Название документа

Synthetic left thyroxine which contains in the medicament L-Tiroksin-Pharmak shows the effects identical to that which the hormone cosecreted by a thyroid gland has. Turns into T3 (triiodothyronine) in peripheral bodies and as endogenous hormone influences T3 receptors. There is no difference between functions of endogenous hormone and exogenous left thyroxine.

Indications

Treatment of a benign euthyroid craw.
Prevention of a recurrence after operational treatment of an euthyroid craw, depending on hormone level during the postoperative period.
As replacement therapy at a hypothyroidism.
Supressivnaya therapy of cancer of thyroid gland.
As auxiliary medicament when performing anti-thyroid therapy in a hyperthyroidism.
As diagnostic means at test of thyroid suppression.

Contraindication

Increased individual sensitivity to any of medicament components.
Insufficiency of adrenal glands, hypophysial insufficiency, a thyrotoxicosis which were not treated.
Acute myocardial infarction, acute myocarditis, acute pancarditis.
Combination therapy by left thyroxine and anti-thyroid means during pregnancy is not appointed (see the section "Use during Pregnancy or Feeding by a Breast").

Route of administration and doses.

For treatment of each certain patient depending on his individual requirement the medicament L-Tiroksin-Pharmak exists in the tablets containing 25 mkg, 50 mkg, 100 mkg of left thyroxine of sodium.

Information on dosing has only advisory nature.

Daily dose is defined individually depending on laboratory indicators and a clinical picture of a disease.

As at a number of patients against the background of therapy by left thyroxine observed increase in concentration of T4 and fT4, basal concentration of thyroid stimulating hormone in blood serum is more reliable indicator for further correction of a dose.

hormones of a thyroid gland should begin Therapy with

with a low dose and to increase gradually (each 2-4 weeks) to a necessary therapeutic dose.

Children. For newborns and babies with a congenital hypothyroidism where fast achievement of therapeutic effect is very important, the recommended initial dose makes from 10 to 15 mkg/kg of body weight a day within the first 3 months. After that the dose is adjusted individually, depending on clinical indicators and level (TSH).

to Patients of advanced age with a coronary artery disease, to patients with a heavy or long hypothyroidism treatment it is necessary to begin with extra care, with small doses (12.5 mkg a day), to increase a dose to supporting through wide intervals of time (gradually by 12.5 mkg every 2 week), regularly controlling the level of hormones of a thyroid gland. It is necessary to consider that purpose of doses, smaller optimum, providing full replacement therapy, does not lead to full correction of the TSH level.

Experience of use shows that reception of low doses is sufficient for patients with low body weight and for patients with a nodal craw of the big size.

Indication	Recommended doses (left thyroxine of sodium, mkg/day)
Treatment of a benign euthyroid craw	75-200
Prevention of a recurrence after operational treatment of an euthyroid craw	75-200
In replacement therapy of a hypothyroidism at adults: initial dose; a maintenance dose	25-50 100-200
In replacement therapy of a hypothyroidism at children: initial dose; a maintenance dose	12.5*-50 100-150 mkg/m ² body surfaces
As auxiliary medicament when performing anti-thyroid therapy of a hyperthyroidism	50-100
Supressivnaya therapy of cancer of thyroid gland	150-300

* - to accept

in the corresponding dosage.

Daily dose can be accepted at one time.

Daily dose to accept

in the morning on an empty stomach, in 30 minutes prior to food, washing down with a small amount of water (half-glass of water).

a daily dose of medicament to give

to Babies at one time in 30 minutes prior to the first feeding. To dissolve a tablet in water before receiving suspension which should be prepared just before administration of medicament and to apply after addition still of a small amount of liquid.

L-Tiroksin-Pharmak should be applied during all life as replacement therapy at a hypothyroidism, after surgical interventions (strumectomy or thyroidectomy) and also to prevention of a recurrence after removal of an euthyroid craw. To appoint complex therapy from tireostatika after achievement of an euthyroid state.

duration of treatment is

At a benign form of an euthyroid craw from 6 months to 2 years. If the state after treatment does not improve, it is necessary to appoint surgical intervention or therapy radioiodine.

Overdose

Increase in T3 level (triiodothyronine) is the reliable indicator of overdose by drug, more than increase in T4 and fT4 levels (free) in blood serum.

as a result of overdose the symptoms characteristic of increase in a metabolism can appear (see the section "Side reactions").

in case of overdose should stop use of medicament and to carry out laboratory analyses.

At symptoms which are shown in the form of the significant beta and sympathomimetic effects, such as tachycardia, concern, nervous irritability, hyperkinesia are appointed by beta-blockers. At considerable exceeding a dose carrying out a plasma exchange is recommended.

In some cases at the patients inclined to spasms, development of spasms when the individual admissible dose of medicament was exceeded is possible

Overdose by left thyroxine can cause symptoms of a hyperthyroidism and lead to acute psychosis, especially at patients with risk of developing psychotic disorders.

patients who for many years abused (exceeded the recommended dosage) Have several messages about a sudden coronary lethal case left thyroxine.

Special instructions

Use during pregnancy or feeding by a breast

during pregnancy or feeding by a medicament treatment breast, appointed at a hypothyroidism, it is necessary to continue. During pregnancy there can be a need for increase in a dose of drug. As increase in the TSH level in serum can happen for 4 weeks of pregnancy, the pregnant women accepting left thyroxine should check the TSH level during each trimester. Pregnant women have to have a TSH serumal levels in the corresponding limits set for each trimester. For correction of the increased TSH levels in blood serum it is necessary to increase a left thyroxine dose. As the TSH post-natal levels corresponds to the values which are available until fertilization right after childbirth a dose of a levoteraksin it is necessary to modify according to a dose before pregnancy approach. The TSH necessary level in serums has to be established in 6-8 weeks after the delivery.

Pregnancy.

is not present

Data on teratogenecity and/or a fetotoksichnost at administration of medicament in the recommended therapeutic doses. Reception of very high doses of left thyroxine during pregnancy can negatively affect a fruit and post-natal development of the child.

Combination therapy left thyroxine and anti-thyroid means during pregnancy is not appointed for treatment of a hyperthyroidism as this combination of medicaments demands purpose of higher doses of anti-thyroid means which are capable to pass through a placenta and can cause development of a hypothyroidism in the newborn. The test for thyroid suppression is not carried out to the pregnancy period as use of radioactive materials is contraindicated during pregnancy.

Feeding by a breast.

Levotiroksin is brought by

with breast milk during feeding by a breast, however at use of medicament in the recommended therapeutic doses the level of concentration of medicament in breast milk is insufficient for development of a hyperthyroidism or suppression of secretion of TSH in the baby.

Children

use Drug to children from the birth.

Ability to influence speed of response at control of motor transport or other mechanisms

is not present

Data on potential impact on ability to run motor transport or to work with difficult mechanisms. However, as left thyroxine on the action is identical to natural hormone of a thyroid gland, influence of the medicament L-Tiroksin-Pharmak on speed of response at control of motor transport or other mechanisms is not expected.

Structure

active ingredient: levothyroxine sodium;

1 tablet contains sodium left thyroxine in terms of 100% dry matter of 100 mkg;

excipients: potato starch, lactoses monohydrate, sucrose, magnesium carbonate heavy, magnesium stearate, povidone.

Storage conditions

to Store

in original packing at a temperature not above 25ºС.
to Store
out of children's reach.

Expiration date - 3 years.

not to use medicament after the termination of the expiration date specified on packing.

Characteristics
Active ingredients	Left thyroxine sodium
Amount of active ingredient	0.1 mg
Applicant	Pharmak
Code of automatic telephone exchange	H03AA01 Levotiroksin sodium
Interaction with food	To
Light sensitivity	Not sensitive
Market status	Generic-generic
Origin	Chemical
Prescription status	According to the prescription
Primary packing	blister
Producer	PUBLIC JOINT STOCK COMPANY PHARMAK
Quantity in packing	50 tablets (5 blisters on 10 pieces)
Release form	tablets for internal use
Route of administration	Oral
Sign	Domestic
Storage temperature	from 5 °C to 25 °C
Trade name	L-thyroxine