9 months Potassium iodide (Tablets) Instructions for Use

Marketing Authorization Holder

Valenta Pharm, JSC (Russia)

ATC Code

H03CA (Iodine preparations)

Active Substance

Potassium iodide (Ph.Eur. European Pharmacopoeia)

Dosage Form

9 months Potassium iodide

Tablets 200 mcg: 50 or 100 pcs.

Dosage Form, Packaging, and Composition

Tablets are white or almost white, flat-cylindrical with a bevel.

Excipients: calcium hydrogen phosphate dihydrate, microcrystalline cellulose, colloidal silicon dioxide (aerosil), hypromellose, magnesium stearate, talc.

25 pcs. – blister packs (2) – cardboard packs.
25 pcs. – blister packs (4) – cardboard packs.

Clinical-Pharmacological Group

Iodine preparation for the prevention and treatment of thyroid diseases

Pharmacotherapeutic Group

Thyroxine synthesis regulator – iodine preparation

Pharmacological Action

When iodides enter the cells of the follicular epithelium of the thyroid gland, iodide ions are oxidized under the influence of the enzyme iodide peroxidase to form elemental iodine, which is incorporated into the tyrosine molecule. In this case, one part of the tyrosine radicals in thyroglobulin is iodinated, resulting in the formation of thyronines, the main ones being thyroxine (T₄) and triiodothyronine (T₃). The resulting complex of thyronines and thyroglobulin is released as a stored form of the thyroid hormone into the follicular colloid and remains in this state for several days or weeks. In case of iodine deficiency, this process is disrupted.

Potassium iodide, compensating for iodine deficiency, helps restore impaired synthesis of thyroid hormones, normalizes the T₃/T₄ ratio, thereby normalizing thyroid function and eliminating the symptoms of iodine deficiency.

Pharmacokinetics

Absorption is rapid and complete. Plasma concentration is 0.1-0.5 mcg/dL. It is intensively absorbed by the thyroid gland, where it is oxidized to iodine. It substrate-provides iodination of tyrosine in the thyroid gland with the formation of mono- and diiodotyrosine, T₃ and T₄. It also accumulates in the salivary and lactating mammary glands, and gastric tissue (the content in saliva, milk, and gastric juice exceeds the plasma level by 30 times).

It is excreted by the kidneys, partially by the bronchial, salivary, and lacrimal glands.

Indications

• Prevention of iodine deficiency in the body of women during pregnancy and breastfeeding, when dietary iodine intake is less than 150-300 mcg/day.

ICD codes

Dosage Regimen

Orally, with meals, with plenty of fluid. Use after consultation with a doctor.

Prevention of iodine deficiency in the body of women during pregnancy and breastfeeding: 9 months Potassium iodide is prescribed at a dose of 200 mcg/day (1 tab.), and simultaneous administration of other iodine-containing drugs is not recommended. The duration of the course is determined by the doctor.

Adverse Reactions

When using 9 months Potassium iodide according to the indications in recommended doses, the occurrence of side effects is unlikely.

Allergic reactions: skin rash, angioedema.

Contraindications

• Overt and latent hypothyroidism;
• Dermatitis herpetiformis;
• Hypersensitivity to iodine.

Potassium iodide should not be taken for hypothyroidism, except in cases where its development is caused by severe iodine deficiency. Prescribing the drug should be avoided during radioactive iodine therapy, in the presence of or suspicion of thyroid cancer.

Use in Pregnancy and Lactation

During pregnancy and lactation, the need for iodine increases. 9 months Potassium iodide is prescribed according to indications in cases where dietary iodine intake is less than 150-300 mcg/day.

The drug penetrates the placenta well and, when taken in doses above 500 mcg/day, can cause the development of hypothyroidism and goiter in the fetus. Iodine is also excreted in breast milk. When used by the mother during lactation in doses exceeding 1000 mcg/day, there is a risk of developing hypothyroidism in the breastfed infant.

Therefore, during pregnancy and lactation, the drug should be used only in recommended doses.

Use in Renal Impairment

During therapy in patients with renal insufficiency, hyperkalemia may develop.

Special Precautions

Long-term use of potassium iodide in doses exceeding 1000 mcg/day causes a decrease in iodine absorption by the thyroid gland and the synthesis of thyroid hormones, which subsequently manifests as hypothyroidism and the occurrence of goiter.

During therapy in patients with renal insufficiency, hyperkalemia may develop.

Overdose

Symptoms: brown staining of the mucous membranes, vomiting, abdominal pain, and diarrhea (melena is possible). In severe cases, dehydration and shock may develop.

Treatment: gastric lavage, administration of sodium thiosulfate, symptomatic therapy for water-electrolyte imbalance, anti-shock therapy.

Chronic overdose can lead to the development of the phenomenon of iodism: “metallic” taste in the mouth; swelling and inflammation of the mucous membranes (rhinitis, conjunctivitis, gastroenteritis, bronchitis); acne; dermatitis; swelling of the salivary glands; fever; nervous excitability.

Treatment for chronic overdose: drug withdrawal.

Drug Interactions

Antithyroid drugs and Potassium iodide mutually weaken each other’s effects.

Potassium perchlorate and potassium thiocyanate suppress iodine uptake by the thyroid gland.

Thyroid-stimulating hormone improves iodine uptake by the thyroid gland and stimulates the production of its hormones.

Concomitant use of angiotensin-converting enzyme inhibitors (including captopril, enalapril, lisinopril) increases the risk of hyperkalemia.

High doses of iodine in combination with potassium-sparing diuretics can lead to hyperkalemia.

Concomitant administration of high-dose iodine therapy and lithium preparations promotes the development of goiter and hypothyroidism.

Storage Conditions

Store the drug in a dry place, protected from light, at a temperature not exceeding 25°C (77°F). Keep out of reach of children.

Shelf Life

Shelf life – 2 years. Do not use after the expiration date.

Dispensing Status

The drug is approved for use as an over-the-counter product.

Important Safety Information

This information is for educational purposes only and does not replace professional medical advice. Always consult your doctor before use. Dosage and side effects may vary. Use only as prescribed.