Exilak^® (Lacquer) Instructions for Use

Marketing Authorization Holder

Vertex, JSC (Russia)

ATC Code

D01AE (Other antifungal drugs for topical use)

Active Substances

Terbinafine (Rec.INN registered by WHO)

Econazole (Rec.INN registered by WHO)

Dosage Form

Exilak®

Medicinal nail lacquer 4%+3%: bottle 10 g 1 or 2 pcs.

Dosage Form, Packaging, and Composition

Medicinal nail lacquer in the form of a colorless or light yellow transparent solution, with an odor of ethanol; opalescence is allowed.

Excipients: hypromellose (hydroxypropylcellulose), methacrylic acid and ethyl acrylate copolymer (1:1) (partially neutralized methacrylic acid and ethyl acrylate copolymer), propylene glycol, ethanol 95% (ethyl alcohol 95%).

10 g – bottles (1) complete with nail files (30 pcs.) – cardboard packs.
10 g – bottles (2) complete with nail files (30 pcs.) – cardboard packs.

Clinical-Pharmacological Group

External antifungal drug

Pharmacotherapeutic Group

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

Pharmacological Action

Terbinafine is an allylamine derivative with a broad spectrum of antifungal activity.

In low concentrations, it exerts a fungicidal effect against fungi, including dermatophytes (Trichophyton rubrum, Trichophyton mentagrophytes, Trichophyton verrucosum, Trichophyton tonsurans, Trichophyton violaceum, Microsporum canis, Epidermophyton floccosum), yeast fungi (mainly Candida albicans), and certain dimorphic fungi (Pityrosporum orbiculare or Malassezia furfur).

Activity against yeast fungi, depending on the species, can be fungicidal or fungistatic.

Terbinafine specifically inhibits the early stage of sterol biosynthesis in the fungal cell.

This leads to ergosterol deficiency and intracellular accumulation of squalene, causing fungal cell death.

The action of terbinafine is carried out by inhibiting the enzyme squalene epoxidase in the fungal cell membrane.

Terbinafine does not affect the metabolism of hormones or other drugs.

Econazole is a synthetic imidazole derivative.

It exerts antifungal and antibacterial action.

It inhibits the biosynthesis of ergosterol, which regulates the permeability of the microorganism cell wall.

It is easily soluble in lipids and penetrates tissues well.

Active against dermatophytes Trichophyton, Microsporum, Epidermophyton, yeast-like fungi of the genus Candida, Corynebacterium minutissimum, as well as Malassezia furfur (Pityrosporum orbiculare), which causes tinea versicolor, and some gram-positive bacteria (streptococci, staphylococci).

The mechanism of action of both components is associated with disruption of fungal cell wall synthesis at different stages of the life cycle.

In vitro studies, the combination of terbinafine and econazole exhibited a synergistic effect.

Pharmacokinetics

Terbinafine

With topical application, absorption is less than 5%.

Terbinafine has a minor systemic effect.

Systemic bioavailability is extremely low.

Econazole

With topical application, it penetrates all layers of the skin and the nail plate.

Therapeutic concentrations are achieved in the stratum corneum and other layers of the epidermis, as well as in the dermis.

When applied to the skin, systemic absorption is insignificant.

Indications

Onychomycosis.

ICD codes

Dosage Regimen

Apply the lacquer topically to the affected nail plates once daily.

Before the first application, remove the affected parts of the nails using the supplied nail file.

Clean and degrease the nail surface prior to each application.

Apply a thin layer of lacquer, covering the entire surface of the affected nail, the surrounding skin fold, and the underside of the nail plate tip if possible.

Allow the applied layer to dry completely.

The duration of treatment is determined by the rate of healthy nail regrowth and the severity of infection.

Continue treatment without interruption until the nail is completely regenerated and clinically cured.

Do not exceed a maximum treatment duration of six months.

For optimal results, avoid nail polish or artificial nails on treated nails.

Perform weekly removal of the lacquer film using a nail file or solvent, followed by reapplication.

Irregular use or premature discontinuation of therapy significantly increases the risk of disease recurrence.

Adverse Reactions

With topical application of terbinafine, skin peeling, itching, burning, erythema, skin damage, crusting, pigmentation disorders, contact dermatitis, eczema, and rash may be observed at the application sites.

With topical application of drugs containing econazole, local adverse reactions in the form of itching, irritation and skin hyperemia, urticaria, dryness, pigmentation disorders, and skin atrophy are possible.

According to clinical studies, contact dermatitis was noted in patients using this combination.

Contraindications

Hypersensitivity to terbinafine and/or econazole; pregnancy; breastfeeding period; age under 18 years.

Use in Pregnancy and Lactation

The use of this combination is contraindicated during pregnancy and breastfeeding.

Pediatric Use

Contraindicated for use under 18 years of age.

Special Precautions

This combination should not be used for more than 6 months.

The drug should not be applied to the skin.

Avoid contact with eyes and mucous membranes.

If the lacquer gets into the eyes or on mucous membranes, rinse them immediately with plenty of water.

Persons working with organic solvents should wear impermeable gloves to protect nails coated with the product containing this combination.

Irregular use or premature termination of treatment increases the risk of relapse.

Drug Interactions

Due to low systemic bioavailability with topical application, clinically significant interaction is unlikely.

However, cases of interaction with oral anticoagulants have been reported with topical application of econazole preparations.

Patients taking oral anticoagulants, such as warfarin or acenocoumarol, should exercise caution; monitoring of the anticoagulant effect should be performed.

Storage Conditions

Store at 2°C (36°F) to 25°C (77°F). Keep in original packaging, protected from light. Keep out of reach of children.

Dispensing Status

Over-the-Counter

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.