Sertaconazole Nitrate [Topical]

Approved Indications:

• Tinea Pedis (Athlete’s Foot): Treatment of interdigital tinea pedis caused by Trichophyton mentagrophytes and Epidermophyton floccosum.
• Tinea Cruris (Jock Itch): Treatment of fungal infections in the groin area.
• Tinea Corporis (Ringworm): Treatment of dermatophytic infections on the body.
• Cutaneous Candidiasis: Indicated for superficial skin infections caused by Candida albicans.
• Pityriasis Versicolor: Used to treat superficial infections due to Malassezia furfur.

Off-label/Clinically Accepted Uses:

• Seborrheic Dermatitis: Occasionally used for its antifungal and anti-inflammatory properties in cases of mild-to-moderate seborrheic dermatitis.

Adults:

• Tinea Pedis: Apply a thin layer to the affected area twice daily for 4 weeks.
• Tinea Cruris, Tinea Corporis, Cutaneous Candidiasis, and Pityriasis Versicolor: Apply twice daily for 2 to 4 weeks depending on the severity and response.

Pediatrics:

• Not routinely recommended in children under 12 years. Use only under medical supervision if clearly indicated.

Elderly:

• Same dosage as adults. No specific dose adjustment required.

Special Groups:

• Renal/Hepatic Impairment: No adjustment needed due to minimal systemic absorption.

Administration Notes:

• Apply sufficient cream to cover the affected area and surrounding 1 cm margin.
• Gently rub in until completely absorbed.
• Hands should be washed after application.
• Avoid contact with eyes, mucous membranes, or broken skin.

Sertaconazole nitrate is a broad-spectrum imidazole antifungal that disrupts the synthesis of ergosterol, an essential component of the fungal cell membrane. It inhibits the enzyme lanosterol 14α-demethylase, leading to membrane instability, leakage of cellular contents, and ultimately fungal cell death. Sertaconazole also exhibits anti-inflammatory and antibacterial properties, contributing to its clinical efficacy in inflammatory mycoses.

• Absorption: Systemic absorption is negligible after topical application.
• Distribution: Confined to the stratum corneum and epidermis.
• Metabolism: Not significantly metabolized due to lack of systemic absorption.
• Elimination: Systemic excretion not relevant; eliminated locally.
• Bioavailability: Not applicable.
• Half-life: Not systemically relevant.
• Onset of Action: Clinical improvement often begins within a few days of starting therapy.

• Pregnancy: FDA Category C. No well-controlled studies in pregnant women. Animal studies have shown some risk at high doses. Use only if the potential benefit justifies the potential risk.
• Lactation: Unknown if excreted in human milk. Due to minimal systemic absorption, risk to nursing infant is likely low. Avoid application to the breast area while breastfeeding.

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

• Hypersensitivity to sertaconazole nitrate or other imidazole antifungals.
• Known hypersensitivity to any component of the formulation.
• Avoid use on broken or inflamed skin unless directed by a physician.

• Hypersensitivity Reactions: Discontinue immediately if signs of allergic reaction or severe irritation occur.
• Avoid Ocular Exposure: Not for ophthalmic use.
• Treatment Duration: If no improvement is observed within 4 weeks, reassess diagnosis.
• Pediatric Use: Safety not established in children under 12 years.
• Secondary Infection: Bacterial superinfection may require separate antibiotic treatment.

Common (Localized):

• Burning or stinging at the site of application
• Dryness, scaling, or itching
• Redness or irritation

Less Common:

• Contact dermatitis
• Localized swelling
• Blistering

Rare but Serious:

• Allergic contact dermatitis
• Severe hypersensitivity reactions (very rare)

• Systemic Drug Interactions: None known due to negligible systemic absorption.
• Topical Interactions: Avoid using other topical medications concurrently on the same site unless advised by a physician.
• Enzyme Interactions: No significant CYP450 interactions.

• Recent reviews reaffirm its dual antifungal and anti-inflammatory role, making it favorable for inflammatory fungal dermatoses.
• No recent changes in FDA indications or safety labeling.
• International dermatology societies acknowledge sertaconazole’s role in mild seborrheic dermatitis and pityriasis versicolor.

• Storage Temperature: Store at 20°C to 25°C (68°F to 77°F); excursions allowed between 15°C to 30°C.
• Humidity/Light: Store in a dry place, away from direct light.
• Do Not Freeze.
• Packaging: Keep the tube tightly closed after use. For external use only. Keep out of reach of children.