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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

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Cream, External, as olamine:

Ciclodan: 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]

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

Generic: 8 %

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: <2% 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%); 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

Cream/suspension: Treatment of tinea pedis (athlete's foot), tinea cruris (jock itch), tinea corporis (ringworm), cutaneous candidiasis, and tinea versicolor (pityriasis)

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

Dosage

Topical:

Children >10 years and Adults: Tinea pedis, tinea cruris, tinea corporis, cutaneous candidiasis, and tinea versicolor: Cream/suspension: Apply twice daily, gently massage into affected areas; if no improvement after 4 weeks of treatment, re-evaluate the diagnosis.

Children ≥12 years and Adults: Onychomycosis of the fingernails and toenails: 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.

Children >16 years and Adults:

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

Seborrheic dermatitis of the scalp:

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.

Dosage adjustment in renal impairment: No dosage adjustment provided in manufacturer’s labeling.

Dosage adjustment in hepatic impairment: No dosage adjustment provided in manufacturer’s labeling.

Administration

Topical:

Cream, suspension: 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.

Storage

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

Lacquer (solution): Store at room temperature of 15°C to 30°C (59°F to 86°F). Flammable; keep away from heat and flame.

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

Drug Interactions

There are no known significant interactions.

Adverse Reactions

Cardiovascular: Ventricular tachycardia (shampoo)

Central nervous system: Headache

Dermatologic: Acne, alopecia, contact dermatitis, dry skin, erythema, facial edema, hair discoloration (rare; shampoo formulation in light-haired individuals), nail disorder (shape or color change with lacquer), pruritus, rash

Local: Burning sensation (gel: 7% to 34%; ≤1% with other forms), irritation, pain, or redness

Ocular: Eye pain

Warnings/Precautions

Concerns related to adverse effects:

• Irritation: Discontinue if sensitivity or irritation occurs.

Special populations:

• Immunocompromised patients: 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

Teratogenic effects were not observed in animal studies, however, there are no adequate and well-controlled studies in pregnant women. Use during pregnancy only if clearly needed.

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 hair discoloration or skin or nail changes. Have patient report immediately to prescriber edema, skin sores, oozing, hemorrhaging, severe skin irritation, or significant 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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