TERTROXIN

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. Elderly 5 micrograms daily Paediatric population 5 micrograms daily.

Method of Administration:

Oral • 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 5mcg dose; 10 mL for a 10mcg 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 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 (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 and 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.

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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 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. 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.