Country: Malta
Language: English
Source: Medicines Authority
LEVOTHYROXINE SODIUM
Mercury Pharma Group Limited
H03AA01
LEVOTHYROXINE SODIUM
TABLET
LEVOTHYROXINE SODIUM 50 µg
POM
THYROID THERAPY
Authorised
2007-05-15
3. HOW TO TAKE ELTROXIN ® TABLETS Always take Eltroxin ® Tablets exactly as your doctor has told you. Do NOT take more than your doctor tells you to. You should check with your doctor or pharmacist if you are not sure. Swallow the tablets with a glass of water, preferably before breakfast. The usual starting dose for adults is 50 to 100 micrograms daily. This may be adjusted after a few weeks depending on the response to your treatment which will be monitored by blood tests. For patients over 50 years the starting dose will not usually exceed 50 micrograms. CHILDREN UNDER 12 YEARS: The dose for children depends on their age, weight and the condition being treated. Your child will be monitored to make sure he/she gets the right dose. Give your child this medicine at least half an hour before the first meal of the day. CONGENITAL HYPOTHYROIDISM IN INFANTS: Initially 10 to 15 micrograms/kg body weight a day for the first 3 months. The dose will then be adjusted depending on response to treatment. ACQUIRED HYPOTHYROIDISM IN CHILDREN: Initially 12.5 to 50 micrograms a day. The dose should be increased gradually every 2 to 4 weeks depending on response to treatment. If required the tablets can be dissolved in 10 to 15ml of drinkable water and given freshly prepared with some more liquid (5 to 10ml). In the event of stopping treatment, Eltroxin ® tablets should be withdrawn gradually under the supervision of your doctor. IF YOU TAKE MORE ELTROXIN ® TABLETS THAN YOU SHOULD: If you think that you, or any other person, have taken too many tablets, contact your doctor or hospital casualty department immediately. Take Read the complete document
SUMMARY OF PRODUCT CHARACTERISTICS 1. NAME OF THE MEDICINAL PRODUCT Eltroxin 50mcg tablets Levothyroxine 50mcg tablets 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Each tablet contains 50 micrograms levothyroxine sodium BP 3. PHARMACEUTICAL FORM Tablet. White, uncoated, biconvex tablets engraved on one face “FW21” and a scoreline on the other. 4. CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Recommended clinical indications: Control of hypothyroidism, congenital hypothyroidism and juvenile myxoedema. 4.2 POSOLOGY AND METHOD OF ADMINISTRATION Adults: Initially 50 to 100 micrograms daily, preferably taken before breakfast. Adjust at three to four week intervals by 50 micrograms until normal metabolism is steadily maintained: this may require doses of 100 to 200 micrograms daily. For patients over 50 years, it is not advisable to exceed 50 micrograms daily initially and where there is cardiac disease, 25 micrograms daily or 50 micrograms on alternate days is more suitable initially. In this condition the daily dose may be increased by 25 micrograms at intervals of perhaps 4 weeks. For patients younger than 50 years, and in the absence of heart disease, a serum Levothyroxine (T4) level of 70 to 160 nanomols per litre, or a serum thyrotrophin level of less than 5 milli-units per litre should be targeted. For patients aged over 50 years, with or without cardiac disease, clinical response is probably a more acceptable criteria of dosage rather than serum levels. A pre-therapy ECG is valuable because ECG changes due Read the complete document