Composition, form of production and packaging
? Tablets from almost white to yellowish-gray color round tablets, flat on both sides, with bevelled edges. On both sides of the tablet there is a dividing risk, on one side of the tablet is an engraving "EM 33".
1 tab.
potassium iodide 130.8 Ојg,
which corresponds to an iodine content of 100 Ојg
Excipients: magnesium stearate, microcrystalline cellulose, silicon dioxide colloid, corn starch, cellulose powder, lactose monohydrate.
25 pcs. - blisters (2) - packs of cardboard.
25 pcs. - blisters (4) - packs of cardboard.
? Tablets from almost white to yellowish-gray color round tablets, flat on both sides, with bevelled edges. On the top side of the tablet is an engraving "EM 70", on the underside of the tablet - a decorative risk.
1 tab.
potassium iodide 261.6 Ојg,
which corresponds to an iodine content of 200 Ојg
Excipients: magnesium stearate, microcrystalline cellulose, silicon dioxide colloid, corn starch, cellulose powder, lactose monohydrate.
25 pcs. - blisters (2) - packs of cardboard.
25 pcs. - blisters (4) - packs of cardboard.
INSTRUCTION FOR THE SPECIALIST.
Description of the drug approved by the manufacturer for the printed edition of 2015.
PHARMACHOLOGIC EFFECT
The regulator of the synthesis of thyroxine is an iodine preparation. Iodine is a vital microelement, it is an integral part of the thyroid hormones. Thyroid hormones are involved in the regulation of metabolic processes in the body: protein, fat, carbohydrate and energy; are necessary for the development of all organs and systems, regulate the activity of the brain, nervous and cardiovascular systems, genital organs and mammary glands, play an important role in the growth and development of the child, the formation of his intellectual abilities. Iodine is especially necessary for children, adolescents, women during pregnancy and lactation (breastfeeding).
Iodalance В® , being the source of iodine, compensates for its deficiency in the body, prevents the development of iodine deficiency diseases, prevents the development of goiter associated with lack of iodine in food. Normalizes the size of the thyroid gland in newborns, children, adolescents and adults.
PHARMACOKINETICS
Suction and distribution
When ingested, the drug is almost completely absorbed into the small intestine.
The average V d for healthy people is approximately 23 liters (38% of body weight). Plasma concentration of iodine is normally from 0.001 to 0.005 Ојg / ml. It accumulates in the thyroid gland, salivary glands, mammary glands and stomach tissues. Concentration in saliva, gastric juice and breast milk is approximately 30 times higher than in blood plasma.
Excretion
It is excreted in the urine. The concentration of iodine in the urine relative to creatinine (Ојg / g) is an indicator of its intake into the body.
INDICATIONS
- prevention of iodine deficiency diseases, including endemic goiter (especially in pregnant and lactating women);
- prevention of recurrence of goiter after its surgical removal, as well as after the treatment of goiter with drugs of thyroid hormones;
- treatment of diffuse euthyroid goiter in newborns, children, adolescents and adult patients of young age.
DOSING MODE
When determining the necessary dose of Iodbalance В® , regional and individual characteristics of iodine intake with food should be taken into account. Especially it is important in prescribing the drug to newborns and children under the age of 4 years.
For the prevention of iodine deficiency diseases, newborns and children are prescribed a drug at the rate of 50-100 micrograms of iodine / day (1 / 2-1 table of iodalance В® 100 Ојg); adolescents and adults - 100-200 mcg iodine / day (1 table of Iodbalance В® 100 mcg or 1 table of Iodbalance В® 200 mcg); during pregnancy and lactation (breastfeeding) - 100-200 mcg iodine / day (1 table Iodalance В® 100 Ојg or 1 tablet Iodbalance В® 200 Ојg).
For the prevention of recurrence of goiter after its surgical removal or after completion of the treatment of goiter with thyroid hormone preparations , 100-200 Ојg of iodine daily (1 table of Iodbalance В® 100 Ојg or 1 table of Iodbalance В® 200 Ојg).
In the treatment of euthyroid goiter, newborns and children are prescribed 100-200 Ојg iodine / day (1 table of Iodbalance В® 100 Ојg or 1 table of Iodbalance В® 200 Ојg). Adolescents, adult patients of young age are prescribed 200 mcg of iodine / day (2 tablets of Iodbalance В® 100 Ојg or 1 table of Iodbalance В® 200 Ојg).
The daily dose should be taken at 1 reception, after eating, with a sufficient amount of liquid. For newborns and children under 3 years of age, it is recommended to dissolve the tablet in a small amount (1 tablespoon) of boiled water at room temperature.
The use of the drug for prophylactic purposes is usually carried out for several months or years, often for the whole life.
To treat goiter in newborns, in most cases, 2-4 weeks is sufficient; in children, adolescents and adults , it usually takes 6-12 months or more. The duration of treatment is determined by the doctor individually.
SIDE EFFECT
Allergic reactions: rarely - skin rash, angioedema.
CONTRAINDICATIONS
- hyperthyroidism;
- subclinical hyperthyroidism (when taking iodine in a dose of more than 150 Ојg / day);
- herpetiform dermatitis of DГјhring;
- solitary toxic thyroid adenomas and functional autonomy of the thyroid gland (focal and diffuse);
- nodal toxic goiter (with the exception of preoperative therapy for the purpose of blocking the thyroid gland);
- hypersensitivity to iodine.
Iodalance В® should not be taken with hypothyroidism, except when the latter is caused by a pronounced iodine deficiency.
Prescribing the drug should be avoided with radioactive iodine therapy, if there is or if there is a suspicion of thyroid cancer.
The drug contains lactose monohydrate, therefore, it is not recommended to appoint patients with rare hereditary diseases associated with intolerance to galactose, deficiency of lactase or glucose-galactose malabsorption.
PREGNANCY AND LACTATION
During pregnancy and during breastfeeding, the need for iodine increases, so it is especially important to use iodinebalance В® in sufficient doses to ensure adequate intake of iodine in the body. The drug penetrates the placental barrier.
The drug is excreted in breast milk. If a lactating woman takes Iodobalance В® , then the supplemental prescription of the drug for infants who are breastfeeding is not required.
The use of the drug during pregnancy and during breastfeeding is possible only in recommended doses.
When carrying out therapy, it is necessary to take into account the amount of iodine coming with food.
APPLICATION FOR FUNCTIONS OF THE LIVER
It should be borne in mind that against the background of drug therapy in patients with renal insufficiency, it is possible to develop hyperkalemia.
SPECIAL INSTRUCTIONS
It should be borne in mind that against the background of drug therapy in patients with renal insufficiency, it is possible to develop hyperkalemia.
Before the start of therapy, it is necessary to exclude the presence of hyperthyroidism or nodular toxic goiter in the patient, as well as the presence of these diseases in the anamnesis.
If there is a predisposition to autoimmune thyroid diseases, the formation of antibodies to thyroid peroxidase is possible.
Saturation of the thyroid gland with iodine can prevent the accumulation of radioactive iodine used for therapeutic or diagnostic purposes. In this regard, it is not recommended to take the drug before carrying out activities using radioactive iodine.
Impact on the ability to drive vehicles and manage mechanisms
Iodalance В® does not affect the ability to drive vehicles and control mechanisms.
OVERDOSE
Symptoms: when the drug is prescribed at a dose of more than 150 Ојg / day in patients with foci of functional autonomy in the thyroid gland, the development of iodine-induced hyperthyroidism is possible.
When iodine preparations are administered in very high doses (> 1000 Ојg / day), iodine-induced goiter and hypothyroidism may develop in some cases.
Chronic overdose can lead to the development of iodine - a metallic taste in the mouth, swelling and inflammation of the mucous membranes (rhinitis, conjunctivitis, gastroenteritis, bronchitis), acne, dermatitis, swelling of the salivary glands, fever, irritability.
Treatment: for chronic overdose, it is recommended to stop using the drug. When developing iodine-induced hyperthyroidism, it is recommended to stop the use of the drug and prescribe therapy with antithyroid drugs. In especially severe cases, intensive therapy, plasmapheresis or thyroidectomy should be performed. When developing hypothyroidism, it is recommended to stop the use of the drug and prescribe therapy with iodine-containing thyroid hormones.
DRUG INTERACTION
The effectiveness of treatment with antithyroid drugs while taking iodine medications is decreasing.
Potassium perchlorate suppresses the absorption of iodine by the thyroid gland.
The use of iodine preparations in high doses and simultaneous administration of potassium-sparing diuretics can lead to the development of hyperkalemia.
Simultaneous administration of iodine preparations in high doses and lithium preparations promotes the development of goiter and hypothyroidism.
Absorption of iodine by the thyroid gland and its metabolism are stimulated by TSH.
TERMS OF RELEASE FROM PHARMACY
The drug is approved for use as a means of OTC.
TERMS AND CONDITIONS OF STORAGE
The drug should be stored out of reach of children, protected from light at a temperature of no higher than 30 В° C. Shelf life - 3 years.
