L-Tiroxine (levothyroxine sodium) 125 tablets 125 mcg. №50

Description

L-Tiroxine 125 mcg Storage
active substance:
levothyroxine sodium;

1 tablet contains levothyroxine sodium 125 mcg;

Excipients
calcium hydrogen phosphate dihydrate, microcrystalline cellulose, dextrin, sodium starch glycolate (type A), long-chain partial glycerides.

L-Tiroxine 125 mcg Dosage form
Tablets.

Basic physical and chemical properties:
round, slightly convex tablets from almost white to slightly beige, with a notch for separation on one side and embossed “125” on the other.

The tablet can be divided into dose levels.

L-Tiroxine 125 mcg Pharmacotherapeutic group
Thyroid therapy, thyroid hormones. ATC code H03A A01.

Pharmacological properties
Pharmacodynamics

Mechanism of action.

Synthetic levothyroxine, which is found in the preparation L-Thyroxine 125 Berlin-Chemie, is identical in its action to the natural thyroid hormone, which is produced mainly by the thyroid gland. There are no differences between endogenously formed and exogenous levothyroxine for the body.

Pharmacodynamic effects.

After partial conversion to liothyronine (T3), mainly in the liver and kidneys, and transition to body cells, the characteristic effects of thyroid hormones are observed on the development, growth and metabolism due to the activation of T3 receptors.

Clinical efficacy and safety.

Substitution of thyroid hormones leads to the normalization of metabolic processes. For example, taking levothyroxine leads to a significant reduction in elevated cholesterol levels caused by hypothyroidism.

Pharmacokinetics

Absorption.

Absorption of orally taken levothyroxine occurs mainly in the upper small intestine, the degree of absorption of which depends mainly on the galenic form of the drug and can be up to 80% when taken on an empty stomach. If the drug is taken with food, its absorption is significantly reduced.

The maximum concentration in blood plasma is reached approximately in 2-3 hours after reception.

The effect of the drug is observed 3-5 days after the start of oral therapy.

Distribution.

The volume of distribution is approximately 10-12 liters. Levothyroxine is approximately 99.97% bound to specific plasma proteins. The binding of proteins to hormones is not covalent, so there is a constant and very rapid exchange between free and bound hormone.

Breeding.

The metabolic clearance for levothyroxine is approximately 1.2 liters of plasma per day. Cleavage occurs mainly in the liver, kidneys, brain and muscles. Metabolites are excreted in urine and feces. The half-life of the drug is approximately 7 days; with hyperthyroidism, this period is reduced (up to 3-4 days), and with hypothyroidism – prolonged (approximately 9-10 days).

Pregnancy and breastfeeding.

Levothyroxine penetrates the placenta only in small amounts. If the drug is taken in normal doses, levothyroxine is excreted in breast milk only in small amounts.

Renal dysfunction.

Due to the high level of protein binding, neither hemodialysis nor hemoperfusion affect levothyroxine levels.

Clinical characteristics
Indication.

– Replacement therapy for hypothyroidism of various etiologies;

– prevention of goiter recurrence after goiter resection with euthyroid thyroid function;

– benign goiter with euthyroid thyroid function;

– suppressive and replacement therapy for malignant thyroid tumors, mainly after thyroidectomy.

L-Tiroxine 125 mcg Contraindication.

Hypersensitivity to the active substance or to any of the excipients. Untreated hyperthyroidism of any origin. Untreated adrenal insufficiency. Untreated pituitary insufficiency (this leads to adrenal insufficiency that needs treatment). Acute myocardial infarction. Acute myocarditis. Acute pancarditis.