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Home > Medical Reference > Encyclopedia (English)

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Pronunciation:

(sye kloe PEER oks)

U.S. Brand Names:

Loprox®; Penlac®

Synonyms:

Ciclopirox Olamine

Generic Available:

Yes: Cream, topical suspension

Canadian Brand Names:

Loprox®; Penlac®

Use:

Cream/suspension: Treatment of tinea pedis (athlete's foot), tinea cruris (jock itch), tinea corporis (ringworm), cutaneous candidiasis, and tinea versicolor (pityriasis)

Gel: Treatment of tinea pedis (athlete's foot), tinea corporis (ringworm); seborrheic dermatitis of the scalp

Lacquer (solution): Topical treatment of mild-to-moderate onychomycosis of the fingernails and toenails due to Trichophyton rubrum (not involving the lunula) and the immediately-adjacent skin

Shampoo: Treatment of seborrheic dermatitis of the scalp

Pregnancy Risk Factor:

B

Pregnancy Implications:

Teratogenic effects were not observed in animal studies, however, there are no adequate and well-controlled studies in pregnant women. Use during pregnancy only if clearly needed.

Lactation:

Excretion in breast milk unknown/use caution

Contraindications:

Hypersensitivity to ciclopirox or any component of the formulation; avoid occlusive wrappings or dressings

Warnings/Precautions:

For external use only; avoid contact with eyes; nail lacquer is for topical use only and has not been studied in conjunction with systemic therapy or in patients with type 1 diabetes mellitus (insulin dependent, IDDM).

Adverse Reactions:

>10%: Local: Burning sensation (gel: 34%; 1% with other forms)

1% to 10%:

Central nervous system: Headache

Dermatologic: Erythema, nail disorder, pruritus, rash

Local: Irritation, redness, or pain

<1%: Alopecia, dry skin, facial edema

Drug Interactions:

No data reported

Stability:

Cream, suspension: Store between 5°C to 25°C (41°F to 77°F)

Lacquer (solution): Store at room temperature of 15°C to 30°C (59°F to 86°F); protect from light. Flammable; keep away from heat and flame.

Gel, shampoo: Store at room temperature of 15°C to 30°C (59°F to 86°F)

Mechanism of Action:

Inhibiting transport of essential elements in the fungal cell disrupting the synthesis of DNA, RNA, and protein

Pharmacodynamics/Kinetics:

Absorption: Cream, solution: <2% through intact skin; increased with gel; <5% with lacquer

Distribution: Scalp application: To epidermis, corium (dermis), including hair, hair follicles, and sebaceous glands

Protein binding: 94% to 98%

Half-life elimination: Biologic: 1.7 hours (solution); elimination: 5.5 hours (gel)

Excretion: Urine (gel: 3% to 10%); feces (small amounts)

Dosage:

Topical:

Children >10 years and Adults: Tinea pedis, tinea cruris, tinea corporis, cutaneous candidiasis, and tinea versicolor: Cream/suspension: Apply twice daily, gently massage into affected areas; if no improvement after 4 weeks of treatment, re-evaluate the diagnosis

Children >16 years and Adults:

Tinea pedis, tinea corporis, seborrheic dermatitis of the scalp: Gel: Apply twice daily, gently massage into affected areas and surrounding skin; if no improvement after 4 weeks of treatment, re-evaluate diagnosis

Seborrheic dermatitis of the scalp: Shampoo: Apply to wet hair, lather, and leave in place ~3 minute; rinse. Repeat twice weekly for 4 weeks; allow a minimum of 3 days between applications.

Onychomycosis of the fingernails and toenails: Children 12 years and Adults: Lacquer (solution): Apply to adjacent skin and affected nails daily (as a part of a comprehensive management program for onychomycosis). Remove with alcohol every 7 days

Administration:

Topical:

Cream, suspension: Gently massage into affected areas.

Gel: Gently massage into affected areas and adjacent skin.

Lacquer (solution): Apply evenly over nail and surrounding skin at bedtime (or allow 8 hours before washing); apply daily over previous coat for 7 days; after 7 days, may remove with alcohol and continue cycle.

Shampoo: Apply to wet hair; lather and leave in place for ~3 minutes; rinse.

Patient Education:

Avoid contact with eyes; if sensitivity or irritation occurs, discontinue use

Dental Health: Effects on Dental Treatment:

No significant effects or complications reported

Dental Health: Vasoconstrictor/Local Anesthetic Precautions:

No information available to require special precautions

Mental Health: Effects on Mental Status:

None reported

Mental Health: Effects on Psychiatric Treatment:

None reported

Dosage Forms:

Cream, as olamine (Loprox®): 0.77% (15 g, 30 g, 90 g)

Gel (Loprox®): 0.77% (30 g, 45 g, 100 g)

Shampoo (Loprox®): 1% (120 mL)

Solution, topical [nail lacquer] (Penlac®): 8% (6.6 mL)

Suspension, topical, as olamine (Loprox®): 0.77% (30 mL, 60 mL)

International Brand Names:

Aquomin® (ES); Batrafen® (AT, BG, CH, CL, CZ, DE, EC, ES, HK, HU, ID, IE, IL, IN, IT, NZ, PL, RO, RU); Brumixol® (IT); Canolen® (TR); Ciclochem® (ES); Ciclochem Vaginal® (ES); Cicloderm® (IL, RO); Dafnegil Neo® (CH); Dafnegin® (CZ, IT, PL, RO, RU); Dermaflor® (AR); Fungirox® (BR); Fungopirox® (CL); Fungowas® (ES); Fungowas Vaginal® (ES); Gidacid® (DO); Gino-Loprox® (BR); Hascofungin® (PL); Loprox® (AR, BR, CA, CR, DO, GT, HN, MX, NL, PA, SV, TH); Loprox Nail Lacquer® (ID); Miclast® (IT); Micomicen® (IT); Micopirox® (AR); Micoxolamina® (IT); Mikium® (CL); Mycofen® (DK); Mycoster® (FR, LU, PT); Nagel Batrafen® (DE); Nail Batrafen® (NZ); Nibulen® (TR); Obytin® (YU); Olamin® (IN); Penlac™ (CA); Pirolam® (PL); Primax® (CO); Rimafungol® (ES); Sebiprox® (DE, ES, FR, IT); Stieprox® (DK, FI, IE, PL, SG, TH)

The information provided herein should not be used during any medical emergency or for the diagnosis or treatment of any medical condition. A licensed medical professional should be consulted for diagnosis and treatment of any and all medical conditions. Call 911 for all medical emergencies. Links to other sites are provided for information only -- they do not constitute endorsements of those other sites. © 1997- A.D.A.M., Inc. Any duplication or distribution of the information contained herein is strictly prohibited.
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