L-thyroxine-acry - instructions for use, dose, side effects, contraindications

Composition:1 tablet contains:
active substance: levothyroxine sodium 100 mcg;
Excipients: lactose monohydrate (sugar milk), lupus (monohydrate lactose, povidone, crospovidone), magnesium stearate.

Description:Tablets are white or white with a creamy shade of color, square with rounded edges, biconvex with a cross-shaped notch on one side and embossed letters "L T" on the other side.

Pharmacotherapeutic group:Thyroid agent.

ATX: & nbsp

H.03.A.A Thyroid hormones

H.03.A.A.01 Levothyroxine sodium

Pharmacodynamics:Synthetic levorotatory isomer of thyroxine. After partial conversion to tri-odytronin (in the liver and kidneys) and transition into the cells of the body, it affects the development: both tissue growth and metabolism. In small doses, it has an anabolic effect on protein and fat metabolism. In medium doses stimulates growth and development, raises the need for tissues in oxygen, stimulates the metabolism of proteins, fats and carbohydrates, increases the functional activity of the cardiovascular system and the central nervous system.
In large doses oppresses the production of thyrotropin-releasing hormone hypothalamus and thyroid-stimulating hormone of the pituitary gland.
Therapeutic effect is observed after 7-12 days, during the same time the action remains after drug discontinuation. The clinical effect with hypothyroidism is manifested in 3-5 days. Diffuse goiter decreases or disappears within 3-6 months.

Pharmacokinetics:When administered, levothyroxine is absorbed almost exclusively in the upper part of the small intestine. Absorbed up to 80% of the dose of the drug. Eating lowers the absorption of levothyroxine.The maximum concentration in the serum is reached approximately 5-6 hours after ingestion. After absorption, more than 99% of the drug binds to serum proteins (thyroxin-binding globulin, thyroxine-binding prealbumin and albumin). In different tissues, approximately 80% of levothyroxine is monodegraded with the formation of triiodothyronine (T3) and inactive products. Thyroid hormones are metabolized mainly in the liver, kidneys, brain and muscles. A small amount of the drug is subjected to deamination and decarboxylation, as well as conjugation with sulfuric and glucuronic acids (in the liver). Metabolites are excreted in urine and bile. The half-life of the drug is 6-7 days. With thyrotoxicosis, the half-life period is shortened to 3-4 days, and with hypothyroidism it lengthens to 9-10 days.

Indications:- hypothyroidism;
- euthyroid goiter;
- as a replacement therapy and for the prevention of recurrence of goiter after resection of the thyroid gland;
- Thyroid cancer (after surgical treatment);
- diffuse toxic goiter: after reaching the euthyroid status with thyrostatics (in the form of combined ormonotherapy);
- as a diagnostic tool in the test of thyroid suppression.

Contraindications:- Increased individual sensitivity to the drug;
- untreated thyrotoxicosis;
- Acute myocardial infarction, acute myocarditis;
- untreated insufficiency of the adrenal glands.

Carefully:With caution should prescribe the drug for diseases of the cardiovascular system: IHD (atherosclerosis, angina pectoris, myocardial infarction in history), arterial hypertension, arrhythmia; with diabetes, severe long-term hypothyroidism, diabetes insipidus, history of thyrotoxicosis, pituitary insufficiency, malabsorption syndrome (dose adjustment may be required).

Pregnancy and lactation:During pregnancy and breastfeeding, therapy with levothyroxine, prescribed for hypothyroidism, should continue. During pregnancy, an increase in the dose of the drug is required due to an increase in the level of thyroxine-binding globulin. The amount of thyroid hormone, secreted in breast milk during lactation (even during treatment with high doses of the drug), not enough to cause any disorder in the child.Application in pregnancy of the drug in combination with thyreostatics is contraindicated, since taking levothyroxine may require an increase in thyrotoxic doses. Since thyreostatics, in contrast to levothyroxine, can penetrate the placenta, the fetus may develop hypothyroidism. During breastfeeding, the drug should be taken with caution, strictly at recommended doses; under the supervision of a doctor.

Dosing and Administration:

The daily dose is determined individually depending on the indications.

L-Tyroxine-Acry® in a daily dose take in the morning on an empty stomach, at least 30 minutes before a meal, with a small amount of liquid (half a cup of water) and without chewing.

When carrying out substitution therapy for hypothyroidism in patients younger than 55 years with no cardiovascular disease, levothyroxine is prescribed in a daily dose of 1.6-1.8 μg/kg body weight; in patients older than 55 years or with cardiovascular diseases - 0,9 mkg/kg body weight. With significant obesity, the calculation should be done on "ideal weight".

The initial stage of replacement therapy for hypothyroidism

Patients without cardiovascular disease younger than 55 years

the initial dose: women - 75-100 mcg / day,

men -100-150 mcg / day

Patients with cardiovascular diseases or over 55 years of age

The initial dose is 25 mcg / day;

Increase by 25 mcg with an interval of 2 months to normalize the level of TSH in the blood;

When cardiac symptoms appear or worsen, correct cardiac therapy

Recommended doses of L-thyroxine-acry® for the treatment of congenital hypothyroidism
Age	The daily dose of levothyroxine (μg)	The dose of levothyroxine in terms of body weight (μg / kg)
0-6 months	25-50	10-15
6-12 months	50-75	6-8
1-5 years	75-100	5-6
6-12 years old	100-150	4-5
> 12 years	100-200	2-3

Indications	Recommended doses (levothyroxine, mcg / day)
Treatment of euthyroid goiter	75-200
Prevention of relapse after surgical treatment of euthyroid goiter	75-200
In the complex therapy of thyrotoxicosis	50-100
Suppressive Thyroid Cancer Therapy	150-300
Thyroid suppression test	4 weeks before the test	3 weeks before the test	2 weeks before the test	1 week before the test
	75 mcg / day	75 mcg / day	150-200 mcg / day	150-200 mcg / day

Breast children a daily dose L-Tyroxine-Acry® is given at one time 30 minutes before the first feeding. The tablet is dissolved in water to a fine suspension, which is prepared immediately before taking the drug.In patients with severe long-term hypothyroidism, treatment should be started with extreme caution, from small doses from 12.5 μg / day, the dose is increased to maintenance at longer intervals - by 12.51 μg / day every 2 weeks and more often determined by the level TTG in the blood. With hypothyroidism L- Thyroxine-Acry® takes, as a rule, throughout life. With thyrotoxicosis L- Thyroxine-Acry® is used in complex therapy with thyreostatics after reaching the euthyroid status. In all cases, the duration of treatment with the drug is determined by the doctor.

Side effects:With proper application under the supervision of a doctor, side effects are not observed.
With hypersensitivity to the drug, allergic reactions can be observed.

Overdose:In case of an overdose of the drug, symptoms typical of thyrotoxicosis are observed: palpitation, heart rhythm disturbance, heart pain, anxiety, tremor, sleep disturbance; increased sweating, increased appetite, weight loss, diarrhea. Depending on the severity of symptoms, a doctor may recommend a reduction in the daily dose of the drug, a break in treatment for several days, the appointment of beta-blockers.After the disappearance of side effects, treatment should be initiated with caution from a lower dose.

Interaction:Levothyroxine increases the effect of indirect anticoagulants, which may require a reduction in their dose.
The use of tricyclic antidepressants with levothyroxine may lead to an increase in the action of antidepressants.
Thyroid hormones can increase the need for insulin and oral hypoglycemic drugs. More frequent monitoring of blood glucose levels is recommended during the start of treatment with levothyroxine, as well as when changing its dosage regimen.
Levothyroxine reduces the action of cardiac glycosides. With simultaneous application colestramine, colestipol and aluminum hydroxide reduce the plasma concentration of levothyroxine due to inhibition of its absorption in the intestine.
When used simultaneously with anabolic steroids, asparaginase, tamoxifen, pharmacokinetic interaction at the level of binding to the protein is possible.
When used simultaneously with phenytoin, salicylates, clofibrate, furosemide in high doses, the content of non-protein-bound blood plasma levothyroxine and T₄.
The use of estrogen-containing drugs increases the content of thyroxine-binding globulin, which may increase the need for levothyroxine in some patients. Somatotropin with simultaneous application with levothyroxine may accelerate the closure of epiphyseal growth zones.
The intake of phenobarbital, carbamazepine and rifampicin may increase the clearance of levothyroxine and require an increase in the dose.
Synthesis, secretion, distribution and metabolism of the drug are affected amiodarone, aminoglutethimide, PASK, ethionamide, antithyroid drugs, beta-blockers, chloral hydrate, diazepam, levodopa, dopamine, metoclopramide, lovastatin, somatostatin.

Special instructions:When hypothyroidism, due to the pituitary lesion, it is necessary to find out whether there is a simultaneous insufficiency of the adrenal cortex. In this case, glucocorticosteroid replacement therapy should be started before thyroid hormone therapy begins to avoid hypothyroidism in order to avoid the development of acute adrenal insufficiency.

Effect on the ability to drive transp. cf. and fur:The drug does not affect the professional activities associated with driving vehicles and controlling mechanisms.

Form release / dosage:Tablets 100 mcg.

Packaging:For 10 tablets in a planar cell package. 2, 3, 5 or 10 contour mesh packs, together with instructions for use in a pack of cardboard.

Storage conditions:In a dry, the dark place at a temperature of no higher than 25 ° C.
Keep out of the reach of children.

Shelf life:3 years. Do not use after the expiration date.

Terms of leave from pharmacies:On prescription

Registration number:P N000680 / 01

Date of registration:07.08.2007

Expiration Date:Unlimited

Date of cancellation:2018-02-16

The owner of the registration certificate:AKRIKHIN HFK, JSC AKRIKHIN HFK, JSC Russia

Manufacturer: & nbsp

AKRIKHIN HFK, JSC Russia

Information update date: & nbsp18.02.2018

Illustrated instructions

Instructions

L-thyroxine-acry® (L-Thyroxin-Akri)