CICLOPIROX

INDICATIONS AND USAGE Superficial Dermatophyte Infections Ciclopirox Gel, 0.77% is indicated for the topical treatment of interdigital tinea pedis and tinea corporis due to Trichophyton rubrum, Trichophyton mentagrophytes, or Epidermophyton floccosum . Seborrheic Dermatitis Ciclopirox Gel, 0.77% is indicated for the topical treatment of seborrheic dermatitis of the scalp.

DOSAGE AND ADMINISTRATION Superficial Dermatophyte Infections Gently massage Ciclopirox Gel, 0.77% into the affected areas and surrounding skin twice daily, in the morning and evening immediately after cleaning or washing the areas to be treated. Interdigital tinea pedis and tinea corporis should be treated for 4 weeks. If a patient shows no clinical improvement after 4 weeks of treatment, the diagnosis should be reviewed. Seborrheic Dermatitis of the Scalp Apply Ciclopirox Gel, 0.77% to affected scalp areas twice daily, in the morning and evening for 4 weeks. Clinical improvement usually occurs within the first week with continuing resolution of signs and symptoms through the fourth week of treatment. If a patient shows no clinical improvement after 4 weeks of treatment, the diagnosis should be reviewed.

CONTRAINDICATIONS Ciclopirox Gel, 0.77% is contraindicated in individuals who have shown hypersensitivity to any of its components.

ADVERSE REACTIONS In clinical trials, 140 (39%) of 359 subjects treated with Ciclopirox Gel, 0.77% reported adverse experiences, irrespective of relationship to test materials, which resulted in 8 subjects discontinuing treatment. The most frequent experience reported was skin burning sensation upon application, which occurred in approximately 34% of seborrheic dermatitis patients and 7% of tinea pedis patients. Adverse experiences occurring between 1% to 5% were contact dermatitis and pruritus. Other reactions that occurred in less than 1% included dry skin, acne, rash, alopecia, pain upon application, eye pain, and facial edema.

Mechanism of Action Ciclopirox is a hydroxypyridone antifungal agent although the relevance of this property for the indication of seborrheic dermatitis is not known. Ciclopirox acts by chelation of polyvalent cations (Fe 3+ or Al 3+ ), resulting in the inhibition of the metal-dependent enzymes that are responsible for the degradation of peroxides within the fungal cell.

DESCRIPTION Ciclopirox Gel, 0.77% contains a synthetic antifungal agent, ciclopirox. It is intended for topical dermatologic use only. Each gram of Ciclopirox Gel, 0.77% contains 7.70 mg of ciclopirox in a gel consisting of Purified Water USP, Isopropyl Alcohol USP, Octyldodecanol NF, Dimethicone Copolyol 190, Carbomer 980, Sodium Hydroxide NF, and Docusate Sodium USP. Ciclopirox Gel, 0.77% is a white, slightly fluid gel. The chemical name for ciclopirox is 6-cyclohexyl-1-hydroxy-4-methyl-2(1 H )- pyridinone, with the empirical formula C 12 H 17 NO 2 and a molecular weight of 207.27. The CAS Registry Number is [29342-05-0]. The chemical structure is: Ciclopirox Gel Structural Formula

HOW SUPPLIED Ciclopirox gel 0.77% is supplied in aluminum tubes and LDPE tubes. 30 g tubes (NDC 68462-455-35), 45 g tubes (NDC 68462-455-47) and 100 g tubes (NDC 68462-455-94). Store at 20°C to 25°C (68°F to 77°F) [See USP Controlled Room Temperature]. Distributed by: Glenmark Pharmaceuticals Inc., USA Elmwood Park, NJ 07407 Questions? 1 (888)721-7115 www.glenmarkpharma-us.com April 2025 glenmarklogo