Clinail

Approved Indications:

• Onychomycosis (fungal nail infections) caused by dermatophytes, yeasts (e.g., Candida spp.), and molds.
• Tinea Pedis (Athlete’s foot) and Tinea Cruris, when used in cream formulations.
• Cutaneous candidiasis and pityriasis versicolor, particularly in patients with superficial fungal skin infections.

Clinically Accepted Off-label Uses:

• Adjunct therapy in resistant or recurrent fungal nail infections when systemic antifungals are contraindicated.
• Maintenance therapy following oral antifungal treatment to reduce recurrence.

Adults and Elderly:

• For Nail Lacquer (5%): Apply once or twice weekly to the affected fingernails or toenails.
• Duration:
• Fingernails: up to 6 months
• Toenails: up to 9–12 months
• Administration:
• File the infected nail surface with the provided nail file.
• Clean with an alcohol swab.
• Apply lacquer evenly and allow to dry for 3–5 minutes.
• Do not wash hands/feet for at least 6 hours post-application.

Pediatric Use:

• Safety and efficacy in children under 18 years have not been established.

Special Populations:

• Renal or Hepatic Impairment: No dose adjustment needed as systemic absorption is negligible.

Amorolfine Hydrochloride is a morpholine derivative that inhibits ergosterol biosynthesis, a critical component of fungal cell membranes. It primarily acts by dual inhibition of Δ14-reductase and Δ7–Δ8-isomerase enzymes. This disrupts fungal membrane structure, increasing permeability and leading to cell death. Its fungicidal and fungistatic effects make it effective against a broad range of fungal pathogens.

• Absorption: Minimal systemic absorption; <0.5% of the dose penetrates the systemic circulation when applied topically.
• Distribution: Localized at the site of application with high concentrations in the nail plate and nail bed.
• Metabolism: Negligible systemic metabolism.
• Elimination: Undetectable plasma levels; excretion pathways are not clinically significant due to limited systemic exposure.
• Onset of Action: Clinical improvement may begin after 1–2 months of regular use.

• Pregnancy: Limited human data available. Animal studies show no teratogenic effects. Use only if clearly needed.
  (FDA Pregnancy Category: Not formally assigned post-FDA update; previously classified as Category C.)
• Lactation: No data on excretion into breast milk. Due to minimal systemic absorption, risk to infants is unlikely. Topical use on non-breast areas is acceptable with caution.

• Primary Class: Topical Antifungal Agent
• Subclass: Morpholine Antifungal Derivative

• Known hypersensitivity to amorolfine or any formulation component
• Application to mucous membranes, eyes, or open wounds
• Not recommended in children under 18 years due to insufficient safety data

• Avoid contact with eyes, ears, or mucosal tissues.
• Do not use artificial nails or cosmetic lacquers during treatment.
• Patients should not share nail files to prevent spread of infection.
• Use with caution in diabetic patients, those with peripheral vascular disease, or immunosuppression.
• Clinical monitoring is needed in cases of severe nail dystrophy or suspected deeper infection.

Common (≥1%):

• Mild local irritation at the application site
• Nail discoloration
• Brittle nails

Uncommon/Rare:

• Burning sensation, erythema, or contact dermatitis
• Nail detachment (onycholysis)
• Allergic skin reactions

Severity and Timing:

• Most side effects are mild and occur within the first few weeks of application. Discontinue if allergic reaction occurs.

• No significant drug-drug interactions due to negligible systemic absorption
• Avoid concurrent use with other topical antifungal agents on the same site
• No known interaction with food or alcohol

• Recent dermatology guidelines continue to support amorolfine as a first-line topical therapy for mild to moderate onychomycosis.
• Emphasis placed on early initiation and patient adherence for better outcomes.
• Updated consensus advises combined use with systemic antifungals in resistant or severe cases.

• Store below 25°C (77°F) in a dry place
• Protect from light and moisture
• Keep container tightly closed after each use
• Do not refrigerate or freeze
• Keep out of reach of children
• Use within 6 months of opening (varies by manufacturer)