Source: Marketing Authorisation Holder Revision Year: 2018 Publisher: Merck Healthcare KGaA, Frankfurter Strasse 250, 64293 Darmstadt, Germany
Euthyrox 25-200 microgram:
Euthyrox 25-100 microgram:
Euthyrox 100/150/200 microgram:
In order to treat each patient according to his/her individual needs, tablets are available with a levothyroxine sodium content ranging from 25 to 200 microgram. Patients therefore usually need to take only one tablet per day.
The dosage recommendations given are only for guidance.
The individual daily dose should be determined on the basis of laboratory tests and clinical examinations. As a number of patients show elevated concentrations of T4 and fT4, basal serum concentration of thyroidstimulating hormone provides a more reliable basis for following treatment course. Thyroid hormone therapy should be started at low dose and increased gradually every 2 to 4 weeks until the full replacement dose is reached.
For neonates and infants with congenital hypothyroidism, where rapid replacement is important, the initial recommended dosage is 10 to 15 micrograms per kg BW per day for the first 3 months. Thereafter, the dose should be adjusted individually according to the clinical findings and thyroid hormone and TSH values. In older patients, in patients with coronary heart disease, and in patients with severe or longexisting hypothyroidism, special caution is required when initiating therapy with thyroid hormones, that is, a low initial dose (for example 12.5 microgram/day) should be given which should then be increased slowly and at lengthy intervals (e.g. a gradual increment of 12.5 microgram/day fortnightly) with frequent monitoring of thyroid hormones. A dosage, lower than optimal dosage giving complete replacement therapy, consequentially not resulting in a complete correction of TSH level, might therefore need to be considered.
Experience has shown that a lower dose is sufficient in low-weight patients and in patients with a large nodular goitre.
| Indication | Recommended dose (microgram levothyroxine sodium/day) | ||||
|---|---|---|---|---|---|
| Treatment of benign euthyroid goitre | 75 – 200 | ||||
| Prophylaxis of relapse after surgery for euthyroid goitre | 75 – 200 | ||||
| Substitution therapy in hypothyroidism in adults | |||||
| -initial dose | 100 – 200 | ||||
| -maintenance dose | 25 – 50 | ||||
| Substitution therapy in hypothyroidism in children | |||||
| -initial dose | 12.5 – 50 | ||||
| -maintenance dose | 100 – 150 microgram/m² body surface | ||||
| Concomitant supplementation during anti-thyroid drug treatment of hyperthyroidism | 50 – 100 | ||||
| Suppression therapy in thyroid cancer | 150 – 300 | ||||
| Diagnostic use for thyroid suppression testing | Week 4 prior to test | Week 3 prior to test | Week 2 prior to test | Week 1 prior to test | |
| Euthyrox 200 microgram | -- | -- | 1 Tabl/day | 1 Tabl/day | |
| uthyrox 100 microgram | 2 Tabl/day | 2 Tabl/day | |||
| Euthyrox 150 microgram | 1/2 Tabl/day | 1/2 Tabl/day | 1 Tabl/day | 1 Tabl/day |
The daily doses can be given in a single administration.
Ingestion: as a single daily dose in the morning on an empty stomach, half an hour before breakfast, preferably with a little liquid, (for example, half a glass of water).
Infants receive the entire dose at once at least 30 minutes before the first meal of the day. Tablets are to be disintegrated in some water and the resultant suspension, which must be prepared freshly as required, is to be administered with some more liquid.
Duration of treatment is usually for life in the case of substitution in hypothyroidism and after strumectomy or thyroidectomy and for relapse prophylaxis after euthyroid goitre removal. Concomitant therapy of hyperthyroidism after achieving euthyroid status is indicated for the period in which the anti-thyroid drug is given.
For benign euthyroid goitre, a treatment duration of 6 months up to 2 years is necessary. If the medical treatment was not sufficient within this time, surgery or radioiodine therapy of the goitre should be considered.
An elevated T3 level is a reliable indicator of overdose, more than elevated T4 or fT4 levels. After overdose the symptoms of a sharp increase in the metabolic rate occur (see section 4.8). Depending on the extent of the overdose it is recommended that treatment with the tablets is interrupted and that tests are carried out.
Symptoms consisting of intense beta-sympathomimetic effects such as tachycardia, anxiety, agitation and hyperkinesia can be relieved by betablockers. After extreme doses plasmapheresis may be of help.
In predisposed patients isolated cases of seizures have been reported when the individual dose tolerance limit was exceeded.
Overdose of levothyroxine may result in hyperthyroidism and could lead to symptoms of acute psychosis, especially in patients at risk of psychotic disorders.
Several cases of sudden cardiac death have been reported in patients with long years of levothyroxine abuse.
3 years.
Do not store above 30°C. Keep container in the outer carton, in order to protect from light.
Blister pack: Polypropylene base film and aluminium cover foil, or alternatively PVC base film with aluminium cover foil.
Pack size:
Additionally for Euthyrox 25 / 50 / 100 microgram tablets
Bottles: HDPE bottle with a polypropylene screw cap.
Pack sizes:
Not all pack sizes may be marketed.
No special requirements.
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