Ciclopirox olamine
Therapeutic agent (verify pharmacological class)
What it is used for
INDICATIONS AND USAGE Ciclopirox olamine cream is indicated for the topical treatment of the following dermal infections: tinea pedis, tinea cruris, and tinea corporis due to Trichophyton rubrum, Trichophyton mentagrophytes, Epidermophyton floccosum, and Microsporum canis; candidiasis (moniliasis) due to Candida albicans; and tinea (pityriasis) versicolor due to Malassezia furfur.
Warnings
Obtain allergy and medication history. Adjust for renal/hepatic impairment, pregnancy, lactation, extremes of age and interacting drugs. Use the lowest effective dose for the shortest appropriate duration. Monitor for expected class adverse effects.
Possible side effects
ADVERSE REACTIONS In all controlled clinical studies with 514 patients using ciclopirox olamine cream and in 296 patients using the vehicle cream, the incidence of adverse reactions was low. This included pruritus at the site of application in one patient and worsening of the clinical signs and symptoms in another patient using ciclopirox olamine cream and burning in one patient and worsening of the clinical signs and symptoms in another patient using the vehicle cream. To report SUSPECTED ADVERSE REACTIONS, contact Padagis ® at 1-866-634-9120 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch .
Storage
HOW SUPPLIED Ciclopirox Olamine Cream USP, 0.77% is available as follows: 15 g tube (NDC 45802- 138 -35) 30 g tube (NDC 45802- 138 -11) 90 g tube (NDC 45802- 138 -18)
No reviewed patient-education article is available. The fields shown are from the currently verified medicine record and unavailable fields are not inferred.