Potassium iodide - instructions for use, dose, side effects, contraindications

Active substance: potassium iodide - 0.131 mg, in terms of iodine - 0.100 mg. Excipients: lactose monohydrate (sugar milk) - 83,169 mg, microcrystalline cellulose - 12,000 mg, sodium carboxymethyl starch - 2,000 mg, corn starch - 1,200 mg, silicon dioxide colloid - 0.500 mg, magnesium stearate -1,000 mg.

Composition per 1 tablet 0.2 mg

Active substance: Potassium iodide - 0.262 mg, converted to iodine - 0.200 mg. Excipients: lactose monohydrate (milk sugar) - 83,038 mg, microcrystalline cellulose - 12,000 mg, sodium carboxymethyl starch - 2.000 mg, corn starch - 1,200 mg. silicon dioxide colloid - 0,500 mg, magnesium stearate - 1,000 mg.

Description:

0.1 mg: round biconvex tablets white or almost white, with a risk on one side.

0.2 mg: round flat-cylindrical tablets of white or almost white color, with a risk on one side and with a bevel.

Pharmacotherapeutic group:Thyroxine synthesis regulator - iodine drug

ATX: & nbsp

H.03.C.A Preparations of iodine

Pharmacodynamics:

Iodine is irreplaceable microelements necessary for normal functioning of the thyroid gland. When iodides enter the epithelial cells of the thyroid follicle, iodine ions under the influence of iodide-peroxidase enzyme are oxidized to form elemental iodine, which is included in the tyrosine molecule. In this case, one part of the tyrosine radicals in thyroglobulin is iodinated, resulting in the formation of tyronins, the main ones being thyroxine (T₄) and triiodothyronine (T₃). Tyronins form a complex with protein thyroglobulin, which is deposited in the colloid of the thyroid follicle. Iodine, entering the body in physiological quantities, prevents the development of endemic goiter (associated with a lack of iodine in food); normalizes the size of the thyroid gland in newborns, children and adolescents; and also affects the ratio T₃/ T₄, the concentration of thyroid-stimulating hormone.

Pharmacokinetics:

When ingested quickly and completely absorbed in the small intestine and within 2 hours is distributed in the intracellular space.

It accumulates mainly in the thyroid gland (concentration of iodide more than 0.5 mg / g of tissue), as well as in the salivary and mammary glands, the mucous membrane of the stomach.

It penetrates well through the placenta.

It is excreted mainly by the kidneys (trace amounts are determined in the urine 10 minutes after the admission, 80% of the dose is excreted within 48 hours, the rest - within 10-20 days), in part - with the secrets of the salivary, bronchial, sweat and other glands.

Indications:

- Prevention of endemic goiter, including during pregnancy;

- prevention of recurrence of goiter after completion of the treatment of goiter with drugs of thyroid hormones or after its surgical removal;

- treatment of diffuse euthyroid goiter in newborns, children, adolescents and adult patients of young age.

Contraindications:

- Hypersensitivity to iodine;

- severe thyrotoxicosis;

- latent thyrotoxicosis (with the use of doses exceeding 0.15 mg / day);

- herpetiform dermatitis;

- toxic adenoma, nodular goiter when used in doses more than 0.3 mg / day (with the exception of preoperative therapy for the purpose of blocking the thyroid gland);

- hereditary diseases associated with intolerance to galactose, deficiency of lactase or glucose-galactose malabsorption.

Potassium Iodide should not be taken with hypothyroidism, except when the development of the latter is caused by a pronounced iodine deficiency. Use of the drug should be avoided with radioactive iodine therapy, the presence or suspected of thyroid cancer.

Carefully:

In patients with impaired renal function.

Pregnancy and lactation:

During pregnancy and breastfeeding, the need for iodine increases. Potassium iodide appoint according to the indications in those cases when the intake of iodine from food is less than 0.15-0.3 mg / day.The drug penetrates well through the placenta and can cause the development of hypothyroidism and goiter in the fetus. Iodine also excreted in breast milk. Therefore, during pregnancy and breastfeeding, the drug should be used only at recommended doses.

Dosing and Administration:

The daily dose of the drug should be taken orally in a single meal, after eating, with plenty of liquid.

When using the drug in newborns and children under 3 years, it is recommended to dissolve the tablet in a small amount (1 tablespoon) of boiled water at room temperature.

Recommended doses (in terms of iodine):

Prevention of endemic goiter:

newborns and children: 0.1 mg / day;

adolescents and adults: 0,1-0,2 mg / day;

during pregnancy and during breastfeeding: 0,15-0,2 mg / day;

Preventive maintenance of a recurrence of a struma after end of a course of treatment of a struma by preparations of hormones of a thyroid gland or after its surgical removal: 0.1-0.2 mg / day.

Treatment of euthyroid goiter:

newborns, children and adolescents: 0,1-0,2 mg / day;

adult patients of a young age: 0,3-0,5 mg / day.

The drug is taken for prophylactic purposes, usually for several months or years, if there is evidence - for life.

Treatment of goiter in newborns is carried out in most cases within 2-4 weeks; in children, adolescents and adults usually takes 6-12 months, a long reception is possible. The duration of treatment is determined by the attending physician.

Side effects:

When using the drug according to the indications in the recommended doses, the occurrence of side effects is unlikely.

There may be allergic reactions: rarely - skin rash, swelling Quincke.

Overdose:

When using the drug in a dose exceeding 0.15 mg / day, latent hyperthyroidism can go into a manifest form.

With prolonged use of the drug in a dose exceeding 0.3 mg / day. possibly the development of iodine-induced hyperthyroidism (especially in elderly patients, in the presence of nodular goiter or toxic adenoma).

Symptoms of acute overdose: staining the mucous membranes in brown, reflex vomiting, abdominal pain and diarrhea (possibly, melena). In severe cases, the development of dehydration and shock is possible.

Treatment for acute overdose: gastric lavage, administration of sodium thiosulfate, symptomatic therapy of water-electrolyte balance disturbance, antishock therapy.

Chronic overdose It can lead to the phenomenon of "yodizma", "metallic" aftertaste in the mouth, edema, and mucosal inflammation (rhinitis, conjunctivitis, gastroenteritis, bronchitis), acne, dermatitis, edema, salivary glands, fever, and irritability.

Treatment for chronic overdose: cancellation of the drug.

Interaction:

Simultaneous reception of antithyroid medications weakens the effect of potassium iodide (mutually).

Perchlorate and potassium thiocyanate inhibit the absorption of iodine by the thyroid gland. Thyrotropic hormone improves the absorption of iodine by the thyroid gland and stimulates the production of its hormones.

Simultaneous administration of inhibitors of angiotensin-converting enzyme (including captopril, enalapril, lisinopril) increases the risk of hyperkalemia. High doses of iodine in combination with potassium-sparing diuretics can lead to hyperkalemia.

Simultaneous administration of iodine therapy in high doses and lithium preparations promotes the development of goiter and hypothyroidism.

Reduces thyroid involvement ¹³¹I and ¹²³I.

Special instructions:

Before the beginning of treatment it is necessary to exclude malignant lesion of the thyroid gland, hyperthyroidism or nodal toxic goiter.

On the background of drug therapy in patients with impaired renal function, it is possible to develop hyperkalemia (periodic monitoring of the potassium concentration in the blood is necessary). Due to the presence of lactose monohydrate in the formulation, patients with rare hereditary diseases associated with intolerance to galactose, deficiency of lactase or glucose-galactose malabsorption, should not take the drug.

Effect on the ability to drive transp. cf. and fur:The drug does not affect the ability to drive vehicles and engage in other potentially hazardous activities that require increased concentration and speed of psychomotor reactions.

Form release / dosage:

Tablets 0.1 mg, 0.2 mg.

Packaging:

By 10, 30 or 50 tablets in a contour cell pack of film polyvinylchloride and aluminum foil printed lacquered.

For 10, 20, 30, 40, 50 or 100 tablets in cans of polyethylene terephthalate or cans of polymer from polypropylene for medicines.

One jar or 1, 2, 3, 4, 5, 6, 7, 8, 9 or 10 contour mesh packages together with the instruction for use are placed in a cardboard package (bundle).

Storage conditions:

In the dark place at a temperature of no higher than 25^aboutFROM.

Keep out of the reach of children.

Shelf life:

3 years.

Do not use after the expiration date.

Terms of leave from pharmacies:Without recipe

Registration number:LP-002954

Date of registration:10.04.2015

Expiration Date:10.04.2020

The owner of the registration certificate:ATOLL, LLC ATOLL, LLC Russia

Manufacturer: & nbsp

OZONE, LLC Russia

Information update date: & nbsp20.11.2017

Illustrated instructions

Instructions

Potassium iodide (Potassium iodide)