Instructions for use Iodide-Farmak tablets 200 mcg blister No. 50
Composition
active ingredient: potassium iodide;
1 tablet contains potassium iodide in terms of dry matter 130.8 mcg or 261.6 mcg and iodine 100 mcg or 200 mcg;
Excipients: lactose monohydrate, microcrystalline cellulose, heavy magnesium carbonate, sodium thiosulfate, colloidal anhydrous silicon dioxide, povidone, magnesium stearate.
Dosage form
Pills.
Main physicochemical properties: tablets of white or white with a yellowish tinge, with a flat surface, a score and a bevel.
Pharmacotherapeutic group
Drugs for the treatment of thyroid diseases. Thyroid drugs. Iodine drugs.
ATX code H03C A.
Pharmacological properties
Pharmacodynamics.
Iodide-Farmak® is an inorganic iodine preparation. 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 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 (thyroxine hormone - T4) and 3-iodine derivative (triiodothyronine hormone - T3). Thyronines form a complex with the protein thyroglobulin, which is deposited in the colloid of the thyroid 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, adolescents and young adult patients; affects the T3/T4 ratio and TSH levels.
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; accumulates in the thyroid gland, kidneys, stomach, mammary and salivary glands. The volume of distribution in a healthy person is on average 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 with food.
Clinical characteristics.
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 preparations.
Treatment of diffuse euthyroid iodine-deficiency goiter in children, including newborns, and adults.
Contraindication
Hypersensitivity or history of hypersensitivity to the active substance or other components of the drug. Severe hyperthyroidism. Latent hyperthyroidism in doses exceeding 150 mcg of iodine per day. Presence of autonomous adenoma, as well as focal and diffuse autonomous foci of the thyroid gland in a dose of 300 to 1000 mcg of iodine per day (except for preoperative iodine therapy for the purpose of Plummer's thyroid blockade). 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 inhibit the conversion of iodine to organic compounds in the thyroid gland and, thus, can cause goiter formation.
Substances that are taken up by the thyroid gland by the same "capture" mechanism as iodide can inhibit iodine uptake by the thyroid gland in a competitive manner (e.g., perchlorate, which also inhibits iodide recycling within the thyroid gland). Drugs that are not themselves absorbed, such as thiocyanate at concentrations above 5 mg/dL, can also inhibit iodine uptake.
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 the secretion of thyroid hormones, and lithium salts may contribute to the development of goiter and hypothyroidism.
High doses of potassium iodide in combination with potassium-sparing diuretics can cause hyperkalemia.
Simultaneous use with plant alkaloids and heavy metal salts may lead to the formation of an insoluble precipitate and complicate the absorption of iodine.
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 case of radioactive iodine therapy, presence or suspicion of thyroid cancer. It should be taken into account that during therapy with the drug in patients with renal failure, the development of hyperkalemia is possible.
Iodide-Farmak® contains lactose. Patients with rare hereditary problems of galactose intolerance, the Lapp lactase deficiency or glucose-galactose malabsorption should not take Iodide-Farmak®.
Use during pregnancy or breastfeeding
During pregnancy or breastfeeding, the need for iodine is increased, so a sufficient intake of iodine into the body (250 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 the drug, 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
Does not affect.
Method of administration and doses
Prevention of iodine deficiency and endemic goiter (in cases where the intake of iodine in the adult body is less than 150 - 200 mcg/day).
Infants and children under 12 years of age: 50 - 100 mcg of iodine per day (½ - 1 tablet of Iodid-Farmak®). To be able to dose 50 mcg of iodine, medicines with an appropriate content of the active substance should be used.
Children over 12 years of age and adults: 100–200 mcg of iodine per day (1–2 tablets of Iodid-Farmak®).
Pregnancy or breastfeeding: 200 mcg of iodine per day (1 - 2 tablets of Iodid-Farmak®).
Prevention of recurrence of iodine-deficiency goiter after surgical treatment, as well as after completion of complex treatment with thyroid hormone preparations.
Children and adults: 100 – 200 mcg of iodine per day (1-2 tablets of Iodide-Farmak®).
Treatment of diffuse euthyroid iodine-deficiency goiter.
Infants and children: 100-200 mcg of iodine per day (1-2 tablets of Iodid-Farmak®).
Adults: 300 – 500 mcg of iodine per day (1½ to 5 tablets of Iodid-Farmak®).
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 drug in crushed form, mixed with food. The drug is used for preventive purposes, as a rule, for several months or years, and more often - throughout life. 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. The dosage and duration of use of the drug for preventive measures or for the treatment of thyroid diseases is decided by the doctor individually.
Children. The drug is used in children.
Overdose
Symptoms of intoxication: brown discoloration of the mucous membranes, reflex vomiting (blue vomiting 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 has been noted. Fatal cases have been observed. 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 irritation 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 normalize water and electrolyte balance, 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 form of the course: mild forms usually do not require treatment, in severe forms, thyreostatic therapy is used (the effectiveness of which is manifested with a delay). In severe cases (thyrotoxic crisis), intensive therapy, plasmapheresis or thyroidectomy are necessary.
Adverse reactions
With prophylactic use of iodide at any age, as well as with therapeutic use in infants, children and adolescents, undesirable effects are usually not observed. However, in the presence of large foci of thyroid autonomy and when iodine is prescribed in daily doses exceeding 150 μg, it is impossible to completely exclude the appearance 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 (≥ 1/10,000 to < 1/1,000); very rare (< 1/10,000), not known (cannot be estimated from the available data).
On the part of the endocrine system: very rarely: in the treatment of diffuse euthyroid iodine-deficient goiter in adults (daily dose from 300 to 1000 μg of iodine), in some cases, the development of iodine-induced hyperthyroidism is possible. In the vast majority of cases, the prerequisite for this is the presence of diffuse or limited areas of thyroid autonomy. This primarily applies to elderly patients who have had goiter for a long time.
Immune system disorders: very rare: hypersensitivity reactions (such as iodine-induced rhinitis, bullous or tuberous iododerma, exfoliative dermatitis, angioedema, fever, acne and salivary gland swelling).
Also possible: manifestations of iodism (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 used in high doses, goiter and hypothyroidism may occur in some cases.
Expiration date
5 years.
Do not use the drug after the expiration date indicated on the package.
Storage conditions
Store in a place protected from light and out of reach of children at a temperature not exceeding 25 °C.
Packaging
10 tablets in a blister; 5 blisters in a pack.
Vacation category
Without a prescription.
Producer
JSC "Farmak".
Location of the manufacturer and its business address.
Ukraine, 04080, Kyiv, Kyrylivska St., 74.
