ketoconazole hydrochloride Nursing Considerations & Management

• 3.3–6.6 mg/kg/day PO as a single dose.

• Safety and efficacy not established.

Shampoo

• Moisten hair and scalp thoroughly with water; apply sufficient shampoo to produce a lather; gently massage for 1 min; rinse hair with warm water; repeat, leaving on hair for 3 min. Shampoo twice a week for 4 wk with at least 3 days between shampooing.

• Apply thin film of gel or cream once daily to affected areas for 2 wk; do not wash this area for 3 hr after applying. Wait 20 min before applying makeup or sunscreen.

• Impairs the synthesis of ergosterol, the main sterol of fungal cell membranes, allowing increased permeability and leakage of cellular components and causing cell death.

• Treatment of systemic fungal infections: Candidiasis, chronic mucocutaneous candidiasis, oral thrush, candiduria, blastomycosis, coccidioidomycosis, histoplasmosis, chromomycosis, paracoccidioidomycosis
• Treatment of dermatophytosis (recalcitrant infections not responding to topical or griseofulvin therapy)
• Topical treatment of seborrheic dermatitis in patients > 12 yr
• Cream: Tinea corporis (ringworm), tinea cruris (jock itch), and tinea pedis (athlete’s foot)
• Shampoo: Reduction of scaling due to dandruff
• Orphan drug use: With cyclosporine to diminish cyclosporine-induced nephrotoxicity in organ transplant
• Unlabeled uses: Treatment of onychomycosis, pityriasis versicolor, vaginal candidiasis; CNS fungal infections at high doses (800–1,200 mg/day); treatment of advanced prostate cancer at doses of 400 mg q 8 hr; treatment of Cushing’s syndrome (800–1,200 mg/day)

• CNS: Headache, dizziness, somnolence, photophobia
• GI: Hepatotoxicity, nausea, vomiting, abdominal pain
• GU:Impotence, oligospermia (with very high doses)
• Hematologic:Thrombocytopenia, leukopenia, hemolytic anemia
• Hypersensitivity:Urticaria to anaphylaxis
• Local: Severe irritation, pruritus, stinging with topical application
• Other: Pruritus, fever, chills, gynecomastia

• Contraindicated with allergy to ketoconazole; fungal meningitis; pregnancy; lactation.
• Use cautiously with hepatic failure (increased risk of hepatocellular necrosis).

• Culture fungus before therapy; begin treatment before return of laboratory results.
• WARNING; Keep epinephrine readily available in case of severe anaphylaxis after first dose.
• Administer oral drug with food to decrease GI upset.
• Do not administer with antacids, H2-blockers, proton pump inhibitors; ketoconazole requires an acidic environment for absorption; if antacids are required, administer at least 2 hr apart.
• Continue administration for long-term therapy until infection is eradicated: Candidiasis, 1–2 wk; other systemic mycoses, 6 mo; chronic mucocutaneous candidiasis, often requires maintenance therapy; tinea versicolor, 2 wk of topical application.
• Stop treatment, and consult physician about diagnosis if no improvement is seen within 2 wk of topical application.
• Administer shampoo as follows: Moisten hair and scalp thoroughly with water; apply sufficient shampoo to produce a lather; gently massage for 1 min; rinse hair with warm water; repeat, leaving on hair for 3 min.
• Arrange to monitor hepatic function tests before therapy and monthly or more frequently throughout treatment.

• Take the full course of drug therapy. Long-term use of the drug will be needed; beneficial effects may not be seen for several weeks.
• Take oral drug with meals to decrease GI upset.
• If using shampoo, moisten hair and scalp thoroughly with water; apply sufficient shampoo to produce a lather; gently massage for 1 minute; rinse hair with warm water; repeat, leaving on hair for 3 minutes. Shampoo twice a week for 4 weeks with at least 3 days between shampooing.
• Use appropriate hygiene measures to prevent reinfection or spread of infection.
• Do not take antacids, H2-blockers, proton pump inhibitors with this drug; if they are needed, take this drug at least 2 hours after their administration.
• You may experience these side effects: Nausea, vomiting, diarrhea (take drug with food); sedation, dizziness, confusion (avoid driving or performing tasks that require alertness); stinging, irritation (local application).
• Report rash, severe nausea, vomiting, diarrhea, fever, sore throat, unusual bleeding or bruising, yellow skin or eyes, dark urine or pale stools, severe irritation (local application).