Tolnaftate

Allopathic
Indications
  • Approved Indications:
    • Treatment of superficial dermatophytic infections including:
      • Tinea pedis (athlete's foot)
      • Tinea corporis (ringworm)
      • Tinea cruris (jock itch)
    • Treatment of candidiasis involving skin and nails (limited use)
  • Off-label / Clinically Accepted Uses:
    • Mild fungal infections caused by dermatophytes and yeasts on skin surfaces
    • Prophylaxis against recurrent superficial fungal infections in susceptible individuals
Dosage & Administration
  • Adults and Pediatrics (≥2 years):
    • Topical application: Apply a thin layer of tolnaftate cream, powder, or solution to the affected area twice daily (morning and night)
    • Continue treatment for 2 to 4 weeks or at least 1 week after symptoms resolve to prevent relapse
  • Special Populations:
    • No specific dose adjustments needed; topical use minimizes systemic exposure
    • Use caution in patients with extensive skin lesions or impaired skin barrier
  • Administration Route:
    • Topical application directly to affected skin areas
    • Clean and dry affected area before application
    • Avoid contact with eyes, mouth, and mucous membranes
Mechanism of Action (MOA)

Tolnaftate is a synthetic antifungal agent classified as a thiocarbamate. It exerts its antifungal effect by inhibiting the enzyme squalene epoxidase, which is crucial in the ergosterol biosynthesis pathway in fungal cell membranes. This inhibition leads to accumulation of squalene within fungal cells, which is toxic to them, and a depletion of ergosterol, an essential component for maintaining fungal cell membrane integrity. Disruption of membrane synthesis compromises fungal cell membrane function and structure, leading to fungal cell death and resolution of infection.

Pharmacokinetics
  • Absorption:
    • Minimal systemic absorption following topical application to intact skin
  • Distribution:
    • Mainly localized to the site of application; negligible systemic distribution
  • Metabolism:
    • Not well characterized due to minimal systemic absorption
  • Elimination:
    • Excreted unchanged in small amounts through the skin; systemic elimination data are limited
Pregnancy Category & Lactation
  • Pregnancy:
    • No adequate human studies; considered category C by FDA or unavailable data
    • Topical use generally considered low risk due to minimal systemic absorption, but use only if clearly needed
  • Lactation:
    • No data on excretion into breast milk; topical use unlikely to pose risk but caution advised
Therapeutic Class
  • Primary class: Antifungal agent
  • Subclass: Thiocarbamate antifungal
Contraindications
  • Known hypersensitivity to tolnaftate or any formulation excipients
  • Use on mucous membranes or open wounds
  • Severe skin conditions where systemic antifungal therapy is indicated
Warnings & Precautions
  • Avoid contact with eyes, nose, mouth, and other mucous membranes; if contact occurs, rinse thoroughly
  • Discontinue use if irritation, burning, or allergic reaction develops
  • Use with caution in patients with severely compromised skin integrity
  • Not for systemic fungal infections or nail infections requiring oral therapy
  • Safety and efficacy in children under 2 years not established
Side Effects
  • Common:
    • Mild local irritation, burning, itching, or redness at application site
  • Rare:
    • Allergic contact dermatitis
    • Severe hypersensitivity reactions (very rare)
  • Typically well tolerated due to minimal systemic absorption
Drug Interactions
  • No significant drug-drug, drug-food, or drug-alcohol interactions expected due to minimal systemic absorption
  • Concurrent use with other topical agents should be under medical supervision to avoid additive irritation
Recent Updates or Guidelines
  • Continued recommendation as first-line topical treatment for uncomplicated superficial dermatophytosis
  • Emphasis on completing full course to reduce recurrence risk
  • No major changes in approved indications or dosing recently
  • Guidelines highlight importance of patient education on hygiene and prevention measures alongside therapy
Storage Conditions
  • Store at 20°C to 25°C (room temperature)
  • Protect from moisture and excessive heat
  • Keep container tightly closed when not in use
  • Keep out of reach of children
  • No special reconstitution or refrigeration required