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miconazole topical (Desenex, Fungoid Tincture, Monistat Derm, Micatin, Zeasorb-AF, Cavilon Antifungal Cream)

 

Classes: Antifungals, Topical

Dosing and uses of Desenex, Fungoid Tincture (miconazole topical)

 

Adult dosage forms and 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

 

Pediatric dosage forms and 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

 

Desenex, Fungoid Tincture (miconazole topical) adverse (side) effects

Frequency not defined

Irritation

Burning

Maceration

Allergic contact dermatitis

Irritation, burning, maceration, allergic contact dermatitis (all rare)

 

Warnings

Contraindications

Hypersensitivity

 

Pregnancy and 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 of Desenex, Fungoid Tincture (miconazole topical)

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