Dosing and uses of Nizoral Topical, Extina (ketoconazole topical)
Adult dosage forms and strengths
cream/gel/foam
- 2%
shampoo
- 1%
- 2%
Seborrheic Dermatitis
Foam: Apply to affected area q12hr for 4 weeks
Cream: Apply q12hr for 4 weeks or until clear
Shampoo: Apply twice weekly for 4 weeks, with at least 3 days between each shampoo
Tinea Versicolor
Shampoo
- Wet hair, massage into scalp for 1 min, and rinse
- Repeat, leaving on scalp for 3 additional min
- Shampoo twice weekly for 4 weeks, allowing 3 days between each shampoo
Tinea Corporis, Tinea Cruris, Tinea Pedis
Cream: Apply qDay for 2 weeks (6 weeks for tinea pedis), covering affected area
Pediatric dosage forms and strengths
cream/gel/foam
- 2%
shampoo
- 1%
- 2%
Seborrheic Dermatitis
<12 years: Safety and efficacy not established
≥12 years (shampoo): Apply twice weekly for 4 weeks, with at least 3 days between each shampoo
≥12 years (cream/foam): Apply to affected area q12hr x4 weeks
Nizoral Topical, Extina (ketoconazole topical) adverse (side) effects
1-10%
Irritation, severe
Pruritus
Stinging
Frequency not defined
Shampoo
- Hair loss/alopecia
- Irritation
- Abnormal hair texture
- Scalp pustules
- Dry skin
- Pruritus
- Oiliness/dryness of hair and scalp
Postmarketing Reports
Burning sensation
Pain
Skin irritation
Erythema
Warnings
Contraindications
Hypersensitivity
Cautions
Discontinue if irritation occurs
Angioedema reported
Formulation contains alcohol; do not expose to flames or smoking following application of the product
Pregnancy and lactation
Pregnancy category: C
Lactation: Not known if distributed into milk; use caution
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.
Pharmacology of Nizoral Topical, Extina (ketoconazole topical)
Mechanism of action
Fungistatic in action, but may be fungicidal at high concentrations after prolonged incubation or against very susceptible organisms
Alters cellular membranes, resulting in increased membrane permeability, secondary metabolic effects, and growth inhibition
Absorption
MinimaL
