Thyreotom^® (Tablets) Instructions for Use

Marketing Authorization Holder

Berlin-Pharma CJS (Russia)

Manufactured By

Berlin-Chemie AG/Menarini Group (Germany)

ATC Code

H03AA03 (Levothyroxine in combination with liothyronine)

Active Substances

Liothyronine (Rec.INN registered by WHO)

Levothyroxine sodium (Rec.INN registered by WHO)

Dosage Form

Thyreotom®

Tablets 40 mcg+10 mcg: 50, 60 or 100 pcs.

Dosage Form, Packaging, and Composition

Tablets are white, round, flat-cylindrical, with a beveled edge and a score on one side for dividing.

Excipients: lactose monohydrate, corn starch, gelatin, colloidal silicon dioxide, magnesium stearate, glycerol 85%.

50 pcs. – blisters (1) – cardboard packs.
50 pcs. – blisters (2) – cardboard packs.
60 pcs. – glass bottles (1) – cardboard packs.

Clinical-Pharmacological Group

Thyroid hormone preparation

Pharmacotherapeutic Group

Thyroid agent

Pharmacological Action

[I] – Instructions for medical use approved by the Pharmacological Committee of the Ministry of Health of the Russian Federation

A preparation of synthetic thyroid hormones. Replenishes the deficiency of thyroid hormones.

It increases tissue oxygen demand, stimulates their growth and differentiation, and increases the level of basal metabolism (proteins, fats, and carbohydrates).

In small doses, it has an anabolic effect, while in large doses, it has a catabolic effect.

It inhibits the production of thyroid-stimulating hormone.

It enhances energy processes and has a positive effect on the functions of the nervous and cardiovascular systems, liver, and kidneys.

Pharmacokinetics

Levothyroxine. When taken orally, levothyroxine is absorbed almost exclusively in the upper part of the small intestine. Up to 80% of the administered dose is absorbed. Food intake reduces the absorption of levothyroxine.

C_max in blood serum is reached approximately 5-6 hours after oral administration.

After absorption, more than 99% of the drug is bound to serum proteins (thyroxine-binding globulin, thyroxine-binding prealbumin, and albumin).

In various tissues, about 80% of levothyroxine undergoes monodeiodination to form triiodothyronine and inactive products.

Thyroid hormones are metabolized mainly in the liver, kidneys, brain, and muscles.

A small amount of the drug undergoes deamination and decarboxylation, as well as conjugation with sulfuric and glucuronic acids (in the liver).

Metabolites are excreted in the urine and bile. The T_1/2 of levothyroxine is 6-7 days.

In thyrotoxicosis, T_1/2 is shortened to 3-4 days, and in hypothyroidism, it is prolonged to 9-10 days.

Liothyronine. Absorption upon oral administration is 95% (within 4 hours). Binding to plasma proteins is high. T_1/2 is 2.5 days.

Indications

• Hypothyroidism;
• Euthyroid goiter;
• As replacement therapy and for the prevention of goiter recurrence after thyroid resection;
• Thyroid cancer (after surgical treatment);
• Diffuse toxic goiter: after achieving a euthyroid state with thyrostatics (as combination therapy).

ICD codes

Dosage Regimen

The daily dose is determined individually depending on the indications.

Hypothyroidism.

Adults: treatment begins with 1 tab. of Thyreotom^® per day, then the dose can be increased by 1 tab. every 2-4 weeks until a maintenance daily dose of 2-5 tabs is reached.

Children: when selecting a dose for long-term treatment, the child’s body weight, height, and body surface area are taken into account. The average recommended maintenance dose is 2-2.5 tabs. of Thyreotom^® per day.

Euthyroid goiter.

Adults: initial dose is 1-2 tabs/day, maintenance dose is 3-6 tabs/day.

Adolescents: initial dose is 1-1.5 tabs/day, maintenance dose is 2.5-3.5 tabs/day.

Children: 1/2-1 tab./day is prescribed.

Prevention of goiter recurrence after surgical treatment.

Adults are prescribed 2-3 tabs./day.

After surgical treatment for thyroid cancer, the initial dose is 3 tabs./day, the maintenance dose is 6 tabs./day.

The daily dose of the drug should be taken once in the morning, at least 30 minutes before breakfast, without chewing and with a sufficient amount of liquid.

The drug should be taken regularly.

The duration of treatment is determined by the form of the disease. As a rule, for hypothyroidism and after thyroidectomy for thyroid cancer, treatment is carried out for life.

The duration of use for euthyroid goiter, as well as for the prevention of goiter recurrence after surgical treatment, ranges from several months or years to lifelong use.

Adverse Reactions

With proper use under medical supervision, side effects are usually not observed.

Allergic reactions, progression of heart failure and angina pectoris may occur.

Contraindications

• Increased individual sensitivity to the drug;
• Untreated thyrotoxicosis;
• Acute myocardial infarction, angina pectoris III-IV functional class;
• Acute myocarditis;
• Untreated adrenal insufficiency.

With caution, the drug should be prescribed for cardiovascular diseases: coronary artery disease (atherosclerosis, angina pectoris I-II functional class, history of myocardial infarction), heart failure, arterial hypertension, tachycardia, tachyarrhythmia; diabetes mellitus; severe long-standing hypothyroidism; malabsorption syndrome (dose adjustment may be required); elderly age.

Use in Pregnancy and Lactation

During pregnancy and breastfeeding, therapy with thyroid hormones prescribed for hypothyroidism should be continued. During pregnancy, an increase in the dose of the drug is required due to an increase in the level of thyroxine-binding globulin.

The use of the drug in combination with thyrostatics during pregnancy is contraindicated, as it may require an increase in the doses of thyrostatics.

Since thyrostatics, unlike levothyroxine, can cross the placenta, hypothyroidism may develop in the fetus.

The amount of thyroid hormones secreted in breast milk during lactation (even when treated with high doses of the drug) is insufficient to cause any disorders in the child.

However, during breastfeeding, the drug should be taken with caution, strictly in the recommended doses under medical supervision.

Pediatric Use

Used according to indications.

Geriatric Use

The drug should be prescribed with caution to elderly patients.

Special Precautions

In hypothyroidism due to pituitary damage, it is necessary to determine whether there is concomitant adrenal cortex insufficiency.

In this case, replacement therapy with glucocorticosteroids should be started before initiating treatment of hypothyroidism with thyroid hormones to avoid the development of acute adrenal insufficiency.

Effect on the ability to drive vehicles and mechanisms

The drug does not affect professional activities related to driving vehicles and operating mechanisms.

Overdose

In case of drug overdose, symptoms characteristic of thyrotoxicosis are observed: palpitations, cardiac arrhythmia, heart pain, anxiety, tremor, sleep disturbance, increased sweating, increased appetite, weight loss, diarrhea.

Depending on the severity of the symptoms, the doctor may recommend a reduction in the daily dose of the drug, a break in treatment for several days, or the prescription of beta-blockers.

After the side effects disappear, treatment should be started cautiously with a lower dose.

Drug Interactions

Thyreotom^® enhances the effect of indirect anticoagulants, which may require a reduction in their dose.

The use of tricyclic antidepressants with Thyreotom^® may lead to an enhancement of the antidepressant effect.

Thyroid hormones may increase the need for insulin and oral hypoglycemic drugs. More frequent monitoring of blood glucose levels is recommended during the periods of starting treatment with the drug, as well as when changing its dosage regimen.

Thyreotom^® reduces the effect of cardiac glycosides.

With simultaneous use, cholestyramine, colestipol, and aluminum hydroxide reduce the plasma concentration of the drug by inhibiting its absorption in the intestine.

With simultaneous use with anabolic steroids, asparaginase, tamoxifen, pharmacokinetic interaction at the level of protein binding is possible.

With simultaneous use with phenytoin, salicylates, clofibrate, furosemide in high doses (250 mg), the content of thyroid hormones not bound to plasma proteins increases.

Taking estrogen-containing drugs increases the content of thyroxine-binding globulin, which may increase the need for Thyreotom^® in some patients.

Somatotropin, when used simultaneously with Thyreotom^®, may accelerate the closure of epiphyseal growth zones.

Taking phenobarbital, carbamazepine, and rifampicin may increase the clearance of levothyroxine and require an increase in the dose of Thyreotom^®.

Storage Conditions

List B.

Store at a temperature between 15°C and 25°C (77°F) in a place inaccessible to children.

Shelf Life

The shelf life is 3 years.

Do not use after the expiration date printed on the packaging.

Dispensing Status

The drug is dispensed by prescription.

Important Safety Information

This information is for educational purposes only and does not replace professional medical advice. Always consult your doctor before use. Dosage and side effects may vary. Use only as prescribed.