LIOTHYRONINE SODIUM

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. Myxedema 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. • For doses lower than 20 micrograms, the tablet should be allowed to dissolve/disperse in 20 mL of water for 10 minutes, in a small measuring cup. • The patient should gently swirl the solution occasionally to aid the dissolution/dispersion.

The patient should then swirl the solution for a few seconds prior to using a suitable oral syringe to withdraw the amount of liquid corresponding to the dose prescribed (5mL for a 5micrograms dose; 10 mL for a 10micrograms dose). • The patient can then squirt the liquid directly into their mouth from the suitable oral syringe by gently pressing the plunger.

• Any remaining liquid should be discarded. • The 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 Immune system disorders Not known Hypersensitivity reactions including rash, pruritus and oedema also reported. Metabolism and nutrition disorders Not known Excessive loss of weight. Psychiatric disorders Not known Restlessness, excitability, insomnia.

Nervous system disorders Not known Headache, tremor. Cardiac disorders Not known Anginal pain, cardiac arrhythmias, palpitations, tachycardia. Vascular disorders Not known Flushing. Gastrointestinal disorders Not known Diarrhoea, vomiting.

Skin and subcutaneous tissue disorders Not known Sweating. Musculoskeletal and connective tissue disorders Not known Muscle cramps, muscular weakness. General disorders and administration site conditions Not known Fever, flushing, heat intolerance.

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. It allows continued monitoring of the benefit/risk balance of the medicinal product.

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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. 6). If metabolism increases too rapidly (causing diarrhoea, nervousness, rapid pulse, insomnia, tremors and sometimes anginal pain where there is latent myocardial ischaemia), reduce dose or withhold for 1-2 days and start again at a lower dose.

Thyroid function should continue to be monitored throughout treatment to avoid over- or under-treatment. The risks of over-treatment include atrial fibrillation, osteoporosis and bone fractures. Interferences with laboratory test Biotin may interfere with thyroid immunoassays that are based on a biotin/streptavidin interaction, leading to either falsely decreased or falsely increased test results.

The risk of interference increases with higher doses of biotin. When interpreting results of laboratory tests, possible biotin interference has to be taken into consideration, especially if a lack of coherence with the clinical presentation is observed.

For patients taking biotin-containing products, laboratory personnel should be informed when a thyroid function test is requested. 5). Excipients This medicine contains less than 1 mmol sodium (23 mg) per dose, that is to say essentially ‘sodium-free’.

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