Potassium iodide

INSTRUCTIONS FOR MEDICAL USE OF THE MEDICINAL PRODUCT POTASSIUM IODIDE (POTASSIUM IODIDE)

Composition:

Active substance: potassium iodide;

1 ml of solution contains 20 mg of potassium iodide;

Excipients: sodium chloride, sodium thiosulfate, disodium edetate, chlorhexidine diacetate, sodium hydroxide, water for injections.

Pharmaceutical form. Eye drops, solution.

Main physicochemical properties: clear, colorless solution free from mechanical particles.

Pharmacotherapeutic group. Medicinal products used in ophthalmology. ATC Code S01XA04.

Pharmacological Properties

Pharmacodynamics

Potassium iodide 2% is an ophthalmological, anti-sclerotic, and resorptive medicinal agent. The active ingredient of iodine drops is iodine, present in microdoses. Due to this, the preparation activates metabolic processes and affects protein and lipid metabolism, resulting in increased blood lipoprotein levels and enhanced fibrinolytic activity. Iodide ions increase the dispersibility of colloids, leading to reduced blood viscosity. Decreased colloidal dispersibility correlates with signs of aging and atherosclerosis. These effects, combined with extensive clinical experience in using iodine therapeutically, indicate that iodine salts prevent the development of atherosclerotic processes or reduce their intensity. The action of iodide ions on colloids is associated with vasodilation, resulting in improved tissue perfusion.

The use of iodine-containing eye drops is the only treatment approach when there is no direct effect on the site of pathology or when the affected area is inaccessible. Iodine compounds exert a direct influence on the resorption process, particularly in recently diagnosed cases. In the case of developed senile cataract, it is unlikely to halt the process completely; however, its progression (cataract growth, reduction in visual acuity) can be slowed by using iodides.

Pharmacokinetics

After instillation into the conjunctival sac, iodides penetrate into ocular structures; however, detailed information on the distribution of iodides within ocular tissues is lacking. Following instillation into the conjunctival sac, a portion of iodides is absorbed into the systemic circulation. They reach the nasal cavity via the nasolacrimal duct and are absorbed into the systemic circulation through the nasal mucosa.

Iodine is excreted very slowly from the body. Potassium iodide (an inorganic ionic compound) is not metabolized. The corresponding ions (K+, I-) are excreted by the kidneys.

Clinical characteristics.

Indications.

Support of resorption processes in the eyes, particularly in the presence of inflammatory exudates, hemorrhages, and opacities of the vitreous body of various etiologies (age, high arterial pressure, diabetes mellitus), in myopic and atherosclerotic changes of retinal and choroidal vessels, retinal degenerative processes, early-stage cataracts, optic nerve atrophy (due to syphilis), as well as an adjunctive treatment in the management of fungal conjunctivitis and keratitis.

Contraindications.

• Hypersensitivity to the active substance or other components of the drug;
• Chronic facial pyoderma, hemorrhagic diathesis, and thyroid gland dysfunction.

Interaction with other medicinal products and other types of interactions.

Since a portion of iodine and iodides may be absorbed into the systemic circulation through the nasal mucosa (after reaching the nose via the nasolacrimal duct) following local instillation into the conjunctival sac, potential interactions with other medicinal products used by the patient should be taken into account.

Prolonged use may affect laboratory measurements of protein-bound iodine levels in blood serum or interfere with test results involving radioactive iodine used in the evaluation of thyroid disorders.

Special precautions for use.

In fungal diseases of the anterior segment of the eye, specific targeted therapy should be applied (iodine treatment is only an adjunctive therapy).

Patients must not wear soft contact lenses during use of the medicinal product. Also, rigid contact lenses should not be used during treatment, or, at the very least, the patient must always remove them before applying the medicinal product and may reinsert them no sooner than 20 minutes after instillation of the drops.

Use during pregnancy or breastfeeding.

Contraindicated.

Ability to affect reaction speed when driving vehicles or operating machinery.

There is no information regarding negative effects of the drug on the ability to perform tasks requiring high attention (such as driving vehicles or operating machinery). However, blurred vision may occur immediately after instillation of the medicinal product; therefore, it is recommended to refrain from such activities for 15 minutes after administration of the drug.

Method of administration and dosage.

Method of administration: instill into the lower conjunctival sac of the eye.

Recommended dosage for adults (including elderly patients) and children.

The dosage and duration of treatment should be determined by a physician. The usual dosage is 1–2 drops 2–4 times daily.

As with the use of any solution in the form of eye drops, it is recommended to gently press on the area of the lacrimal sac located at the inner corner of the eye to reduce potential systemic absorption, and release it after one minute following instillation of the drops. This should be done immediately after administration of each drop.

Contact lenses should be removed before instilling eye drops; they may be reinserted 20 minutes after administration.

If more than one topical ophthalmic agent is used, the interval between applications of different agents should be at least 5 minutes.

Children.

The medication must not be used in newborns.

Overdose.

Overdose has not been observed with the use of recommended doses. In case of accidental ingestion of the medication by a child, symptomatic treatment should be administered.

Adverse reactions.

The drug is usually well tolerated.

Adverse reactions are classified according to their frequency of occurrence: very common (≥1/10), common (≥1/100 to <1/10), very rare (<1/10,000).

Very common: In thyroid disorders, a negative effect on thyroid function may be observed.

Common: A mild burning sensation may occur immediately after instillation.

Very rare: Iodine is very slowly eliminated from the body; therefore, prolonged and uncontrolled use (in excessive doses) may cause the so-called condition of iodism in sensitive patients. Symptoms of this condition include irritation and hyperemia of the conjunctiva, increased lacrimation, eyelid edema (angioneurotic edema), and lacrimal gland swelling. Skin manifestations may include erythema, acne, dermatitis, and purpura, as well as hypersensitivity reactions including rash and pruritus.

Shelf life.

3 years.

The shelf life of the product after first opening of the container is 28 days.

Storage conditions.

Store in a place inaccessible to children, at a temperature not exceeding 25 °C, in the original packaging. Do not freeze. After first opening, do not store for more than 28 days.

Packaging.

10 ml in a plastic dropper container closed with a tamper-evident cap.

1 dropper container with a package leaflet for medical use in a cardboard box.

Prescription status.

Prescription only.

Manufacturer.

LLC "UNIMED PHARMA" / "UNIMED PHARMA Ltd".

Manufacturer's address and location of business activity.

Orieskova 11, 821 05 Bratislava, Slovak Republic /
Orieskova 11, 821 05 Bratislava, Slovak Republic