Dosing & Uses
Dosage Forms & Strengths
cream/aerosol powder & spray/tincture
- 2%
Tinea
Tinea cruris, corporis & cutaneous canidiasis: Apply to affected area BID x2 weeks
Tinea versicolor: Apply qDay to affected area x2 weeks
Tinea pedis: Apply BID to affected area x4 weeks
Otitis Externa (Orphan)
Orphan designation for treatment of fungal otitis externa (otomycosis)
Sponsor
- Hill Dermaceuticals, Inc; 2650 S. Mellonville Ave; Sanford, FL 32773-9311
Dosage Forms & Strengths
cream/aerosol powder & spray/tincture
- 2%
Tinea
<2 years: Safety and efficacy not established
≥2 years: Apply topical cream or powder BID for up to 1 month
Adverse Effects
Frequency Not Defined
Irritation
Burning
Maceration
Allergic contact dermatitis
Irritation, burning, maceration, allergic contact dermatitis (all rare)
Warnings
Contraindications
Hypersensitivity
Pregnancy & Lactation
Pregnancy Category: C
Lactation: not known whether 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
Absorption: none
Enzymes inhibited: hepatic CYP3A4
Mechanism of Action
Exerts its antifungal and antibacterial activity by altering cell membrane permeability; its site of action on cell membranes has not been elucidated
As a result of this alteration of permeability, the cell membrane is unable to function as a selective barrier, and potassium and other cellular constituents are lost
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Formulary
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