Version May 2024
Cutaneous candidiasis: Topical: Cream 2%: Apply once daily to cover the affected and immediate surrounding area for 2 weeks. Note: Canadian labeling recommends a duration of 2 to 3 weeks.
Dandruff:
Shampoo 1% (OTC labeling): Topical: Apply to wet hair, lather, and rinse thoroughly; repeat. Use every 3 to 4 days for up to 8 weeks or as directed by a health care provider; then apply only as needed to control dandruff.
Shampoo 2% (Canadian product only): Topical: Apply 5 to 10 mL to wet scalp, lather, leave on 3 to 5 minutes, and rinse; apply once every 1 to 2 weeks (prophylaxis) or twice weekly for 2 to 4 weeks (treatment).
Seborrheic dermatitis: Topical:
Cream 2%: Apply to the affected area twice daily for 4 weeks or until clinical response is noted.
Foam 2%: Apply to affected area twice daily for 4 weeks.
Gel 2%: Apply to the affected area once daily for 2 weeks.
Shampoo 2% (Canadian product only): Apply 5 to 10 mL to wet scalp, lather, leave on 3 to 5 minutes, and rinse; apply twice weekly for 2 to 4 weeks.
Tinea infections:
Tinea corporis/tinea cruris: Topical: Cream 2%: Apply to affected and surrounding area(s) once daily until clinical resolution, typically 1 to 3 weeks (Goldstein 2021; van Zuuren 2015; manufacturer’s labeling).
Tinea pedis (labeled use)/tinea manuum (off-label use): Topical: Cream 2%: Apply to affected and surrounding area(s) once daily until 1 week after clinical resolution, typically for 4 to 6 weeks total (Goldstein 2021; Weinstein 2002; manufacturer’s labeling).
Tinea versicolor (pityriasis versicolor): Topical:
Cream 2%: Apply to affected area(s) and immediate surrounding skin once daily for 2 weeks (Savin 1986; manufacturer’s labeling). Note: Canadian labeling recommends a duration of 2 to 3 weeks.
Shampoo 2%: Apply to affected area(s) of damp skin, lather, leave on 5 minutes, and rinse. One application is usually sufficient (Lange 1998; manufacturer’s labeling); some experts prefer once-daily application for 3 consecutive days (Goldstein 2022).
There are no dosage adjustments provided in the manufacturer's labeling. However, dosage adjustment unlikely due to low systemic absorption.
There are no dosage adjustments provided in the manufacturer's labeling. However, dosage adjustment unlikely due to low systemic absorption.
Refer to adult dosing.
(For additional information see "Ketoconazole (topical): Pediatric drug information")
Dandruff (flaking, scaling, and itching):
Shampoo (ketoconazole 1%): Children ≥12 years and Adolescents: Topical: OTC labeling: Shampoo every 3 to 4 days for up to 8 weeks; then use only as needed to control dandruff.
Shampoo (ketoconazole 2%): Canadian labeling: Children ≥12 years and Adolescents:
Prophylaxis: Topical: Shampoo with 5 to 10 mL once every 1 to 2 weeks.
Treatment: Topical: Shampoo with 5 to 10 mL twice weekly for 2 to 4 weeks.
Seborrheic dermatitis, treatment:
Cream: Limited data available: Infants and Children ≤2 years: Topical: Apply to affected area once or twice daily for 10 to 15 days (Bender 2020; Ruiz-Maldonado 1989; Taieb 1990; Wannanukul 2004).
Foam: Children ≥12 years and Adolescents: Topical: Apply to affected area twice daily for 4 weeks.
Gel: Children ≥12 years and Adolescents: Topical: Apply to affected area once daily for 2 weeks.
Shampoo:
Infants: Very limited data available: Ketoconazole 1% or 2%: Topical: Shampoo with a small amount twice weekly for 1 month (Brodell 1998).
Children and Adolescents: Very limited data available: Ketoconazole 1% or 2%: Topical: Shampoo with a small amount several times weekly up to daily until disease control achieved, then decrease to once weekly to reduce risk of relapse (Bender 2020).
Canadian labeling (ketoconazole 2%): Children ≥12 years and Adolescents: Topical: Shampoo with 5 to 10 mL twice weekly for 2 to 4 weeks.
There are no dosage adjustments provided in manufacturer's labeling; however, dosage adjustment unlikely necessary due to low systemic absorption.
There are no dosage adjustments provided in the manufacturer's labeling; however, dosage adjustment unlikely due to low systemic absorption.
The following adverse drug reactions and incidences are derived from product labeling unless otherwise specified.
1% to 10%:
Dermatologic: Application-site pruritus (cream: ≤5%; shampoo: 1% to 3%; foam, gel: <1%), stinging of the skin (cream: ≤5%), xeroderma (shampoo: 1% to 3%; foam, gel: <1%)
Local: Application site reaction (foam: 6%; shampoo: 1% to 3%), local irritation (cream: ≤5%; foam, shampoo <1%), application site burning (gel: 4%; foam, shampoo: <1%)
Frequency not defined: Dermatologic: Dry hair, dry scalp, oily hair
<1%, postmarketing, and/or case reports: Abnormal hair texture, acne vulgaris, alopecia, anaphylaxis, angioedema, application-site dermatitis, application site discharge, application site erythema, application site pain, cheilitis, contact dermatitis, dizziness, dry eye syndrome, eye irritation, facial swelling, hair discoloration, headache, hypersensitivity reaction, impetigo, localized warm feeling, nail discoloration, paresthesia, pustules, pyogenic granuloma, skin irritation, skin rash, swelling of eye, urticaria
Hypersensitivity to ketoconazole or any component of the formulation.
OTC labeling: When used for self-medication, do not use on scalp that is broken or inflamed.
Concerns related to adverse effects:
• Hypersensitivity reactions: Severe hypersensitivity reactions, including contact sensitization, photoallergenicity, and anaphylaxis (rare) have been reported; discontinue use if hypersensitivity occurs.
• Irritation: May cause irritation at the site of application; discontinue use if irritation occurs.
Dosage form specific issues:
• Foam: Formulation contains alcohol and propane/butane; do not expose to open flame and/or smoking during or immediately after application. Do not puncture and/or incinerate container.
• Gel: Flammable; avoid exposure to fire, flames, or smoking during or immediately after application.
• Shampoo: Use may remove curl from permanently wavy hair, cause hair discoloration, and changes in hair texture.
• Sulfites: Some dosage forms contain sulfites which may cause allergic-type reactions (including anaphylaxis) as well as life-threatening or less severe asthmatic episodes in certain individuals.
Other warnings/precautions:
• Appropriate use: Avoid contact with the eyes and other mucous membranes. Not for ophthalmic, oral, or intravaginal use. If condition worsens or does not improve after the treatment period, discontinue use and contact health care provider.
Some dosage forms may contain propylene glycol; in neonates large amounts of propylene glycol delivered orally, intravenously (eg, >3,000 mg/day), or topically have been associated with potentially fatal toxicities which can include metabolic acidosis, seizures, renal failure, and CNS depression; toxicities have also been reported in children and adults including hyperosmolality, lactic acidosis, seizures, and respiratory depression; use caution (AAP 1997; Shehab 2009).
Excipient information presented when available (limited, particularly for generics); consult specific product labeling. [DSC] = Discontinued product
Cream, External:
Generic: 2% (15 g, 30 g, 60 g)
Foam, External:
Extina: 2% (50 g [DSC], 100 g [DSC]) [cfc free; contains alcohol, usp, cetyl alcohol, propylene glycol]
Ketodan: 2% (100 g) [contains alcohol, usp, cetyl alcohol, propylene glycol]
Generic: 2% (50 g, 100 g)
Gel, External:
Xolegel: 2% (45 g [DSC]) [contains alcohol, usp, fd&c yellow #6 (sunset yellow), propylene glycol, quinoline yellow (d&c yellow #10)]
Kit, External:
Ketodan: 2% [DSC] [contains cetyl alcohol, edetate (edta) disodium, propylene glycol]
Shampoo, External:
Nizoral: 2% (120 mL [DSC]) [contains fd&c red #40 (allura red ac dye)]
Nizoral A-D: 1% (125 mL [DSC])
Nizoral A-D: 1% (125 mL [DSC], 200 mL [DSC]) [contains edetate (edta) sodium (tetrasodium), fd&c blue #1 (brilliant blue)]
Generic: 2% (120 mL)
May be product dependent
Cream (Ketoconazole External)
2% (per gram): $1.32 - $8.75
Foam (Ketoconazole External)
2% (per gram): $14.17
Foam (Ketodan External)
2% (per gram): $8.34
Shampoo (Ketoconazole External)
2% (per mL): $0.20 - $0.25
Disclaimer: A representative AWP (Average Wholesale Price) price or price range is provided as reference price only. A range is provided when more than one manufacturer's AWP price is available and uses the low and high price reported by the manufacturers to determine the range. The pricing data should be used for benchmarking purposes only, and as such should not be used alone to set or adjudicate any prices for reimbursement or purchasing functions or considered to be an exact price for a single product and/or manufacturer. Medi-Span expressly disclaims all warranties of any kind or nature, whether express or implied, and assumes no liability with respect to accuracy of price or price range data published in its solutions. In no event shall Medi-Span be liable for special, indirect, incidental, or consequential damages arising from use of price or price range data. Pricing data is updated monthly.
Excipient information presented when available (limited, particularly for generics); consult specific product labeling.
Cream, External:
Ketoderm: 2% (30 g) [contains cetyl alcohol, polysorbate 80, propylene glycol]
Topical: For external use only; not for ophthalmic, oral, or intravaginal use. Avoid contact with the eyes and other mucous membranes. Wash hands after application.
Cream: Apply to the affected and immediate surrounding area.
Foam: Dispense foam into the cap of the can or other cool surface; do not dispense directly onto hands (foam will begin to melt upon contact with warm skin). Pick up small amounts of foam with the fingertips and gently massage into the affected area until the foam disappears. For hair-bearing areas, part the hair so that foam may be applied directly to the skin (rather than on the hair). Avoid exposure to flame or smoking during and immediately following application.
Gel: Apply a thin layer to affected area with fingertips. Do not wash affected area for at least 3 hours after application; wait at least 20 minutes after gel application before applying makeup or sunscreen to the treated areas.
Shampoo:
Thoroughly wet affected area, apply shampoo, lather generously, and rinse thoroughly; the Canadian labeling recommends leaving on for 3 to 5 minutes before rinsing. Do not use on areas that are broken or inflamed.
For tinea versicolor (pityriasis versicolor), apply shampoo to damp skin of the affected area; leave on skin for 5 minutes before rinsing.
Topical: For external use only; not for ophthalmic, oral, or intravaginal use. Avoid contact with eyes and other mucous membranes.
Foam: Children ≥12 years and Adolescents: Hold the container upright and dispense foam into cap or other cool surface; do not dispense into hands as foam will begin to melt immediately upon contact with warm skin. If fingers are warm, rinse in cold water and dry thoroughly; pick up small amounts of foam with the fingers, and gently massage into the affected area(s) until foam disappears. For hair-bearing areas, part the hair, so foam may be applied directly to skin (rather than on the hair). Avoid fire, flame, and/or smoking during and immediately following application.
Gel: Children ≥12 years and Adolescents: Apply thin layer on affected skin; wait at least 3 hours after application before washing area(s). Avoid fire, flame, and/or smoking during and immediately following application. Wait at least 20 minutes after applying the gel before putting makeup or sunscreen on the affected areas.
Shampoo:
1% [OTC product]:
Infants: Apply to wet scalp, lather, leave on for 3 minutes, and rinse (Brodell 1998).
Children ≥12 years and Adolescents: Apply to wet hair, lather, and rinse hair thoroughly; repeat.
2%:
Infants: Apply to wet scalp, lather, leave on for 3 minutes, and rinse (Brodell 1998).
Children and Adolescents: Apply to wet hair, lather, leave on for 3 to 5 minutes, and rinse.
Cream: Treatment of tinea corporis (ringworm), tinea cruris (jock itch), and tinea pedis (athlete's foot) caused by Trichophyton rubrum, Trichophyton mentagrophytes, and Epidermophyton floccosum; treatment of tinea versicolor (pityriasis versicolor) caused by Pityrosporum orbiculare (also known as Malassezia furfur); treatment of cutaneous candidiasis caused by Candida sp; treatment of seborrheic dermatitis
Foam, gel: Treatment of seborrheic dermatitis in immunocompetent adults and children 12 years and older
Limitations of use: Safety and efficacy for the treatment of fungal infections have not been established.
Shampoo:
US labeling: Treatment of tinea versicolor caused by or presumed to be caused by P. orbiculare (M. furfur or Malassezia orbiculare)
Canadian labeling: Treatment and prophylaxis of conditions caused by Pityrosporum (eg, pityriasis capitis [dandruff]); treatment of seborrheic dermatitis
OTC labeling: Controls flaking, scaling, and itching associated with dandruff
Tinea manuum
Nizoral may be confused with Nasarel, Neoral, Nitrol
None known.
There are no known significant interactions.
Ketoconazole is not detectable in the plasma following chronic use of the shampoo.
Topical ketoconazole may be used for the treatment of infectious atopic dermatitis complications in pregnant women (Vestergaard 2019).
Ketoconazole has been detected in breast milk following oral dosing. Although it is not detected in the plasma following chronic use of the shampoo, and concentrations in the plasma following application of the gel are <250 times those observed with oral dosing, the manufacturers recommend the decision to breastfeed during therapy should consider the risk of infant exposure, the benefits of breastfeeding to the infant, and the benefits of treatment to the mother. Do not apply to the nipple or surrounding area to avoid direct contact with infants who are breastfeeding.
Alters the permeability of the cell wall by blocking fungal cytochrome P450; inhibits biosynthesis of triglycerides and phospholipids by fungi; inhibits several fungal enzymes that results in a build-up of toxic concentrations of hydrogen peroxide; also inhibits androgen synthesis
Absorption: Shampoo: None; Cream, Foam, Gel: Minimal
آیا می خواهید مدیلیب را به صفحه اصلی خود اضافه کنید؟
