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אלטרוקסין טבליות 50 מק"ג ELTROXIN TABLETS 50 MCG (LEVOTHYROXINE SODIUM)

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צורת מתן:

פומי : PER OS

צורת מינון:

טבליה : TABLETS

Posology : מינונים

4.2    Posology and method of administration

Posology
General
If the dose is increased too rapidly symptoms such as diarrhoea, nervousness, high heart rate, insomnia, tremor and at times pain in the heart with latent myocardial ischaemia may occur. In such cases the dose should be reduced or treatment omitted for one or two days and then restarted at a lower dose. ECG changes caused by hypothyroidism may be confused with ECG signs of ischaemia. Therefore, it is recommended to have an ECG performed prior to start of Eltroxin.

In patients on medicines including levothyroxine and known interfering substances administration should be at least 4 hours apart (see section 4.5 Interactions).

Adults
The treatment is initiated with 50-100 micrograms daily, which is increased by 50 micrograms in intervals of 4 to 6 weeks until clinical and biochemical euthyroidism is obtained. This may require doses of 100-200 micrograms daily.

Elderly patients and patients with heart disease or serious, prolonged hypothyroidism Use with caution in patients over 50 years old, patients with heart disease and patients with serious or prolonged hypothyroidism.


For patients over 50 years it is not recommended to initially exceed 50 micrograms daily.
For heart disease 50 micrograms every second day is more suitable, and the dose may be increased by 50 micrograms every second day with intervals of around four weeks.

Paediatric population
For congenital hypothyroidism and juvenile myxoedema the largest dose not leading to a toxic effect is given. The dose is depending on clinical response, assessment of growth and relevant tests of thyroid function. Clinically normal pulse rate and absence of diarrhoea or constipation are the most useful indicators.
As a consequence of the readjustment of the hypothalamic-pituitary axis the thyrotropin level may remain elevated during the first year of life in children with neonatal hypothyroidism.

A suitable initial dose for infants with congenital hypothyroidism would be 50 micrograms levothyroxine sodium every second day. This is increased with 50 micrograms every second day at two-to-four-week intervals until optimal response is achieved.
The same procedure can be used for children with juvenile myxoedema, except that the initial dose in children over 1 year of age is 2.5-5 micrograms/kg/day.

The calculated daily dose equivalent should be rounded to the nearest 25 micrograms to determine the actual prescribed dose.

Eltroxin tablets should not be divided. If a dosage of 25 micrograms is required, other registered products containing Levothyroxine 50mcg that can be divided to 25 mcg, can be used.

Administration

For oral administration.
As limited data are available Eltroxin tablets should not be crushed, and Eltroxin tablets without a scoreline should not be divided.

Eltroxin tablets should preferably be taken in the fasting state.

If a dose is forgotten it should be taken as soon as the patient remembers it, unless it is almost time for the patient's next dose. A double dose should not be taken.

שימוש לפי פנקס קופ''ח כללית 1994 Thyroid deficiency states
תאריך הכללה מקורי בסל 01/01/1995
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