LEVOTHYROXINE Oral solution Ref.[6943] Active ingredients: Levothyroxine

Posology

The treatment of any thyroid disorder should be determined on an individual basis, taking account of clinical response, biochemical tests and regular monitoring.

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.

Patients switching from the oral solution to the tablet form or from the tablet form to the oral solution should be monitored closely.

Levothyroxine is best taken as a single dose on an empty stomach, usually before breakfast.

Hypothyroidism (congenital or acquired)

Adults, children over 12 years

Initial dose: 50-100 micrograms daily before breakfast.

Usual maintenance dose: 100-200 micrograms daily.

The initial dose is adjusted by 25 to 50 microgram increments at 3–4 week intervals until clinical response and measurements of plasma thyroxine and thyroid stimulating hormone indicate that the thyroid deficiency is corrected and a maintenance dose established.

Diffuse non toxic goitre or goitre associated with Hashimoto’s thyroiditis

The recommended dose is 50-200 micrograms/day.

Suppression therapy in thyroid carcinoma

The recommended dose is 150-300 micrograms/day.

Susceptible patient populations

In elderly 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 micrograms/day) should be given which should then be increased slowly and at lengthy intervals (e.g. a gradual increment of 12.5 micrograms/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.

Paediatric population

The maintenance dose is generally 100 to 150 micrograms per m² body surface area.

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.

For children with acquired hypothyroidism, the initial recommended dosage is 12.5-50 micrograms per day. The dose should be increased gradually every 2 to 4 weeks according to the clinical findings and thyroid hormone and TSH values until the full replacement dose is reached.

Infants should be given the total daily dose at least half an hour before the first meal of the day.

Duration of treatment is usually for life in the case of hypothyroidism, non toxic goitre and goitre associated with Hashimoto’s thyroiditis.

For patients with non toxic diffuse goitre and normal T4 and TSH levels treatment with levothyroxine can be considered. If no discernible decrease in size of the goitre occurs after 6 to 12 month, thyroxine therapy should be stopped.

Method of administration

Oral use.

A graduated oral syringe and a Press-In Bottle Adaptor (PIBA) are provided with the product.

1. Open the bottle and at first use insert the Press-In Bottle Adaptor (PIBA).
2. Insert the syringe into the PIBA and draw out the required volume from the inverted bottle.
3. Remove the filled syringe from the bottle in the upright position.
4. Discharge the syringe contents into the mouth. Repeat steps 2 to 4 as needed to achieve the required dose.
5. Rinse the syringe and replace the cap on the bottle (PIBA remains in place).

Note: If necessary, Levothyroxine Oral Solution can be administered via a nasogastric feeding tube that should be rinsed twice with 10 ml of water immediately after administration.

An elevated T3 value is a more reliable indicator of overdose than elevated T4 or FT4 values.

In the event of an overdose, symptoms displaying a marked increase in metabolic activity occur (see section 4.8). Depending on the extent of the overdose, it is recommended that the patient stops taking the product and undergoes a check-up.

Symptoms may manifest themselves as marked beta-adrenergic effects, such as tachycardia, anxiety states, agitation and hyperkinesis. The symptoms may be reduced by beta-receptor blockers. At extreme doses, plasmapheresis may be useful.

Following overdose in humans (with suicidal intent) doses of 10 mg levothyroxine were tolerated without complications.

There are some reports of sudden cardiac death in patients who have misused levothyroxine over many years.

Overdosage following recent ingestion can be treated using gastric lavage/emesis. Propranolol and other supportive measures are used to maintain the circulation. Antithyroid drugs such as propylthiouracil and lithium are unlikely to be of benefit to prevent thyrotoxic crisis due to delayed absorption/onset of action.

Shelf life: 18 months.

After first opening do not store above 25°C and use within 2 months.

Do not store above 25°C.

Store in the original package in order to protect from light.

Levothyroxine oral solution is packed in amber (Type III) glass bottle 100 ml, with child-resistant, tamper-evident screw cap with an LDPE liner, a 5ml graduated oral dosing syringe and a “press-in” syringe/bottle adaptor.

No special requirements.