CICLOPIROX

1 INDICATIONS AND USAGE Ciclopirox shampoo, 1 % is indicated for the topical treatment of seborrheic dermatitis of the scalp in adults. Ciclopirox shampoo is an antifungal indicated for the topical treatment of seborrheic dermatitis of the scalp in adults. ( 1 )

2 DOSAGE AND ADMINISTRATION Ciclopirox shampoo is not for ophthalmic, oral, or intravaginal use. Wet hair and apply approximately 1 teaspoon (5 mL) of ciclopirox shampoo 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, the diagnosis should be reviewed. Apply approximately 1 teaspoon of ciciopirox shampoo to the scalp twice per week for 4 weeks. ( 2 ) For topical use only. Not for ophthalmic, oral, or intravaginal use. ( 2 )

5 WARNINGS AND PRECAUTIONS If signs of irritation occur, discontinue use. ( 5.1 ) Avoid contact with eyes. ( 5.1 ) Hair discoloration has been reported with ciclopirox use. ( 5.1 ) 5.1 Local Effects If a reaction suggesting sensitivity or irritation occurs with the use of ciclopirox shampoo, treatment should be discontinued and appropriate therapy instituted. Contact of cicloplrox shampoo with the eyes should be avoided. If contact occurs, rinse thoroughly with water. In patients with lighter hair color, hair discoloration has been reported.

4 CONTRAINDICATIONS None. None

8.1 PREGNANCY Teratogenic Effects: Pregnancy Category B There are no adequate or well-controlled studies in pregnant women. Therefore, ciclopirox shampoo should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus. Oral embryofetal developmental studies were conducted in mice, rats, rabbits and monkeys. Ciclopirox or ciclopirox olamine was orally administered during the period of organogenesis. No maternal toxicity, embryotoxicity or teratogenicity were noted at the highest doses of 77, 125, 80 and 38.5 mg/kg/day ciclopirox in mice, rats, rabbits and monkeys, respectively (approximately 13, 42, 54 and 26 times the maximum recommended human dose based on body surface area comparisons, respectively). Dermal embryofetal developmental studies were conducted in rats and rabbits with ciclopirox olamine dissolved in PEG 400. Ciclopirox olamine was topically administered during the period of organogenesis. No maternal toxicity, embryotoxicity or teratogenicity were noted at the highest doses of 92 mg/kg/day and 77 mg/kg/day ciclopirox in rats and rabbits, respectively (approximately 31 and 54 times the maximum recommended human dose based on body surface area comparisons, respectively).

8.3 NURSING MOTHERS It is not known whether this drug is excreted in human milk. Because many drugs are excreted in human milk, caution should be exercised when ciclopirox shampoo is administered to a nursing woman.

6 ADVERSE REACTIONS The most frequently reported adverse reactions are pruritus, burning, and erythema. ( 6.1 ) To report SUSPECTED ADVERSE REACTIONS, contact Encube Ethicals Private Limited at 1-833-285-4151, and/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 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 POSTMARKETING EXPERIENCE The following adverse reactions have been identified during post approval use of ciclopirox shampoo: 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.