Triiodothyronine 50 Berlin-chemie (Tablets) Instructions for Use

Marketing Authorization Holder

Berlin-Chemie AG/Menarini Group (Germany)

ATC Code

H03AA02 (Liothyronine sodium)

Active Substance

Liothyronine

Dosage Form

Triiodothyronine 50 Berlin-chemie

Tablets 50 mcg: 60 pcs.

Dosage Form, Packaging, and Composition

Tablets are flat-cylindrical, pink in color, with a score on one side.

Excipients: lactose, corn starch, gelatin, magnesium stearate, colloidal silicon dioxide, dye Ponceau 4R cochineal red (E124).

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

Synthetic thyroid hormone, compensates for 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, and in large doses, it has a catabolic effect.

It inhibits the production of thyroid-stimulating hormone.

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

The maximum pharmacological effect develops after 2-3 days.

Pharmacokinetics

Absorption – 95% (within 4 hours). Plasma protein binding is high. T_1/2 – 2.5 days.

Indications

• hypothyroidism of any genesis;
• euthyroid goiter;
• Prevention of goiter recurrence after surgical treatment or therapy with radioactive iodine;
• diffuse toxic goiter: after achieving a euthyroid state with thyrostatics (as part of combination therapy).

ICD codes

Dosage Regimen

Administer orally, at least 30 minutes before meals.

Initiate therapy in adults with a dose of 1/2 tablet (25 mcg) per day.

Increase the dose gradually, in increments of 1/2 to 1 tablet.

Perform dose titration every 2 to 4 weeks based on clinical response and laboratory parameters.

The average maintenance dose ranges from 1 to 1.5 tablets (50-75 mcg) daily.

Individualize the final dosage; requirements may vary significantly between patients.

Monitor for signs of overdosage, particularly in patients with pre-existing cardiovascular disease.

Adjust the regimen cautiously in elderly patients and those with angina pectoris or cardiac arrhythmias.

In hypothyroidism of pituitary origin, rule out and treat concomitant adrenal insufficiency prior to initiation.

Adverse Reactions

Allergic reactions; progression of heart failure and angina.

Contraindications

• Hypersensitivity to the drug;
• Untreated thyrotoxicosis;
• coronary artery disease (myocardial infarction, angina pectoris III-IV functional class);
• Acute myocarditis;
• Untreated adrenal insufficiency;
• cachexia.

With caution in tachycardia; tachyarrhythmia; angina pectoris I-II functional class; heart failure; diabetes mellitus; elderly age.

Use in Pregnancy and Lactation

Triiodothyronine 50 Berlin-Chemie is not recommended for use during pregnancy as part of combination therapy for the treatment of thyrotoxicosis in combination with thyrostatic agents, as this may lead to the development of hypothyroidism in the fetus.

Geriatric Use

With caution: in elderly patients.

Special Precautions

Careful dose selection and frequent medical supervision are required in elderly patients, with angina pectoris I-II functional class, heart failure, and with some forms of cardiac rhythm disturbances (tachyarrhythmia).

Overdose of liothyronine, manifested by the development of thyrotoxicosis, should be avoided, especially in angina pectoris I-II functional class, heart failure, or tachyarrhythmia.

In hypothyroidism caused by pituitary damage, it is necessary to determine whether adrenal cortex insufficiency is also present. In this case, treatment of adrenal insufficiency should be started before prescribing thyroid hormone therapy.

Overdose

Drug overdose is characterized by symptoms typical of thyrotoxicosis: palpitations, cardiac arrhythmia, tachycardia, heart pain, tremor, irritability, insomnia, increased sweating, increased appetite, weight loss, diarrhea, headache, dysmenorrhea.

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

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

Drug Interactions

It reduces the effect of hypoglycemic agents and enhances the effect of indirect anticoagulants and vasoconstrictor drugs.

Cholestyramine reduces the absorption of liothyronine.

Oral contraceptives reduce the effect of liothyronine.

Phenytoin, salicylates, dicumarol, furosemide (in high doses), clofibrate, antidepressants, cardiac glycosides, ketamine increase the concentration and risk of liothyronine side effects.

Storage Conditions

List B.

At a temperature not exceeding 25°C (77°F), in a place protected from light and out of reach of children.

Shelf Life

Shelf life – 3 years.

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

Dispensing Status

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.