Dosing & Uses
Dosage Forms & Strengths
cream/lotion/gel
- 0.77%
shampoo
- 1%
nail lacquer
- 8%
Mild to Moderate Onychomycosis of Fingernails & Toenails
Nail lacquer topical solution: Apply evenly over entire nail plate qDay (preferably HS or 8 hours before washing) to all affected nails with applicator brush provided
Tinea Pedis or Tinea Corporis
Cream and suspension: Apply BID; gently massage into affected areas; if no improvement after 4 weeks re-evaluate diagnosis
Gel: Apply BID; gently massage into affected areas and surrounding skin if no improvement after 4 weeks re-evaluate diagnosis
Tinea Cruris, Cutaneous Candidiasis, Tinea Vesicolor
Cream and suspension: Apply BID; gently massage into affected areas; if no improvement after 4 weeks re-evaluate diagnosis
Seborrheic Dermatitis of the Scalp
Gel: Apply BID; gently massage into affected areas; if no improvement after 4 weeks re-evaluate diagnosis
Shampoo: Apply 5 mL (1 teaspoonful) to wet hair; lather, and leave in place for approximately 3 minutes before rinsing; may use up to 10 mL for longer hair; repeat BID qWeek for 4 weeks; allow minimum of 3 days between applications
Other Information
Remove all coats with alcohol once/week
Other Indications & Uses
Loprox: Tinea & candida infections due to C. albicans, E. floccosum, M. canis, M. furfur, T. mentagrophytes, T. rubrum
Penlac: Onchomycosis due to Trichophyton rubrum without lunula involvement
Dosage Forms & Strengths
cream/lotion/gel
- 0.77%
shampoo
- 1%
nail lacquer
- 8%
Tinea Pedis or Tinea Corporis
<10 years: Safety and efficacy not established
≥10 years: May use cream and suspension as in adults
≥16 years: May use Gel
Tinea Cruris, Cutaneous Candidiasis, Tinea Vesicolor
<10 years: Safety and efficacy not established
&ge:10 years: As in adults
Seborrheic Dermatitis of the Scalp
<16 years: Safety and efficacy not established
≥16 years: May use gel and shampoo as in adults
Mild to Moderate Onychomycosis of Fingernails & Toenails
<12 years: Safety and efficacy not established
≥12 years: May use laquer solution as in adults
Erythropoietic Porphyria (Orphan)
Orphan designation for congenital erythropoietic porphyria
Sponsor
- Atlas Molecular Pharma S.L.; Parque Tecnológico de Bizkaia, Building 800; Derio, Spain
Adverse Effects
1-10%
Periungual erythema (5%)
Pruritus (1-5%)
Erythema of the proximal nail fold (1%)
Transient burning sensation of the skin & pain
Dry skin
Acne
Rash
<1%
Alopecia
Warnings
Contraindications
Hypersensitivity
Should not be applied to the eye nor administered orally or intravaginally
Cautions
Onychomycosis: 6 months of therapy may be required for initial improvement in symptoms and they also should be notified that completely clear nail(s) may not be achieved with use of ciclopirox topical solution (nail lacquer)
Pregnancy & Lactation
Pregnancy Category: B
Lactation: not known if distributed in breast milk
Pregnancy Categories
A: Generally acceptable. Controlled studies in pregnant women show no evidence of fetal risk.
B: May be acceptable. Either animal studies show no risk but human studies not available or animal studies showed minor risks and human studies done and showed no risk. C: Use with caution if benefits outweigh risks. Animal studies show risk and human studies not available or neither animal nor human studies done. D: Use in LIFE-THREATENING emergencies when no safer drug available. Positive evidence of human fetal risk. X: Do not use in pregnancy. Risks involved outweigh potential benefits. Safer alternatives exist. NA: Information not available.Pharmacology
Half-Life: 1.7 hr
Protein Bound: 94-98%
Absorption: rapid but minimal
Metabolism: appears to be almost completely conjugated with glucuronic acid; 1-2% appears to be metabolized to N-desoxyciclopirox & an unidentified metabolite
Excretion: urine 1.3%
Mechanism of Action
Synthetic benzylamine topical antifungal similar to allylamines (terbinafine, naftifine) that inhibits intermediary in synthesis of ergosterol, an essential component of fungal cell membranes
Mechanism is considered fungistatic
Images
| BRAND | FORM. | UNIT PRICE | PILL IMAGE |
|---|---|---|---|
| Loprox (as olamine) topical - | 0.77 % cream |  | |
| Loprox (as olamine) topical - | 0.77 % suspension |  |
Copyright © 2010 First DataBank, Inc.
Formulary
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