IRAKSIN

Posology Adults:

Starting dose of 10 or 20 micrograms every 8 hours, increasing after one week, if necessary, to the usual recommended daily dose of 60 micrograms in two or three divided doses. Myxoedema Coma: 60 micrograms given by stomach tube, then 20 micrograms every 8 hours.

It is more usual to start treatment with intravenous liothyronine. Adjunct to carbimazole treatment of thyrotoxicosis: 20 micrograms every 8 hours.

Paediatric population:

Children below 12 years: A dose of 5 micrograms daily.

Adolescents: 12 – 17 years:

Initially 10-20 micrograms daily; increased to 60 micrograms daily in 2-3 divided doses.

Elderly:

A dose of 5 micrograms daily. Method of administration For oral use only. Patients who have difficulty in swallowing a whole tablet, such as the elderly and young children, a whole tablet may be crushed and allowed to dissolve, with swirling, in a minimum 20 ml of water for 5 minutes.

The entire volume of liquid should be consumed to ensure ingestion of the full dose. Solubility of liothyronine in water enables this as a method of administration.

The following effects are indicative of excessive dosage and usually disappear on reduction of dosage or withdrawal of treatment for a day or two. The undesirable effects are listed below by organ class and the following frequency convention: Not known: frequency cannot be estimated from the available data System Organ Class Frequency Adverse Events Cardiac disorders Not known Anginal pain, cardiac arrhythmias, palpitations, tachycardia Gastrointestinal Disorders Not known Diarrhoea, vomiting General disorders and administration site Not known Fever, flushing, fever and heat intolerance conditions Immune system disorders Not known Hypersensitivity reactions including rash, pruritus and oedema also reported.

Metabolism and nutrition disorders Not known Excessive loss of weight Musculoskeletal and connective tissue disorders Not known Muscle cramps, muscular weakness Nervous system Disorders Not known Headache, tremor Psychiatric disorders Not known Restlessness, excitability, insomnia Skin and subcutaneous tissue disorders Not known Sweating Vascular disorders Not known Flushing Paediatric population: • Transient hair loss in children (Not Known) Reporting of suspected adverse reactions Reporting suspected adverse reactions after authorisation of the medicinal product is important.

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In severe and prolonged hypothyroidism, adrenocortical activity may be decreased. When thyroid replacement therapy is started, metabolism increases more than adrenocortical activity and this can lead to adrenocortical insufficiency requiring supplemental adrenocortical steroids.

Liothyronine rather than levothyroxine would be the replacement therapy of choice during block and replace treatment of thyrotoxicosis with propylthiouracil (PTU) due to the inhibition by PTU of the peripheral conversion of T4 to T3.

Liothyronine sodium treatment may result in an increase in insulin or anti-diabetic drug requirements. Care is required for patients with diabetes mellitus and diabetes insipidus. In myxoedema, care must be taken to avoid imposing excessive burden on cardiac muscle affected by prolonged severe thyroid depletion.

Particular care is needed in the elderly who have a greater risk of occult cardiovascular disease. Baseline ECG is recommended prior to commencement of liothyronine treatment in order to detect changes consistent with ischaemia. Patients should undergo cardiovascular monitoring, including periodic ECGs, during liothyronine treatment.

3) in which case, levothyroxine, with cautious dose escalation, is recommended instead. Patients with rare hereditary problems of galactose intolerance, the total lactase deficiency or glucose-galactose malabsorption should not take this medication.

Panhypopituitarism or predisposition to adrenal insufficiency (initiate corticosteroid therapy before starting liothyronine), pregnancy, breast-feeding (see section

1. Patients with angina of effort or cardiovascular diseases and thyrotoxicosis.