Ciclopirox

Ciclopirox is a prescription topical antifungal agent intended for topical use on fingernail and toenails as well as immediately adjacent skin.

• Ciclopirox is available under the following different brand names: Loprox and Penlac.

Adult and Pediatric Dosages:

Cream/lotion/gel

• 0.77%

Shampoo

• 1%

Nail lacquer

• 8%

Dosage Considerations – Should be Given as Follows:

Mild to Moderate Onychomycosis of Fingernails and Toenails

Adult Dosage:

• Nail lacquer topical solution: Apply evenly over the entire nail plate once daily (preferably in the evening or 8 hours before washing) to all affected nails with the applicator brush provided

Pediatric Dosage:

• Children under 12 years old: Safety and efficacy not established
• Children over 12 years old: May use lacquer solution as in adults

Tinea Pedis or Tinea Corporis

Adult Dosage:

• Cream and suspension: Apply twice daily; gently massage into affected areas; if no improvement after 4 weeks re-evaluate diagnosis
• Gel: Apply twice daily; gently massage into affected areas and surrounding skin if no improvement after 4 weeks re-evaluate diagnosis

Pediatric Dosage:

• Children under 10 years old: Safety and efficacy not established
• Children over 10 years old: May use cream and suspension as in adults
• Children over 16 years old: May use gel

Tinea Cruris, Cutaneous Candidiasis, Tinea Vesicolor

Adult Dosage:

• Cream and suspension: Apply twice daily; gently massage into affected areas; if no improvement after 4 weeks re-evaluate diagnosis

Pediatric Dosage:

• Children under 10 years old: Safety and efficacy not established
• Children over 10 years old: As in adults

Seborrheic Dermatitis of the Scalp

Adult Dosage:

• Gel: Apply twice daily; 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 twice each week for 4 weeks; allow a minimum of 3 days between applications

Pediatric Dosage:

• Children under 16 years old: Safety and efficacy not established
• Children over 16 years old: May use gel and shampoo as in adults

Other information

• Remove all coats with alcohol once/week

Other indications and uses

• Loprox: Tinea and candida infections due to C. albicans, E. floccosum, M. canis, M. furfur, T. mentagrophytes, T. rubrum
• Penlac: Onychomycosis due to Trichophyton rubrum without lunula involvement

Common side effects of ciclopirox include:

• redness around finger/toe nails
• severe itching
• changes of the cuticle and/or nail plate
• transient burning sensation of the skin and pain
• dry skin
• acne
• rash
• hair loss
• nail disorders (shape change, irritation, ingrown toenails and discoloration)
• elevated creatine phosphokinase levels (CPK)

This document does not contain all possible side effects and others may occur. Check with your physician for additional information about side effects.

If your doctor has directed you to use this medication, your doctor or pharmacist may already be aware of any possible drug interactions and may be monitoring you for them. Do not start, stop, or change the dosage of any medicine before checking with your doctor, health care provider, or pharmacist first.

• Ciclopirox has no known severe interactions with other drugs.
• Ciclopirox has no known serious interactions with other drugs.
• Ciclopirox has no known moderate interactions with other drugs.
• Ciclopirox has no known minor interactions with other drugs.

This information does not contain all possible interactions or adverse effects. Therefore, before using this product, tell your doctor or pharmacist of all the products you use. Keep a list of all your medications with you, and share this information with your doctor and pharmacist. Check with your health care professional or doctor for additional medical advice, or if you have health questions, concerns, or for more information about this medicine.

Warnings

• This medication contains ciclopirox. Do not take Loprox or Penlac if you are allergic to ciclopirox or any ingredients contained in this drug.
• Keep out of reach of children. In case of overdose, get medical help or contact a Poison Control Center immediately.

Contraindications

• Hypersensitivity
• Should not be applied to the eye nor administered orally or intravaginally
• Effects of Drug Abuse
• None

Short-Term Effects

• See "What Are Side Effects Associated with Using Ciclopirox?"

Long-Term Effects

• See "What Are Side Effects Associated with Using Ciclopirox?"

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 the use of ciclopirox topical solution (nail lacquer)

Pregnancy and Lactation

• Ciclopirox is generally acceptable for use during pregnancy. Controlled studies in pregnant women show no evidence of fetal risk (oral dosage). Use ciclopirox with caution during pregnancy if doses exceed the recommended daily average. Animal studies show risk and human studies are not available, or neither animal nor human studies were done.
• It is unknown if ciclopirox is distributed into breast milk; consult your physician if breastfeeding.