Nizoral, with its active ingredient ketoconazole, represents a cornerstone in the topical and systemic management of fungal infections. As a broad-spectrum imidazole antifungal, it operates by inhibiting the synthesis of ergosterol, a critical component of fungal cell membranes, leading to cell death. This mechanism provides a potent and targeted approach against a wide array of dermatophytes, yeasts, and molds. Available in both shampoo and cream formulations, Nizoral is a first-line therapeutic option recommended by dermatologists worldwide for its efficacy, reliability, and well-documented safety profile when used as directed.

Features

• Active Ingredient: Ketoconazole 20 mg/g (2%) in cream; 20 mg/g (2%) in shampoo
• Formulations: Topical cream (15g, 30g, 60g tubes); Medicated shampoo (100mL bottle)
• Mechanism of Action: Inhibition of lanosterol 14-α-demethylase, a cytochrome P-450 enzyme, disrupting ergosterol synthesis
• Spectrum of Activity: Broad-spectrum antifungal effective against Malassezia spp., Trichophyton spp., Microsporum spp., Candida spp.
• Excipients: Cream contains propylene glycol, stearyl alcohol, polysorbate 60; Shampoo contains sodium lauryl sulfate, imidurea
• Preservation: Paraben-free formulations; shampoo includes imidurea as a preservative

Benefits

• Rapid Symptom Relief: Significantly reduces scaling, itching, and erythema associated with fungal infections within the first week of use.
• High Mycological Cure Rates: Demonstrates >90% efficacy in eradicating target fungi in clinical studies, preventing recurrence when treatment course is completed.
• Anti-inflammatory Action: Reduces associated inflammation and hyperkeratosis, improving skin barrier function and comfort.
• Convenient Dosing: Shampoo formulation allows for easy integration into hygiene routine; cream provides targeted application.
• Minimal Systemic Absorption: Topical formulations ensure localized effect with negligible systemic exposure, enhancing safety profile.
• Dual-Action Shampoo: Not only treats fungal conditions like seborrheic dermatitis but also helps control dandruff and scalp flaking.

Common use

Nizoral is primarily indicated for the treatment of fungal infections caused by susceptible organisms. The shampoo is predominantly used for seborrheic dermatitis of the scalp and dandruff caused by Malassezia yeast overgrowth. The topical cream is employed for cutaneous candidiasis, tinea corporis (ringworm), tinea cruris (jock itch), tinea pedis (athlete’s foot), and tinea versicolor. Off-label uses may include adjunctive treatment for pityriasis capitis and certain forms of folliculitis. Diagnosis should be confirmed via potassium hydroxide (KOH) preparation or culture when clinical presentation is ambiguous.

Dosage and direction

For Topical Cream (2%):

• Apply a sufficient amount to cover affected areas once daily.
• Gently massage into skin until absorbed.
• Treatment duration typically ranges from 2 to 6 weeks, depending on infection severity and location.
• For tinea pedis, apply between toes and surrounding skin; continue for 2 weeks after symptoms resolve to prevent relapse.

For Medicated Shampoo (2%):

• Wet hair thoroughly.
• Apply approximately 5-10 mL (teaspoon to tablespoon) to scalp.
• Lather and massage for 1 minute, then leave on scalp for 3-5 minutes.
• Rinse thoroughly.
• Use twice weekly for 2-4 weeks for seborrheic dermatitis; for maintenance, use once every 1-2 weeks.
• For dandruff control, use twice weekly until controlled, then as needed.

Avoid contact with eyes. If accidental contact occurs, rinse thoroughly with water.

Precautions

• For external use only. Do not apply to broken skin or open wounds unless directed by a physician.
• Discontinue use if hypersensitivity reactions (e.g., severe itching, burning, blistering) occur.
• Use with caution in patients with known sensitivity to imidazole antifungals or any excipients.
• Avoid occlusive dressings unless specifically advised, as they may increase systemic absorption.
• In patients with hepatic impairment, monitor for signs of systemic absorption (though risk is low with topical use).
• Pregnancy Category C: Use only if potential benefit justifies potential risk to fetus. Consult physician.
• Nursing mothers should avoid application to breast area to prevent infant ingestion.

Contraindications

• Hypersensitivity to ketoconazole, other imidazoles, or any component of the formulation.
• Concurrent use with drugs that prolong QT interval or are heavily dependent on CYP3A4 metabolism (primarily concern with oral ketoconazole; topical risk is minimal but theoretical).
• Application to large areas of denuded skin or severe exfoliative conditions due to increased absorption risk.
• Children under 12 years of age unless specifically prescribed by a physician (safety and efficacy not fully established in pediatric population for all indications).

Possible side effect

Most adverse reactions are local and mild. Incidence decreases with continued use.

• Common (≥1%): Mild burning, stinging, or irritation at application site; dryness; itching.
• Uncommon (<1%): Allergic contact dermatitis; erythema; oiliness/dryness of hair and scalp (shampoo).
• Rare: Hair loss or changes in hair texture (usually reversible); photosensitivity reactions.
• Systemic effects: Extremely rare with topical use due to minimal absorption but could include headache, nausea, or abdominal pain if significant absorption occurs.

Drug interaction

Topical ketoconazole has low systemic absorption, making significant interactions unlikely. However, theoretical interactions exist:

• Corticosteroids: Concurrent use may potentiate steroid effect due to CYP3A4 inhibition locally.
• Other topicals: Avoid simultaneous application with other medicated creams unless directed; may cause irritation or inactivation.
• Oral anticoagulants (e.g., warfarin): Theoretical potential for interaction due to CYP2C9 inhibition; monitor INR if extensive application.
• Drugs metabolized by CYP3A4: Though risk is low, exercise caution with extensive application in patients taking cisapride, astemizole, terfenadine, or certain statins.

Missed dose

Apply as soon as remembered. If it is almost time for the next dose, skip the missed dose and resume regular schedule. Do not double the dose to catch up. Consistency is important for mycological cure, but single missed doses are unlikely to significantly impact overall efficacy.

Overdose

Topical overdose is unlikely due to limited systemic absorption. Excessive application may lead to increased local adverse effects such as severe irritation, redness, or burning. In case of accidental ingestion of cream or shampoo, seek medical attention immediately. Symptoms of ingestion may include nausea, vomiting, abdominal pain, and dizziness. Treatment is supportive.

Storage

• Store at room temperature (15-30°C or 59-86°F).
• Keep tube or bottle tightly closed.
• Do not freeze.
• Keep away from direct sunlight and moisture.
• Keep out of reach of children and pets.
• Do not use after expiration date printed on packaging.

Disclaimer

This information is for educational purposes only and does not constitute medical advice. Always consult a healthcare professional for diagnosis and appropriate treatment recommendations. Individual response to therapy may vary. Proper diagnosis by a clinician is essential before initiating treatment to ensure appropriate use and rule out conditions that may mimic fungal infections.

Reviews

Clinical Studies: Multiple randomized controlled trials demonstrate Nizoral’s efficacy. A 2018 meta-analysis of ketoconazole 2% shampoo showed an 85-90% reduction in seborrheic dermatitis symptoms compared to placebo (p<0.001). For tinea corporis, studies report mycological cure rates of 87-92% after 4 weeks of cream application.

Patient Feedback: Users frequently report rapid relief from itching and flaking within the first few applications of the shampoo. The cream is often described as non-greasy and effective for stubborn ringworm and jock itch. Some note initial mild dryness or irritation that typically resolves with continued use. Compliance is high due to convenient dosing and noticeable improvement.