- Approval Id
- ccce1fcb7d212fe2
- Drug Approval Emc Name
- Liothyronine sodium 5 micrograms Hard Capsules
- Drug Name
- Liothyronine sodium 5 micrograms Hard Capsules
- Company Name
- Roma Pharmaceuticals Limited
- Company Address
- Gibraltar House, Crown Square, First Avenue, Centrum 100, Burton upon Trent, Staffordshire, DE14 2WE
- Company Website
- http://www.romapharma.co.uk/
- Company Telephone
- 01283 890091
- Company Medical Info Email
- medinfo@romapharma.co.uk
- Atc Code
- H03AA02
- Legal Category
- Prescription only medicine
- Authorisation Holder
- ROMA Pharmaceuticals Limited
Gibraltar House,Crown Square,Centrum 100,Burton-upon-TrentDE14 2WEUnited Kingdom
- Authorisation Number
- PL 49578/0018
- Authorisation Date
- 11/08/2021
- Instruction Authorisation Holder
- ROMA Pharmaceuticals Limited
Gibraltar House,Crown Square,Centrum 100,Burton-upon-TrentDE14 2WEUnited Kingdom
- Instruction Authorisation Number
- PL 49578/0018
- Instruction Authorisation Date
- 11/08/2021
- Instruction Composition
- Each hard capsule contains 5 micrograms of liothyronine sodium.
For the full list of excipients, see section 6.1.
- Instruction Dosage Form
- Hard Capsule
Natural transparent hard gelatin capsules of size 4.
- Instruction Clinical Particulars
- 4.1 Therapeutic indications
Liothyronine is indicated in adults and children 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 sub-clinical 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.
\*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 and Paediatric population\*
5 micrograms daily.
\*\*Method of administration\*\*
Oral use.
In patients who have difficulty in swallowing a whole capsule, the contents of a capsule should be emptied into a minimum of 20 ml of water. The entire liquid should be consumed after swirling the mixture to ensure ingestion of the full dose. The solubility of liothyronine in water enables this as a method of administration.
For doses lower than 20 micrograms, Liothyronine sodium 5 micrograms Hard Capsules and Liothyronine sodium 10 micrograms Hard Capsules are also available.4.3 Contraindications
Hypersensitivity to any components of Liothyronine sodium hard capsules.
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 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.
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.
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 1-2days 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 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. Alternative tests not susceptible to biotin interference should be used, if available (see section 4.5).
This medicine contains less than 1 mmol sodium (23 mg) per 5micrograms, 10micrograms and 20 micrograms hard capsule, that is to say essentially 'sodium-free'.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 antidepressants. 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 triiodothyronine 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 hypothyroidism may be increased by oestrogens.
\*\*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 (see section 4.4).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.
\*\*Lactation\*\*
Liothyronine sodium is excreted into breast milk in low concentrations.
This may interfere with neonatal screening programmes.
\*\*Fertility\*\*
There are no fertility data available.4.7 Effects on ability to drive and use machines
None.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:
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. It allows continued monitoring of the benefit/risk balance of the medicinal product. Healthcare professionals are asked to report any suspected adverse reactions via 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
If patient is seen within a few hours of overdosage: gastric lavage or emesis. 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.
Treatment is symptomatic. Tachycardia in adults may be controlled with 40mg propranolol every 6 hours.
- Instruction Pharmacology
- 5.1 Pharmacodynamic properties
Pharmacotherapeutic group: Thyroid preparations, thyroid hormones, ATC code: H03AA02
Liothyronine sodium is a naturally occurring thyroid hormone.
Liothyronine sodium hard capsules are qualitatively similar in biological action to thyroxine but the effect develops in a few hours and lasts for 24 to 48 hours after stopping the treatment.5.2 Pharmacokinetic properties
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.
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
No further relevant data.
- Instruction Pharmaceutical Particulars
- 6.1 List of excipients
Maize Starch
Magnesium Stearate (E 572)
\*\*Shell Formulation\*\*
Gelatin6.2 Incompatibilities
None stated.6.3 Shelf life
2 years6.4 Special precautions for storage
Do not store above 25°C.
Keep the blister in the outer carton in order to protect from light.6.5 Nature and contents of container
Liothyronine sodium 5 micrograms, 10 micrograms and 20 micrograms Hard Capsules are packed in opaque PVC/PVDC/aluminium blisters. Each blister contains 7 or 10 capsules.
Pack sizes: 28, 56, 100, 112 hard capsules.
Not all pack sizes may be marketed.6.6 Special precautions for disposal and other handling
None.
- Instruction Content
- ## Composition
Each hard capsule contains 5 micrograms of liothyronine sodium.
For the full list of excipients, see section 6.1.
## Pharmaceutical Form
Hard Capsule
Natural transparent hard gelatin capsules of size 4.
## Clinical Particulars
4.1 Therapeutic indications
Liothyronine is indicated in adults and children 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 sub-clinical 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.
\*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 and Paediatric population\*
5 micrograms daily.
\*\*Method of administration\*\*
Oral use.
In patients who have difficulty in swallowing a whole capsule, the contents of a capsule should be emptied into a minimum of 20 ml of water. The entire liquid should be consumed after swirling the mixture to ensure ingestion of the full dose. The solubility of liothyronine in water enables this as a method of administration.
For doses lower than 20 micrograms, Liothyronine sodium 5 micrograms Hard Capsules and Liothyronine sodium 10 micrograms Hard Capsules are also available.4.3 Contraindications
Hypersensitivity to any components of Liothyronine sodium hard capsules.
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 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.
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.
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 1-2days 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 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. Alternative tests not susceptible to biotin interference should be used, if available (see section 4.5).
This medicine contains less than 1 mmol sodium (23 mg) per 5micrograms, 10micrograms and 20 micrograms hard capsule, that is to say essentially 'sodium-free'.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 antidepressants. 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 triiodothyronine 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 hypothyroidism may be increased by oestrogens.
\*\*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 (see section 4.4).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.
\*\*Lactation\*\*
Liothyronine sodium is excreted into breast milk in low concentrations.
This may interfere with neonatal screening programmes.
\*\*Fertility\*\*
There are no fertility data available.4.7 Effects on ability to drive and use machines
None.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:
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. It allows continued monitoring of the benefit/risk balance of the medicinal product. Healthcare professionals are asked to report any suspected adverse reactions via 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
If patient is seen within a few hours of overdosage: gastric lavage or emesis. 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.
Treatment is symptomatic. Tachycardia in adults may be controlled with 40mg propranolol every 6 hours.
## Pharmacological Properties
5.1 Pharmacodynamic properties
Pharmacotherapeutic group: Thyroid preparations, thyroid hormones, ATC code: H03AA02
Liothyronine sodium is a naturally occurring thyroid hormone.
Liothyronine sodium hard capsules are qualitatively similar in biological action to thyroxine but the effect develops in a few hours and lasts for 24 to 48 hours after stopping the treatment.5.2 Pharmacokinetic properties
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.
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
No further relevant data.
## Pharmaceutical Particulars
6.1 List of excipients
Maize Starch
Magnesium Stearate (E 572)
\*\*Shell Formulation\*\*
Gelatin6.2 Incompatibilities
None stated.6.3 Shelf life
2 years6.4 Special precautions for storage
Do not store above 25°C.
Keep the blister in the outer carton in order to protect from light.6.5 Nature and contents of container
Liothyronine sodium 5 micrograms, 10 micrograms and 20 micrograms Hard Capsules are packed in opaque PVC/PVDC/aluminium blisters. Each blister contains 7 or 10 capsules.
Pack sizes: 28, 56, 100, 112 hard capsules.
Not all pack sizes may be marketed.6.6 Special precautions for disposal and other handling
None.
