Amorolfine (0.25% w/w) + Phenoxyethanol (1% w/w)

Clinical Pharmacologist's Monograph

⚠️ Prescription Only: This medicine is Schedule H/H1. Do not self-medicate.

1. Clinical Overview

A topical antifungal combination used primarily for the treatment of superficial fungal infections. Amorolfine is a morpholine derivative antifungal with broad-spectrum fungicidal and fungistatic activity. Phenoxyethanol acts as a preservative and has mild antiseptic properties, enhancing the formulation's stability and providing a secondary antimicrobial effect against bacteria and fungi.

OnsetDurationBioavailability
Clinical improvement is typically observed within 1-2 weeks of starting therapy.The fungicidal effect of amorolfine persists for several days after application due to its accumulation in the stratum corneum.Negligible systemic absorption (<1%) following topical application to intact skin.

2. Mechanism of Action

Amorolfine exerts its antifungal effect by a dual mechanism: 1) Inhibition of delta-14-reductase and delta-7-delta-8 isomerase in the ergosterol biosynthesis pathway. This leads to depletion of ergosterol (an essential component of fungal cell membranes) and accumulation of toxic sterol intermediates. 2) Direct membrane damage due to altered sterol composition. Phenoxyethanol disrupts bacterial and fungal cell membranes and inhibits cellular enzymes.

3. Indications & Uses

  • Tinea pedis (Athlete's foot)
  • Tinea corporis (Ringworm)
  • Tinea cruris (Jock itch)
  • Cutaneous candidiasis
  • Pityriasis versicolor

4. Dosage & Administration

Adult Dosage: Apply a thin layer once daily to the affected skin and surrounding area. Duration: Tinea corporis/cruris: 2-3 weeks. Tinea pedis: 4-6 weeks. Pityriasis versicolor: 2-3 weeks.

Administration: 1. Clean and dry the affected area thoroughly. 2. Apply a thin layer and rub gently. 3. Wash hands after application unless hands are being treated. 4. Do not cover with occlusive dressings unless advised by a doctor. 5. Continue use for the full prescribed duration, even if symptoms improve earlier.

5. Side Effects

Common side effects may include:

  • Mild burning or stinging at application site
  • Localized erythema (redness)
  • Itching (pruritus)

6. Drug Interactions

DrugEffectSeverity
No specific data available. Consult doctor.

7. Patient Counselling

  • DO clean and dry the area before application.
  • DO use regularly for the full course prescribed.
  • DO wash hands after application.
  • DON'T apply to eyes, nose, mouth, or mucous membranes.
  • DON'T share your medication with others.
  • DON'T use occlusive dressings unless directed.
  • DON'T use for nail infections unless specified as a nail lacquer.

8. Toxicology & Storage

Overdose: Topical overdose is unlikely to cause systemic symptoms. Excessive local application may lead to severe skin irritation, redness, and burning.

Storage: Store below 30°C. Keep the tube tightly closed. Protect from light and moisture. Keep out of reach of children. Do not freeze.