Euthyrox

Levothyroxine sodium.

Euthyrox contains the synthetic levothyroxine which is identical in effect with the naturally occurring major hormone secreted by the thyroid. It develops the characteristic thyroid hormone effects on development, growth and metabolic systems.

Goitre (euthyroid goitre), prevention of goitre recurrence after goitre surgery (relapse prophylaxis after strumectomy), as concomitant therapy when taking medication for the treatment of thyroid overactivity (hyperthyroidism) after normal function has been achieved, thyroid underactivity (hypothyroidism), after total surgical removal of the thyroid gland (thyroidectomy) due to thyroid carcinoma.

The individual daily dose should be determined by laboratory tests and clinical examinations. Particular caution must be exercised when starting treatment with thyroid hormones in elderly patients, patients with coronary heart disease and patients with severe or long-standing hypothyroidism, that is, a small dose should be chosen to start with which can then be increased gradually and at long intervals with frequent thyroid hormone checks. Experience has shown that a small dose is also sufficient for patients with a low body weight and patients with a large nodular goitre.
Goitre (Euthyroid Goitre): Adults: 75-200 mcg once daily. Adolescents: 50-150 mcg once daily.
Prevention of Goitre Recurrence After Goitre Surgery  (Strumectomy): 75-200 mcg once daily.
Hypothyroidism in Adults at the Start of Therapy: 25-50 mcg once daily (increase by 25-50 mcg at 2- to 4-weekly intervals). Maintenance Therapy: 125-250 mcg once daily.
Children: Start of therapy: 12.5-50 mcg once daily. Maintenance therapy: 100-150 mcg/m² body surface once daily.
Concomitant Therapy with Medication Against Hyperthyroidism: 50-100 mcg once daily.
After Total Surgical Removal of the Thyroid (Thyroidectomy): 150-300 mcg once daily.
Thyroid Suppression Test: 200 mcg once daily.
In children with a sound heart, the therapy may be started with the entire dose. In adults, the therapy has to be started using small initial doses and gradually increasing to optimum amounts.
The entire daily dose of Euthyrox should be taken in the morning on an empty stomach, at least half an hour before breakfast with some liquid (ie, half a glass of water). The duration of treatment is generally for life in hypothyroidism and after surgical removal of part or all of the thyroid gland, for some months up to life in the treatment of goitre (euthyroid goitre) and in prevention of goitre recurrence (goitre relapse prophylaxis). In concomitant therapy to treat hyperthyroidism for as long as the drug against hyperthyroidism is taken.
Thyroid Suppression Test: 14 days before the repeat scan.

Hyperthyroidism of any origin. Exception: As concomitant therapy in the treatment of hyperthyroidism with antithyroid drugs after normal function has been achieved. In pregnancy, however, such a concomitant therapy, is not indicated.
Thyrotoxicosis, acute myocardial infarction and uncorrected adrenal insufficiency.

In patients with hypothyroidism due to a disease of the pituitary gland, it must be clarified whether underactivity of the adrenal cortex (adrenocortical insufficiency) is also present. If so, the latter should be treated before initiating thyroid hormone therapy.
Thyroid hormone therapy in patients with concomitant diabetes mellitus or diabetes insipidus, or adrenal cortical insufficiency aggravates the intensity of the symptoms. Appropriate adjustments of the various therapeutic measures directed at those concomitant endocrine diseases are required. The therapy of myxedema coma may require simultaneous administration of glucocorticoids.
Drugs with thyroid hormone activity, alone or together with other therapeutic agents, have been used for the treatment of obesity. In euthyroid patients, doses within the range of daily hormonal requirements are ineffective for weight reduction. Larger doses may produce serious or even life-threatening manifestation of toxicity, particularly when given in association with sympathomimetic amines eg, those used for anoretic effects.
Effects on the Ability to Drive or Operate Machinery: There are no indications that Euthyrox interferes with driving a vehicle, operating machinery or working without a firm hold.
Use in pregnancy & lactation: Systematic treatment with thyroid hormones is of special importance during pregnancy and the nursing period and must therefore be maintained.
During pregnancy, however, levothyroxine should not be taken together with medication for the treatment of hyperthyroidism (antithyroid drugs) as additional intake of levothyroxine may make a higher dose of the antithyroid drug necessary.
In contrast to levothyroxine, antithyroid drugs cross the placenta and can cause decreased thyroid activity in the unborn infant.
Use in children: Diagnosis and institution of therapy for creatinism should be done as soon as after birth as possible to prevent developmental deficiency screening for serum T4 and TSH will identify this group of newborn patients. In infants, excessive doses of thyroid hormone preparations may produce craniosynostosis.
Use in the elderly: Elderly people should dosed very carefully. A small dose should be chosen to start with, which can be increased gradually and at long intervals with frequent thyroid hormone checks. Even mild hyperthyroidism due to levothyroxine must be avoided by all means, especially in patients with coronary heart disease, heart failure or heart rhythm disturbances of the rapid type.

Systematic treatment with thyroid hormones is of special importance during pregnancy and the nursing period and must therefore be maintained.
During pregnancy, however, levothyroxine should not be taken together with medication for the treatment of hyperthyroidism (antithyroid drugs) as additional intake of levothyroxine may make a higher dose of the antithyroid drug necessary.
In contrast to levothyroxine, antithyroid drugs cross the placenta and can cause decreased thyroid activity in the unborn infant.

If taken according to the directions and under the physician's supervision, side effects are not to be expected during treatment with Euthyrox. If the individual tolerance limit for levothyroxine is exceeded or in the case of overdosage, the known symptoms of hyperthyroidism may occur, especially if the dose is increased too quickly at the start of treatment. Such symptoms include finger tremor, palpitation (pounding of the heart), heart rhythm disturbances, excessive sweating, diarrhea, weight loss, sleeplessness or restlessness.
Consult the physician immediately if any side effects are observed, the patient will take any appropriate counter measures if necessary. If signs of hyperthyroidism is observed, the physician will recommend the patient to discontinue the medication if necessary, and will start on a lower dose again once the complaints have disappeared.

Levothyroxine may increase the effect of certain drugs which inhibit blood clotting (coumarin derivatives) and reduce the effect of drugs which lower the blood sugar.
Being treated simultaneously with colestyramine and levothyroxine, there should be an interval of 4 or 5 hrs between intake of the 2 drugs as colestyramine inhibits the uptake of levothyroxine in the body.
Rapid IV administration of phenytoin may raise plasma levels of free levothyroxine and liothyronine, and in isolated cases may favour the development of heart rhythm disturbances.
Levothyroxine may be displaced from its plasma protein-binding by salicylates, dicoumarol, high-dosed furosemide (250 mg), clofibrate and other substances.

Do not store above 25°C. Protect from light.

Thyroid Hormones

H03AA01 - levothyroxine sodium ; Belongs to the class of thyroid hormones.

G