Composition, form of production and packaging
IodocombВ® В® 50/150
Tablets are white or almost white in color, round, plane-parallel, with bevelled edges and one-sided risk.
1 tab.
levothyroxine sodium monohydrate (in terms of levothyroxine sodium) 50 Ојg
potassium iodide 196 Ојg,
which corresponds to an iodine content of 150 Ојg
Excipients: hypromellose, magnesium hydroxycarbonate (magnesium carbonate basic light), microcrystalline cellulose, corn starch, silicon dioxide colloid, calcium behenate *.
10 pieces. - blisters (5) - packs of cardboard.
10 pieces. - blisters (10) - packs of cardboard.
25 pcs. - blisters (5) - packs of cardboard.
25 pcs. - blisters (10) - packs of cardboard.
IodocombВ® В® 75/150
Tablets are white or almost white in color, round, plane-parallel, with bevelled edges and one-sided risk.
1 tab.
levothyroxine sodium monohydrate (in terms of levothyroxine sodium) 75 Ојg
potassium iodide 196 Ојg,
which corresponds to an iodine content of 150 Ојg
Excipients: hypromellose, magnesium hydroxycarbonate (magnesium carbonate basic light), microcrystalline cellulose, corn starch, silicon dioxide colloid, calcium behenate *.
10 pieces. - blisters (5) - packs of cardboard.
10 pieces. - blisters (10) - packs of cardboard.
25 pcs. - blisters (5) - packs of cardboard.
25 pcs. - blisters (10) - packs of cardboard.
* a mixture of calcium salts of higher fatty acids: behenic, arachine, lignoceric, palmitic, stearic, oleic. Substance contains from 5.7 to 6.3% of calcium.
INSTRUCTION FOR THE SPECIALIST.
Description of the drug approved by the manufacturer for the printed edition of 2014.
PHARMACHOLOGIC EFFECT
Combined drug containing levothyroxine sodium and a preparation of inorganic iodine. Levotiroksin sodium - a synthetic hormone, the action is identical to natural hormone thyroid gland. The effect of exogenously injected iodine in a human body depends on the daily dose of iodine, the type of dosage form, and also on the state of the thyroid gland (a healthy organ, a latent or manifested disease course).
Being a structural element for the synthesis of thyroid hormones - thyroxine and triiodothyronine, iodine is an indispensable component of food. The need for iodine, that is, the amount of iodine that must be supplied daily to prevent the development of endemic goiter, is 100-250 Ојg / day and differs depending on the age and condition of the thyroid gland. Iodine in physiological amounts (up to 300 Ојg) prevents the formation of goiter caused by iodine deficiency, normalizes the size of the thyroid gland in newborns, children and adolescents, and also affects a number of disturbed biochemical parameters (coefficient of triiodothyronine (T 3 ) / thyroxine (T 4 )) , level TTG.
PHARMACOKINETICS
Suction and distribution
After ingestion, levothyroxine sodium is absorbed mainly from the small intestine (up to 80% of the dose taken on an empty stomach) and reaches C maxapproximately 6 hours after administration. C ss is achieved 3-5 days after the initiation of oral therapy. Levotiroksin sodium is more than 99% associated with plasma proteins.
Inorganic iodine is absorbed from the small intestine by almost 100%. V d in healthy people is an average of about 23 liters (38% of body weight). The concentration of inorganic iodine in the serum is usually 0.1-0.5 Ојg / dl. In the body, iodine accumulates in the thyroid gland and other tissues, such as the salivary glands, mammary glands and stomach. In saliva, gastric juice and breast milk, the concentration of iodine is 30 times higher than its concentration in the plasma.
Metabolism and excretion
Levotiroksin sodium is metabolized mainly in the liver, kidneys, muscles and brain tissues.
Iodine, in general, is excreted by the kidneys, a small part of iodine is released through the intestine.
INDICATIONS
- Treatment of diffuse euthyroid goiter caused by iodine deficiency;
- prevention of recurrence of goiter after resection of the thyroid gland or therapy with radioactive iodine.
DOSING MODE
Take inside 1 tablet / day. The tablet is taken in the morning on an empty stomach 30 minutes before breakfast, without chewing, squeezed a small amount of liquid.
The duration of the course of treatment is established by the attending physician and usually ranges from a few months or years to a lifetime.
If treatment is started with the preparation Iodocomb В® 50/150, then if you need to increase the dose (based on the results of laboratory and diagnostic studies) it is recommended to take Iodocomb В® 75/150.
SIDE EFFECT
Side effect is usually not observed.
In some cases, there may be symptoms of hyperthyroidism: tachycardia, arrhythmia, angina pectoris, tremor, inner anxiety, insomnia, hyperhidrosis, weight loss, diarrhea.
In such cases, the daily dose should be reduced or for a few days to stop taking the drug. After the disappearance of this symptomatology, treatment can be continued under the control of the level of TTG and T 4 .
With hypersensitivity, allergic reactions are possible : skin rash, eosinophilia; in some cases - anaphylactic shock.
CONTRAINDICATIONS
- increased function of the thyroid gland of any genesis;
- recently transferred myocardial infarction;
- angina pectoris;
acute myocarditis;
- untreated insufficiency of the adrenal cortex;
- focal or diffuse autonomy of the thyroid gland function;
- herpetiform dermatitis of DГјhring;
- pituitary insufficiency;
- children's age till 18 years;
- Hypersensitivity to the components of the drug.
With caution , the drug should be prescribed for CHD, heart failure, tachyarrhythmia, arterial hypertension, epilepsy (including history), diabetes mellitus, diabetes insipidus, long-standing hypothyroidism, adrenal insufficiency, malabsorption syndrome, and elderly patients (older 65 years old).
PREGNANCY AND LACTATION
The use of the drug during pregnancy and during lactation is possible only in recommended doses. During pregnancy, dose adjustment is possible.
APPLICATION FOR CHILDREN
Contraindicated in children and adolescents under 18 years.
APPLICATION IN ELDERLY PATIENTS
With caution should prescribe the drug to elderly patients (over 65 years).
SPECIAL INSTRUCTIONS
Before the beginning of therapy with thyroid hormones, the following diseases should be excluded or treated: IHD, pituitary insufficiency or insufficiency of the adrenal cortex, autonomy of the thyroid gland function (in case of suspicion of thyroid autonomy, a test with TTRH or suppression scintigraphy should be performed).
Impact on the ability to drive vehicles and manage mechanisms
The effect of the drug on the ability to drive vehicles and control mechanisms is not known.
OVERDOSE
Overdose may develop hyperthyroidism.
Symptoms: tachycardia, arrhythmia, angina pectoris, tremor, inner anxiety, insomnia, hyperhidrosis, weight loss, diarrhea.
Treatment: with relatively moderate signs of overdose - a decrease in the dose of the drug; at the expressed signs - the termination or discontinuance of reception of a preparation, a lavage of a stomach, purpose or appointment kolestiramina, oksigenoterapija, application of beta adrenoblockers, GKS, cardiac glycosides. Antithyroid drugs should not be prescribed. When taking the drug in extreme doses (suicide attempt) it is possible to conduct plasmapheresis.
In hyperthyroidism, caused by the presence of iodine in the drug (in the presence of autonomy of the thyroid gland), thyreostatic therapy is indicated. In severe cases (thyrotoxic crisis) intensive therapy, plasmapheresis and, if necessary, thyroidectomy are indicated.
DRUG INTERACTION
With hyperthyroidism, iodine deficiency increases, and its excess reduces the effectiveness of therapy with antithyroid drugs, so before and during treatment of hyperthyroidism, any possible intake of iodine in the body should be avoided.
Amiodarone due to high iodine content can cause both hyperthyroidism and hypothyroidism. Special caution is required for nodular goiter with possibly unrecognized autonomy of thyroid function.
Kolestyramin and colestipol reduce the absorption of levothyroxine sodium, and therefore they should be taken only 4-5 hours after taking the drug IodocombВ®.
Aluminum-containing antacids and iron salts can reduce absorption of levothyroxine sodium while they are taken. Therefore, Iodocomb В® should be taken at least 2 hours before taking these drugs.
Rapid intravenous injection of phenytoin can lead to an increase in the level of free levothyroxine in the plasma and in some cases contribute to the development of cardiac rhythm disturbances.
Salicylates, dicoumarol, furosemide in high doses (250 mg), clofibrate can displace levothyroxine sodium from its compounds with plasma proteins.
Because the levothyroxine sodium displaces anticoagulants (coumarin derivatives) from their compounds with plasma proteins, the effect of therapy with these drugs may worsen. For this reason, simultaneous use of these drugs requires regular monitoring of blood coagulability and, if necessary, correction (reduction) of the dose of anticoagulants.
Levotiroksin sodium can weaken the effect of hypoglycemic drugs, therefore in patients with diabetes, especially at the beginning of therapy with thyroid hormones, it is necessary to regularly monitor blood glucose and, if necessary, dose adjustment of hypoglycemic drugs.
TERMS OF RELEASE FROM PHARMACY
The drug is released by prescription.
TERMS AND CONDITIONS OF STORAGE
The drug should be stored out of reach of children at a temperature of no higher than 25 В° C. Shelf life - 2 years.
