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 formulation for skin use. It treats fungal skin infections such as dermatophyte infections, seborrheic dermatitis, and pityriasis versicolor in adults and children.

GNH India supplies Nizoral as a licensed, GDP‑compliant international pharmaceutical supplier serving hospitals, pharmacies and clinics worldwide.

Manufacturer / TM Owner

Clonmel Healthcare Ltd.

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Indications & Clinical Uses

Ketoconazole is an azole antifungal that targets fungal skin conditions.

  • Dermatophyte infections: reduces fungal growth and clears skin lesions.
  • Seborrheic dermatitis: alleviates scaling and erythema on the scalp and face.
  • Pityriasis versicolor: eliminates Malassezia species and restores normal skin pigmentation.

How It Works

  • Ketoconazole inhibits the fungal enzyme lanosterol 14α‑demethylase, a key step in ergosterol synthesis. By blocking ergosterol production, the drug disrupts the integrity of the fungal cell membrane, leading to increased permeability and ultimately fungal cell death.

Side Effects

Topical ketoconazole may cause local or systemic adverse reactions, although most are mild.

Common Side Effects

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

Serious or Rare Side Effects

  • Hepatotoxicity: rare systemic absorption leading to liver enzyme elevation.
  • Severe allergic reaction: anaphylaxis or angioedema.
  • Stevens‑Johnson syndrome: extremely rare severe skin reaction.

Precautions & Warnings

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

  • Assess skin integrity: avoid application on broken or inflamed skin.
  • Limit area: restrict use to the prescribed body surface area.
  • Duration: do not exceed the treatment period recommended by the prescriber.
  • Concomitant therapy: inform healthcare provider of other topical or systemic antifungals.
  • Pregnancy and lactation: discuss risks with a healthcare professional before use.
  • 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 medicines, especially when systemic absorption occurs.

Major Interactions (Avoid)

  • Systemic azoles: concurrent use may increase risk of hepatotoxicity.
  • CYP3A4 substrates: strong inhibitors may raise plasma levels of drugs metabolized by this enzyme.
  • Warfarin: may potentiate anticoagulant effect.

Moderate Interactions (Monitor Closely)

  • Topical corticosteroids: may enhance skin irritation.
  • Antihistamines: monitor for increased sedation if systemic absorption occurs.
  • Oral contraceptives: may reduce efficacy; advise alternative contraception.

Frequently Asked Questions

Nizoral, containing ketoconazole, is used to treat fungal skin conditions such as dermatophyte infections (e.g., athlete's foot, ringworm), seborrheic dermatitis (scalp and facial scaling), and pityriasis versicolor, a discoloration caused by Malassezia yeast overgrowth.

Ketoconazole blocks the fungal enzyme lanosterol 14α‑demethylase, which is essential for synthesising ergosterol, a key component of the fungal cell membrane. Without ergosterol, the membrane becomes leaky, leading to fungal cell death and clearance of the infection.

The specific dose and frequency of Nizoral are determined by the prescribing healthcare professional based on the type and severity of the infection, the patient’s age, and other clinical factors. Patients should follow the prescriber’s instructions exactly.

Safety data for topical ketoconazole in 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 order Nizoral, submit an enquiry on the 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 and any necessary import documentation.

Nizoral (ketoconazole) belongs to the azole class, which is effective against a broad range of dermatophytes and yeasts. Compared with allylamine agents such as terbinafine, azoles have a broader spectrum but may carry a higher risk of hepatic interaction when absorbed systemically.

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 area, usually once or twice daily as directed by a healthcare professional. The skin should be clean and dry before application, and the medication should be gently rubbed in until fully absorbed.

Although rare, serious risks include systemic hepatotoxicity, severe allergic reactions such as anaphylaxis, and rare severe skin reactions like Stevens‑Johnson syndrome. Any signs of liver dysfunction, widespread rash, or difficulty breathing should prompt immediate medical attention.

Individuals with known hypersensitivity to ketoconazole or any component of the formulation should avoid Nizoral. Patients with extensive broken skin, severe liver disease, or those taking interacting systemic medications should consult a healthcare professional before use.

Published by

GNH India Pharmaceuticals Limited

Licensed pharmaceutical supplier

Last updated:

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