Sulconazole Nitrate

Approved Indications:

• Tinea corporis (ringworm of the body)
• Tinea cruris (jock itch)
• Tinea pedis (athlete’s foot)
• Tinea versicolor (pityriasis versicolor)
• Cutaneous candidiasis
• Tinea manuum (fungal infection of the hands)
• Tinea faciei (fungal infection of the face)

Important Off-label (Clinically Accepted) Uses:

• Seborrheic dermatitis (mild to moderate cases when antifungal treatment is warranted)
• Intertrigo with fungal superinfection (used in combination with topical corticosteroids)

Adults and Adolescents (≥12 years):

• Cream formulation (1%): Apply a thin film to the affected area once or twice daily, typically for 2 to 4 weeks, depending on the infection type.
• Tinea corporis, tinea cruris, tinea pedis: Apply twice daily for 2–4 weeks.
• Cutaneous candidiasis or tinea versicolor: Apply once daily for 2 weeks.

Pediatric Use (<12 years):

• Safety and efficacy not well established. Use only under medical supervision in limited areas and for short durations if necessary.

Geriatric Use:

• No specific dose adjustment required, but monitor for skin irritation or sensitivity.

Renal/Hepatic Impairment:

• No dose adjustment necessary due to minimal systemic absorption.

Administration Route:

• Topical only (for external use on skin). Avoid contact with eyes, mouth, or mucosal surfaces.
• Do not use occlusive dressings unless directed by a physician.

Sulconazole nitrate is an imidazole-class antifungal agent that acts by inhibiting ergosterol synthesis, a crucial component of fungal cell membranes. It binds to cytochrome P450-dependent 14-alpha demethylase, disrupting membrane permeability and function. This leads to fungal cell death by preventing replication and interfering with essential nutrient uptake. Its action is primarily fungistatic but can be fungicidal depending on concentration and fungal species.

• Absorption: Minimal systemic absorption when applied topically.
• Distribution: Limited to the stratum corneum and superficial dermis; negligible plasma levels.
• Metabolism: Not systemically metabolized to a significant extent due to topical use.
• Elimination: Not applicable due to poor systemic absorption.
• Onset of Action: Symptom improvement generally seen within 3–5 days of initiation.
• Bioavailability: Topical use only; oral bioavailability data not relevant.
• Half-life: Not systemically measurable.

• Pregnancy:
  • U.S. FDA Pregnancy Category C.
  • Animal studies have shown adverse fetal effects at high systemic doses.
  • Use during pregnancy only if clearly needed and the benefits outweigh potential risks.
• Lactation:
  • Unknown if sulconazole is excreted in human milk.
  • Likely safe when used topically in limited areas and not near the breast/nipple.
  • Caution advised: Avoid application on or near the breast to prevent infant exposure.

• Primary Class: Topical Antifungal
• Subclass: Imidazole derivative
• Generation: First-generation imidazole antifungal

• Known hypersensitivity to sulconazole nitrate or any imidazole antifungal
• Allergy to any excipients in the formulation
• Use in the eyes, oral cavity, or vaginal mucosa is contraindicated

• Hypersensitivity reactions (e.g., rash, pruritus, contact dermatitis) may occur.
• Discontinue if irritation or worsening of the condition develops.
• Avoid use on broken or inflamed skin unless directed by a physician.
• Not for ophthalmic or intravaginal use.
• Patients with a history of allergic contact dermatitis to imidazoles should use with caution.
• Safety of use for more than 4 weeks has not been established.

Common (≥1%):

• Local burning sensation
• Itching (pruritus)
• Stinging at the application site
• Dryness or peeling of skin

Less Common (<1%):

• Contact dermatitis
• Erythema
• Rash

Rare/Serious:

• Allergic reactions (angioedema, anaphylaxis – extremely rare)
• Severe skin irritation or blistering

Timing:

• Most side effects occur within the first few days of use.
• Dose-dependent reactions are rare due to topical formulation.

• Topical sulconazole has minimal systemic absorption, so drug-drug interactions are extremely rare.
• No known significant interactions with other topical or systemic medications.
• Enzyme Systems: Minimal involvement with CYP450 isoenzymes due to poor systemic absorption.
• Avoid use with other irritant topical agents (e.g., alcohol-based products, exfoliants) to prevent compounded irritation.

• No major guideline changes or FDA label updates in recent years.
• Remains approved for superficial dermatomycoses as a topical antifungal.
• Not included in current WHO essential medicines list but recognized in clinical dermatology protocols for superficial fungal infections.

• Store at: 20°C to 25°C (68°F to 77°F)
• Permitted range: 15°C to 30°C (59°F to 86°F)
• Do not freeze.
• Protect from excessive heat, moisture, and direct sunlight.
• Keep tube tightly closed after use.
• Keep out of reach of children.