CICLOPIROX

Ciclopirox Shampoo, 1% contains the synthetic antifungal agent, ciclopirox for topical use. Each gram (equivalent to 0.96 mL) of Ciclopirox Shampoo, 1% contains 10 mg ciclopirox in a shampoo base consisting of disodium laureth sulfosuccinate, laureth-2, purified water, sodium chloride, and sodium laureth sulfate. Ciclopirox Shampoo, 1% is a colorless, translucent solution. The chemical name for ciclopirox is 6-cyclohexyl-1-hydroxy-4-methyl-2(1 H )-pyridone, 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: chemical structure image

Ciclopirox Shampoo, 1% is indicated for the topical treatment of seborrheic dermatitis of the scalp in adults. • Ciclopirox Shampoo, 1% is an antifungal indicated for the topical treatment of seborrheic dermatitis of the scalp in adults. ( 1 )

Ciclopirox Shampoo, 1% is not for ophthalmic, oral, or intravaginal use. Wet hair and apply approximately 1 teaspoon (5 mL) of Ciclopirox Shampoo, 1% to the scalp. Up to 2 teaspoons (10 mL) may be used for long hair. Lather and leave on hair and scalp for 3 minutes. A timer may be used. Avoid contact with eyes. Rinse off. Treatment should be repeated twice per week for 4 weeks, with a minimum of 3 days between applications. If a patient with seborrheic dermatitis shows no clinical improvement after 4 weeks of treatment with Ciclopirox Shampoo, 1%, the diagnosis should be reviewed. • Apply approximately 1 teaspoon of Ciclopirox Shampoo, 1% to the scalp twice per week for 4 weeks. ( 2 ) • For topical use only. Not for ophthalmic, oral, or intravaginal use. ( 2 )

None. None ( 4 )

• The most frequently reported adverse reactions are pruritus, burning, and erythema. ( 6.1 ) To report SUSPECTED ADVERSE REACTIONS, contact Padagis at 1-866-634-9120 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch. 6.1 Clinical Trials Experience Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in clinical practice. In 626 subjects treated with ciclopirox shampoo, 1% twice weekly in the two pivotal clinical trials, the most frequent adverse events were increased itching in 1% of subjects, and application site reactions, such as burning, erythema, and itching, also in 1% of subjects. 6.2 Post Marketing Experience The following adverse reactions have been identified during post approval use of Ciclopirox Shampoo, 1%: hair discoloration and abnormal hair texture, alopecia, irritation and rash. Because these events are reported voluntarily from a population of uncertain size, it is not possible to reliably estimate their frequency or establish a causal relationship to drug exposure.