T-cure2%

T-cure is a topical allylamine antifungal indicated for the treatment of superficial fungal skin infections.

FDA-Approved Indications

• Interdigital tinea pedis (athlete's foot) caused by Trichophyton rubrum, Trichophyton mentagrophytes, and Epidermophyton floccosum, in patients 12 years of age and older.
• Tinea cruris (jock itch) caused by the same organisms, in patients 12 years of age and older.
• Tinea corporis (ringworm) caused by the same organisms, in patients 12 years of age and older.

Other Reported Activity (Not an Approved Indication)

T-cure also demonstrates fungistatic activity against some Candida species in vitro; however, it is not FDA-approved for treatment of candidal skin infections and should not be relied upon for that purpose.

Each formulation of Naftifine Hydrochloride topical cream or gel contains Naftifine Hydrochloride 1% w/w or 2% w/w as the active ingredient, in a base containing pharmaceutically acceptable excipients such as cetyl alcohol, stearyl alcohol, propylene glycol, and preservatives, depending on the specific formulation.

T-cure is a synthetic allylamine-class antifungal agent formulated for topical application. It is fungicidal against common dermatophytes responsible for tinea infections and is available as a 1% or 2% cream or gel for once- or twice-daily use depending on strength.

Topical Antifungal — Allylamine derivative. T-cure is a representative agent of this class.

Naftifine Hydrochloride is an allylamine antifungal that inhibits squalene epoxidase, an enzyme required for the conversion of squalene to ergosterol in the fungal cell membrane. This leads to squalene accumulation and ergosterol depletion, disrupting fungal cell membrane synthesis.

The result is a fungicidal effect against dermatophytes (Trichophyton, Epidermophyton species) and a fungistatic effect against Candida species. Following topical application, systemic absorption of Naftifine Hydrochloride is minimal.

Wash and dry the affected area before applying T-cure. Apply a thin layer to cover the affected skin and the immediately surrounding area, then gently rub in. Wash hands after application unless the hands are the area being treated. Avoid contact with eyes, nose, mouth, and other mucous membranes.

Because T-cure is applied topically and has minimal systemic absorption, no clinically significant systemic drug interactions have been well established.

Avoid concurrent application of other topical medications, cosmetics, or irritant skin products on the same area unless advised by a physician, as this may affect drug delivery or increase local irritation.

Adverse reactions to T-cure are generally mild and localized to the application site.

• Burning or stinging sensation
• Dryness of the skin
• Erythema (redness)
• Itching (pruritus)
• Rarely, contact dermatitis or allergic sensitization

Discontinue use and consult a physician if irritation or signs of sensitization develop (see Precautions and Warnings).

T-cure should be used during pregnancy only if clearly needed and if the potential benefit justifies the potential risk to the fetus. Adequate and well-controlled studies in pregnant women are not available; a physician should be consulted before use.

It is not known whether T-cure is excreted in human breast milk. Caution is advised, and a physician should be consulted before use while breastfeeding, particularly if applied near the breast/nipple area.

T-cure is for external/topical use only and must not be taken orally or used systemically.

• Avoid contact with the eyes, nose, mouth, and other mucous membranes; if accidental contact occurs, rinse thoroughly with water.
• Do not apply to open wounds or broken skin.
• Discontinue use and consult a physician if signs of irritation, worsening redness, or sensitization occur.
• Complete the full prescribed course of treatment even if symptoms improve before completion; stopping early may lead to incomplete eradication of the fungal infection and recurrence.
• Some gel formulations contain alcohol and are flammable; keep away from open flame or heat during and immediately after application.

T-cure is intended for topical use only, and systemic toxicity from topical overdose is unlikely. If accidental ingestion occurs, or if excessive application leads to a significant local reaction, seek immediate medical attention or contact a poison control center. Do not attempt unsupervised home treatment for suspected ingestion.

Store at room temperature (below 30°C), away from light and moisture. Keep out of reach of children. Gel formulations containing alcohol should be kept away from heat and open flame.

Renal/Hepatic Impairment: No dose adjustment is established or generally required, as systemic absorption of T-cure after topical use is minimal.

Elderly: No specific dose adjustment is established; clinical studies did not identify differences in response relative to younger adults.

Pediatric: Safety and efficacy in patients younger than 12 years of age have not been established (see Pediatric Uses).

Treatment duration with T-cure depends on strength: typically up to 4 weeks for 1% formulations, and 2 weeks for 2% formulations. The full course should be completed as directed even if symptoms resolve earlier, to reduce the risk of relapse.

Allylamine antifungal (topical).

Naftifine Hydrochloride acts by inhibiting fungal squalene epoxidase, blocking conversion of squalene to ergosterol, an essential component of the fungal cell membrane. This results in ergosterol depletion and toxic squalene accumulation, producing a fungicidal effect against dermatophytes.

Category B (FDA legacy pregnancy classification)

The safety and efficacy of T-cure 1% and 2% formulations have been established in patients 12 years of age and older for the approved indications. Safety and efficacy in pediatric patients younger than 12 years of age have not been established, and use in this age group should only be considered under medical supervision.