Йодомарин100

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Йодомарин100

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Overview of Йодомарин100

Quick Facts

Property Description
Active ingredient Potassium iodide (Калия йодид)
Form Oral Tablets
Pharmacological class Iodine preparations (H03CA)
General purpose Iodine supplementation for thyroid support
Origin Synthetic inorganic compound

What is the Composition and Form of Йодомарин 100?

Йодомарин 100 is a specific pharmaceutical preparation, typically associated with the Berlin-Chemie/Menarini Group, designated as a monopreparation. Its sole active ingredient is the synthetic inorganic compound Potassium iodide (Калия йодид). The medicine is supplied for oral administration in the solid physical form of Tablets. Potassium iodide is recognized for its high solubility, ensuring the rapid and reliable release of the essential trace element iodide. The tablet’s structural integrity is maintained by excipients, including key components such as Lactose monohydrate and Magnesium stearate.

Йодомарин 100: Pharmacological Class and General Purpose

The preparation is classified within the Iodine therapy pharmacological group, specifically targeting thyroid function, and is officially categorized under the ATC code H03CA. The essential general purpose of Йодомарин 100 is iodine supply/supplementation, a requirement for maintaining overall physiological health. By delivering a consistent input of iodide, the preparation aids the body's mandatory requirement for this element, particularly in supporting the thyroid gland's core function.

Understanding the Primary Action of Йодомарин 100

The primary physiological action of the drug involves substrate delivery rather than acting as a hormone substitute. The absorbed iodide, derived from the Potassium iodide, is actively utilized by the thyroid gland as the indispensable raw material for synthesizing its key metabolic regulators: thyroxine (T4) and triiodothyronine (T3). This supply-side action supports the homeostatic functioning of the thyroid gland, which is essential for healthy metabolic and neurological development.

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What side effects are possible with Йодомарин100?

Possible Side Effects and Safety Information

The safety profile for Йодомарин 100 (Potassium Iodide, 100 micrograms) is derived from authoritative government regulatory documents focusing on the adverse reactions associated with its active ingredient.

Adverse Reaction Scope and Organ Systems

The adverse reactions recognized in regulatory documents generally affect specific system-organ classes. Reactions are typically mild and transient, especially at the low dose used for prophylaxis.

System-Organ Class Recognized Adverse Reactions
Skin and Subcutaneous Tissue Disorders Skin rash, hives (urticaria), Iododerma
Gastrointestinal Disorders Nausea, vomiting, diarrhea, stomach upset
Endocrine Disorders Changes in Thyroid Function (e.g., hypothyroidism, hyperthyroidism)
Immune System Disorders Hypersensitivity and allergic reactions
General Disorders Swelling of the salivary glands (Sialadenitis)

Serious Adverse Reactions and Contraindications

Serious adverse reactions, while uncommon, require immediate medical attention. These include severe allergic reactions (e.g., difficulty breathing, swelling of the face, throat, or tongue) and symptoms of chronic Iodine Toxicity (Iodism), such as a metallic taste, soreness of teeth and gums, or severe headache.

Use of the product is generally contraindicated in individuals with a known hypersensitivity to iodine.

Safety Considerations by Population and Exposure

  • Infants and Neonates: This group carries the highest risk of developing hypothyroidism, particularly with repeated exposure, and must be monitored closely.
  • Pre-existing Thyroid Conditions: Individuals with thyroid disorders (e.g., nodular goiter, Hashimoto’s) may be at increased risk of adverse effects related to thyroid function.
  • Exposure Duration: The risk of developing more significant adverse events, like chronic Iodism or persistent changes in thyroid function, generally increases with long-term use or repeated high doses.
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Overdose and Emergency Response

Overdose and when to seek help

Overdose with Йодомарин 100 (Potassium Iodide) is officially documented as two distinct patterns: acute toxicity from a high single dose and chronic toxicity, often referred to as Iodism.


Documented Overdose Manifestations

Acute toxicity may present with severe systemic and gastrointestinal effects, including a metallic taste in the mouth, a burning sensation in the throat, abdominal pain, and severe vomiting or diarrhoea. Chronic overexposure (Iodism) typically involves inflammation of the mucous membranes, such as rhinitis, laryngitis, and swelling of the salivary glands, alongside symptoms like skin rash, headache, and mental depression.


Severe Outcomes and Emergency Action

Regulatory documentation identifies severe outcomes such as circulatory failure, shock, anuria (absence of urine output), and oedema of the glottis (laryngeal swelling) as potential risks. Furthermore, overdose can lead to severe endocrine conditions, including iodine-induced hyperthyroidism or hypothyroidism.

In the event of suspected overdose or the manifestation of severe symptoms, the official regulatory instruction is to seek immediate medical attention. Because no specific antidote is known, management is restricted to symptomatic and supportive treatment; monitoring of vital signs and thyroid function is required. Special overdose considerations apply to neonates, who are at high risk for transient hypothyroidism, and to patients with pre-existing thyroid or renal impairment.

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Therapeutic Uses of Йодомарин100

Quick Facts

  • Support for Thyroid Health: Helps sustain healthy thyroid function.
  • Iodine Deficiency: Supports addressing iodine deficiency.
  • Goiter Prevention: Utilized in the prevention of endemic goiter.
  • Goiter Treatment: Used in the management of diffuse euthyroid goiter in specific age groups.

What Йодомарин 100 Treats: Main Uses and Benefits

Йодомарин 100 (Potassium Iodide) is a medication that plays a role in supporting the body's need for iodine, an essential element for the production of thyroid hormones. The medication is used to help address conditions related to inadequate iodine intake.

One primary application is the prevention of endemic goiter (enlargement of the thyroid gland) in populations residing in areas with documented iodine deficiency. This application is often relevant for children, adolescents, and women who are pregnant or breastfeeding, as these groups have increased iodine requirements.

It is also used to help prevent the recurrence of goiter following surgical removal or after medical management with thyroid hormones has concluded. Furthermore, Йодомарин 100 is employed in the therapeutic management of diffuse euthyroid goiter caused by iodine deficiency, typically in specific patient cohorts such as newborns, children, adolescents, and adults under 40 years of age. Treatment protocols involving the use of this medication are often initiated under the guidance of a healthcare professional.


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Eligibility and Restrictions for Use

Who can and cannot use Йодомарин 100?

Eligibility for Йодомарин 100 is defined by regulatory authorities based on age, physiological status, and the absence of certain thyroid conditions. The medicine is primarily intended for populations with increased iodine requirements or those affected by iodine deficiency.

Populations Allowed and Prohibited

Classification Status Rationale (Official Labeling)
Pediatric Groups Permitted Approved for prophylaxis and treatment of goiter in newborns, children, and adolescents.
Pregnancy/Lactation Permitted Approved for prophylaxis in pregnant and breastfeeding women due to increased iodine need.
Manifest Hyperthyroidism Contraindicated Absolutely prohibited in patients with a clinically overactive thyroid gland.
Latent Hyperthyroidism Conditional Prohibition Prohibited only if the daily iodine dosage exceeds 150 μg.
Hypersensitivity Contraindicated Prohibited for patients allergic to Potassium iodide or any tablet excipients.

Eligibility is dependent on the absence of a hyperactive thyroid state. The drug is typically used in euthyroid (normally functioning thyroid) patients for deficiency management. Use is conditional for patients with lactose intolerance due to the presence of lactose excipients.

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What should I know about interactions with other medicines?

Interactions with other medicines and products

The interaction profile for Йодомарин 100 (Potassium iodide) focuses on specific pharmacological effects and electrolyte balance, as documented in official regulatory prescribing information. The primary documented interactions are pharmacodynamic and related to the element's influence on the thyroid gland or the potassium component.

Documented Interaction Patterns

Interacting Substance/Class Documented Effect and Relevance
Lithium and compounds affecting the thyroid There is a documented risk of additive hypothyroid and goitrogenic effects when co-administered with Lithium, which may potentially exacerbate or induce hypothyroidism.
ACE Inhibitors (e.g., Captopril, Enalapril) Co-administration increases the risk and severity of hyperkalemia (elevated potassium levels) due to the combined potassium-elevating action.
Potassium-Sparing Diuretics (e.g., Amiloride, Triamterene) Combining with these agents similarly increases the risk of hyperkalemia as stated in official labeling.

Interaction Constraints

No formal contraindications (absolute prohibitions for co-administration) are universally stated in regulatory texts for general iodine supplementation. However, official prescribing information notes that the risk of hyperkalemia is heightened in patients with renal or adrenal insufficiency when using Potassium iodide alongside potassium-elevating medicines. No specific interactions with food, alcohol, or herbal products are documented.

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Mechanism of Action

Йодомарин 100 provides a source of iodide (I^-) ions, which are selectively accumulated by the thyroid follicular cells. The primary biological target is the sodium/iodide symporter (NIS) on the basolateral membrane, which actively transports iodide from the circulation into the cell, utilizing the electrochemical gradient generated by the Na^+/ K^+-ATPase. Within the follicular cell, iodide is then transported into the follicular lumen via the pendrin transporter. This concentrated iodide serves as an essential substrate for the synthesis of thyroid hormones, specifically L-thyroxine ( T4) and triiodothyronine ( T3).

The molecular pathway involves the enzyme thyroid peroxidase (TPO), located at the apical membrane, which catalyzes the oxidation of I^- to organic iodine. This iodine then participates in the organification of tyrosine residues on the large glycoprotein thyroglobulin (Tg), forming monoiodotyrosine (MIT) and diiodotyrosine (DIT). TPO subsequently mediates the coupling reaction of MIT and DIT pairs to form T3 and T4 stored within Tg in the colloid.

Downstream, the release of T4 and T3 into the circulation modulates systemic physiological processes, including metabolic rate, protein synthesis, and cellular oxygen consumption. This interaction acts as a substrate replacement, normalizing the availability of the critical component required for the hypothalamic-pituitary-thyroid (HPT) axis to maintain systemic thyroid hormone homeostasis.

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Dosage and Administration Information

Official Administration Guidelines

This section details the procedural steps for using Йодомарин 100 (Potassium Iodide). It does not provide clinical advice, therapeutic context, or safety information.


Administration Instructions

Entity Instruction
Route of Administration The medication is for oral administration (by mouth) only.
Dosing Schedule Dosing adheres to the specific daily microgram amount established for the patient's age and physiological state (e.g., pregnancy, infancy) and whether the use is for prophylaxis or treatment. The tablet is scored to facilitate dose adjustments.
Timing in Relation to Meals Tablets are generally taken after a meal with a small amount of liquid.
Preparation Requirements For infants and small children who cannot swallow tablets, the tablet may be crushed and mixed with a small amount of soft food (e.g., puree) or liquid. The resulting mixture must be consumed immediately.
Age-Group Rules Specific doses are directed for infants and children, while specific doses are directed for pregnant and breastfeeding women due to increased iodide requirements.

Procedural Summary

To ensure correct use, the administration sequence requires adherence to the following steps:

  1. Determine the dose: Identify the precise microgram dose required based on the patient's age and the intended use (prophylaxis or goiter treatment).
  2. Preparation: For individuals unable to swallow, divide the scored tablet or crush the required segment and mix it immediately into a liquid or soft food.
  3. Intake: The full dose is taken once daily with liquid, generally after a meal.
  4. Missed Dose: If a dose is missed, take the next dose at the usual scheduled time and do not take a double dose to compensate for the forgotten one.

These instructions define the standardized protocol for administering the medicine, ensuring that the route, frequency, and preparation steps are followed.

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Recent Clinical Evidence

Research Evidence / Overview of Studies for Йодомарин 100


Research Evidence for Goiter Prevention in Iodine-Deficient Areas

Research has explored the role of iodine supplementation in addressing thyroid enlargement, or goiter. The research base includes Randomized Controlled Trials (RCTs) and very large-scale Epidemiological Studies (research that tracks disease patterns) that monitored public health programs. The studies examined the use of iodine in populations characterized by insufficient iodine status, including school-age children, adolescents, and women who are pregnant or lactating.

Studies described patterns of measured shifts in the levels of Urinary Iodine Concentration (UIC) in study populations. Furthermore, long-term epidemiological evidence includes data related to goiter prevalence over many years in regions that implemented supplementation programs. Trials also reported measurements of Thyroid Volume (TVol). Some meta-analyses reported limited and heterogeneous findings regarding the impact on neurodevelopmental outcomes.


Research Evidence for the Management of Diffuse Euthyroid Goiter

Research explored the use of iodine supplementation in the context of an already-developed goiter that is non-toxic (euthyroid) and generalized (diffuse). This area relies on Randomized Controlled Trials and clinical intervention studies. Outcomes tracked included changes in Thyroid Volume (TVol), assessed via ultrasound, and monitoring biochemical markers like Thyroglobulin (Tg, a thyroid protein marker).

Trials reported how symptoms evolved in the observed populations, including patterns of measured shifts in Thyroid Volume during the intermediate follow-up periods (e.g., six to twelve months), particularly in children and adolescents. Research describes that measured changes may be slower or less noticeable in older study participants.


Areas of Research Uncertainty and Study Gaps

Uncertainty remains regarding the durability of these findings. Follow-up durations were limited in many trials, meaning the long-term outcomes for thyroid volume are not fully established. Evidence quality varies across studies, and there is limited information for long-term outcomes in many specific subgroups. Furthermore, the modest sample sizes of some interventional trials mean that results apply only to the populations studied and do not determine whether an individual will respond similarly.

Key Studies & References

  1. Effect of Iodine Nutrition During Pregnancy and Lactation on Child Cognitive Outcomes: A Review (Addressing U-shaped association and physiological requirements)
  2. Effect of iodine nutritional status on the recurrence of hyperthyroidism and antithyroid drug efficacy in adult patients with Graves' disease: a systemic review (Addressing recurrence data and quality of evidence)
  3. ATC code H03CA - Iodine therapy (WHO Collaborating Centre for Drug Statistics Methodology: Classification context)
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Frequently Asked Questions (FAQ)

Common questions about Йодомарин 100 (FAQ)


Q: What exactly is Йодомарин 100 used for?

Official product information states that this medicine is used primarily for the prophylaxis, or prevention, of conditions caused by iodine deficiency. This includes preventing endemic goiter (enlargement of the thyroid gland) from developing. The drug is also used to prevent goiter from recurring after it has been successfully treated or surgically removed.


Q: Is Йодомарин 100 a vitamin or a hormone medicine?

According to the official pharmacotherapeutic classification, this medicine is an inorganic iodine preparation. It is considered a mineral substance that supplies the body with iodide. It is neither classified as a vitamin nor a thyroid hormone replacement drug itself.


Q: How long is the typical treatment period described in official documents?

For the treatment of existing goiter, regulatory guidance suggests administration typically lasts for several months, often between six to twelve months. For the purpose of prophylaxis (prevention), official documents state that continuous or long-term administration may be required.


Q: What is the role of iodine in the body that this medicine addresses?

This medicine addresses the body's need for iodide ions, which are an essential nutrient. Iodide is required by the thyroid gland to support the synthesis of the body's natural thyroid hormones, such as T4 and T3.


Q: Why is the number '100' used in the medicine's name?

The number '100' typically refers to the dose of the active substance in the tablet. It indicates that the tablet contains 100 micrograms (μg) of iodide.


Q: Is this medicine available without a prescription?

Regulatory labeling in some countries confirms that low-dose potassium iodide preparations for iodine prophylaxis are available as medicinal products not requiring a prescription. This classification can vary depending on the local health authority.


Q: What are the main goals listed for taking Йодомарин 100?

The main goals established in official documents are to correct iodine deficiency, prevent the development of endemic goiter, and prevent the return of goiter after successful treatment.


Q: Can children take Йодомарин 100?

Yes, official regulatory documents define specific, lower daily microgram amounts for infants and children based on age groups for prophylaxis and treatment.


Q: Is Йодомарин 100 officially recommended for use during pregnancy?

Yes, specific, often higher, daily microgram amounts are often cited in official documents for pregnant and breastfeeding women. This is due to the significantly increased iodine requirement necessary for the proper development of the fetus and infant.


Q: Is this medicine appropriate for use by men?

Yes, the standard adult dosing recommendations and indications apply to adult men for the prevention and treatment of iodine-deficiency-related conditions.


Q: Are there specific age restrictions for using this medicine?

While the drug is commonly used in children, regulatory texts advise caution and sometimes avoidance in certain sensitive populations, such as older individuals with pre-existing thyroid conditions. Use in any sensitive group must align with specific regulatory guidelines.


Q: Is the drug used for people with pre-existing thyroid conditions?

Official warnings caution that the use of iodide in patients with certain pre-existing conditions, such as asymptomatic nodular goitre, latent Graves' disease, or active hyperthyroidism, requires medical supervision or may be listed as contraindicated.


Q: Is this product suitable for individuals following a vegetarian or vegan diet?

The suitability depends on the specific excipients used in the tablet formulation. Official documentation for many formulations confirms that lactose is included, which is derived from milk and may be a consideration for those following a strict vegan diet.


Q: Is it generally considered safe to use this medicine for an extended period of time?

Prophylaxis may be required long-term, but continued use requires medical monitoring, as prolonged or excessive use may carry a low risk of developing iodine-induced thyroid dysfunction. Regulatory texts detail the risks associated with such use.


Q: What are the official contraindications listed in the drug's regulatory information?

Official contraindications (reasons the drug must not be used) typically include known hypersensitivity (allergy) to the active substance or excipients. Contraindications also include hyperthyroidism and certain rare skin or vascular conditions.


Q: What are the most commonly reported side effects of Йодомарин 100?

Reported side effects are generally uncommon but include symptoms such as a skin rash, swelling of the salivary glands, or mild gastrointestinal disturbances, which are listed as possible undesirable effects. A full list is contained in the safety information section.


Q: Does Йодомарин 100 cause noticeable weight gain or loss?

Weight changes are not directly listed as common side effects. However, the drug is involved with the thyroid gland, and thyroid dysfunction is a potential, though rare, adverse reaction that can indirectly affect body weight.


Q: Are there any known serious allergic reactions associated with this medicine?

Yes, regulatory texts state that serious hypersensitivity (allergic) reactions are listed as possible side effects. Patients with a known iodide sensitivity should be particularly cautious.


Q: Is it normal to feel slight stomach discomfort when first starting the treatment?

Gastrointestinal disturbances are listed among the possible undesirable effects in official documentation. These may include feelings of nausea, vomiting, or stomach pain.


Q: Does Йодомарин 100 have a known effect on sleep patterns?

The official documentation on undesirable effects notes that continued administration may rarely lead to side effects like insomnia and nervousness.


Q: What signs are associated with consuming excessive iodine, based on regulatory descriptions?

Symptoms of acute overdose, known as Iodism, are described in regulatory documents. These signs may include a burning sensation in the mouth or throat, a metallic taste, severe headache, and irritation or swelling of the eyes and gums.


Q: Is it necessary to take the medicine at the exact same time every day?

Official instructions specify the dose is to be taken once daily, indicating the need for consistency in frequency. However, regulatory information does not typically specify a critical timing beyond the stated once-daily frequency.


Q: Does Йодомарин 100 interact with common multivitamin supplements?

Specific interactions with common multivitamins are generally not listed. However, caution is advised when co-administering this drug with any other supplements that contain high amounts of iodine or potassium, due to the potential risk of exceeding safe intake levels.


Q: Does taking certain thyroid hormones at the same time affect the action of Йодомарин 100?

Yes, regulatory documents indicate that the effect of this drug can be affected by co-administration with other thyroid-acting substances. For example, the drug's efficacy may be altered if taken alongside thyreostatics or lithium salts.


Q: Is it necessary to have blood or thyroid tests while taking this medicine?

Regulatory texts advise that monitoring of thyroid function is recommended during treatment, especially for patients with a history of thyroid disease or those taking the drug long-term. This monitoring may involve checking levels such as Thyroid-Stimulating Hormone (TSH).


Q: Can one stop taking the medicine suddenly without consulting official information?

For prophylaxis, the duration may be required for many years, and for goiter treatment, use should continue for the prescribed duration (e.g., 6–12 months) to meet the therapeutic goal. The use and cessation of this drug should align with the original therapeutic objective.


Q: Is Йодомарин 100 the same chemical composition as other common iodine solutions?

The active substance in this medicine is Potassium Iodide (KI). This is the same essential chemical compound used in various other iodide preparations.


Q: How does this drug differ from general iodine supplements sold over-the-counter?

This product is regulated as a medicinal product with a specific dosage and officially approved therapeutic indications. Unlike general dietary supplements, it is subject to stricter quality and efficacy regulations set by health authorities.


Q: What are the geographic regions where iodine deficiency is commonly addressed with this type of medicine?

The indication for 'endemic goiter' implies regions where iodine intake in the diet is naturally low. These areas are typically non-coastal or mountainous, where the soil lacks sufficient iodine.


Q: Does this medicine contain ingredients like lactose or gluten?

The official List of Excipients confirms that many formulations of this product contain lactose as a non-active ingredient. Regulatory texts do not typically list gluten unless it's a specific concern, but the lactose content is clearly documented.


Q: Why might people confuse this drug with high-dose potassium iodide tablets used for radiation protection?

The confusion arises because both products contain the active substance Potassium Iodide. However, this drug is a low-dose prophylactic medication for deficiency, while radiation protection tablets are a very high-dose emergency treatment with a completely different regulatory indication.


Q: Is there published long-term data on the safety profile of this medicine?

Yes, regulatory texts detail the risks associated with prolonged use, such as the potential for thyroid dysfunction. These warnings and monitoring recommendations are based on existing long-term safety data.


Q: What is the evidence supporting its use in preventing thyroid enlargement (goiter)?

The prevention of endemic goiter is explicitly approved by health authorities as one of the medicine's primary therapeutic indications. This approval is based on clinical evidence of its efficacy in populations with iodine deficiency.


Q: Which international regulatory bodies have reviewed and approved the use of Йодомарин 100?

The product is approved by national health authorities in the countries where it is sold. In Europe, this often includes agencies like the German Federal Institute for Drugs and Medical Devices (BfArM) and similar governing bodies, adhering to EU regulatory standards.


Q: Has research examined the effects of Йодомарин 100 on fertility or reproductive health?

Official product information often states that animal studies show no effect on fertility up to high doses. However, human data specifically detailing the effect on fertility is typically noted as unavailable in regulatory documents.


Q: Is there a maximum official duration for the use of this medication?

There is no single maximum duration specified. For prophylaxis (prevention), the use may be required for many years or indefinitely. However, for the treatment of goiter, the duration is typically time-limited, such as 6 to 12 months.


Q: Can Йодомарин 100 be used by people who have had thyroid surgery?

Yes, one of the primary therapeutic indications officially listed is the prevention of goiter recurrence following successful surgical removal or treatment for iodine-deficiency goiter.

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How should Йодомарин100 be stored and disposed of?

How to Store and Dispose of Йодомарин 100?

The official storage conditions for Йодомарин 100 define the precise requirements for maintaining the product's quality and stability.

Storage Requirements

Domain Official Requirement
Temperature Store between +5 C and +25 C.
Protection Keep in a dry place and protect from direct sunlight.
Safety Keep out of the reach of children.
Expiration Do not use the tablets after the expiry date printed on the label and outer carton.

These instructions structure the official storage profile, emphasizing that the medication must be stored within the specified temperature range and protected from light and moisture. Following these conditions and adhering to the printed expiry date ensures product integrity until the end of its shelf life. The requirement to keep the product out of the reach of children is a mandatory safety handling constraint.

Attention! Always consult to a doctor or pharmacist before using pills or medicines.

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