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 imidazole antifungal presented as a topical formulation for skin application. It is used to treat superficial fungal infections such as dandruff, seborrheic dermatitis, and various tinea conditions in adults and children.

GNH India supplies Nizoral as a licensed, GDP‑compliant international pharmaceutical supplier serving hospitals, pharmacies and clinics worldwide. The company ensures quality compliance with EU standards and provides reliable logistics for global distribution. Clients benefit from dedicated regulatory support and consistent product availability across multiple markets.

Manufacturer / TM Owner

Stada Gmbh

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Indications & Clinical Uses

Nizoral (ketoconazole) is applied topically to address fungal skin conditions within the dermatological infection spectrum.

  • Seborrheic dermatitis: reduces inflammation and flaking caused by Malassezia yeast.
  • Dandruff (pityriasis capitis): controls scalp scaling and itching.
  • Tinea corporis: clears body ringworm lesions.
  • Tinea cruris: treats groin fungal infection.
  • Tinea versicolor: eliminates pigment‑changing yeast overgrowth.

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 cell death. This action is selective for fungi, sparing human cells.

Side Effects

Topical ketoconazole may cause local skin reactions, ranging from mild irritation to rare systemic events.

Common Side Effects

  • Burning or stinging sensation at the application site.
  • Itching (pruritus) of the treated area.
  • Redness or erythema.
  • Dryness or flaking of skin.
  • Contact dermatitis.

Serious or Rare Side Effects

  • Severe allergic reaction (angioedema, anaphylaxis).
  • Hepatotoxicity (rare with extensive use).
  • Stevens‑Johnson syndrome or toxic epidermal necrolysis.
  • Significant skin discoloration.
  • Systemic absorption leading to endocrine effects (e.g., gynecomastia) – extremely rare.

Precautions & Warnings

Before using Nizoral, consider the following safety measures.

  • Assess skin integrity: avoid application on broken or inflamed skin.
  • Review medical history: caution in patients with known liver disease.
  • Pregnancy and lactation: consult a healthcare professional before use.
  • Concomitant topical agents: do not combine with other irritating products.
  • Allergic reactions: discontinue if signs of hypersensitivity appear.
  • Store at room temperature: keep in original container, protect from moisture and direct sunlight.

Avoid Interactions

Ketoconazole can interact with other medicines, primarily through inhibition of hepatic enzymes.

Major Interactions (Avoid)

  • Systemic azole antifungals: increased risk of cumulative toxicity.
  • Warfarin: potentiation of anticoagulant effect.
  • Cyclosporine: elevated blood levels leading to nephrotoxicity.

Moderate Interactions (Monitor Closely)

  • Oral contraceptives: possible reduction in efficacy.
  • Antihistamines: may increase sedation.
  • Topical corticosteroids: enhanced skin irritation.

Frequently Asked Questions

Nizoral is indicated for the topical treatment of several superficial fungal skin disorders, including seborrheic dermatitis, dandruff (pityriasis capitis), tinea corporis (body ringworm), tinea cruris (jock itch), and tinea versicolor (pityriasis versicolor). It targets the underlying yeast or dermatophyte infection to relieve symptoms and clear lesions.

Ketoconazole belongs to the imidazole class of antifungals. It blocks the fungal enzyme lanosterol 14α‑demethylase, which is essential for converting lanosterol to ergosterol, a key component of the fungal cell membrane. Inhibiting ergosterol synthesis compromises membrane integrity, causing increased permeability and ultimately fungal cell death.

The amount of Nizoral to apply and the duration of therapy are determined by the prescribing healthcare professional based on the specific condition, severity, patient age, and treatment response. The prescriber will provide individualized instructions on how much cream to use and how often it should be applied.

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. The prescriber may recommend alternative treatments if concerns arise.

To request 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 (including any cold‑chain requirements), and necessary import documentation.

Ketoconazole offers a broad spectrum against yeasts and dermatophytes and is available as a convenient topical cream. Compared with allylamine agents such as terbinafine, ketoconazole may be preferred for seborrheic dermatitis and dandruff due to its anti‑yeast activity, while terbinafine is often chosen for nail infections. Choice depends on the infection type, patient tolerance, and prescriber preference.

Store Nizoral at room temperature, ideally below 25 °C, in its original packaging. Keep the container tightly closed, protect it from moisture and direct sunlight, and keep it out of reach of children. Do not freeze the product, and discard any cream that appears discolored or contaminated.

Clean and gently dry the affected skin area before application. Apply a thin layer of the cream to the lesion and surrounding skin, usually twice daily or as directed by the prescriber. Rub gently until the product is absorbed, and wash hands after use to avoid accidental contact with eyes or mucous membranes.

Although rare, serious adverse reactions can include severe allergic responses such as angioedema or anaphylaxis, Stevens‑Johnson syndrome, toxic epidermal necrolysis, and significant liver toxicity with extensive systemic absorption. Patients should seek immediate medical attention if they experience swelling of the face, lips, tongue, widespread rash, or signs of liver dysfunction.

Individuals with a known hypersensitivity to ketoconazole, other imidazole antifungals, or any component of the formulation should avoid using Nizoral. It is also contraindicated on severely damaged or inflamed skin, and caution is advised for patients with pre‑existing liver disease or those taking medications that may interact significantly with ketoconazole.

Published by

GNH India Pharmaceuticals Limited

Licensed pharmaceutical supplier

Last updated:

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