Brand Name: Nizoral

Generic Name: Ketoconazole

Indications: Treatment of a variety of cutaneous fungal infections, tinea corporis (ringworm), tinea
cruris (jock itch), tinea pedis (athlete’s foot), tinea versicolor caused by susceptible
organisms; seborrheic dermatitis; cutaneous candidiasis.
Dandruff.
Drug Classification: Therapeutic: antifungal
Mechanism of Action: Ketoconazole affects the synthesis of the fungal cell wall, allowing leakage
of cellular contents. Fungistatic or fungicidal action decreases symptoms
of fungal infection.
Dosage: Topical (Adults): Apply cream once daily for cutaneous candidiasis or twice daily for
seborrheic dermatitis. For dandruff, use shampoo twice weekly (wait for
3 days between treatments) for 4 weeks, then intermittently.
Special Precaution:
 Use cautiously in nail and scalp infections, in pregnant and breast-feeding women.
 Use oral form cautiously in patients with hepatic disease.
 Alcoholism.
Pregnancy Risk Category: C
Adverse Reaction: CNS: headache, nervousness, dizziness, somnolence, photophobia, suicidal
tendencies, severe depression (with oral administration).
 GI: nausea, vomiting, abdominal pain, diarrhea (with oral administration).
GU: gynecomastia with tenderness, impotence (with oral administration).
Hematologic: thrombocytopenia, hemolytic anemia, leukopenia (with oral
administration)
Hepatic: transient elevations in AST, ALT, and alkaline phosphatase levels;
fatal hepatotoxicity (with oral administration).
EENT: photophobia
Metabolic: transient alterations in serum cholesterol and triglyceride levels.
Skin: severe irritation, pruritus, stinging with cream use; increase in normal
hair loss, irritation, abnormal hair texture, scalp pustules, pruritus, oiliness or
dryness of hair and scalp with shampoo use.
Other: fever, chills.
Contraindications: Contraindicated in patients with hypersensitivity to drug or its components.
Contraindicated in patients
taking oral triazolam because serious cardiovascular events can occur.
Form: Cream: 2%
Shampoo: 1%, 2%
Tablets: 200 mg
(continuation Nizoral)
Nursing Responsibilities:
 Most patients show improvement soon after treatment begins.
 Treatment of tinea corporis or tinea cruris should continue for at least 2 weeks to reduce
possibility of recurrence.
 Alert: Product contains sodium sulfite anhydrous, which may cause severe or life-
threatening allergic reactions, including anaphylaxis, in asthmatic patients.
 Oral form requires acidity for absorption; give with citrus juice. Adjust administration for
patients with achlorhydria.
 Monitor for signs and symptoms of hepatotoxicity: persistent nausea, unusual fatigue,
jaundice, dark urine, and pale stools.
 Don't use oral form alone to treat fungal meningitis because these patients have low CSF
concentrations.
 Tell patient to stop drug and notify doctor if hypersensitivity reaction occurs.
 Advise patient to check with doctor if condition worsens; drug may have to be
discontinued and diagnosis reevaluated.
 Warn patient to avoid contact of drug with eyes.
 Tell patient not to store drug above room temperature (77° F [25° C]); protect from light.
 Instruct achlorhydric patients to dissolve each tablet in 4 ml of 0.2N hydrochloric acid
solution or take with 200 ml of 0.1N hydrochloric acid. Use a glass or plastic straw to
avoid damaging tooth enamel. After each dose, drink a glass of water.
 Tell patient to avoid driving or performing other hazardous activities if dizziness or
drowsiness occur; these often occur early in treatment but abate as treatment continues.
 Caution patient not to alter dose or dosage interval or to discontinue drug without medical
approval; therapy must continue until active fungal infection is completely eradicated, to
prevent recurrence.
 Reassure patient that nausea will subside; to minimize reaction; patient may take drug
with food or may divide dosage into two doses.
 Advise patient to avoid self-prescribed preparations for GI distress (such as antacids);
some may alter gastric pH levels and interfere with drug action.
 Instruct patient to apply medication as directed for full course of therapy even if feeling
better. Emphasize the importance of avoiding the eyes.
 Caution patient that some products may stain fabric, skin, or hair.s