Ciclopirox Olamine

Antifungal;1 2 3 chemically unrelated to imidazoles or other antifungal agents currently available in US.4

Administration

Topical Administration

Apply topically to the skin as a cream,1 gel,28 lotion,66 or shampoo65 and to nails as a solution (nail lacquer).40

Do not apply to the eye1 25 28 40 65 66 or administer orally or intravaginally.23 24 40 65 Avoid contact with mucous membranes.28 40 65

Apply a sufficient amount of cream, gel, or lotion in the morning and evening; rub gently into cleansed, affected area and surrounding skin.1 23 25 31 66

Do not use with occlusive dressings or wrappings.1 28 66

If contact with eye(s) occurs, rinse thoroughly with water.65

Use in conjunction with frequent (e.g., monthly) appointments with a qualified clinician in nail disorders and weekly self-trimming of infected nail(s).40

Remove any loose nail or nail material (using nail clippers or nail files) before initiating therapy.40

Apply solution evenly over entire nail bed, undersurface of nail plate (if free of nail bed), and 5 mm of surrounding skin using applicator brush provided by the manufacturer.40

Avoid contact with skin other than that immediately surrounding the treated nail(s) (because of risk of adverse dermatologic reactions).40

After applying solution, wait ≥8 hours before bathing.40

Allow nail(s) to dry (about 30 seconds) before wearing socks or stockings.40

Do not apply nail polish or other cosmetic nail products on treated nail(s).40

Dosage

Available as ciclopirox and ciclopirox olamine; dosage expressed in terms of ciclopirox.1 28 40 65 66

Pediatric Patients

Children ≥10 years of age: Apply 0.77% cream or lotion twice daily.1 23 25 31 66

If clinical improvement does not occur after 4 weeks of treatment, reevaluate the diagnosis.1 25 66

Children ≥10 years of age: Apply 0.77% cream or lotion twice daily.1 23 25 31 66

Clinical improvement usually occurs after 2 weeks of treatment.1 25 66

Adults

Apply 0.77% cream or lotion twice daily.1 23 25 31 66 Alternatively, in the treatment of interdigital tinea pedis or tinea corporis, apply 0.77% gel twice daily.28

If clinical improvement does not occur after 4 weeks of treatment, reevaluate the diagnosis.1 25 66

Apply 0.77% cream or lotion twice daily.1 23 25 31 66

Clinical improvement usually occurs after 2 weeks of treatment.1 25 66

Apply 0.77% gel to affected areas twice daily.28

Alternatively, apply approximately 5 mL (10 mL for long hair) of 1% shampoo to wet hair and scalp and lather.65 Allow drug to remain on the scalp for 3 minutes and then rinse.65 Repeat treatment twice weekly for 4 weeks, with a minimum of 3 days between applications.65

If clinical improvement does not occur after 4 weeks of treatment, reevaluate the diagnosis.65

Apply 8% topical solution (nail lacquer) once daily (preferably at bedtime).40 Remove accumulated applications of the drug with alcohol every 7 days; daily removal of solution is not recommended.40

Initial improvement of symptoms may require 6 months of therapy and up to 48 weeks of continuous comprehensive therapy to achieve clear or almost clear nail(s).40

Systemic Antifungal Agents

No studies conducted in patients with onychomycosis to determine whether topical ciclopirox solution might reduce efficacy of systemic antifungals; combined use of the topical solution with a systemic antifungal agent is not recommended.40

Consult your pharmacist.

How to use Ciclopirox Olamine Powder

Consult your pharmacist.

Consult your pharmacist.

If someone has overdosed and has serious symptoms such as passing out or trouble breathing, call 911. Otherwise, call a poison control center right away. US residents can call their local poison control center at 1-800-222-1222. Canada residents can call a provincial poison control center.

Notes

Missed Dose

Consult your pharmacist.

Storage

Consult your pharmacist.

Do not flush medications down the toilet or pour them into a drain unless instructed to do so. Properly discard this product when it is expired or no longer needed. Consult your pharmacist or local waste disposal company for more details about how to safely discard your product.

Information last revised July 2016. Copyright(c) 2016 First Databank, Inc.