TEOBON-DITHIOMIKOTSID

INSTRUCTIONS for medical use of the medicinal product THEOBON-DIOTHIOCYCID

Composition:

active substance: potassium N-(1,1-dioxothiolan-3-yl)dithiocarbamate;
1 g of ointment contains potassium N-(1,1-dioxothiolan-3-yl)dithiocarbamate 50 mg;

excipient: white soft paraffin.

Pharmaceutical form. Ointment.

Main physicochemical properties: ointment of white or light-yellow color with a weak specific odor.

Pharmacotherapeutic group. Antifungal agents for topical use.
ATC code D01AE.

Pharmacological properties.

Pharmacodynamics. The medicinal product exerts a pronounced fungicidal effect against Candida albicans, Candida tropicalis, Trichophyton rubrum, Microsporum canis, and a bactericidal effect against gram-positive and gram-negative microorganisms. Teobon-dithiomycocid is a low-toxicity agent. It does not exhibit carcinogenic, allergenic, mutagenic, or teratogenic effects and does not accumulate in the body.

Pharmacokinetics. The medicinal product does not produce skin-resorptive or irritating effects and does not enter the systemic circulation.

Clinical characteristics.

Indications. Treatment and prevention of fungal skin infections.

Contraindications. Individual hypersensitivity to the medicinal product.

Safety precautions. The medicinal product is intended for external use only. Consult a physician before starting treatment!

Interaction with other medicinal products and other forms of interactions. Not studied.

Usage Notes.

Use during pregnancy or breastfeeding. There is no experience with the use of the medicinal product during pregnancy and breastfeeding.

Ability to affect reaction rate when driving or operating machinery. Not studied.

Method of Administration and Dosage.

Apply the ointment in a thin layer to the affected area of skin 1–2 times daily and gently rub in with light movements, including a small area of surrounding skin. Moist eroded skin areas should be dried with a gauze pad before applying the ointment. Signs of improvement appear within 3–5 days after starting treatment; the treatment course lasts 12–14 days.

Children. Do not use in children due to lack of clinical experience.

Overdose. Data regarding overdose of the medicinal product are lacking.

Side effects.

Possible hypersensitivity reactions, including hyperemia, itching.

Shelf life. 2 years.

Storage conditions. Store in a dry, dark place, protected from light and inaccessible to children, at a temperature not exceeding 25 °C.

Packaging. 15 g of ointment in a tube, 1 tube per cardboard box.

Availability. Over-the-counter (without prescription).

Manufacturer/Marketing authorization holder. State Enterprise "Experimental Plant of Medical Drugs of the Institute of Organic Chemistry and Petrochemistry of the National Academy of Sciences of Ukraine" / V.P. Kukhar Institute of Organic Chemistry and Petrochemistry of the National Academy of Sciences of Ukraine.

Manufacturer's address and place of business. 15-A, Zroshuvalna Street, Kyiv, 02099, Ukraine.