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Ciclopirox

Pronunciation: sigh-kloe-PEER-ox
Class: Antifungal

Trade Names

Ciclodan
- Solution, topical 8%

Ciclopirox Olamine
- Cream, topical 0.77%
- Suspension, topical 0.77%

Loprox
- Gel 0.77%
- Shampoo 1%

Pedipirox
- Solution, topical 8%

Penlac
- Solution, topical 8%

Stieprox (Canada)
Loprox (Canada)

Pharmacology

Broad-spectrum, antifungal agent with an unknown mechanism of action.

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Pharmacokinetics

Absorption

Absorption is 1.3% with topical application followed by occlusion for 6 h.

Elimination

The primary route of metabolism is glucuronidation. The t ½ is 1.7 h with excretion primarily via the kidney.

Indications and Usage

Shampoo/Gel

Topical treatment of seborrheic dermatitis of the scalp in adults.

Gel

Interdigital tinea pedis and tinea corporis caused by T. rubrum , T. mentagrophytes , or E. floccosum .

Cream/Suspension

Tinea pedis (athlete's foot), tinea cruris (jock itch), and tinea corporis (ringworm) caused by T. rubrum , T. mentagrophytes , E. floccosum , and M. canis ; cutaneous candidiasis (moniliasis) caused by C. albicans ; tinea (pityriasis) versicolor caused by M. furfur .

Ciclodan , Pedipirox , Penlac

As a component of a comprehensive management program for topical treatment in immunocompetent patients with mild to moderate onychomycosis of fingernails and toenails without lunula involvement, caused by T. rubrum .

Contraindications

Hypersensitivity to any component.

Dosage and Administration

Shampoo
Adults and children 16 y and older

Topical Wet hair and apply approximately 5 mL to the scalp. Up to 10 mL may be used for long hair. Lather and leave on hair and scalp for 3 min. Rinse off. Repeat treatment 2 times/wk for 4 wk, with a minimum of 3 days between applications. If no improvement after 4 wk of treatment, reevaluate the diagnosis.

Cream/suspension
Adults and children 10 y and older

Topical Gently massage cream into the affected and surrounding skin areas twice daily, morning and evening. If no improvement after 4 wk of treatment, reevaluate the diagnosis.

Gel
Adults and children 16 y and older

Topical Gently massage gel into affected skin areas of scalp areas twice daily, morning and evening. If no improvement after 4 wk of treatment, reevaluate the diagnosis.

Ciclodan / Pedipirox / Penlac
Adults

Topical Apply every day, at bedtime or 8 h before washing, to all affected nails with the provided applicator. Apply evenly over the entire nail plate. If possible, apply to nail bed, hyponychium, and the under surface of the nail plate when it is free of the nail bed (eg, onycholysis). Do not remove product on a daily basis. Make daily applications over the previous coat and remove with alcohol every 7 days, repeating this cycle throughout the duration of therapy. As a comprehensive management program for onychomycosis, removal of the unattached, infected nail, as frequently as monthly, by a health care professional, weekly trimming by the patient, and daily application of the medication are integral parts of therapy.

General Advice

  • For topical use only. Not for ophthalmic, otic, oral, or intravaginal use.
  • Do not use occlusive wraps or dressings on treated areas.

Storage/Stability

Store at 59° to 86°F. Discard any unused shampoo 8 wk after opening. Protect solution from light and away from heat and flame. Keep solution tightly capped and stored in original carton after each use.

Drug Interactions

None well documented.

Adverse Reactions

Cardiovascular

Ventricular tachycardia.

Dermatologic

Acne; alopecia; application site reactions (eg, burning, erythema, itching); contact dermatitis; dry skin; nail disorders (eg, shape change, irritation); periungual erythema and erythema of the proximal nail fold; pruritus; rash; seborrhea; skin burning and/or pain sensation upon application; skin disorder.

Miscellaneous

Eye pain; facial edema; headache.

Precautions

Monitor

Application site reactions

Monitor for application site reactions, including redness, itching, burning, blistering, swelling, or oozing. Inform health care provider if noted and significant.

Skin/Nail assessment

Assess the skin or nails, as appropriate, and identify areas where medication is to be applied. Assess and document skin or nail condition before initial application and periodically throughout treatment.


Pregnancy

Category B .

Lactation

Undetermined.

Children

Shampoo/gel

Safety and efficacy not established in children younger than 16 y of age.

Cream/suspension

Safety and efficacy not established in children younger than 10 y of age.

Ciclodan / Pedipirox

Safety and efficacy not established in children younger than 12 y.

Penlac

Safety and efficacy not established.

Application

For external use only, avoid contact with the eyes.

Sensitivity

If sensitivity or chemical irritation occurs, discontinue treatment and institute appropriate therapy.

Patient Information

  • Advise patient that improvement in symptoms may take a week or longer to occur but to notify health care provider if symptoms have not improved after 4 wk of continuous use.
  • Instruct patient to use medication for the full treatment time even if symptoms have improved.
  • Advise patient that shampoo is used 2 times/wk, with a minimum of 3 days between applications.
  • Advise patient that cream, gel, or suspension should be applied topically to skin lesions twice daily.
  • Advise patient that topical solution is applied to affected nails every day at bedtime or 8 h before washing.
  • Teach patient proper technique for applying cream, suspension, or gel: wash hands; wash and dry areas to be treated; gently massage small amount into the affected and surrounding skin areas. Wash hands after applying medication.
  • Inform patient that a sensation of burning or stinging may be felt shortly after application of the gel and that this is expected and should be of no concern.
  • Caution patient to avoid using occlusive dressings or wraps following application of cream, gel, or suspension.
  • Teach patient proper technique for applying shampoo: wet hair; apply approximately 1 tsp (up to 2 tsp for long hair) of shampoo to scalp; lather and leave on hair and scalp for 3 min then rinse hair and scalp. Avoid contact with eyes; if contact occurs, rinse thoroughly with water.
  • Teach patient proper technique for applying topical solution: review Patient Information and Instructions sheet provided with medication; wash hands; apply small amount of solution to affected nails and skin immediately surrounding the treated nails using applicator brush supplied with bottle; apply solution under surface of nail when it is free of the nail bed; daily applications should be made over the previous coat and then removed with alcohol every 7 days following which the nails should be trimmed and loose nail material filed away with emery board. The cycle is then repeated. Professional removal of unattached infected nails should be performed as frequently as monthly by health care provider.
  • Caution diabetic patient using solution to talk with health care provider before trimming or removing any nail material.
  • Advise patient using solution on nails not to use nail polish or other nail cosmetic products on treated nails.
  • Caution patient using solution to avoid use near open flame because product is flammable.
  • Advise patient that if application site of any of these products shows signs of increased irritation (eg, redness, itching, burning, blistering, swelling, oozing) to stop using the medication and contact health care provider.
  • Advise patient that follow-up visits to examine the skin or nail lesions may be necessary and to keep appointments.

Copyright © 2009 Wolters Kluwer Health.

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