Cutaneous candidiasis: Topical: Cream 0.77%, suspension 0.77%: Apply twice daily, gently massage into affected areas and surrounding skin; if no improvement after 4 weeks of treatment, re-evaluate the diagnosis.
Onychomycosis, mild to moderate:
Note: For patients with distal subungual onychomycosis involving ≤50% of the nail and sparing the matrix/lunula (Ref).
Topical: Lacquer (solution): Apply to affected fingernail(s) and/or toenail(s) and adjacent skin once daily in combination with weekly nail trimming and periodic nail debridement. Remove with alcohol every 7 days; continue therapy until nail clearance (maximum duration: 48 weeks) (Ref).
Seborrheic dermatitis of the scalp: Topical:
Gel 0.77%: Apply twice daily, gently massage into affected area; if no improvement after 4 weeks of treatment, re-evaluate diagnosis.
Shampoo 1%: 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.
Tinea infections:
Tinea corporis/tinea cruris: Topical: Cream 0.77%, gel 0.77% (gel is for tinea corporis only), lotion 1% [Canadian product], suspension 0.77%: Apply to affected and surrounding area(s) twice daily until clinical resolution, typically 1 to 4 weeks (Ref).
Tinea pedis (labeled use)/tinea manuum (off- label use): Topical: Cream 0.77%, gel 0.77%, lotion 1% [Canadian product], suspension 0.77%: Apply to affected and surrounding area(s) once or twice daily until 1 week after clinical resolution, typically for 4 weeks total (Ref).
Tinea versicolor (pityriasis versicolor): Topical: Cream 0.77%, suspension 0.77%: Apply to affected area(s) and immediate surrounding skin twice daily for 2 weeks (Ref).
There are no dosage adjustments provided in the manufacturer's labeling.
There are no dosage adjustments provided in the manufacturer's labeling.
Refer to adult dosing.
(For additional information see "Ciclopirox: Pediatric drug information")
Cutaneous candidiasis, tinea cruris, and tinea versicolor (pityriasis 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
There are no dosage adjustments provided in the manufacturer's labeling.
There are no dosage adjustments provided in the manufacturer's labeling.
The following adverse drug reactions and incidences are derived from product labeling unless otherwise specified.
>10%: Local: Application-site reaction (including application-site burning [≤34%], application-site erythema [1%], application-site irritation, application-site pain [<1%], application-site pruritus [≤5%])
1% to 10%: Dermatologic: Contact dermatitis (gel: 1% to 5%), erythematous condition (solution: erythema of proximal nail fold [≤5%], periungual erythema [≤5%]), pruritus (1% to 5%)
<1%:
Dermatologic: Acne vulgaris (gel), alopecia (gel, shampoo), skin rash (gel, shampoo), xeroderma (gel)
Hypersensitivity: Facial edema (gel)
Ophthalmic: Eye pain (gel)
Frequency not defined: Dermatologic: Changes in nails (solution: shape), nail discoloration (solution)
Postmarketing: Dermatologic: Abnormal hair texture (shampoo), hair discoloration (shampoo)
Hypersensitivity to ciclopirox or any component of the formulation
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.
Some dosage forms may contain propylene glycol; in neonates large amounts of propylene glycol delivered orally, intravenously (eg, >3,000 mg/day), or topically have been associated with potentially fatal toxicities which can include metabolic acidosis, seizures, renal failure, and CNS depression; toxicities have also been reported in children and adults including hyperosmolality, lactic acidosis, seizures and respiratory depression; use caution (AAP 1997; Shehab 2009).
Excipient information presented when available (limited, particularly for generics); consult specific product labeling. [DSC] = Discontinued product
Cream, External, as olamine [strength expressed as base]:
Loprox: 0.77% (90 g [DSC]) [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:
Ciclopirox Treatment: 8% [contains edetate (edta) disodium, isopropyl alcohol, menthol]
Loprox: 0.77% [DSC] [contains benzyl alcohol, cetyl alcohol]
Loprox: 0.77% [DSC] [contains benzyl alcohol, cetyl alcohol, edetate (edta) disodium, propylene glycol]
Shampoo, External:
Loprox: 1% (120 mL [DSC])
Generic: 1% (120 mL)
Solution, External:
Ciclodan: 8% (6.6 mL) [contains isopropyl alcohol]
Generic: 8% (6.6 mL)
Suspension, External, as olamine [strength expressed as base]:
Loprox: 0.77% (60 mL [DSC]) [contains benzyl alcohol, cetyl alcohol]
Generic: 0.77% (30 mL, 60 mL)
Yes
Cream (Ciclopirox Olamine External)
0.77% (per gram): $1.70 - $2.93
Gel (Ciclopirox External)
0.77% (per gram): $2.69 - $3.37
Shampoo (Ciclopirox External)
1% (per mL): $0.78 - $1.23
Solution (Ciclodan External)
8% (per mL): $88.32
Solution (Ciclopirox External)
8% (per mL): $8.02 - $27.12
Suspension (Ciclopirox Olamine External)
0.77% (per mL): $1.62 - $2.43
Disclaimer: A representative AWP (Average Wholesale Price) price or price range is provided as reference price only. A range is provided when more than one manufacturer's AWP price is available and uses the low and high price reported by the manufacturers to determine the range. The pricing data should be used for benchmarking purposes only, and as such should not be used alone to set or adjudicate any prices for reimbursement or purchasing functions or considered to be an exact price for a single product and/or manufacturer. Medi-Span expressly disclaims all warranties of any kind or nature, whether express or implied, and assumes no liability with respect to accuracy of price or price range data published in its solutions. In no event shall Medi-Span be liable for special, indirect, incidental, or consequential damages arising from use of price or price range data. Pricing data is updated monthly.
Excipient information presented when available (limited, particularly for generics); consult specific product labeling. [DSC] = Discontinued product
Cream, External:
Loprox: 1% (45 g) [contains benzyl alcohol, cetyl alcohol]
Lotion, External:
Loprox: 1% (60 mL) [contains benzyl alcohol, cetyl alcohol]
Shampoo, External:
Stieprox: 1.5% ([DSC]) [contains polysorbate 80]
Solution, External:
Penlac Nail Lacquer: 8% (3 g, 6 g, 12 g) [contains ethyl acetate, isopropyl alcohol]
Generic: 8% (6 g)
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.
Topical: For topical use only; not for ophthalmic, oral, or intravaginal use.
Cream, gel, suspension (lotion): Gently massage into affected areas and surrounding skin in the morning and evening. Avoid contact with eyes and mucous membranes; do not administer orally or intravaginally. Do not occlude affected area with dressings or wrappings. Shake suspension (lotion) vigorously before application.
Shampoo: Apply to wet hair and scalp, lather, and leave in place ~3 minutes; rinse thoroughly. Avoid contact with eyes.
Solution (lacquer): Apply evenly over the entire nail plate and 5 mm of surrounding skin using the applicator brush; allow to dry for 30 seconds; apply at bedtime (or allow 8 hours before washing). Solution can be reapplied daily over previous applications; remove with alcohol 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. Avoid contact with eyes and mucous membranes; do not administer orally or intravaginally. Do not use nail polish or other nail cosmetic products on the treated nails.
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.
Tinea manuum
None known.
There are no known significant interactions.
Adverse events were not observed in animal reproduction studies.
It is not known if ciclopirox is excreted in breast milk. The manufacturer recommends that caution be exercised when administering ciclopirox to nursing women.
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
Half-life elimination: Biologic: Cream, suspension: 1.7 hours; Elimination: Gel: 5.5 hours
Excretion: Urine (Gel: 3% to 10%; Shampoo: <0.5%; Cream, suspension: 0.01%); feces (small amounts)
Do you want to add Medilib to your home screen?