4014
0.8 mg - Vm 10434/4015