drugs

EUTIROX ® Levothyroxine

EUTIROX ® a drug based on levothyroxine sodium

THERAPEUTIC GROUP: Thyroid preparations

IndicationsAction mechanismStudies and clinical effectiveness Usage and dosage instructionsWarnings Pregnancy and lactationInteractionsContraindicationsUndesirable effects

Indications EUTIROX ® Levothyroxine

EUTIROX ® is indicated in all conditions of reduced thyroid function such as goiter, relapse prophylaxis after surgery, thyroid hypofunction, inflammatory processes, antithyroid therapies to restore normal hormonal balance.

Mechanism of action EUTIROX ® Levothyroxine

The levothyroxine contained in EUTIROX ® constitutes the deficient hormone in the course of hypothyroidism, thus representing a direct replacement therapy.

Taken orally, thanks to the particular structure of the molecule, it is absorbed at the gastro-intestinal level for about 42 - 74% of the total dose taken, and bound to plasma proteins such as thyroglobulin, transthyretin and albumin in a small part, is distributed to various tissues.

In these sites, therefore, following diodination mediated by specific enzymes, the hormone can interact with its specific nuclear receptor by regulating various biological functions such as:

  • Protein synthesis and enzymatic activity, involved in growth and body development;
  • Thermogenesis;
  • Heart rate and contraction;
  • Basal metabolism;
  • Catecholamine-induced lipolysis;
  • Cholesterol metabolism.

It is therefore easy to imagine how the condition of hypothyroidism is characterized by a general slowing of the body's basal metabolism, myxedema, weight gain, reduction of physical and cognitive abilities, hyperlipidemia, alterations of the menstrual cycle, goiter, intolerance to cold and bradycardia.

After a long half-life of several days, the thyroid hormones are partly metabolized at the hepatic level and eliminated with bile and partly recycled through the entero-hepatic recirculation mechanism.

Studies carried out and clinical efficacy

1. THE EFFICACY OF LEVOTHYROXINE IN THE TREATMENT OF MULTINODULAR THYROID

This study evaluates the efficacy of levothyroxine treatment in delaying the clinical development of multi nodular thyroid disease. The preventive effect of this hormone seems justified by the suppression of the endogenous production of TSH, certainly involved in the genesis and development of the disease.

2. SUBSTITUTE THERAPY AFTER TOTAL THYROIDECTOMY

Total removal of the thyroid gland becomes a surgical procedure sometimes indicated in the treatment of some serious pathologies. In patients totally lacking this important endocrine gland, T4 hormone replacement therapy has been shown to be effective and well tolerated by patients.

3. PREGNANCY AND HYPOTHYROIDISM

The need for thyroid hormones increases by about 20 - 40% during pregnancy, so in patients with hypothyroidism the proportion of EUTIROX used should be proportionally increased. Although various studies show that an adequate therapy can preserve both the maternal and fetal metabolic balance, to date there is no standardized therapeutic protocol that can allow the doctor to easily treat this condition.

Method of use and dosage

EUTIROX ® tablets containing 25/50/75/100/125/150/175/200 mcg of levothyroxine sodium:

the effective dosage of levothyroxine should be established by the physician based on the physio-pathological conditions of the patient, his physical characteristics and the relative clinical picture.

The various formulations are in fact representative of an important interindividual variability of the therapeutic needs of the patient, and at the same time, allow the doctor to better adapt the therapy itself.

In any case, the therapeutic range for an adult individual fluctuates between 50 and 200mcg daily, to be taken with a sip of water in the morning, preferably on an empty stomach.

Warnings EUTIROX ® Levothyroxine

Treatment with levothyroxine-based drugs should be preceded by a careful evaluation of the patient's clinical condition, useful for characterizing the real causes of hypothyroidism and treating all other possible etiological aspects incompatible with drug treatment with EUTIROX ®

During the therapeutic procedure, the physician should periodically monitor TSH levels, to assess the efficacy of the therapy and possibly adjust the dosage, and liver function, to exclude any organ fatigue and important changes in the pharmacokinetic properties of the levothyroxine.

The metabolic action of the drug on the bone, could facilitate the onset of osteoporosis in patients at risk as for menopausal women.

EUTIROX ® contains lactose, therefore patients with lactose intolerance, glucose / galactose malabsorption syndrome or lactase enzyme deficiency may develop gastro-intestinal symptoms after taking this medicine.

Headache, dizziness and other neurological symptoms associated with taking EUTIROX ® may make the use of machinery and driving vehicles dangerous.

PREGNANCY AND BREASTFEEDING

Levothyroxine has been shown to be able to cross the placental barrier reaching the fetal circulation. Despite this pharmacokinetic characteristic, the therapeutic doses used in the treatment of hypothyroidism do not seem to determine teratogenic or toxic effects on the fetus, much less induce hyperthyroidism or inhibition of TSH production.

Consequently the intake of EUTIROX ® in pregnancy could be realized in case of real necessity but under strict medical control.

Interactions

Given the central role of levothyroxine in metabolic control, it is easy to imagine how the intake of EUTIROX ® can interfere with numerous functional aspects and with as many active ingredients.

More precisely, levothyroxine may interact with:

  • Hypoglycemic drugs, reducing their therapeutic effect;
  • Coumarin derivatives, enhancing the anticoagulant effect and increasing the risk of bleeding.

On the contrary, the therapeutic effect of EUTIROX ® could be altered by the concomitant use of cholestyramine, drugs containing aluminum, iron and calcium, salicylates, dicumarol, furosemide, clofibrate, phenytoin, glucoriticoids, beta-sympatholithics, amiodarone and media containing iodine, estrogens, barbiturates, proguanil, antiepiliectics and compounds containing soy (delaying absorption).

Contraindications EUTIROX ® Levothyroxine

EUTIROX ® contraindicated in case of untreated adrenal insufficiency, untreated hypophysial insufficiency, untreated thyrotoxicosis, acute myocardial infarction, acute myocarditis and pancarditis.

EUTIROX ® should not be used in patients who are hypersensitive to the active substance or to one of its excipients.

Undesirable effects - Side effects

Medical therapy of hypothyroidism with levothyroxine seems to be well tolerated and devoid of particular side effects, when the dosage used reflects the real needs of the patient.

On the other hand, side effects of varying clinical relevance can be observed in case of ill-defined formulations or in the absence of therapeutic necessity (doping practice or search for a slimming effect).

Adverse reactions clearly fall within the symptomatology of hyperthyroidism with:

  • Cardiovascular disorders: arrhythmias, tachycardia, anginal pain, hypertension, insufficiency and cardiac arrest;
  • Central nervous system disorders: headache, hyperexcitability, insomnia, tremors, emotional lability and epilepsy;
  • Dermatological disorders: hair loss and widespread inflammatory reactions;
  • Endocrine disorders: changes in the menstrual cycle and adrenal function;
  • Gastro-intestinal disorders and annexed glands: transaminase changes, nausea, vomiting, cramps and abdominal pain;
  • Musculoskeletal disorders: osteoporosis, weakness and muscle cramps.

Note

EUTIROX ® sold only under medical prescription.

EUTIROX ® is part of the doping class: Hormones and related substances (prohibited in and out of competition)