Producer: JSC Pharmak Ukraine
Code of automatic telephone exchange: H03AA01
Release form: Firm dosage forms. Tablets.
General characteristics. Structure:
Active ingredient: levothyroxine sodium;
1 tablet contains sodium left thyroxine in terms of 100% and dry matter of 25 mkg, 50 mkg, 100 mkg;
excipients: potato starch, lactoses monohydrate, sucrose, magnesium carbonate heavy, magnesium stearate, povidone.
Pharmacodynamics. Synthetic left-handed isomer of thyroxine. After partial transformation into triiodothyronine (in a liver and kidneys) and transition to cells of an organism influences development of fabrics and a metabolism. In low doses also the lipometabolism has anabolic effect on proteinaceous. Stimulates growth and development in average doses, increases the need of fabrics for oxygen, stimulates metabolism of proteins, fats and carbohydrates, increases functional activity of cardiovascular system and TsNS. In high doses oppresses products thyrotropin-rileasing of hormone of a hypothalamus and thyritropic hormone of a hypophysis.
The therapeutic effect develops in 7-12 days, throughout the same time action after drug withdrawal remains. The clinical effect at a hypothyroidism is shown in 3-5 days. The diffusion craw decreases or disappears for 3-6 months.
Pharmacokinetics. After intake left thyroxine is almost completely soaked up in an upper part of a small intestine. About 80% of the accepted drug dose are soaked up. Meal reduces digestibility of left thyroxine. The maximum concentration in blood serum is reached approximately in 5-6 h after intake. After absorption more than 99% of drug contact serum proteins (tiroksinsvyazyvayushchy globulin, tiroksinsvyazyvayushchy prealbumin and albumine). In different fabrics there is a monodeiodinating about 80% of left thyroxine to formation of triiodothyronine (T3) and inactive connections. Thyroid hormones are metabolized mainly in a liver, kidneys, a brain and muscles. A small amount of drug is deaminized and decarboxylized, and also conjugated with sulfuric and glucuronic acids (in a liver). Metabolites are removed with urine and bile. An elimination half-life — 6-7 days. At a thyrotoxicosis the elimination half-life is reduced to 3-4 days, and at a hypothyroidism is extended up to 9-10 days.
Main physical and chemical properties: tablets of color, white with a yellowish shade, ploskotsilindrichesky form, risky and facet.
Indications to use:
· After a resection of a thyroid gland as replacement therapy and for prevention of a recurrence of a craw.
· Cancer of a thyroid gland after operational treatment.
· Diffusion toxic craw: after achievement of an euthyroid condition of a tireostatikama (as monotherapy, and in a complex with other medicines).
· As diagnostic means for test of thyroid suppression.
Route of administration and doses:
The daily dose is defined individually, depending on indications.
The pill is taken whole inside in the morning on an empty stomach in 30 minutes prior to food, washing down with a small amount of liquid (1/2 glasses of water).
Indications the Recommended L-Тироксина-Фармак® doses,
mkg a day
Treatment of an euthyroid craw 75-200
Prevention of a recurrence after surgical
treatments of an euthyroid craw 75-200
In complex therapy of a thyrotoxicosis at adults:
- initial dose 25-50
- maintenance dose 100-200
In complex therapy of a thyrotoxicosis at children:
- initial dose 12,5-50
- maintenance dose 100-150
Suppressive therapy of cancer of thyroid gland 150-300
Diffusion toxic craw after achievement of an euthyroid state
tireostatikam (in the form of a combination therapy or monotherapy) 50-100
Test of thyroid suppression In 4 weeks prior to the test – 75 mkg a day.
In 3 weeks prior to the test – 75 mkg a day.
In 2 weeks prior to the test of-150-200 mkg a day.
In 1 week prior to the test – 150-200 mkg a day.
Children aged till 1 year a daily dose of L-Тироксина-Фармак® are given in one step in 30 minutes prior to the first feeding. The tablet is dissolved in water before formation of a suspension just before administration of drug.
Newborns should begin treatment with lower doses – 12,5 mkg a day, gradually increasing to a maintenance dose every 2-4 week.
Patients of advanced age with cardiovascular pathology and with a heavy long hypothyroidism should begin treatment with extra care, with low doses — 12,5 mkg/days. The dose is raised to supporting through more long intervals of time — on 12,5 mkg/days, each 2 weeks determine the level of thyritropic hormone (TTG) in blood serum also more often.
L-Тироксин-Фармак® apply throughout all life at a thyrotoxicosis, after surgical interventions – strumectomies or thyroidectomies, and also to the prevention of a recurrence after removal of an euthyroid craw. Complex therapy from tireostatika is appointed after achievement of an euthyroid state.
At an easy form of an euthyroid craw duration of treatment makes from 6 months to 2 years. If the state after treatment does not improve, appoint surgical treatment or therapy a radioiodine.
Features of use:
Before an initiation of treatment thyroid hormones or conducting test on thyroid suppression it is necessary to exclude existence or to cure the following diseases: a coronary disease of heart, stenocardia, arteriosclerosis, the increased arterial pressure, pituitary insufficiency, insufficiency of adrenal glands. Also it is necessary to exclude an autoimmune thyroiditis or to cure this disease prior to performing therapy of thyroid hormones.
It is necessary to avoid even the insignificant displays of a thyrotoxicosis caused by administration of drug in patients who suffer from a coronary disease of heart, heart failure, a tachyarrhythmia. Therefore at treatment of such patients thyroid hormones it is necessary to control the level of thyroid hormones regularly.
In case of development of a secondary thyrotoxicosis the reason should be established before purpose of replacement therapy, if necessary it is necessary to conduct a course of replacement therapy for compensation of insufficiency of bark of adrenal glands.
At suspicion on an autoimmune thyroiditis it is necessary to determine the TTG level or to carry out a tireostsintigrafiya prior to treatment.
For women in the postclimacteric period who suffer from a hypothyroidism in the conditions of the increased risk of development of osteoporosis it is necessary to avoid very high level of left thyroxine in blood serum which exceeds physiological level. Therefore it is necessary to control function of a thyroid gland carefully.
Thyroid hormones do not promote decrease in body weight. Purpose of physiological doses does not lead to decrease in body weight at patients with normally functioning thyroid gland (an euthyroid state). At exceeding of the recommended doses emergence of by-effects is possible (watch the section "Overdose").
After the beginning of reception of left thyroxine or change of drug it is recommended to correct a drug dosage according to reaction of the patient to drug, these laboratory analyses.
Drug contains lactose therefore to patients with rare hereditary intolerance of a galactose, a lactose intolerance or disturbance of absorbability of glucose galactose, it is not necessary to use drug.
Drug contains sugar therefore patients should use with care drug with a diabetes mellitus (see the section "Interaction with Other Medicines and Other Types of Interactions").
Ability to influence speed of response at control of motor transport or work with other mechanisms.
Data are absent.
At observance of recommendations about use and control of clinical laboratory indicators side reactions were not observed.
In case of drug overdose, especially at bystry increase in a dose at the beginning of therapy, the symptoms characteristic of a thyrotoxicosis were observed: tachycardia, a heart consciousness, arrhythmia, stenocardia, a headache, muscular weakness, spasms, temperature increase, fever, vomiting, disturbance of a menstrual cycle, a brain pseudoneoplasm, a tremor, concern, sleeplessness, the increased perspiration, a body degrowth, diarrhea.
Depending on expressiveness of symptoms the doctor can recommend reduction of a daily dose of drug or having rummaged in treatment for several days. After disappearance of side effects it is necessary to appoint treatment with care.
At hypersensitivity to drug allergic reactions on skin can develop and from respiratory system.
Interaction with other medicines:
Thyroid hormones can increase the need for insulin and peroral hypoglycemic drugs. More frequent control of level of glucose is recommended to be carried out to blood in an initiation of treatment by left thyroxine, and also at change of a dose of drug.
Left thyroxine strengthens effect of indirect anticoagulants that can demand decrease in their dose.
Use of tricyclic antidepressants with left thyroxine can lead to strengthening of effect of antidepressants.
At simultaneous use with Colestyraminum, kolestipoly and drugs which contain aluminum, iron, calcium carbonate concentration of left thyroxine in a blood plasma due to braking of its absorption in intestines decreases. L-Тироксин-Фармак® should accept in 4-5 hours prior to use of a kolisteramin, a kolestipol and not less than in 2 hours before use of the drugs containing aluminum.
At simultaneous use with salicylates, furosemide in high doses (250 mg), Dicumarinum, Clofibratum, Phenytoinum the content of left thyroxine, untied with proteins of a blood plasma, and thyroxine increases.
Propylthiouracil, glucocorticoids, beta-blockers, Amiodaronum and drugs which contain iodine inhibit peripheral transformation of thyroxine (T4) into triiodothyronine (T3).
Owing to the high content of iodine Amiodaronum promotes development both a thyrotoxicosis, and a hypothyroidism. The special attention should be paid to cases of a nodal craw which, perhaps, can develop owing to an autoimmune thyroiditis which was not diagnosed.
Sertalin, chloroquine can reduce effect of left thyroxine and increase the TTG level.
Barbiturates can increase hepatic clearance of left thyroxine.
Higher doses of left thyroxine can be necessary for women who accept the contraceptives containing estrogen and also women of postclimacteric age who accept gormonozamestitelny therapy.
The drugs containing soy can oppress sodium left thyroxine absorption in intestines. It is necessary to adjust drug doses.
· Hypersensitivity to drug components.
· Not treated thyrotoxicosis, not treated adrenal insufficiency, not treated pituitary insufficiency.
· Complex therapy from tireostatika during pregnancy.
Symptoms: tachycardia, arrhythmia, a cardialgia, concern, a tremor, a sleep disorder, the increased perspiration, a loss of appetite and body weights, diarrhea. It is known several cases of sudden death caused by disturbance of cardiac performance in patients who within many years abused (exceeded the recommended doses) left thyroxine.
Treatment: or having rummaged decrease in a daily dose in treatment for several days, purpose of blockers of β-adrenoceptors.......... At considerable overdose carrying out a plasma exchange is recommended. After disappearance of symptoms treatment is continued, since a smaller dose.
Use during pregnancy and feeding by a breast.
During pregnancy or feeding by a breast therapy by the drug appointed concerning a hypothyroidism should be continued. During pregnancy increase in a dose of drug in connection with the increased level of tiroksinsvyazyvayushchy globulin is necessary. Very high doses of left thyroxine can have negative effect on pre-natal fetation.
Amount of thyroid hormone which cosecretes with breast milk when feeding by a breast (even at use of drug in high doses), insufficient to cause disturbances in the child. Inclusion during pregnancy in combinations from tireostatika is contraindicated as use of left thyroxine can demand increase in doses of tireostatik. Tireostatiki, unlike left thyroxine, can get through a placenta, causing development of a hypothyroidism in a fruit.
During feeding by a breast drug should be used with care, only in the recommended doses and under medical control.
Drug is used for treatment of children since the birth.
Period of validity. 3 years. Not to use drug after the termination of the period of validity specified on packaging. To store in protected from light and the place, unavailable to children, at a temperature not above 25 °C.
According to the recipe
On 10 tablets in the blister. On 5 blisters enclosed in a pack.