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Ketoconazole topical

Pronunciation

Class: Azoles
VA Class: DE102
Chemical Name: cis-1-acetyl-4-[4-[[2-(2,4-dichlorophenyl)-2-(1H-imidazol-1-ylmethyl)-1,3-dioxolan-4-yl] methoxy]phenyl] piperazine
Molecular Formula: C26H28Cl2N4O4
CAS Number: 65277-42-1
Brands: Extina, Nizoral, Nizoral A-D, Xolegel

Introduction

Antifungal; azole (imidazole derivative).1 3 4 5 6 11 23 32 72 105 106 110

Uses for Ketoconazole

Dermatophytoses

Treatment of tinea corporis, tinea cruris, and tinea pedis caused by Epidermophyton floccosum, Trichophyton mentagrophytes, or T. rubrum.1 2 25 27 28 56 58 59 60 61 62 66 78 79 110

A drug of first choice for topical treatment of tinea corporis or tinea cruris.81 85 Oral antifungals preferred when tinea corporis or tinea cruris is extensive, dermatophyte folliculitis is present, infection is chronic or does not respond to topical therapy, or patient is immunocompromised or has coexisting disease.80 81 82 83 84

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Treatment of tinea manuum caused by Trichophyton2 25 58 59 60 61 62 and tinea corporis caused by Microsporum.2 25 59

Cutaneous Candidiasis

Treatment of cutaneous candidiasis caused by Candida albicans.1 2 25 58 59 67 68 69 110

Pityriasis (Tinea) Versicolor

Treatment of pityriasis (tinea) versicolor caused by or presumed to be caused by Malassezia furfur (Pityrosporum orbiculare or P. ovale).1 2 25 26 63 72 97 110

Seborrheic Dermatitis and Dandruff

Treatment of seborrheic dermatitis, including seborrheic dermatitis of the scalp.1 12 42 43 44 67 71 73 76 98 99 101 103 105 106 107 108 109

Self-medication (OTC use) for reduction of flaking, scaling, and itching associated with dandruff.74 75 77 99 100 101 102 104

Ketoconazole Dosage and Administration

Administration

Topical Administration

Apply topically to skin as a 2% cream,1 110 foam,106 gel,105 or shampoo.72 97

Apply topically to hair and scalp as a 1% shampoo.100 104 Also has been applied topically to hair and scalp as a 2% shampoo.76 98 99 101 103

Cream, foam, gel, and shampoo are for external use only.1 72 104 105 106 Do not apply to eyes1 72 104 105 106 and do not administer orally105 106 or intravaginally.56 57 105 106

If contact with eyes, mouth, or vagina occurs, rinse thoroughly with water.104 106

When using the 2% foam, hold the can containing the foam upright and spray a small amount into the cap of the can or other cool surface.106 Do not dispense foam directly onto affected areas or onto hands since the foam will begin to melt immediately on contact with warm skin.106 If fingers are warm, rinse them in cold water and dry before handling the foam.106 Using the fingertips, gently massage small amounts of foam onto affected areas until the foam disappears and entire affected area has been treated.106

When using the 2% gel, do not apply sunscreen or cosmetics to the affected area until at least 20 minutes after application of the gel.105 Do not wash the affected area for at least 3 hours after application of the gel.105

Avoid fire, flame, and/or smoking during and immediately after application of 2% foam or gel.105 106 (See Flammability under Cautions.)

Dosage

Pediatric Patients

Topical Seborrheic Dermatitis in Children ≥12 Years of Age

2% gel: Apply to affected areas once daily for 2 weeks.105 107 108

2% foam: Apply to affected areas twice daily for 4 weeks.106 109

Dandruff in Children ≥12 Years of Age
Topical

1% shampoo: For self-medication, apply to wet hair, lather, and rinse thoroughly; then repeat application, lathering, and rinsing.104 Use every 3 or 4 days for up to 8 weeks as needed or as directed by a clinician.104 Thereafter, use as needed to control dandruff.104

Adults

Dermatophytoses
Tinea Corporis or Tinea Cruris
Topical

2% cream: Apply and rub gently into affected and surrounding area of skin once or twice daily for 2 weeks.1 2 25 58 59 62 110 There is some evidence that twice-daily regimen may occasionally be more effective than once-daily regimen.25 62 If clinical improvement does not occur after treatment, reevaluate diagnosis.1 110

Tinea Pedis
Topical

2% cream: Apply and rub gently into affected and surrounding area of skin once or twice daily for 6 weeks.1 2 60 66 79 110 If clinical improvement does not occur after treatment, reevaluate diagnosis.1 110

Moccasin-type (dry-type) tinea pedis may require more prolonged therapy.66 79

Cutaneous Candidiasis
Topical

2% cream: Apply and rub gently into affected and surrounding area of skin once or twice daily for 2 weeks.1 2 25 58 59 110 If clinical improvement does not occur after treatment, reevaluate diagnosis.1 110

Pityriasis (Tinea) Versicolor
Topical

2% cream: Apply and rub gently into affected and surrounding area of skin once daily for 2 weeks.1 110 If clinical improvement does not occur after treatment, reevaluate diagnosis.1 110

2% shampoo: Apply to damp skin of the affected area and a wide margin surrounding this area and lather; after 5 minutes, rinse with water.72 A single application should be sufficient,72 97 although once-daily application for 3 days also has been used.97

Seborrheic Dermatitis
Topical

2% cream: Apply and rub gently into affected areas twice daily1 12 42 43 44 67 71 for 4 weeks or until clinical clearing.1 12 42 43 44 71

2% foam: Apply and gently massage into affected areas twice daily for 4 weeks.106 109

2% gel: Apply to affected areas once daily for 2 weeks.105 107 108

2% shampoo: For seborrheic dermatitis of the scalp, has been used to wash the hair and scalp 2 or 3 times weekly for 2–4 weeks.76 98 99 101 After a response was obtained, has been used once weekly every other week to prevent relapse.98

Dandruff
Topical

1% shampoo: For self-medication to control flaking, scaling, and itching associated with dandruff, apply to thoroughly wet hair, lather and rinse thoroughly; then repeat application, lathering, and rinsing.104 Use every 3 or 4 days for up to 8 weeks as needed or as directed by a clinician.104 Thereafter, use as needed to control dandruff.104

2% shampoo: For treatment of dandruff, has been used to wash the hair and scalp 2 or 3 times weekly for 2–4 weeks.76 98 99 101 After a response was obtained, has been used once weekly every other week to prevent relapse.98

Cautions for Ketoconazole

Contraindications

  • Hypersensitivity to ketoconazole or any ingredient in the formulation.1 72 105 110

Warnings/Precautions

Sensitivity Reactions

Hypersensitivity Reactions

Contact dermatitis reported following topical application of ketoconazole or other imidazole-derivative azole antifungals.61 89 90 91 92 93 94 110

If a reaction suggesting sensitivity or chemical irritation occurs (e.g., rash), discontinue the drug.1 72 104 105 106 110

Possible cross-sensitization among the imidazole derivatives.89 90 91 92 93 94

Sulfite Sensitivity

Some formulations of the 2% cream contain sodium sulfite, which may cause allergic-type reactions (including anaphylaxis and life-threatening or less severe asthmatic episodes) in certain susceptible individuals.110 Overall prevalence of sulfite sensitivity in the general population is unknown, but probably low; such sensitivity appears to occur more frequently in asthmatic than in nonasthmatic individuals.110

General Precautions

Systemic Adverse Effects

Although hepatotoxicity, decreased testosterone concentrations, and decreased ACTH-induced corticosteroid concentrations have been reported with oral ketoconazole,32 105 110 these adverse effects have not been reported with topical ketoconazole105 110 and are unlikely since the drug does not appear to be appreciably absorbed following topical application to skin.2 56 57

Flammability

2% foam and gel are flammable.105 106 Avoid fire, flame, and/or smoking during and immediately after application of foam or gel.105 106 (See Storage under Stability.)

Specific Populations

Pregnancy

Category C.1 72 105 106 110

2% cream, foam, gel, or shampoo: Use during pregnancy only when potential benefits justify possible risks to the fetus.1 72 105 106 110

1% shampoo: Pregnant women considering self-medication should consult a clinician before using the preparation.104

Lactation

Not known whether ketoconazole distributed into milk following topical application.1 105 106 110

2% cream: Discontinue nursing or the cream.1 110

2% foam, gel, or shampoo: Use with caution.72 105 106

1% shampoo: Nursing women considering self-medication should consult clinician before using the preparation.104

Pediatric Use

2% cream: Safety and efficacy not established in children;1 110 has been used without unusual adverse effect in children 2 days to 12 years of age.15 17

2% foam: Safety and efficacy not established in children <12 years of age.106

2% gel: Safety and efficacy not established in children <12 years of age.105

1% shampoo: Safety and efficacy for self-medication not established in children <12 years of age.104

2% shampoo: Safety and efficacy not established in children.72

Common Adverse Effects

2% cream: Local reactions at application site (severe irritation, pruritus, stinging).1 2 25 26 58 59 60 61 110

2% foam: Application site reactions (e.g., burning).106 109

2% gel: Application site reactions (e.g., burning), headache.105 107 108

2% shampoo: When applied to the skin, pruritus, application site reaction, dry skin.72 When applied to scalp, increased hair loss, irritation, abnormal hair texture, loss of hair curl in patients with permanently waved (“permed”) hair, scalp pustules, dry skin, pruritus, oiliness or dryness of the hair and scalp.72

Interactions for Ketoconazole

No formal drug interaction studies to date.105

Ketoconazole Pharmacokinetics

Absorption

Bioavailability

Ketoconazole does not appear to be appreciably absorbed systemically following topical application to skin or scalp.1 2 24 25 56 63 72 105 106 110

2% cream: Topical application to chest, back, and arms of healthy adults with intact skin does not result in detectable blood concentrations.1 2 24 110 Following topical application in vitro in a skin model, ketoconazole was retained in the stratum corneum and the boundary of the stratum corneum and stratum granulosum for up to 16 hours.56 63

2% foam: Topical application of 3 g twice daily for 4 weeks in patients with moderate to severe seborrheic dermatitis resulted in plasma ketoconazole concentrations <6 ng/mL in 75% of patients; maximum plasma concentration was 11 ng/mL.106

2% gel: Topical application once daily for 2 weeks (0.05-3.47 g daily) in patients with severe seborrheic dermatitis (1–14% of body surface area) resulted in mean peak plasma concentrations of 1.35 ng/mL on day 7 and 0.8 ng/mL on day 14.105

2% shampoo: Chronic use of 2% shampoo (4–10 times weekly for 6 months, 2–3 times weekly for 3–26 months) did not result in detectable plasma concentrations.72

Small amounts of ketoconazole are absorbed systemically when the drug is administered intravaginally.24

Distribution

Extent

Not known whether ketoconazole distributed into milk following topical application of 2% cream, foam, gel, or shampoo.1 105 106 110

Stability

Storage

Topical

2% Cream

20–25°C110 or 15–30°C,1 depending on manufacturer.

2% Foam

20–25°C; do not refrigerate or freeze.106

Flammable; do not store in direct sunlight and do not expose to heat or temperatures >49°C.106 Do not puncture and/or incinerate container.106

2% Gel

25°C (may be exposed to 15–30°C).105

1% Shampoo

2–30°C; protect from light and freezing.104

2% Shampoo

≤25°C; protect from light.72

Actions and Spectrum

  • Imidazole-derivative azole antifungal.1 3 4 5 6 11 23 32 72 105 106 110

  • Structurally related to other imidazole-derivative azole antifungals (e.g., butoconazole, clotrimazole, econazole, miconazole, oxiconazole, sulconazole, tioconazole).3 4 5 6 11 23

  • Usually fungistatic; may be fungicidal at high concentrations after prolonged incubation or against very susceptible organisms.3 5 21 34 48 49 50 52 53 54 55

  • Presumably exerts its antifungal activity by altering cellular membranes, resulting in increased membrane permeability, secondary metabolic effects, and growth inhibition.1 21 23 32 48 49 50 51 52 55 105 106 110 Fungistatic activity may result from interference with ergosterol synthesis.1 21 34 49 50 51 55 105 106 110 Fungicidal activity at high concentrations may result from a direct physiochemical effect on the fungal cell membrane.3 55

  • Mechanism(s) of action in the treatment of dandruff not fully determined.72

  • Spectrum of antifungal activity includes many fungi, including yeasts and dermatophytes.1 2 3 10 22 32 40 72 110

  • Dermatophytes: Active against Epidermophyton floccosum,1 4 6 10 22 32 40 72 110 Microsporum audouini,1 10 22 32 40 72 110 M. canis,1 4 10 22 32 40 72 110 M. gypseum,1 4 10 22 32 40 72 110 Trichophyton mentagrophytes,1 4 10 22 32 40 72 110 T. rubrum,1 4 10 22 32 40 72 110 and T. tonsurans.1 4 10 22 32 40 72 110

  • Other fungi: Active against Candida albicans,4 5 6 7 8 10 22 32 36 40 72 110 C. tropicalis,72 110 and Malassezia furfur (Pityrosporum orbiculare, P. ovale).1 39 40 45 72 105 106 110

Advice to Patients

  • Importance of using the medication for the full, prescribed treatment period, even if symptoms improve; importance of consulting with clinician if the skin condition does not improve after a full course of therapy.56 57 104 106

  • Importance of discontinuing use1 72 104 105 110 and contacting clinician if signs or symptoms of irritation or sensitization occur.56 57 104 105 106

  • Importance of not applying 2% cream, foam, or gel to eyes1 105 106 or intravaginally.56 57 105 106

  • If using 2% foam or gel, importance of avoiding fire, flame, and/or smoking during and immediately following application.105 106 Importance of not throwing foam container into a fire, even if can is empty.106

  • If using shampoo, importance of avoiding contact with eyes;72 104 if contact with eyes occurs, rinse thoroughly with water.104

  • Importance of not using the 1% shampoo for self-medication of dandruff if the scalp is broken or inflamed.104 Importance of discontinuing use and contacting a clinician if rash occurs or the condition worsens or does not improve within 2–4 weeks.104

  • Importance of informing clinicians of existing or contemplated therapy, including prescription and OTC drugs, or any concomitant illnesses.1 105

  • Importance of women informing clinicians if they are or plan to become pregnant or plan to breast-feed.1 72 104 105 106 110

  • Importance of informing patients of other important precautionary information. (See Cautions.)

Preparations

Excipients in commercially available drug preparations may have clinically important effects in some individuals; consult specific product labeling for details.

* available from one or more manufacturer, distributor, and/or repackager by generic (nonproprietary) name

Ketoconazole

Routes

Dosage Forms

Strengths

Brand Names

Manufacturer

Topical

Cream

2%*

Ketoconazole Cream

Foam

2%

Extina

Stiefel

Gel

2%

Xolegel

Barrier Therapeutics

Shampoo

1%

Nizoral A-D

McNeil

2%*

Ketoconazole Shampoo,

Nizoral

Ortho-McNeil

Comparative Pricing

This pricing information is subject to change at the sole discretion of DS Pharmacy. This pricing information was updated 02/2014. Actual costs to patients will vary depending on the use of specific retail or mail-order locations and health insurance copays.

Extina 2% Foam (GLAXO SMITH KLINE): 50/$198.99 or 150/$563.95

Extina 2% Foam (GLAXO SMITH KLINE): 100/$369.99 or 300/$1,042.02

Ketoconazole 2% Cream (TARO): 15/$19.99 or 45/$45.99

Ketoconazole 2% Cream (TARO): 30/$26.99 or 90/$76.97

Ketoconazole 2% Cream (TARO): 60/$35.99 or 180/$99.99

Ketoconazole 2% Foam (PERRIGO PHARMACEUTICALS): 50/$175.99 or 150/$499.95

Ketoconazole 2% Foam (PERRIGO PHARMACEUTICALS): 100/$326.00 or 300/$925.93

Ketoconazole 2% Shampoo (PERRIGO PHARMACEUTICALS): 120/$27.99 or 240/$49.97

Kuric 2% Cream (JSJ PHARMACEUTICALS): 75/$113.65 or 225/$311.47

Nizoral 2% Shampoo (JANSSEN): 120/$53.99 or 240/$96.97

Xolegel 2% Gel (AQUA PHARMACEUTICALS): 45/$365.98 or 135/$1,040.01

AHFS DI Essentials. © Copyright, 2004-2014, Selected Revisions July 1, 2009. American Society of Health-System Pharmacists, Inc., 7272 Wisconsin Avenue, Bethesda, Maryland 20814.

† Use is not currently included in the labeling approved by the US Food and Drug Administration.

References

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