Dosage Forms
Excipient information presented when available (limited, particularly for generics); consult specific product labeling. [DSC] = Discontinued product
Cream, External, as olamine [strength expressed as base]:
Ciclodan: 0.77% (90 g [DSC]) [contains benzyl alcohol, cetyl alcohol]
Loprox: 0.77% (90 g) [contains benzyl alcohol, cetyl alcohol]
Generic: 0.77% (15 g, 30 g, 90 g)
Gel, External:
Generic: 0.77% (30 g, 45 g, 100 g)
Kit, External:
Ciclodan Cream: 0.77% [DSC] [contains benzyl alcohol, cetyl alcohol, edetate disodium, propylene glycol]
Ciclodan Solution: 8% [contains edetate disodium, isopropyl alcohol, menthol]
Ciclopirox Treatment: 8% [contains edetate disodium, isopropyl alcohol, menthol]
CNL8 Nail: 8% [DSC] [contains isopropyl alcohol]
Loprox: 0.77% [contains benzyl alcohol, cetyl alcohol]
Loprox: 0.77% [contains benzyl alcohol, cetyl alcohol, edetate disodium, propylene glycol]
Shampoo, External:
Loprox: 1% (120 mL)
Generic: 1% (120 mL)
Solution, External:
Ciclodan: 8% (6.6 mL) [contains isopropyl alcohol]
Penlac: 8% (6.6 mL [DSC]) [contains ethyl acetate, isopropyl alcohol]
Generic: 8% (6.6 mL)
Suspension, External, as olamine [strength expressed as base]:
Loprox: 0.77% (60 mL) [contains benzyl alcohol, cetyl alcohol]
Generic: 0.77% (30 mL, 60 mL)
Pharmacology
Mechanism of Action
Inhibiting transport of essential elements in the fungal cell disrupting the synthesis of DNA, RNA, and protein
Pharmacokinetics/Pharmacodynamics
Absorption
Cream, suspension: 1.3% through intact skin; increased with gel; <5% with lacquer
Distribution
Scalp application: To epidermis, corium (dermis), including hair, hair follicles, and sebaceous glands
Metabolism
Conjugated with glucuronic acid
Excretion
Urine (Gel: 3% to 10%; Shampoo: <0.5%; Cream, suspension: 0.01%); feces (small amounts)
Half-Life Elimination
Biologic: Cream, suspension: 1.7 hours; Elimination: Gel: 5.5 hours
Use: Labeled Indications
Dermatologic conditions (infectious and seborrheal):
Cream, suspension: Topical treatment of tinea pedis, tinea cruris, and tinea corporis due to Trichophyton rubrum, Trichophyton mentagrophytes, Epidermophyton floccosum, and Microsporum canis; candidiasis (moniliasis) due to Candida albicans; tinea (pityriasis) versicolor due to Malassezia furfur.
Gel: Topical treatment of interdigital tinea pedis and tinea corporis due to T. rubrum, T. mentagrophytes, or E. floccosum; seborrheic dermatitis of the scalp.
Nail lacquer topical solution: Topical treatment of immunocompetent patients with mild to moderate onychomycosis of fingernails and toenails, without lunula involvement, due to Trichophyton rubrum, as a component of a comprehensive management program.
Shampoo: Topical treatment of seborrheic dermatitis of the scalp in adults.
Contraindications
Hypersensitivity to ciclopirox or any component of the formulation
Dosage and Administration
Dosing: Adult
Tinea pedis, tinea corporis: Topical: Cream, gel, and suspension: Apply twice daily, gently massage into affected areas and surrounding skin; if no improvement after 4 weeks of treatment, re-evaluate the diagnosis.
Tinea cruris, cutaneous candidiasis, and tinea versicolor: Topical: Cream and suspension: Apply twice daily, gently massage into affected areas and surrounding skin; if no improvement after 4 weeks of treatment, re-evaluate the diagnosis.
Onychomycosis of the fingernails and toenails: Topical: Lacquer (solution): Apply to adjacent skin and affected nails daily (as a part of a comprehensive management program for onychomycosis). Remove with alcohol every 7 days.
Seborrheic dermatitis, scalp: Topical:
Gel: Apply twice daily, gently massage into affected area; if no improvement after 4 weeks of treatment, re-evaluate diagnosis.
Shampoo: Apply ~5 mL to wet hair; lather, and leave on hair and scalp for ~3 minutes; rinse. May use up to 10 mL for longer hair. Repeat twice weekly for 4 weeks; allow a minimum of 3 days between applications; if no improvement after 4 weeks of treatment, re-evaluate diagnosis.
Dosing: Geriatric
Refer to adult dosing.
Dosing: Pediatric
Cutaneous candidiasis, tinea cruris, and tinea versicolor: Cream and suspension (lotion): Children ≥10 years and Adolescents: Topical: Apply twice daily (morning and evening) to the affected area; if no improvement after 4 weeks, reevaluate treatment
Tinea corporis, tinea pedis:
Cream and suspension (lotion): Children ≥10 years and Adolescents: Topical: Apply twice daily (morning and evening) to the affected area; if no improvement after 4 weeks, reevaluate treatment
Gel: Adolescents ≥16 years: Topical: Apply twice daily (morning and evening) to affected areas and surrounding skin; if no improvement after 4 weeks of treatment, reevaluate diagnosis
Onychomycosis of the fingernails and toenails: Lacquer (solution): Children ≥12 years and Adolescents: Topical: Apply to adjacent skin and affected nails once daily preferably at bedtime or 8 hours before washing (as a part of a comprehensive management program for onychomycosis). Remove with alcohol every 7 days.
Seborrheic dermatitis of the scalp: Adolescents ≥16 years: Topical:
Gel: Apply twice daily, gently massage into affected areas and surrounding skin; if no improvement after 4 weeks of treatment, reevaluate diagnosis
Shampoo: Apply ~5 mL to wet hair; lather, and leave in place ~3 minutes; rinse. May use up to 10 mL for longer hair. Repeat twice weekly for 4 weeks; allow a minimum of 3 days between applications; if no improvement after 4 weeks of treatment, reevaluate diagnosis
Administration
Topical: For topical use only; not for ophthalmic, oral, or intravaginal use.
Cream: Gently massage into affected areas and surrounding skin in the morning and evening.
Gel: Gently massage into clean, affected areas or to scalp and adjacent skin in the morning and evening.
Lacquer (solution): Apply evenly over nail (apply evenly over entire nail plate, and if possible to nail bed and under nail plate surface) and surrounding skin at bedtime (or allow 8 hours before washing); apply daily over previous coat for 7 days; after 7 days, may remove with alcohol and continue cycle. Every 7 days after ciclopirox is removed with alcohol, file away (with emery board) loose nail material and trim nails, as required or as directed by a health care professional.
Shampoo: Wet hair and apply to the scalp; lather and leave on hair and scalp for ~3 minutes; rinse. Avoid contact with eyes.
Suspension: Shake well before use; gently massage into affected areas and surrounding skin in the morning and evening.
Storage
Cream, gel, shampoo: Store at 15°C to 30°C (59°F to 86°F).
Nail lacquer (solution): Store at 15°C to 30°C (59°F to 86°F). Protect from light. Flammable; keep away from heat and flame.
Suspension: Store at 5°C to 25°C (41°F to 77°F).
Drug Interactions
There are no known significant interactions.
Adverse Reactions
Frequency not always defined.
Cardiovascular: Facial edema, ventricular tachycardia (shampoo)
Central nervous system: Headache
Dermatologic: Acne vulgaris, alopecia, contact dermatitis, erythema, hair discoloration (rare; shampoo formulation in light-haired individuals), localized erythema, nail disease (shape or color change with lacquer), pruritus, skin rash, xeroderma
Local: Application site burning (gel: 7% to 34%; other dose forms: ≤1%), local irritation, local pain
Ophthalmic: Eye pain
Warnings/Precautions
Concerns related to adverse effects:
- Irritation: Discontinue if sensitivity or irritation occurs and institute appropriate therapy.
Special populations:
- Immunocompromised patients: Use with caution; use has not been evaluated in immunosuppressed or immunocompromised patients.
Dosage form specific issues:
- Benzyl alcohol and derivatives: Some dosage forms may contain benzyl alcohol; large amounts of benzyl alcohol (≥99 mg/kg/day) have been associated with a potentially fatal toxicity ("gasping syndrome") in neonates; the "gasping syndrome" consists of metabolic acidosis, respiratory distress, gasping respirations, CNS dysfunction (including convulsions, intracranial hemorrhage), hypotension and cardiovascular collapse (AAP ["Inactive" 1997]; CDC 1982); some data suggests that benzoate displaces bilirubin from protein binding sites (Ahlfors 2001); avoid or use dosage forms containing benzyl alcohol with caution in neonates. See manufacturer’s labeling.
- Nail lacquer: For topical use only; has not been studied in conjunction with systemic therapy or in patients with type 1 diabetes mellitus (insulin dependent, IDDM) or diabetic neuropathy.
- Shampoo: Patients with lighter hair color may experience hair discoloration.
Other warnings/precautions:
- Appropriate use: For topical use only; avoid contact with eyes or mucous membranes. Use of occlusive dressings or wrappings should be avoided.
Pregnancy
Pregnancy Risk Factor
B
Pregnancy Considerations
Adverse events were not observed in animal reproduction studies.
Patient Education
What is this drug used for?
- It is used to treat fungal infections of the skin.
- It is used to treat some nail problems.
- It is used to control seborrheic dermatitis.
- It may be given to you for other reasons. Talk with the doctor.
Frequently reported side effects of this drug
- Hair discoloration
- Skin or nail changes
Other side effects of this drug: Talk with your doctor right away if you have any of these signs of:
- Swelling
- Skin sores
- Blisters
- Oozing
- Bleeding
- Burning
- Redness
- Skin irritation
- Scalp irritation
- Signs of a significant reaction like wheezing; chest tightness; fever; itching; bad cough; blue skin color; seizures; or swelling of face, lips, tongue, or throat.
Note: This is not a comprehensive list of all side effects. Talk to your doctor if you have questions.
Consumer Information Use and Disclaimer: This information should not be used to decide whether or not to take this medicine or any other medicine. Only the healthcare provider has the knowledge and training to decide which medicines are right for a specific patient. This information does not endorse any medicine as safe, effective, or approved for treating any patient or health condition. This is only a brief summary of general information about this medicine. It does NOT include all information about the possible uses, directions, warnings, precautions, interactions, adverse effects, or risks that may apply to this medicine. This information is not specific medical advice and does not replace information you receive from the healthcare provider. You must talk with the healthcare provider for complete information about the risks and benefits of using this medicine.
