Posology : מינונים

4.2    Posology and method of administration
Posology
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 thyroid- stimulating 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.

Paediatric population
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 long-existing 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        75 - 200 goitre
Prophylaxis of relapse after         75 - 200 surgery for euthyroid goitre
Substitution therapy in hypothyroidism in adults
- initial dose               25 - 50
- maintenance dose           100 - 200
Substitution therapy in hypothyroidism in children
- initial dose               12.5 - 50
- maintenance dose           100 - 150 microgram/m² body surface
Concomitant supplementation        50 - 100 during anti-thyroid drug treatment of hyperthyroidism
Suppression therapy in thyroid       150 - 300 cancer
Diagnostic use for thyroid                             Week 4     Week 3       Week 2       Week 1 suppression testing                                    prior to   prior to     prior to     prior to test       test         test         test
Euthyrox 100                              2 Tabl/day   2 Tabl/day microgram levothyroxine 75             75           150          150 sodium 150    mcg/day        mcg/day      mcg/day      mcg/day microgram

Method of administration
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.