Iodomarin tablets 200 µg No. 100

Composition per tablet:

Active substance:

potassium iodide - 0.262 mg (corresponding to 0.2 mg of iodine).
Excipients:
lactose monohydrate, magnesium hydroxycarbonate, gelatin, sodium carboxymethyl starch, colloidal silicon dioxide, magnesium stearate.

Description: round flat-cylindrical tablets of white or almost white color with a chamfer and a score on one side.

Pharmacotherapeutic group: thyroxine synthesis regulator - iodine drug

ATX code: H03CA

Composition and release form

Iodomarin®100

in glass bottles of 50 or 100 pcs.; 1 bottle in a cardboard box.

Iodomarin®200

in a blister pack 25 pcs.; in a cardboard box 2 or 4 packages.

Pharmacological properties

Pharmacodynamics

Iodine is a vital trace element that is a component of the thyroid hormones - thyroxine and triiodothyronine. Thyroid hormones are involved in the development of all organs and systems, in the regulation of metabolic processes in the body: they are responsible for the metabolism of proteins, fats, carbohydrates and energy in the body, regulate the activity of the brain, nervous and cardiovascular systems, reproductive and mammary glands, as well as growth and child development.

Iodine deficiency is especially dangerous for children, adolescents, pregnant and lactating women.

Pharmacokinetics

Suction

When taken orally, potassium iodide is almost completely absorbed in the small intestine.

Distribution

The average volume of distribution for healthy individuals is approximately 23 liters (38% of body weight). The normal plasma iodine concentration ranges from 0.1 to 0.5 μg/dL. Accumulates in the thyroid gland, salivary glands, mammary glands and stomach tissues. The concentration in saliva, gastric juice and breast milk is approximately 30 times higher than in blood plasma.

Removal

Excreted by the kidneys, the concentration of iodine in urine relative to creatinine (mcg/g) is an indicator of its intake into the body.

Instructions for use IODOMARIN 200

The effect that the administration of exogenous iodine has on the human body depends on the daily amount of iodine, the type of iodine preparation and the condition of the thyroid gland (healthy organ, latent or severe form of the disease).

Iodine is an important component of food, which is an element for the synthesis of thyroid hormones - thyroxine and triiodothyronine. Daily requirement for iodine, i.e. the amount of iodine that must be ingested daily in order to prevent the development of endemic goiter is about 100-150 mcg per day. The daily dose recommended by WHO is 150 to 300 mcg.

After the absorption of iodine by electrochemical means (iodization), the oxidation of iodine by hydrogen peroxide (H2O2), which is a cosubstrate, occurs in the epithelial cells of the thyroid follicles, catalyzed by the enzyme iodide peroxidase, resulting in the release of elemental iodine. In this case, part of the tyrosine residues of the glucoprotein (thyroglobulin) is iodinated in positions 3 and, partially, 5 of the aromatic ring (iodization).

As a result of oxidative condensation, the iodinated groups of tyrosine are combined to form the thyronine framework. The main products are thyroxine (T4) and triiodothyronine (T3). The “thyronine-thyroglobulin” complex formed in this way is released, representing the depot form of the thyroid hormone, into the colloid of its follicle. Physiological amounts of iodine (up to approximately 300 mcg) have a replacement effect for iodine deficiency, which occurs in the Federal Republic of Germany, i.e., they prevent the formation of goiter due to iodine deficiency, contribute to the normalization of the size of the thyroid gland in newborns, children and adolescents, and also affect a number of disturbed biochemical parameters (T3/T4 ratio, TSH level).

Pharmacologically active doses of iodine (more than 1 mg/day) can cause the following effects:

• Wolf-Chaikoff effect:

excess iodine leads to inhibition of its intrathyroidal organification. If this excess is maintained, inhibition is replaced by a decrease in iodine absorption. If the Wolf-Chaikoff effect persists under pathological conditions, it leads to hypothyroidism and goiter formation.

• Reduction of intrathyroidal iodine metabolism and colloid proteolysis and the resulting decrease in hormone release. This effect is especially pronounced in hyperthyroidism and is accompanied - especially in immune thyropathies - by a decrease in blood supply, a decrease in the size of the organ, and also its compaction.

Preclinical safety data

• acute toxicity;
• chronic toxicity;
• mutagenic and oncogenic potential;

There is no information about studies to detect mutagenic and carcinogenic potential. There are no indications that iodine and iodide have similar properties.

• toxicity to reproductive organs;

During experimental studies in animals, no indication of the presence of teratogenic effects was obtained. Iodine crosses the placenta and can cause hypothyroidism and goiter in the fetus. Iodine is concentrated in mother's milk and excreted with it. When taking iodine in pharmacologically active doses, there is a risk of developing hypothyroidism in infants.

Contraindications

• hypersensitivity to the active substance or auxiliary components of the drug;
• manifest hyperthyroidism;
• subclinical hyperthyroidism - in doses exceeding 150 mcg of iodine per day;
• solitary toxic adenomas of the thyroid gland and functional autonomy of the thyroid gland (focal and diffuse), nodular toxic goiter (with the exception of preoperative therapy for the purpose of blocking the thyroid gland);
• Dühring's herpetiform (senile) dermatitis;
• lactose intolerance, lactase deficiency or glucose-galactose malabsorption.

The drug should not be used for hypothyroidism, except in cases where the development of the latter is caused by severe iodine deficiency.

The use of the drug should be avoided during therapy with radioactive iodine, the presence or suspicion of thyroid cancer.

Special instructions for the use of the drug Iodomarin

The drug contains lactose, so it should not be used in cases of congenital galactose intolerance, lactase deficiency or glucose-galactose malabsorption syndrome. Use during pregnancy and lactation. During pregnancy and lactation, the need for iodine is increased, so a sufficient intake of iodine in the body (200 mcg/day) is especially important. Due to the penetration of iodine through the placental barrier and the sensitivity of the fetus to it, the recommended doses should not be exceeded. This requirement also applies to the period of breastfeeding, since the concentration of iodine in milk is 30 times higher than that in blood plasma. An exception is high-dose iodine prophylaxis, which is carried out in case of man-made radioactive contamination. Use in children. The drug can be used in children at any age if indicated. The ability to influence reaction speed when driving vehicles or operating machinery. There is no data on negative effects.

Use during pregnancy and breastfeeding

During pregnancy and breastfeeding, the need for iodine increases, so it is especially important to use it in sufficient doses to ensure adequate iodine intake in the mother's body.

Potassium iodide crosses the placenta and enters breast milk, so use of the drug during pregnancy and breastfeeding is possible only in recommended doses.

If a nursing woman takes potassium iodide, additional potassium iodide is not required for breastfed infants.

When carrying out potassium iodide therapy, it is necessary to take into account the amount of iodine supplied with food.

Use of the drug Iodomarin

The drug is taken after meals with a sufficient amount of liquid. For infants, the drug is mixed with food. Prophylactic use of the drug must be carried out for several years, and often throughout life. Treatment of goiter in newborns usually requires 2–4 weeks, and in children, adolescents and adults it usually takes ≥6–12 months. The issue of dosage and duration of use of the drug Iodomarin 100 is decided on an individual basis. Prevention of iodine deficiency and endemic goiter (in cases where the intake of iodine into the body is less than 150–200 mcg per day): infants and older: 1/2–1 tablet of Iodomarin 100 (50–100 mcg of iodine per day); adolescents and adults: 1–2 tablets of Iodomarin 100 (100–200 mcg of iodine per day); period of pregnancy and breastfeeding: 2 tablets of Iodomarin 100 (200 mcg of iodine per day). Prevention of relapses after surgery for euthyroid goiter or its drug treatment Children and adults: 1-2 tablets of Iodomarin 100 (100-200 mcg of iodine per day). These recommendations are of a general nature and in each case it is necessary to take into account the daily amount of iodine entering the body with food. Recommendations regarding dosage are also valid for further treatment after the end of therapy for euthyroid goiter with levothyroxine. Treatment of euthyroid goiter: infants - adolescents: 1-2 tablets of Iodomarin 100 (100-200 mcg of iodine per day); adults: 3–5 tablets of Iodomarin 100 (300–500 mcg of iodine per day).

Directions for use and doses

When determining the required dose of Iodomarin ® 200, it is necessary to take into account regional and individual characteristics of iodine intake from food. This is especially important when prescribing the drug to newborns and children under 4 years of age. Prevention of iodine deficiency diseases:

Newborns and children: 100 mcg of iodine per day (1/2 tablets of Yodomarin ® 200); Teens and adults:

100−200 mcg of iodine per day (1/2 - 1 tablet of the drug Yodomarin ® 200);

During pregnancy and breastfeeding:

100−200 mcg of iodine per day (1/2 - 1 tablet of the drug Yodomarin ® 200).

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

100−200 mcg of iodine per day (1/2 - 1 tablet of the drug Yodomarin ® 200).

Treatment of euthyroid goiter:

Newborns and children: 100−200 mcg of iodine per day (1/2 - 1 tablet of Yodomarin ® 200);

Adolescent and young adult patients:

200 mcg of iodine per day (1 tablet of the drug Yodomarin ® 200).

The daily dose of the drug should be taken in one dose, after meals, 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 carried out for, as a rule, several months or years, and often throughout life.

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

Indications for use

Indications for use of the drug:

• prevention of endemic goiter (associated with insufficient iodine content in the environment);
• prevention of goiter recurrence after completion of a course of conservative treatment with thyroid hormones or surgical removal;
• treatment of euthyroid (non-toxic diffuse) goiter by iodine deficiency in children, adolescents and adults under 40 years of age.

Overdose

Symptoms:

staining of the mucous membranes brown, reflex vomiting (if there are starch-containing components in the food, the vomit becomes blue), abdominal pain and diarrhea (blood may be present in the stool). In severe cases, dehydration and shock may develop. In rare cases, esophageal stenosis has occurred. Cases of death were observed only after taking large amounts of iodine (30 - 250 ml of iodine tincture).

In rare cases, long-term overdose of potassium iodide can lead to the development of so-called “iodism”, i.e. iodine intoxication: metallic taste in the mouth, swelling and irritation of the mucous membranes (runny nose, conjunctivitis, gastroenteritis, bronchitis). Potassium iodide can activate latent inflammatory processes such as tuberculosis. Possible development of edema, erythema, acne-like and bullous rash, hemorrhage, fever and irritability.

Treatment for acute intoxication:

gastric lavage with a solution of starch, protein or 5% sodium thiosulfate solution until all traces of iodine are removed.
Symptomatic treatment of water balance disorders, electrolyte balance, anti-shock therapy. Treatment for chronic intoxication:
drug withdrawal.

Treatment of iodine-induced hypothyroidism:

discontinuation of the drug, normalization of metabolism with the help of thyroid hormones.

Treatment of iodine-induced thyrotoxicosis:

for mild forms, treatment is not required; in severe forms, thyreostatic therapy is required (the effect of which is always delayed). In severe cases (thyrotoxic crisis), intensive therapy, plasmapheresis or thyroidectomy are necessary.

In the case of hyperthyroidism, we cannot talk about an overdose as such, since hyperthyroidism can be caused by an amount of iodine that is normal in other countries.

Interaction with other drugs

Iodine deficiency increases, and iodine excess decreases, the effectiveness of hyperthyroidism treatment with antithyroid drugs. Therefore, before or during treatment for hyperthyroidism, it is recommended to avoid any iodine intake if possible. On the other hand, antithyroid drugs inhibit the conversion of iodine into an organic compound in the thyroid gland and, thus, can cause the formation of goiter.

Substances that enter the thyroid gland through the same mechanism as iodides can compete with iodine and inhibit its uptake by the thyroid gland (for example, perchlorate, which also inhibits the recycling of iodides within the thyroid gland). Iodine absorption may also be reduced when using drugs that do not themselves enter the thyroid gland, for example, thiocyanate in concentrations exceeding 5 mg/dl.

Iodine uptake by the thyroid gland and its metabolism are stimulated by endogenous and exogenously administered thyroid-stimulating hormone (TSH).

Simultaneous treatment with high doses of iodine and lithium salts can contribute to the occurrence of goiter and hypothyroidism. High doses of potassium iodide in combination with potassium-sparing diuretics can lead to hyperkalemia.

special instructions

It should be taken into account that during drug therapy in patients with renal failure, hyperkalemia may develop.

Before starting therapy, it is necessary to exclude the presence of hyperthyroidism or nodular toxic goiter in the patient, as well as a history of these diseases.

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.