ketoconazole hydrochloride

Drug Name
Generic Name : ketoconazole hydrochlorideBrand Name: Nizoral, Xolegel

Classification: Antifungal (Imidazole)

Pregnancy Category C 
Dosage & Route
ADULTS
  • 200 mg PO daily. Up to 400 mg/day in severe infections. Treatment period must be long enough to prevent recurrence, 3 wk–6 mo, depending on infecting organism and site.
PEDIATRIC PATIENTS > 2 YR
  • 3.3–6.6 mg/kg/day PO as a single dose.
PEDIATRIC PATIENTS < 2 YR
  • 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.
PATIENTS > 12 YR

Topical 

  • 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.
Therapeutic actions
  • Impairs the synthesis of ergosterol, the main sterol of fungal cell membranes, allowing increased permeability and leakage of cellular components and causing cell death.
Indications
  • 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)
Adverse effects
  • 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
Contraindications
  • Contraindicated with allergy to ketoconazole; fungal meningitis; pregnancy; lactation.
  • Use cautiously with hepatic failure (increased risk of hepatocellular necrosis).
Nursing considerations
Assessment
  • History: Allergy to ketoconazole, fungal meningitis, hepatic failure, pregnancy, lactation
  • Physical: Skin color, lesions; orientation, reflexes, affect; bowel sounds; LFTs; CBC and differential; culture of area involved
Interventions
  • 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.
Teaching points
  • 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).