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Ciclopirox

Pronunciation

(sye kloe PEER oks)

Index Terms

  • Ciclopirox Olamine

Dosage Forms

Excipient information presented when available (limited, particularly for generics); consult specific product labeling. [DSC] = Discontinued product

Cream, External, as olamine:

Ciclodan: 0.77% (90 g) [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:

Loprox: 0.77% (30 g [DSC], 45 g [DSC], 100 g [DSC]) [contains isopropyl alcohol]

Generic: 0.77% (30 g, 45 g, 100 g)

Kit, External:

Ciclodan Cream: 0.77% [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% [contains isopropyl alcohol]

Loprox: 0.77% [contains benzyl alcohol, cetyl alcohol, edetate disodium, propylene glycol]

Pedipirox-4 Nail: 8% [DSC] [contains isopropyl alcohol]

Generic: 8 % [DSC]

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) [contains ethyl acetate, isopropyl alcohol]

Generic: 8% (6.6 mL)

Suspension, External, as olamine:

Generic: 0.77% (30 mL, 60 mL)

Brand Names: U.S.

  • Ciclodan
  • Ciclodan Cream
  • Ciclodan Solution
  • Ciclopirox Treatment
  • CNL8 Nail
  • Loprox
  • Pedipirox-4 Nail [DSC]
  • Penlac

Pharmacologic Category

  • Antifungal Agent, Topical

Pharmacology

Inhibiting transport of essential elements in the fungal cell disrupting the synthesis of DNA, RNA, and protein

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%; suspension: 0.01%); feces (small amounts)

Half-Life Elimination

Biologic: Cream, suspension: 1.7 hours; Elimination: Gel: 5.5 hours

Protein Binding

94% to 98%

Use: Labeled Indications

Dermatologic conditions (infectious and seborrheal):

Cream, suspension: Treatment of tinea pedis (athlete's foot), tinea cruris (jock itch), and tinea corporis (ringworm) due to Trichophyton rubrum, Trichophyton mentagrophytes, Epidermophyton floccosum, and Microsporum canis; cutaneous candidiasis (moniliasis) due to Candida albicans; and tinea versicolor (pityriasis) due to Malassezia furfur

Gel: Treatment of tinea pedis (athlete's foot), tinea corporis (ringworm); seborrheic dermatitis of the scalp

Lacquer (solution): Topical treatment of mild-to-moderate onychomycosis of the fingernails and toenails due to Trichophyton rubrum (not involving the lunula) and the immediately-adjacent skin

Shampoo: Treatment of seborrheic dermatitis of the scalp

Contraindications

Hypersensitivity to ciclopirox or any component of the formulation

Dosing: Adult

Dermatologic conditions, infectious:

Tinea pedis, tinea corporis: Topical:

Cream and suspension: Apply twice daily, gently massage into affected areas; if no improvement after 4 weeks of treatment, re-evaluate the diagnosis.

Gel: Apply twice daily, gently massage into affected areas and surrounding skin; if no improvement after 4 weeks of treatment, re-evaluate diagnosis

Tinea cruris, cutaneous candidiasis, and tinea versicolor: Topical: Cream and suspension: Apply twice daily, gently massage into affected areas; 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.

Dermatologic conditions, seborrheic: Topical:

Gel: Apply twice daily, gently massage into affected areas and surrounding skin; if no improvement after 4 weeks of treatment, re-evaluate 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, re-evaluate diagnosis.

Dosing: Geriatric

Refer to adult dosing.

Dosing: Pediatric

Dermatologic conditions, infectious:

Tinea pedis, tinea corporis: Topical:

Cream and suspension: Children >10 years and Adolescents ≤16 years: Refer to adult dosing.

Gel: Adolescents >16 years: Refer to adult dosing.

Tinea cruris, cutaneous candidiasis, and tinea versicolor: Topical: Cream and suspension: Children >10 years and Adolescents: Refer to adult dosing.

Onychomycosis of the fingernails and toenails: Topical: Lacquer (solution): Children ≥12 years and Adolescents: Refer to adult dosing.

Dermatologic conditions, seborrheic: Topical: Gel and shampoo: Adolescents >16 years: Refer to adult dosing

Dosing: Renal Impairment

There are no dosage adjustments provided in the manufacturer's labeling.

Dosing: Hepatic Impairment

There are no dosage adjustments provided in the manufacturer's labeling.

Administration

Topical:

Cream: Gently massage into affected areas.

Gel: Gently massage into clean, affected areas and adjacent skin.

Lacquer (solution): Apply evenly over nail 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.

Shampoo: Apply to wet hair; lather and leave in place for ~3 minutes; rinse.

Suspension: Shake well before use; gently massage into affected areas and surrounding skin in the morning and evening.

Storage

Cream, shampoo: Store at 20°C to 25°C (68°F to 77°F).

Gel: Store at 15°C to 30°C (59°F to 86°F).

Lacquer (solution): Store at 15°C to 30°C (59°F to 86°F). 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 doseforms: ≤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 and has not been studied in conjunction with systemic therapy or in patients with type 1 diabetes mellitus (insulin dependent, IDDM).

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 Risk Factor

B

Pregnancy Considerations

Adverse events were not observed in animal reproduction studies.

Patient Education

• Discuss specific use of drug and side effects with patient as it relates to treatment. (HCAHPS: During this hospital stay, were you given any medicine that you had not taken before? Before giving you any new medicine, how often did hospital staff tell you what the medicine was for? How often did hospital staff describe possible side effects in a way you could understand?)

• Patient may experience itching, hair discoloration, or skin or nail changes. Have patient report immediately to prescriber edema, skin sores, oozing, bleeding, burning, severe skin irritation, or severe scalp irritation (HCAHPS).

• Educate patient about signs of a significant reaction (eg, 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. Patient should consult prescriber for additional questions.

Intended Use and Disclaimer: Should not be printed and given to patients. This information is intended to serve as a concise initial reference for healthcare professionals to use when discussing medications with a patient. You must ultimately rely on your own discretion, experience and judgment in diagnosing, treating and advising patients.

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