Eltroxin Tablet 100mcg

Country: Singapore

Language: English

Source: HSA (Health Sciences Authority)

Active ingredient:

Levothyroxine sodium

Available from:

DCH AURIGA SINGAPORE

Dosage:

0.11126mg

Pharmaceutical form:

TABLET

Composition:

Levothyroxine sodium 0.11126mg

Administration route:

ORAL

Prescription type:

Prescription Only

Manufactured by:

Aspen Bad Oldesloe GmbH

Authorization status:

ACTIVE

Authorization date:

2007-04-16

Summary of Product characteristics

ELTROXIN

Levothyroxine sodium
QUALITATIVE AND QUANTITATIVE COMPOSITION
Non-scored tablets containing 50 micrograms (0.05 mg) or 100
micrograms (0.1 mg)
levothyroxine sodium, which is the monosodium salt of the levorotary
isomer of
levothyroxine.
PHARMACEUTICAL FORM
Tablets.
CLINICAL PARTICULARS
INDICATIONS
Hypothyroidism.
POSOLOGY AND METHOD OF ADMINISTRATION
If the dose of
_ELTROXIN _
is increased too rapidly, symptoms such as diarrhoea, nervousness,
rapid pulse, insomnia, tremors and sometimes anginal pain where there
is latent myocardial
ischaemia may occur and the dosage must be reduced or withheld for a
day or two, then
restarted at a lower level. A pre-therapy ECG is valuable, as changes
induced by
hypothyroidism may be confused with ECG evidence of ischaemia.
Due to a lack of data it is not appropriate to crush levothyroxine
tablets and levothyroxine
tablets without a score-line must not be halved.
Levothyroxine tablets should preferably be taken on an empty stomach.
Adults: Initially 50 to 100 mcg daily, preferably taken before
breakfast, and adjusted at three
to four week intervals by 50 mcg until attainment of clinical and
biochemical euthyroidism.
This may require doses of 100 to 200 mcg daily. With patients aged
over 50 years, it is not
advisable to exceed 50 mcg a day initially. Where there is cardiac
disease, 25 mcg daily, or
50 mcg on alternate days, is more suitable. In this condition the
daily dosage may be
increased by 25 mcg at intervals of approximately four weeks. In
younger patients, and in the
absence of heart disease, a serum levothyroxine (T4) level of about 70
to 160 nanomoles per
litre, or a serum thyrotrophin level of less than 5 milli-units per
litre, should be aimed at. In
those aged over 50, and/or in the presence of heart disease, clinical
response is probably a
more acceptable criterion of dosage then serum levels. In the event
that a dose of 25 mcg is
required, the adult may take a 50 mcg tablet on alternative days.
Children: In congenital hypothyroidism and juvenile myxoedem