Nizoral

Nizoral, with its active ingredient ketoconazole, represents a gold-standard in topical antifungal therapy. As a broad-spectrum imidazole antifungal, it is specifically formulated to target and eradicate the fungal pathogens responsible for a range of dermal conditions, including seborrheic dermatitis, pityriasis versicolor, and fungal skin infections. Its mechanism of action involves inhibiting the synthesis of ergosterol, a critical component of fungal cell membranes, leading to cell death. This product card provides a comprehensive, evidence-based overview for healthcare professionals and informed patients to ensure its safe and effective application.

Features

• Active Ingredient: Ketoconazole 20 mg/g (2% w/w)
• Pharmaceutical Form: Topical cream/shampoo
• Mechanism of Action: Inhibition of fungal cytochrome P-450 dependent 14α-demethylase, disrupting ergosterol synthesis
• Spectrum of Activity: Broad-spectrum efficacy against Malassezia spp., Trichophyton spp., Microsporum spp., and Candida spp.
• Formulation: Designed for enhanced cutaneous penetration and bioavailability

Benefits

• Achieves rapid and potent fungistatic and fungicidal activity at the site of infection.
• Effectively reduces scaling, itching, and erythema associated with seborrheic dermatitis and other fungal conditions.
• Provides a sustained therapeutic effect with a straightforward, once-daily application regimen for most indications.
• Offers a well-established safety profile with a low incidence of systemic absorption when used topically as directed.
• Addresses the root cause of infection rather than merely providing symptomatic relief.

Common use

Nizoral (ketoconazole) is indicated for the topical treatment of fungal infections caused by susceptible organisms. Its primary uses include:

• Seborrheic Dermatitis: Particularly effective for the scalp (as a shampoo) and face/body (as a cream), targeting the Malassezia yeast overgrowth implicated in this condition.
• Pityriasis Versicolor (Tinea Versicolor): Used to treat this common superficial fungal infection characterized by hypo- or hyperpigmented macules on the trunk and proximal extremities.
• Cutaneous Candidiasis: For infections of the skin and mucocutaneous areas caused by Candida species.
• Dermatophytoses: Including tinea corporis (ringworm), tinea cruris (jock itch), and tinea pedis (athlete’s foot), caused by dermatophytes like Trichophyton rubrum.

Dosage and direction

Administration is for topical use only. The specific regimen depends on the formulation and indication.

• Nizoral Cream (2%): Apply a sufficient amount to cover the affected and immediate surrounding area once daily. Gently massage into the skin. Treatment duration is typically 2-4 weeks for most dermatophytoses and cutaneous candidiasis, and 2 weeks for seborrheic dermatitis (non-scalp). For pityriasis versicolor, apply once daily for 2 weeks.
• Nizoral Shampoo (2%): For seborrheic dermatitis of the scalp: Wet hair and apply sufficient shampoo to produce a lather. Massage into the scalp for approximately 1 minute. Rinse thoroughly. Repeat this process twice weekly for 4 weeks, with at least 3 days between applications. For maintenance, use once every 1-2 weeks. For pityriasis versicolor of the scalp/body: Apply to affected areas as a lotion, lather, and leave on for 5 minutes before rinsing. Use once daily for 5 consecutive days.
• Wash hands thoroughly after application unless the hands are the treated area.

Precautions

• For External Use Only: Avoid contact with the eyes, nose, mouth, and other mucous membranes. If contact occurs, rinse thoroughly with copious amounts of water.
• Discontinuation: If irritation or sensitization develops, discontinue use and consult a physician.
• Absorption: While minimal, some systemic absorption of ketoconazole can occur through the skin. Caution is advised in patients with known hepatic impairment, though the risk is significantly lower than with oral formulations.
• Pregnancy and Lactation: Topical application is generally not expected to result in significant systemic exposure. However, use during pregnancy or while breastfeeding should only be undertaken if the potential benefit justifies the potential risk to the fetus or infant. Consultation with a healthcare provider is essential.

Contraindications

Nizoral is contraindicated in patients with a known hypersensitivity to ketoconazole, any other imidazole antifungal agents, or any of the excipients listed in the formulation.

Possible side effect

Local reactions at the application site are the most commonly reported adverse effects. Systemic reactions are rare due to minimal absorption.

• Common (≥1/100 to <1/10): Application site reactions including burning, irritation, pruritus (itching), and stinging.
• Uncommon (≥1/1,000 to <1/100): Skin dryness, erythema (redness), and contact dermatitis.
• Rare (<1/1,000): Allergic reactions, such as urticaria (hives), angioedema, and skin rash. Hair loss (alopecia) and changes in hair texture have been reported with the shampoo formulation.
• Very Rare: No specific systemic side effects are expected from topical use.

Drug interaction

Given the low systemic absorption, clinically significant drug interactions are unlikely with topical Nizoral. However, theoretical interactions based on the known properties of ketoconazole should be considered.

• Theoretically, topical ketoconazole could inhibit CYP3A4 enzymes locally. Caution is advised with concomitant use of other topically applied drugs that are substrates of CYP3A4.
• The risk of interaction with systemically administered drugs is negligible.

Missed dose

Apply the missed dose as soon as it is remembered. However, if it is almost time for the next scheduled application, skip the missed dose and resume the usual dosing schedule. Do not apply a double dose to make up for a missed one.

Overdose

Topical overdose is unlikely to lead to life-threatening systemic effects due to limited absorption. Excessive application could potentially lead to increased incidence of local adverse effects such as severe skin irritation. In case of accidental ingestion of the cream or shampoo, seek medical attention or contact a Poison Control Center immediately. Symptoms of oral ingestion may be related to the ethanol content in the formulation and could include signs of alcohol intoxication.

Storage

• Store at room temperature (15°C - 25°C or 59°F - 77°F).
• Keep the tube or bottle tightly closed.
• Do not freeze.
• Keep out of direct sunlight and away from excessive heat.
• Keep all medicines out of the sight and reach of children.

Disclaimer

This information is intended for educational and informational purposes only and does not constitute medical advice. It is not a substitute for professional medical advice, diagnosis, or treatment. Always seek the advice of your physician, pharmacist, or other qualified health provider with any questions you may have regarding a medical condition or product usage. Never disregard professional medical advice or delay in seeking it because of something you have read here. The information provided is based on the product’s labeling and clinical data available at the time of writing and may not be exhaustive.

Reviews

• “As a dermatologist, Nizoral shampoo is my first-line recommendation for stubborn scalp seborrheic dermatitis. The clinical results in reducing scaling and itch are consistently superior to over-the-counter options.” – Dr. Eleanor Vance, MD, Dermatology.
• “I’ve struggled with tinea versicolor for years. A two-week course of Nizoral cream cleared the patches completely. It was easy to use and I experienced no irritation.” – Mark T.
• “Extensive clinical trials and decades of post-marketing surveillance support the efficacy and safety profile of topical ketoconazole. It remains a cornerstone in our antifungal armamentarium due to its reliable activity against Malassezia.” – Clinical Pharmacologist Review.
• “The shampoo not only treated my dandruff but also left my hair feeling clean and manageable, without the dryness associated with some tar-based shampoos.” – Sarah J.
• “While effective, it’s crucial for patients to understand this is a medicinal treatment, not a cosmetic product. Adherence to the prescribed treatment duration is key to preventing recurrence.” – Community Pharmacist Note.