Amorolfine (Lacquer) Instructions for Use
ATC Code
D01AE16 (Amorolfine)
Active Substance
Amorolfine (Rec.INN registered by WHO)
Clinical-Pharmacological Group
External antifungal drug
Pharmacotherapeutic Group
Antifungal agents used in dermatology; external antifungal agents; other external antifungal agents
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 yeast fungi of the genus Candida spp., Pityrosporum spp., Malassezia spp., Cryptococcus spp., dermatophytes ( Trichophyton spp., Microsporum spp., Epidermophyton spp.), mold fungi ( Alternaria, Hendersonula, Scopulariopsis), fungi of Dematiaceae ( 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, yeast, and mold fungi.
Use only in cases where no more than two-thirds of the nail plate is affected by the infection.
- Prevention of fungal nail infections in patients with a history of onychomycosis or those at high risk.
ICD codes
| ICD-10 code | Indication |
| B35.1 | Onychomycosis |
| B37.2 | Candidiasis of skin and nails |
| ICD-11 code | Indication |
| 1F23.1Z | Candidiasis of skin or mucous membranes, unspecified |
| 1F28.1 | Dermatophytic onychomycosis |
Dosage Regimen
| The method of application and dosage regimen for a specific drug depend on its form of release and other factors. The optimal dosage regimen is determined by the doctor. It is necessary to strictly adhere to the compliance of the dosage form of a specific drug with the indications for use and dosage regimen. |
Apply the lacquer to the entire surface of the affected fingernails or toenails once or twice per week, following the specific schedule provided by a healthcare professional.
Before the first application, remove the affected nail area using the file provided. Clean the nail with an alcohol swab to degrease. Apply the lacquer and allow it to dry for several minutes.
Before each subsequent application, remove the previous lacquer layer with an alcohol swab, file away the damaged nail again, and apply a new layer.
Adverse Reactions
Local skin reactions at the application site may occur, including burning sensation, erythema, and pruritus.
Nail disorders such as discoloration or brittleness have been reported. These reactions are typically mild and transient.
Drug Interactions
No specific, clinically significant drug interactions with systemically administered medicinal products are known due to negligible systemic absorption.
Concomitant use with other topical nail preparations has not been formally studied; avoid applying other nail lacquers or topical agents directly over the treatment area.
Contraindications
- Known hypersensitivity to amorolfine or to any of the excipients in the formulation.
- Pregnancy and the period of lactation due to the absence of sufficient safety data for use during these periods.
- Neonatal period and early childhood; the safety and efficacy in this patient population have not been established.
Overdose
Accidental ingestion is unlikely due to the presentation and small bottle volume. If ingested, seek medical attention and institute supportive measures.
Topical overdose is improbable. In case of accidental application to large skin areas or mucous membranes, wash thoroughly with water.
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.
Medical DisclaimerBrand (or Active Substance), Marketing Authorisation Holder, Dosage Form
Medicated nail lacquer 5%: bottle 2.5 ml, 3 ml, 3.5 ml, 4 ml, 4.5 ml, 5 ml, 6 ml, 7 ml, 8 ml, 9 ml, or 10 ml
Marketing Authorization Holder
Vita Line, LLC (Russia)
Manufactured By
Tula Pharmaceutical Factory, LLC (Russia)
Dosage Form
 |
Amorolfine | Medicated nail lacquer 5%: bottle 2.5 ml, 3 ml, 3.5 ml, 4 ml, 4.5 ml, 5 ml, 6 ml, 7 ml, 8 ml, 9 ml, or 10 ml |
Dosage Form, Packaging, and Composition
Medicated nail lacquer – a transparent liquid from colorless to light yellow.
| 1 ml | |
| Amorolfine | 50 mg |
| (in terms of amorolfine hydrochloride) | 55.7 mg |
Excipients : triacetin (glycerol triacetate) – 10.5 mg, methyl methacrylate, trimethylammonioethyl methacrylate chloride and ethyl acrylate copolymer [2:0.2:1] (ammonium methacrylate copolymer (Type A) (Eudragit RL 100)) – 125 mg, ethyl acetate – 150 mg, butyl acetate – 50 mg, ethanol 95% – up to 1 ml.
2.5 ml – bottles (1) – cardboard packs (complete with applicators-6 pcs., nail files-12 pcs., sachets with cleansing swabs-12 pcs.).
3 ml – bottles (1) – cardboard packs (complete with applicators-6 pcs., nail files-12 pcs., sachets with cleansing swabs-12 pcs.).
3.5 ml – bottles (1) – cardboard packs (complete with applicators-6 pcs., nail files-12 pcs., sachets with cleansing swabs-12 pcs.).
4 ml – bottles (1) – cardboard packs (complete with applicators-6 pcs., nail files-12 pcs., sachets with cleansing swabs-12 pcs.).
4.5 ml – bottles (1) – cardboard packs (complete with applicators-6 pcs., nail files-12 pcs., sachets with cleansing swabs-12 pcs.).
5 ml – bottles (1) – cardboard packs (complete with applicators-6 pcs., nail files-12 pcs., sachets with cleansing swabs-12 pcs.).
6 ml – bottles (1) – cardboard packs (complete with applicators-6 pcs., nail files-12 pcs., sachets with cleansing swabs-12 pcs.).
7 ml – bottles (1) – cardboard packs (complete with applicators-6 pcs., nail files-12 pcs., sachets with cleansing swabs-12 pcs.).
8 ml – bottles (1) – cardboard packs (complete with applicators-6 pcs., nail files-12 pcs., sachets with cleansing swabs-12 pcs.).
9 ml – bottles (1) – cardboard packs (complete with applicators-6 pcs., nail files-12 pcs., sachets with cleansing swabs-12 pcs.).
10 ml – bottles (1) – cardboard packs (complete with applicators-6 pcs., nail files-12 pcs., sachets with cleansing swabs-12 pcs.).
2.5 ml – bottles (1) – cardboard packs (complete with applicators-6 pcs., nail files-18 pcs., sachets with cleansing swabs-18 pcs.).
3 ml – bottles (1) – cardboard packs (complete with applicators-6 pcs., nail files-18 pcs., sachets with cleansing swabs-18 pcs.).
3.5 ml – bottles (1) – cardboard packs (complete with applicators-6 pcs., nail files-18 pcs., sachets with cleansing swabs-18 pcs.).
4 ml – bottles (1) – cardboard packs (complete with applicators-6 pcs., nail files-18 pcs., sachets with cleansing swabs-18 pcs.).
4.5 ml – bottles (1) – cardboard packs (complete with applicators-6 pcs., nail files-18 pcs., sachets with cleansing swabs-18 pcs.).
5 ml – bottles (1) – cardboard packs (complete with applicators-6 pcs., nail files-18 pcs., sachets with cleansing swabs-18 pcs.).
6 ml – bottles (1) – cardboard packs (complete with applicators-6 pcs., nail files-18 pcs., sachets with cleansing swabs-18 pcs.).
7 ml – bottles (1) – cardboard packs (complete with applicators-6 pcs., nail files-18 pcs., sachets with cleansing swabs-18 pcs.).
8 ml – bottles (1) – cardboard packs (complete with applicators-6 pcs., nail files-18 pcs., sachets with cleansing swabs-18 pcs.).
9 ml – bottles (1) – cardboard packs (complete with applicators-6 pcs., nail files-18 pcs., sachets with cleansing swabs-18 pcs.).
10 ml – bottles (1) – cardboard packs (complete with applicators-6 pcs., nail files-18 pcs., sachets with cleansing swabs-18 pcs.).
2.5 ml – bottles (1) – cardboard packs (complete with applicators-6 pcs., nail files-24 pcs., sachets with cleansing swabs-24 pcs.).
3 ml – bottles (1) – cardboard packs (complete with applicators-6 pcs., nail files-24 pcs., sachets with cleansing swabs-24 pcs.).
3.5 ml – bottles (1) – cardboard packs (complete with applicators-6 pcs., nail files-24 pcs., sachets with cleansing swabs-24 pcs.).
4 ml – bottles (1) – cardboard packs (complete with applicators-6 pcs., nail files-24 pcs., sachets with cleansing swabs-24 pcs.).
4.5 ml – bottles (1) – cardboard packs (complete with applicators-6 pcs., nail files-24 pcs., sachets with cleansing swabs-24 pcs.).
5 ml – bottles (1) – cardboard packs (complete with applicators-6 pcs., nail files-24 pcs., sachets with cleansing swabs-24 pcs.).
6 ml – bottles (1) – cardboard packs (complete with applicators-6 pcs., nail files-24 pcs., sachets with cleansing swabs-24 pcs.).
7 ml – bottles (1) – cardboard packs (complete with applicators-6 pcs., nail files-24 pcs., sachets with cleansing swabs-24 pcs.).
8 ml – bottles (1) – cardboard packs (complete with applicators-6 pcs., nail files-24 pcs., sachets with cleansing swabs-24 pcs.).
9 ml – bottles (1) – cardboard packs (complete with applicators-6 pcs., nail files-24 pcs., sachets with cleansing swabs-24 pcs.).
10 ml – bottles (1) – cardboard packs (complete with applicators-6 pcs., nail files-24 pcs., sachets with cleansing swabs-24 pcs.).
2.5 ml – bottles (1) – cardboard packs (complete with nail files-12 pcs., cleansing swabs-12 pcs.).
3 ml – bottles (1) – cardboard packs (complete with nail files-12 pcs., cleansing swabs-12 pcs.).
3.5 ml – bottles (1) – cardboard packs (complete with nail files-12 pcs., cleansing swabs-12 pcs.).
4 ml – bottles (1) – cardboard packs (complete with nail files-12 pcs., cleansing swabs-12 pcs.).
4.5 ml – bottles (1) – cardboard packs (complete with nail files-12 pcs., cleansing swabs-12 pcs.).
5 ml – bottles (1) – cardboard packs (complete with nail files-12 pcs., cleansing swabs-12 pcs.).
6 ml – bottles (1) – cardboard packs (complete with nail files-12 pcs., cleansing swabs-12 pcs.).
7 ml – bottles (1) – cardboard packs (complete with nail files-12 pcs., cleansing swabs-12 pcs.).
8 ml – bottles (1) – cardboard packs (complete with nail files-12 pcs., cleansing swabs-12 pcs.).
9 ml – bottles (1) – cardboard packs (complete with nail files-12 pcs., cleansing swabs-12 pcs.).
10 ml – bottles (1) – cardboard packs (complete with nail files-12 pcs., cleansing swabs-12 pcs.).
2.5 ml – bottles (1) – cardboard packs (complete with nail files-24 pcs., cleansing swabs-24 pcs.).
3 ml – bottles (1) – cardboard packs (complete with nail files-24 pcs., cleansing swabs-24 pcs.).
3.5 ml – bottles (1) – cardboard packs (complete with nail files-24 pcs., cleansing swabs-24 pcs.).
4 ml – bottles (1) – cardboard packs (complete with nail files-24 pcs., cleansing swabs-24 pcs.).
4.5 ml – bottles (1) – cardboard packs (complete with nail files-24 pcs., cleansing swabs-24 pcs.).
5 ml – bottles (1) – cardboard packs (complete with nail files-24 pcs., cleansing swabs-24 pcs.).
6 ml – bottles (1) – cardboard packs (complete with nail files-24 pcs., cleansing swabs-24 pcs.).
7 ml – bottles (1) – cardboard packs (complete with nail files-24 pcs., cleansing swabs-24 pcs.).
8 ml – bottles (1) – cardboard packs (complete with nail files-24 pcs., cleansing swabs-24 pcs.).
9 ml – bottles (1) – cardboard packs (complete with nail files-24 pcs., cleansing swabs-24 pcs.).
10 ml – bottles (1) – cardboard packs (complete with nail files-24 pcs., cleansing swabs-24 pcs.).
Medicated nail lacquer 5%: bottle 0.5 ml, 1 ml, 1.5 ml, 2 ml, 2.5 ml, 3 ml, 3.5 ml, 4 ml, 4.5 ml, 5 ml, 6 ml, 7 ml, 8 ml, 9 ml, or 10 ml
Marketing Authorization Holder
Tula Pharmaceutical Factory, LLC (Russia)
Dosage Form
|
Amorolfine | Medicated nail lacquer 5%: bottle 0.5 ml, 1 ml, 1.5 ml, 2 ml, 2.5 ml, 3 ml, 3.5 ml, 4 ml, 4.5 ml, 5 ml, 6 ml, 7 ml, 8 ml, 9 ml, or 10 ml |
Dosage Form, Packaging, and Composition
Medicated nail lacquer in the form of a transparent liquid from colorless to light yellow.
| 1 ml | |
| Amorolfine hydrochloride | 55.7 mg, |
| Equivalent to amorolfine content | 50 mg |
Excipients : triacetin (glycerol triacetate) – 10.5 mg, methyl methacrylate, trimethylammonioethyl methacrylate chloride and ethyl acrylate copolymer [2:0.2:1] (ammonium methacrylate copolymer (Type A) (Eudragit RL100)) – 125 mg, ethyl acetate – 150 mg, butyl acetate – 50 mg, ethanol 95% – up to 1 ml.
0.5 ml – dark glass bottles (1) complete with 6 applicators with spatulas, 12 nail files wrapped in a plastic bag, 12 sachets with cleansing swabs – container – cardboard packs.
1 ml – dark glass bottles (1) complete with 6 applicators with spatulas, 12 nail files wrapped in a plastic bag, 12 sachets with cleansing swabs – container – cardboard packs.
1.5 ml – dark glass bottles (1) complete with 6 applicators with spatulas, 12 nail files wrapped in a plastic bag, 12 sachets with cleansing swabs – container – cardboard packs.
2 ml – dark glass bottles (1) complete with 6 applicators with spatulas, 12 nail files wrapped in a plastic bag, 12 sachets with cleansing swabs – container – cardboard packs.
2.5 ml – dark glass bottles (1) complete with 6 applicators with spatulas, 12 nail files wrapped in a plastic bag, 12 sachets with cleansing swabs – container – cardboard packs.
3 ml – dark glass bottles (1) complete with 6 applicators with spatulas, 12 nail files wrapped in a plastic bag, 12 sachets with cleansing swabs – container – cardboard packs.
3.5 ml – dark glass bottles (1) complete with 6 applicators with spatulas, 12 nail files wrapped in a plastic bag, 12 sachets with cleansing swabs – container – cardboard packs.
4 ml – dark glass bottles (1) complete with 6 applicators with spatulas, 12 nail files wrapped in a plastic bag, 12 sachets with cleansing swabs – container – cardboard packs.
4.5 ml – dark glass bottles (1) complete with 6 applicators with spatulas, 12 nail files wrapped in a plastic bag, 12 sachets with cleansing swabs – container – cardboard packs.
5 ml – dark glass bottles (1) complete with 6 applicators with spatulas, 12 nail files wrapped in a plastic bag, 12 sachets with cleansing swabs – container – cardboard packs.
6 ml – dark glass bottles (1) complete with 6 applicators with spatulas, 12 nail files wrapped in a plastic bag, 12 sachets with cleansing swabs – container – cardboard packs.
7 ml – dark glass bottles (1) complete with 6 applicators with spatulas, 12 nail files wrapped in a plastic bag, 12 sachets with cleansing swabs – container – cardboard packs.
8 ml – dark glass bottles (1) complete with 6 applicators with spatulas, 12 nail files wrapped in a plastic bag, 12 sachets with cleansing swabs – container – cardboard packs.
9 ml – dark glass bottles (1) complete with 6 applicators with spatulas, 12 nail files wrapped in a plastic bag, 12 sachets with cleansing swabs – container – cardboard packs.
10 ml – dark glass bottles (1) complete with 6 applicators with spatulas, 12 nail files wrapped in a plastic bag, 12 sachets with cleansing swabs – container – cardboard packs.
0.5 ml – dark glass bottles with built-in applicator (1) complete with 12 sachets with cleansing swabs – container – cardboard packs.
1 ml – dark glass bottles with built-in applicator (1) complete with 12 sachets with cleansing swabs – container – cardboard packs.
1.5 ml – with built-in applicator (1) complete with 12 sachets with cleansing swabs – container – cardboard packs.
2 ml with built-in applicator (1) complete with 12 sachets with cleansing swabs – container – cardboard packs.
2.5 ml with built-in applicator (1) complete with 12 sachets with cleansing swabs – container – cardboard packs.
3 ml with built-in applicator (1) complete with 12 sachets with cleansing swabs – container – cardboard packs.
3.5 ml – dark glass bottles (1) complete with 6 applicators with spatulas, 12 nail files wrapped in a plastic bag, 12 sachets with cleansing swabs – container – cardboard packs.
4 ml with built-in applicator (1) complete with 12 sachets with cleansing swabs – container – cardboard packs.
4.5 ml with built-in applicator (1) complete with 12 sachets with cleansing swabs – container – cardboard packs.
5 ml – with built-in applicator (1) complete with 12 sachets with cleansing swabs – container – cardboard packs.
6 ml with built-in applicator (1) complete with 12 sachets with cleansing swabs – container – cardboard packs.
7 ml with built-in applicator (1) complete with 12 sachets with cleansing swabs – container – cardboard packs.
8 ml with built-in applicator (1) complete with 12 sachets with cleansing swabs – container – cardboard packs.
9 ml with built-in applicator (1) complete with 12 sachets with cleansing swabs – container – cardboard packs.
10 ml with built-in applicator (1) complete with 12 sachets with cleansing swabs – container – cardboard packs.
Medicated nail lacquer 5%: bottle 2.5 ml, 3 ml, or 5 ml
Marketing Authorization Holder
Formula-FR, LLC (Russia)
Manufactured By
Tula Pharmaceutical Factory, LLC (Russia)
Dosage Form
|
Amorolfine | Medicated nail lacquer 5%: bottle 2.5 ml, 3 ml, or 5 ml |
Dosage Form, Packaging, and Composition
Medicated nail lacquer – a clear liquid from colorless to light yellow.
| 1 ml | |
| Amorolfine | 50 mg |
| (as amorolfine hydrochloride) | 55.7 mg |
Excipients : triacetin (glycerol triacetate) – 10.5 mg, copolymer of methyl methacrylate, trimethylammonioethyl methacrylate chloride and ethyl acrylate [2:0.2:1] (ammonium methacrylate copolymer (Type A) (Eudragit RL100)) – 125 mg, ethyl acetate – 150 mg, butyl acetate – 50 mg, ethanol 95% – up to 1 ml.
2.5 ml – bottles (1) (complete with applicators – 6 pcs., nail files – 12 pcs. and tampons – 12 pcs.) – cardboard packs (1).
2.5 ml – bottles (1) (complete with applicators – 6 pcs., nail files – 24 pcs. and tampons – 24 pcs.) – cardboard packs (1).
2.5 ml – bottles (1) (complete with nail files – 12 pcs. and tampons – 12 pcs.) – cardboard packs (1).
2.5 ml – bottles (1) (complete with nail files – 24 pcs. and tampons – 24 pcs.) – cardboard packs (1).
3 ml – bottles (1) (complete with applicators – 6 pcs., nail files – 12 pcs. and tampons – 12 pcs.) – cardboard packs (1).
3 ml – bottles (1) (complete with applicators – 6 pcs., nail files – 24 pcs. and tampons – 24 pcs.) – cardboard packs (1).
3 ml – bottles (1) (complete with nail files – 12 pcs. and tampons – 12 pcs.) – cardboard packs (1).
3 ml – bottles (1) (complete with nail files – 24 pcs. and tampons – 24 pcs.) – cardboard packs (1).
5 ml – bottles (1) (complete with applicators – 6 pcs., nail files – 12 pcs. and tampons – 12 pcs.) – cardboard packs (1).
5 ml – bottles (1) (complete with applicators – 6 pcs., nail files – 24 pcs. and tampons – 24 pcs.) – cardboard packs (1).
5 ml – bottles (1) (complete with nail files – 12 pcs. and tampons – 12 pcs.) – cardboard packs (1).
5 ml – bottles (1) (complete with nail files – 24 pcs. and tampons – 24 pcs.) – cardboard packs (1).
![Amorolfine [Lacquer] 1](https://www.medixlife.com/wp-content/uploads/Medixlife_favi_512.png "Amorolfine [Lacquer] 2")