Administration
ADMINISTRATION
- IV injection
- Possible intramuscular (IM) injection
- For the treatment of myxoedema coma, a slow intravenous infusion is recommended as loading dose
Posology1
Dose should be adjusted according to individual needs, as well as clinical and laboratory findings.
Hypothyroidism where oral therapy is not feasible
Paediatric
- Daily dose: 10-15 µg/kg/day
- IV treatment: dose ≤ 50-80% of the oral dose
Adults
- Daily dose: 100-150 µg on average
- Dosage established gradually:
- Start with 25 µg/day
- Increase by 25 µg/week - Monitor T3, T4 and TSH* after 4-6 weeks of stable dosage
Elderly
Subjects with cardiovascular factors:
- Lower doses than in adults
- A maintenance dose lower than that required to normalise TSH* levels
Patients with renal/hepatic insufficiency
- Limited experience
Myxoedema coma
Paediatric
- Very limited experience
- Recommended loading dose: 10 µg/kg/day in 3 divided doses for 24 hours as a loading dose, followed by 3 µg/kg/day as maintenance therapy
- Adjust based on clinical and laboratory findings
Adults
- Initial = loading dose: 200-500 µg as a slow IV infusion in 100-250 ml of saline solution to achieve a concentration of the diluted solution of 2 µg/ml- Do not exceed 500µg as loading dose, due to increased risks of cardiovascular events or death
- Daily maintenance dose: 1.2 µg/kg of body weight
OPENING THE SELF-BREAKABLE AMPOULE1
1
- Hold the body of the ampoule between the thumb and folded fore finger, with the head of the ampoule facing up and the coloured dot pointing upwards and facing you.
- Tap the top of the ampule to make the liquid go down from the head of the ampoule
- The break of the ampoule is at the narrowing between the head and the body of the ampoule as indicated in the dotted line on the picture
2
- Cover the top of the ampoule with a compress or a cotton ball and place the thumb of one hand on the coloured dot
3
- Push back on the neck of the ampoule and it will open easily
Any unused medicinal product or waste material should be disposed of in accordance with local requirements.
References:
- Levothyroxine SERB 200 mcg/ml solution for injection/infusion Summary of Product Characteristics (SmPC)