ciclopirox
Generic: CICLOPIROX
Basic Information
Manufacturer
Glenmark Pharmaceuticals Inc., USA
Product Type
HUMAN PRESCRIPTION DRUG
Route of Administration
TOPICAL
FDA Set ID
3c22416e-4293-4ba5-a983-137cbc6022db
Indications & Usage
INDICATIONS AND USAGE Superficial Dermatophyte Infections Ciclopirox gel 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 is indicated for the topical treatment of seborrheic dermatitis of the scalp.
Seborrheic Dermatitis Ciclopirox gel is indicated for the topical treatment of seborrheic dermatitis of the scalp.
Warnings
WARNINGS Ciclopirox gel is not for ophthalmic, oral, or intravaginal use.
Keep out of reach of children.
Keep out of reach of children.
Adverse Reactions
ADVERSE REACTIONS In clinical trials, 140 (39%) of 359 subjects treated with ciclopirox gel 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.
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.