Instruction for use: Jodbalance

ATX Code H03CA Potassium iodide

Active substance Potassium iodide

Pharmacological group

Thyroxine synthesis regulator - iodine preparation [Thyroid and parathyroid gland hormones, their analogs and antagonists (including antithyroid drugs) / 67 /]

Thyroxine synthesis regulator - iodine preparation [Macro and trace elements]

Nosological classification (ICD-10)

E00.9 Syndrome of congenital iodine deficiency, unspecified

Iodine deficiency in newborns, Lack of iodine in the body in children, Iodine deficiency goiter in newborns, Cretinism, Endemic cretinism

E01.0 Diffusive (endemic) goiter associated with iodine deficiency

Goiter, Endemic goiter, Accommodation in regions with iodine deficiency

E01.1 Multi-node (endemic) goiter associated with iodine deficiency

about, Thyroid Node, Nodular goiter of the thyroid gland, Endemic goiter

E04.0 Non-toxic diffuse goiter

Diffuse nontoxic goiter, Diffuse euthyroid goiter

E07.8.0 * Euthyroid syndrome

Goiter after thyroid resection, Recurrence of goiter after resection of the thyroid gland, Euthyroid goiter, Euthyroid hyperplasia of the thyroid gland

Composition

Tablets 1 table.

active substance:

Potassium iodide 130.8 μg\ 261.6 μg

(Corresponding to 100 or 200 μg of iodine)

Auxiliary substances: magnesium stearate; MCC; Silicon dioxide colloid; corn starch; Cellulose powder; Lactose monohydrate

Description of dosage form

Jodbalance®, 100 mcg: 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 - engraving "EM 33".

Jodbalance®, 200 mcg: 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 bottom - an ornamental risk.

pharmachologic effect

Pharmacological action - filling iodine deficiency.

Pharmacodynamics

Iodine is a vital microelement. Without iodine, normal functioning of the thyroid gland is impossible, because It is an integral part of thyroxine and triiodothyronine. Thyroid hormones participate in the development of all organs and systems, in the regulation of metabolic processes in the body: protein, fat, carbohydrate and energy, they also regulate the activity of the brain, nervous system and SSS, sex and mammary glands, the growth and development of the child, the formation of its intellectual Abilities. Especially dangerous is iodine deficiency for children, adolescents, pregnant and lactating women.

Jodbalance®, as a source of iodine, compensates for its deficiency in the body, prevents the development of iodine deficiency disorders, prevents the development of goiter associated with iodine deficiency in food; Normalizes the size of the thyroid gland in newborns, children, adolescents and adults.

Pharmacokinetics

When ingested, the drug is almost completely absorbed into the small intestine. The average Vd for healthy people is approximately 23 liters (38% of body weight). The concentration of iodine in the blood plasma is normally 0.001-0.005 μg / 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. It is excreted in urine, the concentration of iodine in the urine relative to creatinine (μg / g) is an indicator of its intake into the body.

Indications

Prevention of iodine-deficiency diseases, incl. Endemic goiter (especially in pregnant and lactating women);

Prevention of recurrence of goiter after surgical removal or after completion of treatment of goiter with drugs of thyroid hormones;

Treatment of diffuse euthyroid goiter in newborns, children, adolescents and adult patients of young age.

Contraindications

Hyperthyroidism;

Subclinical hyperthyroidism when taking doses of iodine more than 150 mcg / day;

Herpetiform dermatitis of Dühring;

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.

Jodbalance® should not be taken with hypothyroidism, unless the development of the latter is caused by a pronounced iodine deficiency.

Prescribing the drug should be avoided with radioactive iodine therapy, if there is or suspected thyroid cancer.

Due to the fact that the preparation contains lactose monohydrate, it is not recommended for patients with rare hereditary diseases associated with intolerance to galactose, deficiency of lactase or glucose-galactose malabsorption.

pregnancy and lactation

During pregnancy and breastfeeding, the need for iodine increases, so it is especially important to use Jodbalance® in sufficient doses to ensure adequate intake of iodine in the body. The drug penetrates the placenta and is excreted in breast milk. If a lactating woman is taking Jodbalance®, no additional prescription of the drug to infants who are breastfeeding is required.

The use of the drug during pregnancy and during breastfeeding is possible only at recommended doses.

When carrying out therapy, it is necessary to take into account the amount of iodine coming from food.

Interaction

The effectiveness of treatment with antithyroid drugs while taking iodine is reduced.

Potassium perchlorate inhibits the absorption of iodine by the thyroid gland.

Taking high doses of iodine and concomitant administration of potassium-sparing diuretics can lead to the development of hyperkalemia.

Simultaneous administration of iodine in high doses with lithium preparations promotes the development of goiter and hypothyroidism.

Absorption of iodine by the thyroid gland and its metabolism are stimulated by TSH.

Dosing and Administration

Inside.

When determining the necessary dose of Jodbalance®, it is necessary to take into account the regional and individual characteristics of iodine intake from food. Especially it is important in prescribing the drug to newborns and children under 4 years old.

Prevention of iodine deficiency disorders

Newborns and children - 50-100 micrograms of iodine per day (1 / 2-1 table of the preparation Jodbalance® 100 μg).

Adolescents and adults - 100-200 micrograms of iodine per day (1 table of the preparation Yodbalans® 100 mcg or 1 table of the preparation Jodbalance® 200 mcg).

In pregnancy and during breastfeeding, 100-200 μg of iodine per day (1 table of Jodbalance® 100 μg or 1 table of Jodbalance® 200 μg).

Prevention of recurrence of goiter after its surgical removal or after completion of treatment of goiter with drugs of thyroid hormones

100-200 micrograms of iodine daily (1 table of Jodbalance® 100 μg or 1 table of Jodbalance® 200 μg).

Treatment of euthyroid goiter

Newborns and children - 100-200 mcg of iodine per day (1 table of the preparation Jodbalance® 100 mcg or 1 table of the preparation Jodbalance® 200 mcg).

Adolescents and adult patients of young age - 200 mcg of iodine per day (2 tablets of Yodbalans® 100 mcg or 1 table of Jodbalance® 200 mcg).

The daily dose of the drug should be taken in 1 reception, after eating, with a sufficient amount of liquid. When prescribing the drug to 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, and often for the whole life.

To treat goiter in newborns, in most cases, 2-4 weeks is enough; In children, adolescents and adults, it usually takes 6-12 months or more. The duration of treatment is determined by the doctor.

Overdose

Symptoms: with the appointment of the drug at a dose of more than 150 μg / day patients who have foci in the thyroid gland with functional autonomy, possibly the development of iodine-induced hyperthyroidism; When treated with high doses of iodine (more than 1000 μg / day), iodine-induced goiter and hypothyroidism may develop in some cases.

Chronic overdose can lead to the phenomenon of "iodism": metallic taste in the mouth, swelling and inflammation of mucous membranes (rhinitis, conjunctivitis, gastroenteritis, bronchitis); Acne, dermatitis, edema of 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.

With the development of hypothyroidism, it is recommended to stop the use of the drug and prescribe therapy with iodine-containing thyroid hormones.

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 beginning 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.

Jodbalance® does not affect the ability to drive vehicles and control mechanisms.

Form of issue

Tablets, 100 mcg and 200 mcg. On 25 tab. In a PVC blister / aluminum or polypropylene foil / aluminum foil; 2 or 4 blisters in a pack of cardboard.

Terms of leave from pharmacies

Without recipe.

storage Conditions

In the dark place at a temperature of no higher than 30 ° C.

Keep out of the reach of children.

Shelf life

3 years.

Do not use after the expiry date printed on the package.