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
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.
Pharmacodynamics and pharmacokinetics
The use of Iodomarin is indicated for the treatment and prevention of thyroid diseases.
Iodine is an indispensable, vital microelement for the human body, without which normal activity of the thyroid gland .
Its hormones regulate the functioning of the brain , heart , nervous and vascular systems , mammary glands , ovaries in women and testes in men, ensure the correct course of metabolic in the body (including proteins, carbohydrates and fats ), actively participate in energy metabolism, and are also responsible for the growth and normal development of the child.
The use of Iodomarin allows you to compensate for iodine deficiency when it is insufficiently supplied to the body through food, which is especially important in childhood, during periods of childbearing and breastfeeding, as well as for people who live in geochemical zones with iodine soil and water.
Iodine entering the body in physiological quantities makes it possible to normalize the size of the thyroid gland in children and young adults, as well as the ratio of thyroid hormones T3 and T4 and the level of thyroid-stimulating hormone .
After oral administration iodine is almost completely absorbed in the small intestine , after which within 2 hours it is distributed in the intercellular space and accumulates in the thyroid gland, salivary and mammary glands , kidneys, and stomach .
The concentration in blood plasma after using a p/os standard dose is from 10 to 50 ng/ml, while the concentration of iodine in breast milk, saliva and gastric juice is 30 times higher than its concentration in blood plasma .
The thyroid gland contains 75% of all iodine (from 10 to 20 mg).
Iodine from the body mainly through urine , and also, to a lesser extent, the lungs and intestinal .
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.
Side effects
Treatment of non-toxic diffuse goiter in newborn infants, children and adolescents, as well as the use of Iodomarin for preventive purposes (at any age), as a rule, does not provoke side effects.
In rare cases, against the background of long-term use of the drug, the development of iodism - aseptic inflammation of the skin and mucous membranes in places where iodine is released (in the area of the paranasal sinuses , salivary glands , respiratory tract ).
It manifests itself in the form of “cold” symptoms (lacrimation, conjunctivitis , runny nose , cough , “ iodine fever ”, etc.), bronchitis , the appearance of a metallic taste in the mouth and a characteristic odor from the mouth, increased salivation, urticaria , increased thirst, staining oral cavity, diarrhea , cramps , weakness, dizziness, soreness and burning sensation in the throat, a special skin rash (iododerma) and “iodine” acne. Vomit is yellow or blue.
, exfoliative dermatitis or Quincke's edema may develop .
When using the drug in a dose exceeding 150 mcg/day, latent (masked) hyperthyroidism often becomes manifest ( true hyperthyroidism ).
Long-term use of the drug at a dose exceeding 300 mcg/day can provoke iodine-induced thyrotoxicosis (the likelihood of its development is especially high in elderly patients who of goiter for a sufficiently long period of time; in the presence of Graves' disease or nodular goiter ).
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.
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.
Side effects
With the prophylactic use of iodide in patients of any age, as well as with therapeutic use in newborns, infants and children, no side effects are usually observed. however, in the presence of large autonomous foci of the thyroid gland and when iodine is prescribed in daily doses exceeding 150 mcg, it is impossible to completely exclude the occurrence of severe hyperthyroidism.
The following adverse reactions occurred with the following frequency: very often (≥1/10); often (from ≥1/100 to 1/10); uncommon (≥1/1000 to 1/100); rare (≥1/10,000 to 1/1000); very rare (1/10,000); unknown (cannot be estimated from available data).
From the immune system: very rarely - hypersensitivity reactions (for example, rhinitis caused by iodine, bullous or tuberous iododerma, exfoliative dermatitis, angioedema, fever, acne and swelling of the salivary glands).
From the endocrine system: very rarely - during the treatment of diffuse euthyroid iodine deficiency goiter in adults, in some cases the development of hyperthyroidism caused by iodine is possible. In the vast majority of cases, the prerequisite for this is the presence of diffuse or limited autonomous foci of the thyroid gland. First of all, this applies to elderly patients with long-term goiter.
Also possible: manifestations of iodism (including symptoms such as swelling of the nasal mucosa, urticaria, Quincke's edema, skin rash, itching, in isolated cases - anaphylactic shock), eosinophilia, tachycardia, tremor, irritability, sleep disturbance, 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.
Reports of suspected adverse reactions. Reporting of suspected adverse reactions after drug registration plays an important role. This allows continued monitoring of the benefit-risk ratio of the drug. Health care workers should report any suspected adverse reactions through the national reporting system.
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.
Iodomarin 200 mcg No. 100 tab.
Instructions for medical use of the drug Iodomarin® 200 Trade name Iodomarin® 200 International nonproprietary name Potassium iodide Dosage form Tablets 200 mcg Composition One tablet contains the active substance - potassium iodide 0.262 mg (equivalent to iodine 0.200 mg), excipients: lactose monohydrate, magnesium carbonate basic light, gelatin, sodium carboxymethyl starch, type A, anhydrous silicon dioxide, magnesium stearate. Description Tablets are white to almost white in color, with a flat surface, with a bevel and a score on one side. Pharmacotherapeutic group Drugs for the treatment of thyroid diseases. Iodine preparations. ATC code H03CA Pharmacological properties Pharmacokinetics Typically, iodine enters the body through the gastrointestinal tract, but can also enter through the skin and from body cavities. This must be especially taken into account in case of erroneous medicinal administration of iodine. When taken orally, it is quickly absorbed from the gastrointestinal tract. Widely distributed in all tissues and fluids of the body. Inorganic iodine is absorbed in the small intestine almost 100%, and through the skin - insignificantly and uncontrollably. The volume of distribution in healthy people averages about 23 liters (38% of body weight). Serum inorganic iodine levels are usually between 0.1 and 0.5 μg/dL. In the body, iodide accumulates in the thyroid gland and other tissues such as the salivary glands, mammary glands and stomach. In saliva, gastric juice and milk, the concentration of iodide is 30 times higher than its concentration in blood plasma. Urinary iodine excretion, most often indicated in mcg/g creatinine, serves as a criterion for iodine supply, since in a balanced state it correlates with the daily iodine intake from food. Pharmacodynamics The effects that exogenously administered iodine has on the human body depend on the amount of iodine taken per day, on the type of iodine-containing drug, as well as on the condition of the thyroid gland (healthy organ, latent or manifest disease). As an element involved in the synthesis of thyroid hormones - thyroxine and triiodothyronine - iodine is an essential component of food. The need for it, that is, the amount of iodine that must be supplied to the body daily in order to prevent the development of endemic goiter, is about 100 - 150 mcg per day. The WHO recommended amount of iodine that should be consumed daily is 150 - 300 mcg. After iodine is absorbed by electrochemical means (iodination), oxidation occurs in the epithelial cells of the thyroid follicles with hydrogen peroxide (H2O2), which is a cosubstrate, catalyzed by the enzyme iodide peroxidase, from which elemental iodine is released. In this case, part of the tyrosine groups 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 as a depot form of the thyroid hormone into the colloid of its follicle. Physiological amounts of iodine (up to 300 mcg) prevent the formation of goiter, which develops as a result of iodine deficiency, help normalize 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). Indications for use - prevention of iodine deficiency (for example, for the prevention of endemic goiter and after resection of goiter caused by iodine deficiency) - treatment of diffuse euthyroid goiter caused by iodine deficiency in children, including infants, adolescents and young adults. Method of administration and doses Prevention of iodine deficiency diseases (in cases of insufficient intake of alimentary iodine into the body, amounting to at least 150-300 mcg per day): Infants, children 2 - 12 years old - ½ tablet per day Yodomarin® 200 (which corresponds to up to 100 mcg of iodine) Children from 12 years and adults - from ½ to 1 tablet of Iodomarin® 200 (which corresponds to 100 - 200 mcg of iodine) per day Pregnant and lactating: 1 tablet of Iodomarin® 200 (which corresponds to 200 mcg of iodine) per day Prevention of relapses after surgery for euthyroidism goiter or its drug treatment: ½ to 1 tablet of Iodomarin® 200 once a day (which corresponds to 100-200 mcg of iodine). Treatment of euthyroid goiter: Newborns, children and adolescents - from ½ to 1 tablet of Iodomarin® 200 mcg (which corresponds to 100-200 mcg of iodine) per day Adults at a young age - from 1 ½ to 2 ½ tablets of Iodomarin® 200 (which corresponds to 300- 500 mcg of iodine) per day Prophylactic administration of Yodomarin® 200 should usually be carried out for several years, 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 use of the drug is determined by the attending physician under the control of the level of iodine in the blood. The drug is taken after meals with a sufficient amount of liquid. For children, including newborns, it is recommended to first grind the drug and dissolve it in a small amount of milk or water. Side effects Very rarely - in the presence of larger autonomous areas in the thyroid gland and with daily doses of more than 150 mcg of iodine, hyperthyroidism can develop into a manifest form - when using the drug in a dose exceeding 300-1000 mcg of iodine per day, the development of hyperthyroidism is possible ( especially in elderly patients suffering from goiter for a long time, in the presence of nodular or diffuse toxic goiter) Contraindications - hypersensitivity to the active substance or one of the other components of the drug - manifest hyperthyroidism - latent hyperthyroidism in doses exceeding 150 mcg of iodine per day - toxic adenoma thyroid gland, nodular goiter (when used in doses from 300 to 1000 mcg/day), with the exception of preoperative iodine therapy for the purpose of blocking the thyroid gland according to Plummer) Drug interactions Iodine deficiency increases, and iodine excess decreases the response to hyperthyroidism therapy with thyroid drugs; In this regard, before or during treatment for hyperthyroidism, it is recommended to avoid, if possible, any iodine intake. Thyrostatic drugs, for their part, inhibit the transition of iodine to an organic compound in the thyroid gland and, thus, can cause the formation of goiter. The absorption of iodine by the thyroid gland is competitively suppressed by substances, the introduction of which into the thyroid gland occurs through the same “capture” mechanism as the introduction of iodide (for example, perchlorate, which, in addition, inhibits the recirculation of iodine in the thyroid gland), as well as substances that themselves are not transported by themselves, such as thiocyanate in concentrations exceeding 5 mg/dL. The absorption of iodine by the thyroid gland and its metabolism in it are stimulated by endogenous and exogenous thyroid-stimulating hormone (TSH). Simultaneous treatment with high doses of iodine, which suppress the secretion of thyroid hormones, and lithium salts can contribute to the occurrence of goiter and hypothyroidism. Higher doses of potassium iodide in combination with potassium-sparing diuretics may lead to hyperkalemia. Special instructions The drug Yodomarin® 200 contains lactose. Patients suffering from congenital galactose intolerance, lactase deficiency in the body, or glucose-galactose malabsorption syndrome should not take Yodomarin ® 200. Pregnancy and lactation During pregnancy and lactation, the need for iodine increases, so it is especially important to have a sufficient (200 mcg per day) intake of iodine in the body. Due to the diaplacental transition of iodine and the sensitivity of the fetus to pharmacologically active doses, iodine is not recommended to be prescribed in the milligram dose range. This also applies to the lactation period, since the concentration of iodide in milk is 30 times higher than in blood serum. An exception is high-dose iodine prophylaxis carried out after accidents in the field of nuclear technology. Features of the drug's influence on the ability to drive a vehicle or potentially dangerous machinery There are no indications that Yodomarin® 200 limits the ability to participate in street traffic, operate machines, or work without safety nets. Overdose Symptoms: Brown staining of the mucous membranes, reflex vomiting (if starch-containing components are present in food, the vomit becomes blue), abdominal pain and diarrhea (possibly bloody). Dehydration and shock may develop. In rare cases, esophageal stenosis has occurred. Fatal outcomes were observed only after taking large amounts of iodine (from 30 to 250 ml of iodine tincture). Long-term overdose in rare cases leads to the appearance of a phenomenon called iodism: a metallic taste in the mouth, swelling and inflammation of the mucous membranes (runny nose, conjunctivitis, gastroenteritis, bronchitis). Latent inflammations, such as tuberculosis, can be activated under the influence of iodide. The development of edema, erythema, acne-like and bullous rashes, hemorrhages, fever and nervous excitability occurs. Treatment: a) 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 treatment of water and electrolyte imbalances, anti-shock therapy. b) Therapy for chronic intoxication Iodine withdrawal. c) Hypothyroidism induced by iodine Abolition of iodine, normalization of metabolism with the help of thyroid hormones. d) Iodine-induced hyperthyroidism This is not an overdose in the literal sense, because hyperthyroidism can also be caused by amounts of iodine that are physiological in other countries. Treatment in accordance with the form of the course: mild forms, under certain conditions, do not require treatment; in severe forms, thyreostatic therapy is required (the effectiveness of which, however, always appears with a delay). In the most severe cases (thyrotoxic crisis), intensive therapy, plasmapheresis or thyroidectomy are necessary. Release form and packaging 25 tablets are placed in a blister pack made of opaque, rigid polyvinyl chloride (PVC) film (250 microns) and rigid aluminum foil (20 microns). 1, 2 or 4 contour packages together with instructions for medical use in the state and Russian languages are placed in a cardboard pack. Storage conditions Store in a dry place, protected from light, at a temperature not exceeding 25°C. Keep out of the reach of children! Shelf life: 3 years After the expiration of the shelf life, the medicine cannot be used. Conditions for dispensing from pharmacies Without a prescription Manufacturer Berlin-Chemie AG (Menarini Group), Germany Registration certificate holder BERLIN-CHEMIE AG (MENARINI GROUP) Glienikker Weg 125 12489 Berlin, Germany Address of the organization that accepts claims from consumers regarding product quality in the territory of the Republic of Kazakhstan (product): Representative office of JSC Berlin-Chemie AG in the Republic of Kazakhstan Phone number: +7 727 2446183, 2446184, 2446183 fax number: +7 727 2446180 email address
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.
Note!
Description of the drug Iodomarin table. 200mcg No. 50 on this page is a simplified author’s version of the apteka911 website, created on the basis of the instructions for use.
Before purchasing or using the drug, you should consult your doctor and read the manufacturer's original instructions (attached to each package of the drug). Information about the drug is provided for informational purposes only and should not be used as a guide to self-medication. Only a doctor can decide to prescribe the drug, as well as determine the dose and methods of its use.
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.
