Product image of Nizoral (Ketoconazole) supplied by GNH India

Nizoral

Active Ingredient:
Ketoconazole
Origin:
EU

Nizoral (Ketoconazole)

Ketoconazole, the active ingredient in Nizoral, is an azole antifungal presented as a topical preparation for skin use. It is applied to treat fungal infections of the skin and scalp, including dandruff, seborrheic dermatitis, and various tinea infections in adults and children.

GNH India supplies Nizoral as a licensed, GDP‑compliant international pharmaceutical supplier serving hospitals, pharmacies and clinics worldwide. The company adheres to EU quality standards and provides batch‑tested product for global distribution. Customers receive regulatory documentation and support for import compliance.

Manufacturer / TM Owner

Stada Arzneimittel Ag

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Indications & Clinical Uses

Ketoconazole is an azole antifungal that interferes with fungal cell membrane synthesis, making it effective for several dermatologic fungal conditions.

  • Tinea corporis: reduces fungal growth on the body, relieving redness and scaling.
  • Tinea cruris: clears infection in the groin area, diminishing itching and erythema.
  • Seborrheic dermatitis: controls yeast‑related inflammation on the scalp and face, decreasing flaking and irritation.
  • Dandruff: diminishes Malassezia overgrowth, reducing scalp scaling and itch.

How It Works

  • Ketoconazole inhibits the fungal enzyme lanosterol 14α-demethylase, a cytochrome P450 isozyme required for conversion of lanosterol to ergosterol. By blocking this step, the drug disrupts ergosterol synthesis, compromising fungal cell membrane integrity and leading to inhibited growth or cell death. The action is selective for fungal cells, providing topical antifungal activity. Topical application allows high local concentrations while minimizing systemic exposure.

Side Effects

Ketoconazole topical preparations may cause local skin reactions and, rarely, systemic adverse events.

Common Side Effects

  • Skin irritation: mild redness, itching, or burning at the application site.
  • Dryness: localized skin dryness or flaking.
  • Pruritus: increased itching sensation.
  • Contact dermatitis: allergic skin reaction.

Serious or Rare Side Effects

  • Severe allergic reaction: swelling, hives, or difficulty breathing.
  • Hepatotoxicity: abnormal liver function tests observed with extensive use.
  • Hormonal effects: rare inhibition of steroid synthesis leading to endocrine disturbances.

Precautions & Warnings

When using ketoconazole topical products, certain precautions should be observed to ensure safety and effectiveness.

  • Application area: limit use to affected skin and avoid mucous membranes.
  • Duration: follow prescriber instructions; prolonged use may increase risk of irritation.
  • Concurrent skin conditions: avoid use on broken skin or severe eczema without medical advice.
  • Pregnancy and lactation: consult healthcare provider before use, as safety data are limited.
  • Drug interactions: topical ketoconazole has minimal systemic absorption but may interact with other topical agents; discuss with a pharmacist.
  • Store at ambient temperature: keep below 25°C in the original container, protect from moisture and direct sunlight.

Avoid Interactions

Ketoconazole can interact with other medications, primarily through enzyme inhibition, although topical use results in low systemic exposure.

Major Interactions (Avoid)

  • Oral azole antifungals: concurrent use may increase systemic ketoconazole levels and toxicity.
  • Systemic corticosteroids: may enhance risk of adrenal suppression when combined with extensive ketoconazole exposure.
  • Hepatotoxic drugs: co‑administration can raise risk of liver injury.

Moderate Interactions (Monitor Closely)

  • Warfarin: ketoconazole may potentiate anticoagulant effect; monitor INR.
  • Cytochrome P450 substrates: drugs metabolized by CYP3A4 may have altered levels; monitor clinical response.
  • Topical irritants: combined use with other irritating skin products may increase local reactions.

Frequently Asked Questions

Nizoral, containing ketoconazole, is indicated for the topical treatment of fungal skin infections such as tinea corporis and tinea cruris, as well as seborrheic dermatitis and dandruff caused by Malassezia species. It helps to reduce redness, scaling, and itching associated with these conditions.

Ketoconazole blocks the fungal enzyme lanosterol 14α‑demethylase, which is essential for converting lanosterol to ergosterol, a key component of the fungal cell membrane. Inhibiting this step disrupts membrane integrity, halting fungal growth and leading to cell death, while sparing human cells.

The specific amount and frequency of Nizoral application are determined by the prescribing healthcare professional based on the infection type, severity, patient age, and treatment area. Patients should follow the prescriber’s instructions and the product label for proper use.

Safety data for topical ketoconazole during pregnancy and lactation are limited. Women who are pregnant, planning to become pregnant, or breastfeeding should discuss potential risks and benefits with their healthcare provider before using Nizoral.

To place an order, submit an enquiry on the Nizoral product page at gnhindia.com, specifying the required quantity. GNH India works with hospitals, pharmacies, and procurement teams worldwide, verifies trade or institutional credentials, and then provides pricing, availability, shipping details (including any cold‑chain requirements), and necessary import documentation.

Nizoral’s active ingredient, ketoconazole, belongs to the azole class and offers broad‑spectrum activity against dermatophytes and yeasts. Compared with allylamine agents such as terbinafine, ketoconazole may be preferred for seborrheic dermatitis and dandruff, while terbinafine is often chosen for nail infections. Choice depends on infection type, patient tolerance, and clinician preference.

Nizoral should be stored at ambient temperature, preferably below 25 °C. Keep the product in its original packaging, protect it from moisture and direct sunlight, and ensure the container is tightly closed when not in use.

Nizoral is applied topically to the affected skin or scalp area. The prescribed amount is spread thinly and gently massaged into clean, dry skin, usually once or twice daily, or as directed by a healthcare professional. Hands should be washed after application.

While rare, serious adverse reactions can include severe allergic responses such as swelling, hives, or difficulty breathing, as well as liver toxicity indicated by abnormal liver function tests. Patients should seek immediate medical attention if they experience any signs of a severe reaction.

Individuals with known hypersensitivity to ketoconazole or any component of the formulation should not use Nizoral. It should also be avoided on broken or severely inflamed skin unless specifically advised by a clinician, and caution is advised in patients with pre‑existing liver disease.

Published by

GNH India Pharmaceuticals Limited

Licensed pharmaceutical supplier

Last updated:

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