T-cure

• Tinea Infections (Dermatophytosis): Treatment of superficial fungal infections caused by dermatophytes, including tinea corporis (body), tinea cruris (groin), and tinea pedis (athlete’s foot).
• Cutaneous Candidiasis: Management of skin infections caused by Candida species, particularly in moist body folds.
• Pityriasis Versicolor: Treatment of Malassezia (Pityrosporum) yeast infections leading to hypopigmented or hyperpigmented skin patches.
• Other Superficial Fungal Infections: Off-label use for other superficial fungal skin infections as clinically appropriate.

Adults and Adolescents (≥12 years):

• Apply a thin layer of 1% or 2% naftifine hydrochloride cream, gel, or solution once daily to the affected area and surrounding skin.
• Duration: Typically 2 to 4 weeks depending on infection type and severity.
• Continue treatment for at least one week after symptoms resolve to prevent relapse.
• Wash hands after application.

Pediatrics (<12 years):

• Safety and efficacy have not been established; use only if clearly indicated and under medical supervision.

Elderly and Special Populations:

• No specific dose adjustments needed due to minimal systemic absorption.

Administration Notes:

• Clean and dry the affected area before applying.
• Avoid contact with eyes, mucous membranes, and broken skin.
• Do not cover treated areas with occlusive dressings unless instructed.

Naftifine hydrochloride is an allylamine antifungal that selectively inhibits the fungal enzyme squalene epoxidase, a key enzyme in the ergosterol biosynthesis pathway. This inhibition leads to reduced ergosterol synthesis, an essential component of fungal cell membranes, and causes accumulation of toxic squalene within fungal cells. These effects disrupt the integrity and function of the fungal cell membrane, resulting in increased membrane permeability and fungal cell death. Additionally, naftifine exhibits anti-inflammatory properties that help alleviate skin inflammation associated with fungal infections.

• Absorption: Minimal systemic absorption after topical application; plasma concentrations are generally undetectable.
• Distribution: Drug concentrates in the stratum corneum and upper epidermis.
• Metabolism: Negligible systemic metabolism due to minimal absorption.
• Elimination: Eliminated locally from skin; systemic excretion is minimal.

• Pregnancy: Classified as FDA Pregnancy Category B. Animal studies have not shown evidence of harm to the fetus. Limited human data suggest no significant risk. Use during pregnancy only if clearly needed and after consultation with a healthcare provider.
• Lactation: Unknown if naftifine is excreted in human milk. Given minimal systemic absorption, risk to nursing infants is considered low. Use cautiously and avoid applying to breast areas infants may suckle.

• Primary Class: Antifungal agent.
• Subclass: Allylamine antifungal.

• Known hypersensitivity to naftifine hydrochloride or any formulation excipients.
• Caution in patients with a history of allergic reactions to allylamine antifungals.

• Avoid contact with eyes and mucous membranes. If contact occurs, rinse thoroughly with water.
• Use with caution on inflamed, broken, or damaged skin.
• Discontinue if severe irritation or hypersensitivity develops.
• Not intended for systemic fungal infections.
• Keep out of reach of children.

Common:

• Mild local irritation such as burning, stinging, redness, or dryness at the application site.
• Pruritus (itching).

Rare/Serious:

• Allergic contact dermatitis.
• Severe skin reactions (very rare).

• No significant drug-drug interactions due to negligible systemic absorption.
• Avoid simultaneous use of other topical agents on the same area unless directed by a healthcare professional.

• No recent changes in approved indications or dosing by regulatory agencies.
• Clinical guidelines support naftifine as an effective first-line topical antifungal for dermatophytosis, candidiasis, and pityriasis versicolor.
• Emphasis on adherence to full treatment duration to minimize recurrence.

• Store at room temperature, 20°C to 25°C (68°F to 77°F).
• Protect from excessive heat, moisture, and light.
• Keep container tightly closed when not in use.
• Do not freeze.
• Keep out of reach of children.