Nitrofungin-Teva (Solution) Instructions for Use

Marketing Authorization Holder

Teva Pharmaceutical Industries, Ltd. (Israel)

Manufactured By

Teva Czech Industries, s.r.o. (Czech Republic)

ATC Code

D01AE (Other antifungal drugs for topical use)

Active Substance

Chlornitrophenol (Grouping name)

Dosage Form

Nitrofungin-Teva

Topical solution 1%: 25 mL bottle

Dosage Form, Packaging, and Composition

Topical solution transparent, from yellow to greenish-yellow in color, with the odor of ethanol.

Excipients: triethylene glycol, ethanol 96%, purified water.

25 ml – dark glass bottles (1) – cardboard packs.

Clinical-Pharmacological Group

External antifungal drug

Pharmacotherapeutic Group

Antifungal agents used in dermatology; external antifungal agents; other external antifungal agents

Pharmacological Action

Antifungal agent. At a solution concentration of 0.0001%, it inhibits the growth of Microsporum canis, Trichophyton gypseum; at a concentration of 0.0007%, it inhibits the growth of Candida albicans; when the content of the active substance is increased to 0.003%, it exhibits a fungicidal effect.

At a higher concentration, it has an antibacterial effect against gram-positive and gram-negative bacteria.

Indications

Fungal skin lesions:

• Rubrophytia;
• Tinea cruris;
• Trichophytosis;
• Skin candidiasis;
• Foot mycoses;
• Fungal diseases of the external auditory canal.

ICD codes

Dosage Regimen

Apply the solution externally to the affected skin areas using a cotton swab.

Use the solution two to three times daily until clinical manifestations of the fungal infection resolve completely.

To prevent relapse after the initial treatment course, continue application two to three times per week for an additional four to six weeks.

For preventive purposes in individuals with a history of mycosis, apply the solution once to twice weekly for a duration of four weeks.

If a pronounced irritant effect occurs with daily application, dilute the solution with an equal volume of water (1:1 ratio) before use.

Avoid exposing treated skin areas to direct sunlight due to the risk of photodermatitis.

Adverse Reactions

Local irritant effect, photodermatitis, allergic reactions.

Contraindications

• Hypersensitivity to the components of the drug.

Use in Pregnancy and Lactation

Use during pregnancy is possible only in cases where the potential benefit to the mother outweighs the possible risk to the fetus.

During lactation, the issue of discontinuing breastfeeding should be decided.

Special Precautions

In case of a pronounced irritant effect with daily use, a solution diluted with water (1:1) can be used.

Areas of the skin treated with the drug should not be exposed to sunlight.

Drug Interactions

Not known.

Storage Conditions

Store at a temperature between 10°C (50°F) and 25°C (77°F), in a light-protected place, out of the reach of children.

Shelf Life

Shelf life – 5 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.