Oxiconazole Nitrate

Approved Indications:

• Tinea Pedis (Athlete’s Foot):
• Caused by Trichophyton rubrum, Trichophyton mentagrophytes, and Epidermophyton floccosum
• Tinea Cruris (Jock Itch):
• Caused by dermatophytes, particularly E. floccosum
• Tinea Corporis (Ringworm of the Body):
• Caused by T. rubrum, T. mentagrophytes, Microsporum canis, and others
• Tinea Versicolor (Pityriasis Versicolor):
• Caused by Malassezia furfur

Clinically Accepted Off-label Uses:

• Cutaneous Candidiasis:
• Infections due to Candida albicans in moist skin folds
• Interdigital Mycoses (mixed fungal infections):
• As an alternative in cases resistant to other topical azoles

Route of Administration: Topical (cream or lotion)
General Instructions:

• Clean and dry the affected area before application
• Apply a thin layer and gently rub into the skin
• Do not cover with occlusive dressings unless advised

Adults and Adolescents (≥12 years):

• Tinea Pedis: Apply twice daily (morning and evening) for 4 weeks
• Tinea Cruris & Tinea Corporis: Apply once daily for 2 weeks
• Tinea Versicolor: Apply once daily for 2 weeks

Children (<12 years):

• Safety and efficacy not established; use only under medical supervision

Elderly:

• No dose adjustment needed; monitor for skin sensitivity

Renal or Hepatic Impairment:

• No systemic exposure; dose adjustment is not required

Oxiconazole nitrate is an imidazole-class antifungal that inhibits the biosynthesis of ergosterol, a vital component of fungal cell membranes. By blocking the enzyme lanosterol 14α-demethylase, it disrupts membrane integrity, increases permeability, and leads to leakage of essential intracellular components. This results in fungistatic or fungicidal activity depending on drug concentration and organism type.

• Absorption: Minimal systemic absorption following topical application to intact skin
• Distribution: Localized to the stratum corneum and epidermis; systemic circulation levels are negligible
• Metabolism: Not significantly metabolized systemically
• Excretion: Not clinically relevant due to low systemic absorption
• Bioavailability: Negligible systemic bioavailability
• Half-life: Not applicable (topical use only)

• Pregnancy:
• FDA Category B
• Animal studies have not demonstrated fetal harm; no adequate controlled studies in pregnant women
• Use only if clearly needed
• Lactation:
• Unknown whether oxiconazole is excreted in human milk
• If used during breastfeeding, avoid application to the breast area
• Considered low risk if applied away from the chest and used in small quantities

• Primary Class: Topical Antifungal
• Subclass: Imidazole Derivative
• Pharmacologic Category: Ergosterol synthesis inhibitor

• Known hypersensitivity to oxiconazole nitrate or any component of the formulation
• Do not apply to broken, inflamed, or open wounds unless directed
• Avoid use in ocular, oral, or vaginal regions

• Not for Ophthalmic Use: Avoid contact with eyes
• Irritation Risk: Discontinue use if excessive redness, blistering, or stinging occurs
• Superinfection: Monitor for signs of bacterial superinfection; discontinue if suspected
• Hypersensitivity Reactions: Includes pruritus, rash, or allergic dermatitis
• Use Only on Intact Skin: Avoid application to mucosal areas or deep skin wounds

Common:

• Local burning or stinging at application site
• Mild erythema or irritation
• Pruritus

Less Common:

• Skin dryness or peeling
• Contact dermatitis
• Rash

Rare but Serious:

• Hypersensitivity or allergic contact dermatitis
• Blistering
• Anaphylaxis (extremely rare)

Onset: Usually within the first few days of application; generally mild and self-limiting

• Systemic Drug Interactions: None known (due to minimal absorption)
• Topical Interactions:
• Avoid concurrent use with other topical medications at the same site unless medically advised
• Do not mix with corticosteroid creams unless prescribed
• Enzyme Involvement:
• Minimal interaction with cytochrome P450 enzymes due to negligible systemic exposure

• Recent Guidelines (Dermatology Societies 2022–2024):
• Recognized as a safe and effective topical antifungal for superficial mycoses
• Preferred in cases resistant to miconazole or clotrimazole
• No recent safety alerts or formulation changes reported by FDA or EMA
• Resistance Surveillance:
• Resistance is uncommon; however, inappropriate use or under-treatment may promote recurrence

• Storage Temperature: Store at 20°C to 25°C (68°F to 77°F)
• Humidity: Keep away from moisture
• Light: Protect from direct sunlight
• Handling Instructions:
• Keep the tube tightly closed
• Do not freeze
• Discard after expiry
• For external use only