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LIOTHYRONINE SODIUM 20 MCG TABLETS - summary of medicine characteristics

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Summary of medicine characteristics - LIOTHYRONINE SODIUM 20 MCG TABLETS

SUMMARY OF PRODUCT CHARACTERISTICS1 NAME OF THE MEDICINAL PRODUCT

Liothyronine Sodium 20 micrograms Tablets

2 QUALITATIVE AND QUANTITATIVE COMPOSITION

Each tablet contains 20 micrograms liothyronine sodium.

For the full list of excipients, see section 6.1.

3 PHARMACEUTICAL FORM

Tablets

White to off-white round tablets, embossed with “S” above a score line and 73 below the score line on one side and plain on the other side, 6.5 mm diameter. The score line is not intended for breaking the tablet.

4 CLINICAL PARTICULARS

4.1 Therapeutic indications

Used for the treatment of coma of myxoedema, the management of severe chronic thyroid deficiency and hypothyroid states occurring in the treatment of thyrotoxicosis.

Liothyronine sodium can be used also in the treatment of thyrotoxicosis as an adjunct to carbimazole to prevent subclinical hypothyroidism developing during treatment.

Liothyronine sodium may be preferred for treating severe and acute hypothyroid states because of its rapid and more potent effect, but thyroxine sodium is normally the drug of choice for routine replacement therapy.

4.2 Posology and method of administration

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.

Elderly and Paediatric population

5 micrograms daily.

Method of administration

For oral use only.

For 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 in a minimum of 20 mL of water. The entire volume of liquid should be consumed to ensure ingestion of the full dose.

The solubility of liothyronine in water enables this as a method of administration.

If a dose lower than 20 micrograms is required, an appropriate tablet strength should be used.

4.3 Contraindications

Hypersensitivity to the active substance(s) or to any of the excipients listed in section 6.1.

Patients with angina of effort or cardiovascular diseases and thyrotoxicosis.

4.4 Special warnings and precautions for use

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.

Panhypopituitarism or predisposition to adrenal insufficiency (initiate corticosteroid therapy before starting liothyronine), pregnancy, breast-feeding (see section 4.6 Pregnancy and lactation).

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. Liothyronine is contraindicated in established myocardial ischaemia (see section 4.3) in which case, levothyroxine, with cautious dose escalation, is recommended instead.

If metabolism increases too rapidly (causing diarrhoea, nervousness, rapid pulse, insomina, 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.

TSH levels should be monitored during treatment to reduce the risk of over- or undertreatment. The risks of overtreatment include atrial fibrillation, osteoporosis and bone fractures.

4.5 Interaction with other medicinal products and other forms of interaction Liothyronine sodium therapy may potentiate the action of anticoagulants. Phenytoin levels may be increased by liothyronine. Anticonvulsants, such as carbamazepine and phenytoin enhance the metabolism of thyroid hormones and may displace thyroid hormones from plasma proteins. Initiation or discontinuation of anticonvulsant therapy may alter liothyronine dose requirements.

If co-administered with cardiac glycosides, adjustment of dosage of cardiac glycoside may be necessary. Colestyramine and colestipol given concurrently reduces gastrointestinal absorption of liothyronine.

Liothyronine raises blood sugar levels and this may upset the stability of patients receiving antidiabetic agents.

Liothyronine increases receptor sensitivity to catecholamines thus accelerating the response to tricyclic antidepressents. A number of drugs may affect thyroid function tests and this should be borne in mind when monitoring patients on liothyronine therapy.

Co-administration of oral contraceptives may result in an increased dosage requirement of liothyronine sodium.

Amiodarone may inhibit the deiodination of thyroxine to triiodothyronine resulting in a decreased concentration of triidothyronine with a rise in the concentration of inactive reverse triiodothyronine.

As with other thyroid hormones, liothyronine may enhance effects of amitriptyline and effects of imipramine.

Metabolism of thyroid hormones accelerated by barbiturates and primidone (may increase requirements for thyroid hormones in hypothyroidism). Requirements for thyroid hormones in hyprothyroidism may be increased by oestrogens.

4.6 Fertility, pregnancy and lactation

Pregnancy:

Safety during pregnancy is not known. The risk of foetal congenital abnormalities should be weighed against the risk to the foetus of untreated maternal hypothyroidism.

Breast feeding:

Liothyronine sodium is excreted into breast milk in low concentrations. This may interfere with neonatal screening programmes.

Fertility

No human or animal data on the effect of active substance liothyronine on fertility are available.

4.7 Effects on ability to drive and use machines

Liothyronine Sodium Tablets have no influence on the ability to drive and use machines.

4.8 Undesirable effects

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: very common (> 1/10), common (> 1/100 to < 1/10), uncommon (> 1/1,000 to < 1/100), rare (> 1/10,000 to < 1/1,000), not known _______(frequency cannot be estimated from the available data).___________­__________

System organ class

Frequency

Undesirable effecrs

Immune system disorders

Not Known

hypersensitivity reactions including rash, pruritus and oedema

Metabolism and nutrition disorders

Not Known

excessive loss of weight

Nervous system disorders

Not Known

restlessness, excitability, tremor, insomnia

Cardiac disorders

Not Known

Anginal pain, cardiac arrhythmias, palpitations, tachycardia.

Gastrointestinal disorders

Not Known

Diarrhoea, vomiting

Musculoskeletal and connective tissue disorder

Not Known

muscle cramps, muscular weakness,

General disorders and administration site conditions

Not Known

headache, flushing, sweating, fever, heat intolerance

Skin and subcutaneous tissue disorders

Not Known

Transient hair loss in children

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. Healthcare professionals are asked to report any suspected adverse reactions via the

Yellow Card Scheme. Website: www.mhra.gov.uk/yellowcard or search for MHRA Yellow Card in the Google Play or Apple App Store.

4.9 Overdose

4.9 Overdose

Symptoms

There may be exaggeration of the side effects as well as agitation, confusion, irritability, hyperactivity, headache, sweating, mydriasis, tachycardia, arrhythmias, tachypnoea, pyrexia, increased bowel movements and convulsions.

Management

If the patient is seen within a few hours of overdosage: gastric lavage or emesis.

Treatment is symptomatic. Tachycardia in adults may be controlled with 40 mg propranolol every 6 hours.

5 PHARMACOLOGICAL PROPERTIES

5.1 Pharmacodynamic properties

Pharmacotherapeutic group: Thyroid preparations.

ATC code: H03AA02

Liothyronine sodium is a naturally occurring thyroid hormone.

The biological action of liothyronine sodium is quantitatively similar to that of levothyroxine sodium, but the effects develop in a few hours and disappear within 24 to 48 hours of stopping treatment.

5.2 Pharmacokinetic properties

Absorption:

Liothyronine sodium is almost completely absorbed from the gastro-intestinal tract.

Distribution

Liothyronine sodium is almost completely absorbed from the gastro-intestinal tract. It is less readily bound to plasma proteins than thyroxine. About 0.5% is in the unbound form.

Elimination

The half-life of liothyronine in euthyroidism is 1 to 2 days. Thyroid hormones do not readily cross the placenta. Minimal amounts are excreted in breast milk.

5.3 Preclinical safety data

5.3 Preclinical safety data

No further relevant data.

6 PHARMACEUTICAL PARTICULARS

6.1 List of excipients

Calcium sulfate dihydrate

Corn starch

Gelatin

Magnesium stearate

Mannitol (E421)

6.2 Incompatibilities

Not applicable.

6.3 Shelf life

2 years

6.4 Special precautions for storage

Store in the original container in order to protect from light.

6.5 Nature and contents of container

High-density polyethylene (HDPE) container with a polypropylene childresistant closure, with a 2 g canister containing silica gel and a cotton plug.

Pack sizes: 28 and 112 tablets. Not all pack sizes may be marketed.

6.6 Special precautions for disposal

6.6 Special precautions for disposal

Any unused medicinal product or waste material should be disposed of in accordance with local requirements.

7 MARKETING AUTHORISATION HOLDER

Sigmapharm Laboratories International, Ltd.

Palmerston House

Fenian street, 2nd floor

Dublin 2

Ireland

8 MARKETING AUTHORISATION NUMBER(S)

PL 50888/0002

9 DATE OF FIRST AUTHORISATION/RENEWAL OF THEAUTHORISATION

17/12/2021