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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 [strength expressed as base]:

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% (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% [DSC] [contains isopropyl alcohol]

Loprox: 0.77% [contains benzyl alcohol, cetyl 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 [strength expressed as base]:

Loprox: 0.77% (60 mL) [contains benzyl alcohol, cetyl alcohol]

Generic: 0.77% (30 mL, 60 mL)

Brand Names: U.S.

  • Ciclodan
  • Ciclodan Cream
  • Ciclodan Solution
  • Ciclopirox Treatment
  • CNL8 Nail [DSC]
  • 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%; 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

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

Tinea pedis, tinea corporis: Topical:

Cream and suspension: Children >10 years and Adolescents: 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.

Seborrheic dermatitis, scalp: 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: 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 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; 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 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 hair discoloration or skin or nail changes. Have patient report immediately to prescriber edema, skin sores, blisters, oozing, bleeding, burning, redness, skin irritation, or 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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