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 treats fungal skin conditions such as seborrheic dermatitis, tinea infections, and pityriasis versicolor in both adults and children.

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

Manufacturer / TM Owner

Stada Arzneimittel Ag

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Indications & Clinical Uses

Ketoconazole is used to manage fungal skin disorders by inhibiting the growth of dermatophytes and yeasts.

  • Seborrheic dermatitis: reduces scaling, redness and itching on the scalp and face.
  • Tinea corporis (ringworm): clears lesions and prevents spread.
  • Tinea cruris (jock itch): relieves itching and resolves rash.
  • Tinea pedis (athlete's foot): eliminates foot fungus and reduces discomfort.
  • Pityriasis versicolor: restores normal skin pigmentation.
  • Dandruff: controls flaking and scalp irritation.

How It Works

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

Side Effects

Topical ketoconazole may cause local skin reactions, most of which are mild and reversible.

Common Side Effects

  • Burning sensation at the application site.
  • Itching or pruritus.
  • Redness or erythema.
  • Dryness or peeling of the skin.
  • Stinging or tingling.
  • Mild irritation.

Serious or Rare Side Effects

  • Severe allergic reaction (e.g., angioedema, anaphylaxis).
  • Stevens‑Johnson syndrome or toxic epidermal necrolysis.
  • Contact dermatitis.
  • Significant swelling or blistering.
  • Systemic absorption leading to hepatic toxicity (rare).
  • Persistent or worsening skin infection.

Precautions & Warnings

Before using ketoconazole topical formulation, consider the following safety measures.

  • Pregnancy: consult a healthcare professional before use.
  • Breastfeeding: discuss potential risks with a physician.
  • Age: use with caution in children under 12 years.
  • Skin integrity: avoid application on broken or inflamed skin.
  • Concomitant topical agents: do not combine with other antifungal or irritant creams without medical advice.
  • Store at room temperature: keep in the original container, protect from moisture and light.

Avoid Interactions

Ketoconazole can interact with other medications, affecting safety or efficacy.

Major Interactions (Avoid)

  • Oral ketoconazole: increased systemic exposure may raise risk of hepatotoxicity.
  • Systemic azole antifungals: additive inhibition of fungal enzymes can cause toxicity.
  • Topical corticosteroids: may mask infection signs and delay healing.

Moderate Interactions (Monitor Closely)

  • Warfarin: monitor INR as ketoconazole may enhance anticoagulant effect.
  • Rifampin: may reduce ketoconazole efficacy by inducing metabolism.
  • Antihistamines: monitor for increased sedation when used together.

Frequently Asked Questions

Nizoral, containing ketoconazole, is indicated for the topical treatment of fungal skin disorders such as seborrheic dermatitis, tinea corporis, tinea cruris, tinea pedis, pityriasis versicolor, and dandruff. It works by eliminating the fungi responsible for these conditions, helping to relieve symptoms like scaling, itching, and redness.

Ketoconazole blocks the fungal enzyme lanosterol 14α‑demethylase, which is essential for producing ergosterol, a key component of fungal cell membranes. Without ergosterol, the cell membrane becomes defective, leading to fungal cell death and a reduction in infection.

The specific dosage 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 and the product label.

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

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

Store Nizoral at room temperature, below 25 °C. Keep the product in its original packaging, protect it from moisture and direct sunlight, and ensure the container is tightly closed to maintain stability.

Apply a thin layer of the cream or lotion to the affected skin area once or twice daily, as directed by the prescriber. Gently rub it in until fully absorbed, and wash hands after application unless the hands are being treated.

Serious risks, though rare, include severe allergic reactions such as angioedema, Stevens‑Johnson syndrome, toxic epidermal necrolysis, and systemic toxicity like hepatic injury if significant absorption occurs. Patients should seek immediate medical attention if they notice extensive rash, blistering, swelling, or signs of liver dysfunction.

Nizoral should not be used by individuals with known hypersensitivity to ketoconazole or any other component of the formulation. It is also contraindicated on severely damaged or inflamed skin, and caution is advised for patients with pre‑existing liver disease or those taking interacting systemic medications.

Published by

GNH India Pharmaceuticals Limited

Licensed pharmaceutical supplier

Last updated:

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