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ciclopirox (Rx)Brand and Other Names:Loprox, Penlac

 
 
 

Dosing & Uses

AdultPediatric

Dosage Forms & Strengths

cream/lotion/gel

  • 0.77%

shampoo

  • 1%

nail lacquer

  • 8%
more...

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%
more...

Tinea Pedis or Tinea Corporis

<10 years old: Safety & efficacy not established

>10 years old: May use cream and suspension as in adults

>16 years old: May use Gel

Tinea Cruris, Cutaneous Candidiasis, Tinea Vesicolor

<10 years old: Safety & efficacy not established

>10 years old: As in adults

Seborrheic Dermatitis of the Scalp

<16 years old: Safety & efficacy not established

>16 years old: May use gel and shampoo as in adults

Mild to Moderate Onychomycosis of Fingernails & Toenails

<12 years old: Safety & efficacy not established

>12 years old: May use laquer solution as in adults

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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

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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)

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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.

more...
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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

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Images

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Formulary

FormularyPatient Discounts

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The above information is provided for general informational and educational purposes only. Individual plans may vary and formulary information changes. Contact the applicable plan provider for the most current information.

Tier Description
1 This drug is available at the lowest co-pay. Most commonly, these are generic drugs.
2 This drug is available at a middle level co-pay. Most commonly, these are "preferred" (on formulary) brand drugs.
3 This drug is available at a higher level co-pay. Most commonly, these are "non-preferred" brand drugs.
4 This drug is available at a higher level co-pay. Most commonly, these are "non-preferred" brand drugs or specialty prescription products.
5 This drug is available at a higher level co-pay. Most commonly, these are "non-preferred" brand drugs or specialty prescription products.
6 This drug is available at a higher level co-pay. Most commonly, these are "non-preferred" brand drugs or specialty prescription products.
NC NOT COVERED – Drugs that are not covered by the plan.
Code Definition
PA Prior Authorization
Drugs that require prior authorization. This restriction requires that specific clinical criteria be met prior to the approval of the prescription.
QL Quantity Limits
Drugs that have quantity limits associated with each prescription. This restriction typically limits the quantity of the drug that will be covered.
ST Step Therapy
Drugs that have step therapy associated with each prescription. This restriction typically requires that certain criteria be met prior to approval for the prescription.
OR Other Restrictions
Drugs that have restrictions other than prior authorization, quantity limits, and step therapy associated with each prescription.
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