KETOCONAZOLE

Indications & Dose:

TAB; candidiasis, chronic mucocutaneous candidiasis, oral thrush, candiduria, blastomycosis, coccidioidomycosis, histoplasmosis, chromomycosis, paracoccidioidomycosis; severe recalcitrant dermatophyte infections, onychomycosis,* pityriasis versicolor*; tines corporis, pedis, capitus, cruris*; vaginal candidiasis,* advanced prostate cancer (high doses)*; Cushing’s syndrome (high doses)*; CRE: tines corporis, cruris, pedis; pityriasis versicolor, cutaneous candidiasis, seborrheic dermatitis, SHAMPOO: seborrhea 

DOSE

• BY MOUTH

Adult

 • PO 200 mg qd initially, increase to 400 mg qd for serious infections or if clinical response insufficient; duration 1-2 wk (candidiasis), 6 mo (other indicated systemic mycoses)

•CRE: apply qd to affected area for 2 wk (bid for 4 wk for seborrheic dermatitis)

• Shampoo twice weekly for 4 wk with at least 3 days between each shampooing, then intermittently prn 

• BY MOUTH

Child >2 yr 

• PO 3 mg/kg/day as a single dose

Contraindications:

Fungal meningitis (poor CSF penetration)

Side Effects:

Cautions:

Precautions:

Renal disease, hepatic disease, achlorhydria (drug induced), children <2 yr, other hepatotoxic agents, sulfite aensitaiy (CRE) 

Interaction:

Drugs
Alprazolam: Increased plasma alprazolam concentration

Aluminium: Reduced ketoconazole absorption

Amprenavir: Increased plasma amprenavir concentration

Antacids: Reduced ketoconazole absorption

Astemizole: QT prolongation and life-threatening dysrhythmia

Atevirdine: Increased plasma atevirdine concentration

Atorvastatin: Increased plasma atorvastatin concentration with risk of rhabdomyolysis

Buspirone: Increased plasma buspirone concentration

Calcium: Reduced ketoconazole absorption

Chlordiazepoxide: Increased plasma chlordiazepoxide concentration

Cimetidine: Reduced ketoconazole absorption

Cisapride: QT prolongation and dysrhythmia

Cyclosporine: Increased plasma cyclosporine concentration

Diazepam: Increased plasma diazepam concentration

Didanosine: Reduced ketoconazole absorption

Ethanol: Disulfiram-like reaction possible

Famotidine: Reduced ketoconazole absorption

Felodipine: Increased plasma felodipine concentration

Fluvastatin: Increased plasma fluvastatin concentration with risk of rhabdomyolysis

Indinavir: Increased plasma indinavir concentration

Lansoprazole: Reduced ketoconazole absorption

Lovastatin: Increased plasma lovastatin concentration with risk of rhabdomyolysis

Magnesium: Reduced ketoconazole absorption

Methadone: Increased plasma methadone concentration

Methylprednisolone: Increased plasma methylprednisolone concentration

Midazolam: Increased plasma midazolam concentration

Nelfinavir: Increased plasma nelfinavir concentration

Nizatidine: Reduced ketoconazole absorption

Omeprazole: Reduced ketoconazole Absorption 

Oral anticoagulants: Increased hypoprothrombinemic response

Pravastatin: Increased plasma pravastatin concentration with risk of rhabdomyolysis

Quinidine: Increased plasma quinidine concentration

Rifampin: Decreased plasma ketoconazole concentration; decreased plasma rifampin concentratione

Ritonavir: Increased plasma ritonavir concentration

Saquinavir: Increased plasma saquinavir concentration

Simvastatin: Increased, plasma simvastatin concentration with risk of rhabdomyolysis

Sodium bicarbonate: Reduced ketoconazole absorption

Sucralfate: Reduced ketoconazole absorption

Tacralimus: Increased plasma tacrolimus concentration

Terfenadine: QT prolongation and life-threatening dysrhythmia

Tolbutamide: Increased plasma tolbutamide concentration

Triazolam: Increased plasma triazolam concentration

Warfarin: Increased hypoprothrombinemic response 

Warnings:

Adverse Effects:

Lactations:

 Has been used, apparently without harm, for the treatment of vaginal candidiasis during pregnancy; not detected in

plasma with chronic shampoo use; unknown if cre absorbed; oral ketoconazole probably excreted in breast milk; use in breast feeding not recommended

Special Precautions:

Counselling:

Side Effects Or Adverse Reactions:

CNS: Dizziness, headache, somnolence

GI: Abdominal pain, anorexia, diarrhea, hepatotoxicity, nausea, vomiting

GU: Gynecomastia, impotence, oligospermia (high doses)

HEME: Hemolytic anemia, leukopenia, thrombocytopenia

SKIN: Dermatitis, pruritus, purpura, rash, urticaria

MISC.: Chills, fever, photophobia 

Patient And Carer Advice: