Amorolak^® (Lacquer) Instructions for Use

Marketing Authorization Holder

Sun Pharmaceutical Industries, Ltd. (India)

ATC Code

D01AE16 (Amorolfine)

Active Substance

Amorolfine (Rec.INN registered by WHO)

Dosage Form

Amorolak®

Medicated nail lacquer 5%: bottle 2.5 ml or 5 ml

Dosage Form, Packaging, and Composition

Medicated nail lacquer is a transparent, colorless or almost colorless liquid with a characteristic odor.

Excipients: butyl acetate, ethyl acetate, triacetin, copolymer of methyl methacrylate, trimethylammonioethyl methacrylate chloride and ethyl acrylate (2:0.2:1), anhydrous ethanol.

2.5 ml – bottles (1) – cardboard packs (complete with applicators – 30 pcs., nail files – 30 pcs., and tampons – 30 pcs.)
5 ml – bottles (1) – cardboard packs (complete with applicators – 30 pcs., nail files – 30 pcs., and tampons – 30 pcs.)

Clinical-Pharmacological Group

External antifungal drug

Pharmacotherapeutic Group

Antifungal agent

Pharmacological Action

Antifungal agent for external use. It has fungistatic and fungicidal action.

It damages the fungal cell membrane, mainly by disrupting sterol synthesis. It reduces ergosterol content and causes the accumulation of abnormal non-planar stereoisomers of sterols.

It is active against yeasts of the genus Candida spp., Pityrosporum spp., Malassezia spp., Cryptococcus spp., dermatophytes (Trichophyton spp., Microsporum spp., Epidermophyton spp.), molds (Alternaria, Hendersonula, Scopulariopsis), Dematiaceae fungi (Cladosporium, Fonsecaea, Wangiella), dimorphic fungi (Coccidioides, Histoplasma spp., Sporothrix) and actinomycetes.

Pharmacokinetics

When applied externally in appropriate dosage forms, systemic absorption is negligible.

Indications

• Onychomycosis caused by dermatophytes, yeasts, and molds.

Use only when no more than 2/3 of the nail plate is affected by the infection.

• Prevention of fungal nail infections.

ICD codes

Dosage Regimen

Apply once or twice weekly after cleaning the affected nail.

Before the first application, file the affected nail as much as possible using the single-use file provided and clean it with a swab.

Apply the lacquer to the entire surface of the nail plate using the applicator provided. Allow the lacquer to dry for approximately 3 to 5 minutes.

Treatment duration is until the nail is completely regenerated and appears healthy, typically 6 months for fingernails and 9 to 12 months for toenails.

Adverse Reactions

Adverse reactions are typically localized to the site of application.

Common reactions include burning sensation, skin hyperemia (redness), and itching.

In rare cases, nail discoloration, pain, or skin inflammation (contact dermatitis) around the nail may occur.

Discontinue use if severe local irritation or signs of a hypersensitivity reaction develop.

Drug Interactions

No specific drug interactions are known due to negligible systemic absorption.

Concomitant use with other topical nail preparations has not been studied and is not recommended, as it may alter the penetration and efficacy of the lacquer.

Avoid applying cosmetic nail polish or artificial nails over the medicated lacquer during treatment.

Contraindications

• Hypersensitivity to amorolfine or to any of the excipients in the formulation.

• Pregnancy and the lactation period.

• Use in the neonatal period and in early childhood.

Overdose

Overdose from topical application is unlikely due to the mode of administration and negligible systemic absorption.

Accidental ingestion of the lacquer may cause gastrointestinal irritation and requires symptomatic treatment.

In case of accidental contact with eyes or mucous membranes, rinse immediately and thoroughly with plenty of water and seek medical advice if irritation persists.

Use in Pregnancy and Lactation

Contraindicated: pregnancy, lactation period.

Pediatric Use

Contraindicated: neonatal period and early childhood.

Special Precautions

During treatment, it is not recommended to use cosmetic nail polish or artificial nails.

When working with organic solvents, impermeable gloves should be worn.

Nail files used to treat affected nails should not be used on healthy nails.

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.