Instructions for Iodomarin 200 tablets 200 mcg No. 50
Composition
active ingredient: potassium iodide;
1 tablet contains 262 mcg of potassium iodide, which corresponds to 200 mcg of iodide;
Excipients: lactose monohydrate, light magnesium carbonate, gelatin, sodium starch glycolate (type A), colloidal anhydrous silicon dioxide, magnesium stearate.
Dosage form
Pills.
Main physicochemical properties: tablets with plane-parallel surfaces, white or almost white in color, with beveled edges and a score line on one side.
Pharmacotherapeutic group
Medicinal products for the treatment of thyroid diseases. Thyroid medicinal products. Iodine medicinal products. ATC code H03C A.
Pharmacological properties
Pharmacodynamics
Iodomarin® 200 is an inorganic iodine medicine. Iodine is a vital trace element that is a part of the thyroid hormones thyroxine (T4) and triiodothyronine (T3), which ensures its normal functioning.
When iodides enter the cells of the thyroid gland follicle epithelium, under the influence of the enzyme iodide peroxidase, iodine is oxidized to form elemental iodine. The substance enters into a substitution reaction with the aromatic ring of tyrosine, resulting in the formation of thyronines: 3,5-iodine derivative (hormone thyroxine - T4) and 3-iodine derivative (hormone triiodothyronine - T3). Thyronines form a complex with the protein thyroglobulin, which is deposited in the colloid of the thyroid gland follicle and remains in this state for several days and weeks. With iodine deficiency, this process is disrupted. Iodine, which enters the body in physiological quantities, prevents the development of endemic goiter associated with a lack of this element in food; normalizes the size of the thyroid gland in newborns, children and young adult patients; affects the T3/T4 ratio and the level of thyroid-stimulating hormone (TSH).
Pharmacokinetics
After oral administration, iodine is almost completely absorbed in the small intestine. Within 2 hours after absorption, it is distributed in the intercellular space; it accumulates in the thyroid gland, kidneys, stomach, mammary and salivary glands. The volume of distribution in a healthy person averages 23 liters (38% of body weight). The concentration in blood plasma after the use of a standard dose is 10–50 ng/ml, while the iodine content in breast milk, saliva, gastric juice is 30 times higher than the concentration in blood plasma. The thyroid gland contains ¾ (10–20 mg) of all iodine in the body. Iodine is excreted mainly in the urine, to a lesser extent - in feces and exhaled air. When an equilibrium concentration is reached, the amount of iodine excreted is proportional to the daily intake of iodine with food.
Indication
Prevention of iodine deficiency, including during pregnancy or breastfeeding.
Prevention of recurrence of iodine deficiency goiter after surgical treatment, as well as after completion of complex treatment with thyroid hormone medications.
Treatment of diffuse euthyroid goiter in children, including newborns, and young adults.
Contraindication
History of hypersensitivity to the active substance or to any of the excipients of the drug. Severe hyperthyroidism. In case of latent hyperthyroidism, it is contraindicated to use the drug in doses exceeding 150 mcg of iodine per day. In case of autonomous adenoma, as well as focal and diffuse autonomous foci of the thyroid gland, it is contraindicated to use the drug in a dose of 300 to 1000 mcg of iodine per day (except for preoperative iodine therapy for the purpose of blockade of the thyroid gland according to Plummer). Pulmonary tuberculosis. Hemorrhagic diathesis. Herpetiform dermatitis of Duhring (Duhring-Broca syndrome).
Interaction with other medicinal products and other types of interactions
Iodine deficiency increases the response to thyreostatic therapy, while iodine excess reduces it, so iodine intake should be avoided if possible before or during treatment of hyperthyroidism. Thyrostatic drugs, in turn, inhibit the conversion of iodine into organic compounds in the thyroid gland and, thus, can cause goiter formation.
Substances that are taken up by the thyroid gland by the same uptake mechanism as iodine can inhibit iodine uptake by the thyroid gland by a competitive mechanism (e.g., perchlorate, which also inhibits iodide recycling within the thyroid gland). Inhibition is also possible by drugs that are not themselves absorbed, such as thiocyanate at concentrations exceeding 5 mg/dL.
Iodine uptake by the thyroid gland and iodine metabolism in the gland are stimulated by endogenous and exogenous thyroid-stimulating hormone (TSH).
Simultaneous treatment with high doses of iodine, which suppress thyroid hormone secretion, and lithium salts may contribute to the development of goiter and hypothyroidism.
High doses of potassium iodide in combination with potassium-sparing diuretics may cause hyperkalemia.
Simultaneous use with plant alkaloids and heavy metal salts may lead to the formation of an insoluble precipitate and inhibition of iodine absorption.
Application features
The drug should not be used in hypothyroidism, except in cases where hypothyroidism is caused by iodine deficiency. Iodine administration should be avoided in patients undergoing radioactive iodine therapy, in patients with known or suspected thyroid cancer. It should be noted that hyperkalemia may develop in patients with renal insufficiency during drug therapy.
The drug Iodomarin® 200 contains lactose. Patients with rare hereditary forms of galactose intolerance, severe lactase deficiency or glucose-galactose malabsorption syndrome should not take Iodomarin® 200.
Use during pregnancy or breastfeeding
During pregnancy or breastfeeding, the need for iodine is increased, so a sufficient intake of iodine (200 mcg per day) is especially important. Due to the ability of iodine to penetrate the placenta and the sensitivity of the fetus to pharmacologically active doses of iodine, it should be used only in recommended doses. This also applies to the period of breastfeeding, since the concentration of iodine in breast milk is 30 times higher than in blood serum. The exception is high-dose iodine prophylaxis, which is carried out after nuclear accidents.
Ability to influence reaction speed when driving vehicles or other mechanisms
No effect.
Method of administration and doses
Prevention of iodine deficiency and endemic goiter in cases where the intake of iodine in the body of an adult is less than 150–200 mcg/day - it is necessary to additionally use the following amount:
Infants and children under 12 years of age: 50–100 mcg of iodine per day (100 mcg of iodine is equivalent to ½ tablet of Iodomarin® 200. To be able to dose 50 mcg of iodine, medicinal products with the appropriate content of the active substance should be used).
Children over 12 years of age and adults: 100–200 mcg of iodine per day (½ to 1 tablet of Iodomarin® 200).
Pregnancy or breastfeeding: 200 mcg of iodine per day (1 tablet of Iodomarin® 200).
Prevention of recurrence of iodine deficiency goiter after surgical treatment, as well as after completion of complex treatment with thyroid hormone medications.
Children and adults: 100–200 mcg of iodine per day (½ to 1 tablet of Iodomarin® 200).
Treatment of euthyroid goiter.
Newborns and children: 100–200 mcg of iodine per day (½ to 1 tablet of Iodomarin® 200).
Young adults: 300–500 mcg of iodine per day (1½ to 2½ tablets of Iodomarin® 200).
Method of application.
The tablets should be taken after meals and washed down with a sufficient amount of liquid, for example a glass of water. Infants and children under 3 years of age can be given the medicine in crushed form. The medicine is usually used for preventive purposes for several months or years, and more often for a lifetime. In most cases, 2–4 weeks are sufficient for the treatment of goiter in newborns, and 6–12 months or more in children and adults. In general, the dosage and duration of use of the medicine for preventive measures or for the treatment of thyroid diseases is decided by the doctor on an individual basis.
Children
The medicine can be used in children of any age if indicated.
Overdose
Symptoms of intoxication: brown discoloration of the mucous membranes, reflex vomiting (blue discoloration in the presence of starch in the food), abdominal pain, diarrhea (possible presence of blood in the stool), dehydration and shock. In isolated cases, the formation of esophageal stenosis was observed. Fatal cases were noted only after taking a large amount of iodine (30–250 ml of iodine tincture). In some cases, chronic overdose leads to the development of the so-called iodism, i.e. iodine intoxication: metallic taste in the mouth, swelling and inflammation of the mucous membranes (runny nose, conjunctivitis, gastroenteritis, bronchitis). Iodide can activate latent inflammatory processes, such as tuberculosis. The development of edema, erythema, acne-like and bullous rashes, hemorrhages, fever and nervous excitement is possible.
Treatment.
Therapy for acute intoxication: gastric lavage with a solution of starch, protein or 5% sodium thiosulfate solution until all traces of iodine are removed. Symptomatic therapy to eliminate water and electrolyte balance disorders, and if necessary, anti-shock therapy.
Therapy for chronic intoxication: iodine withdrawal.
Hypothyroidism caused by iodine intake: iodine withdrawal, administration of thyroid hormones to normalize metabolism.
Hyperthyroidism caused by iodine intake: This is not an overdose in the literal sense, because hyperthyroidism can also occur from amounts of iodine that are considered physiological in other countries.
Treatment according to the course: mild forms usually do not require treatment, severe forms require thyrostatic therapy (the effectiveness of which is delayed in time). In the most severe cases (thyrotoxic crisis), intensive therapy, plasmapheresis or thyroidectomy are necessary.
Adverse reactions
When using iodide prophylactically in patients of any age, as well as when using it therapeutically in newborns and children, undesirable effects are usually not observed. However, in the presence of large foci of thyroid autonomy and when prescribing iodine in daily doses exceeding 150 μg, it is impossible to completely exclude the occurrence of pronounced hyperthyroidism.
The following adverse reactions occurred with the following frequency: very common (≥1/10); common (≥1/100 to <1/10); uncommon (≥1/1000 to <1/100); rare (≥1/10000 to <1/1000); very rare (<1/10000), not known (cannot be estimated from the available data).
From the immune system.
Very rare: hypersensitivity reactions (such as iodine rhinitis, bullous or tuberous iododerma, exfoliative dermatitis, angioedema, fever, acne and salivary gland swelling).
From the endocrine system.
Very rare: during the treatment of goiter in adults (daily dose of 300 to 1000 mcg of iodine), iodine-induced hyperthyroidism may develop. In the vast majority of cases, this is due to the presence of diffuse or limited areas of thyroid autonomy. This applies primarily to elderly patients who have had goiter for a long time.
Also possible: manifestations of iodism (in particular, symptoms such as swelling of the nasal mucosa, urticaria, angioedema, skin rashes, itching, in rare cases - anaphylactic shock), eosinophilia, tachycardia, tremor, irritability, sleep disturbances, increased sweating, discomfort in the epigastric region, diarrhea. When using the drug in high doses, in some cases, the development of goiter and hypothyroidism is possible.
Reporting of suspected adverse reactions.
Reporting of suspected adverse reactions after the authorisation of a medicinal product plays an important role. This allows for continued monitoring of the benefit-risk balance of the medicinal product. Healthcare professionals should report any suspected adverse reactions.
Expiration date
For packaging containing PVC/aluminum blister – 3 years.
For packaging containing aluminum/aluminum blister – 5 years.
Do not use the medicine after the expiry date stated on the packaging.
Storage conditions
The package containing the PVC/aluminum blister should be stored at a temperature not exceeding 25°C.
No special storage conditions are required for packaging containing aluminum/aluminum blister.
Keep out of reach of children.
Packaging
Cardboard box containing 5 blisters of 10 tablets or 2 blisters of 25 tablets.
Vacation category
Without a prescription.
Producer
BERLIN-CHEMI AG.
Location of the manufacturer and address of its place of business
Glienicker Weg 125, 12489 Berlin, Germany.
