| CICLOPIROX OLAMINE
Loprox, Penlac Nail Lacquer
Classifications: antifungal antibiotic; Therapeutic: antifungal antibiotic
Pregnancy Category: B
1% cream, ointment; 8% nail lacquer; 1% shampoo
Synthetic broad-spectrum antifungal agent with activity against pathogenic fungi. Inhibits transport of amino acids within
fungal cell, thereby interfering with synthesis of fungal protein, RNA, and DNA.
Effective against the following organisms: dermatophytes, yeasts, some species of Mycoplasma and Trichomonas vaginalis, and certain strains of gram-positive and gram-negative bacteria.
Topically for treatment of tinea cruris and tinea corporis (ringworm) due to Trichophyton rubrum, Trichophyton mentagrophytes, Epidermophyton floccosum, and Microsporum canis, and for tinea (pityriasis) versicolor due to M. furfur; also cutaneous candidiasis (moniliasis) caused by Candida albicans. Nail lacquer indicated for onychomycosis of fingernails and toenails due to T. rubrum; seborrheic dermatitis of the scalp.
Hypersensitivity to ciclopirox olamine or to any component in the formulation; concurrent administration of corticosteroid
therapy. Safe use in children <10 y not established.
Type 1 diabetic patient; history of seizure disorder; immunosuppression; pregnancy (category B); lactation.
Route & Dosage
Adult: Topical Massage cream into affected area and surrounding skin twice daily, morning and evening.
Adult: Topical Paint affected nail(s) under the surface of the nail and on the nail bed once daily at bedtime (at least 8 h before washing).
After 7 d, remove lacquer with alcohol and remove or trim away unattached nail. Continue up to 48 wk.
Adult: Topical Wet hair and apply approximately 1 tsp (5 mL) to the scalp (may use up to 10 mL for long hair), leave on scalp for 3 min,
then rinse. Repeat treatment twice/wk x 4 wk, with a min 3 d between applications.
- Wash hands thoroughly before and after treatments.
- Consult with physician about specific procedure for cleansing the skin before medication is applied. Regardless of method
used, dry skin thoroughly before drug application.
- Avoid occlusive dressing, wrapping, or clothing over site where cream is applied.
- Store at 15°30° C (59°86° F) unless otherwise directed.
Adverse Effects (≥1%)Skin:
Irritation, pruritus, burning, worsening of clinical condition.
No clinically significant interactions established.
1.3% absorbed through intact skin. Distribution:
Distributed to epidermis, corium (dermis), including hair and hair follicles and sebaceous glands; not known if crosses
placenta or is distributed into breast milk. Elimination:
Excreted primarily by kidneys. Half-Life:
Assessment & Drug Effects
- Monitor for therapeutic effectiveness. Tinea versicolor generally responds to drug treatment in about 2 wk. Tinea pedis
("athlete's foot"), tinea corporis (ringworm), tinea cruris ("jock itch"), and candidiasis (moniliasis)
require about 4 wk of therapy.
Patient & Family Education
- Use medication for the prescribed time even though symptoms improve.
- Report skin irritation or other possible signs of sensitization. A reaction suggestive of sensitization warrants drug discontinuation.
- Do not use occlusive dressings or wrappings.
- Avoid contact of drug in or near the eyes.
- Wear light clothing and footwear that will allow ventilation. Loose-fitting cotton underwear or socks are preferred.