Product image of Ketoconazole Aurobindo (Ketoconazole) supplied by GNH India

Ketoconazole Aurobindo

Active Ingredient:
Ketoconazole
Origin:
EU

Ketoconazole Aurobindo (Ketoconazole)

Ketoconazole, the active ingredient in Ketoconazole Aurobindo, is an azole antifungal presented as a topical formulation for skin use. It treats fungal skin infections such as tinea corporis, tinea cruris, tinea pedis, seborrheic dermatitis and pityriasis versicolor in adults and children.

GNH India supplies Ketoconazole Aurobindo as a licensed, GDP-compliant international pharmaceutical supplier serving hospitals, pharmacies and clinics worldwide.

Manufacturer / TM Owner

Aurobindo Pharma B.V.

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Indications & Clinical Uses

Ketoconazole is an azole antifungal that disrupts fungal cell membrane synthesis, making it effective for a range of superficial mycoses.

  • Tinea corporis: reduces lesion size and clears the fungal infection.
  • Tinea cruris: alleviates itching and resolves the rash caused by dermatophytes.
  • Tinea pedis: eliminates foot fungus and improves skin condition.
  • Seborrheic dermatitis: controls flaking and redness on scalp and skin.
  • Pityriasis versicolor: clears discolored patches by eradicating Malassezia species.

How It Works

  • Ketoconazole inhibits the fungal enzyme lanosterol 14α-demethylase, a key step in ergosterol synthesis. By blocking ergosterol production, the drug compromises fungal cell membrane integrity, 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 severe events.

Common Side Effects

  • Burning sensation at application site.
  • Itching or pruritus.
  • Dryness or scaling of the skin.
  • Redness or erythema.
  • Stinging or tingling.
  • Contact dermatitis.

Serious or Rare Side Effects

  • Severe allergic reaction (anaphylaxis).
  • Stevens‑Johnson syndrome or toxic epidermal necrolysis.
  • Hepatic toxicity (rare with extensive use).
  • Photosensitivity leading to severe sunburn.
  • Skin necrosis or ulceration.

Precautions & Warnings

When using topical ketoconazole, observe the following precautions to minimize risks.

  • Avoid application on broken or inflamed skin: may increase systemic absorption.
  • Do not apply near eyes, mouth or mucous membranes: risk of irritation.
  • Limit treatment duration as advised by a healthcare professional: prolonged use can promote resistance.
  • Perform a patch test if history of skin sensitivity: monitor for adverse reaction.
  • Use with caution in patients with hepatic impairment: systemic exposure may be higher.
  • Store at below 25°C: keep in the original packaging, protect from moisture and heat.

Avoid Interactions

Ketoconazole can interact with other medicines, especially when systemic absorption occurs.

Major Interactions (Avoid)

  • Concurrent systemic azole antifungals: may lead to additive toxicity.
  • Oral warfarin: ketoconazole can potentiate anticoagulant effect, increasing bleeding risk.
  • Systemic corticosteroids: may enhance systemic exposure and suppress adrenal function.

Moderate Interactions (Monitor Closely)

  • Topical products containing alcohol or irritants: may increase skin irritation.
  • Other topical antifungals or keratolytics: monitor for overlapping toxicity.
  • Sunscreen or photoprotective agents: ketoconazole may increase photosensitivity, adjust usage.

Frequently Asked Questions

Ketoconazole Aurobindo is indicated for the topical treatment of superficial fungal infections such as tinea corporis (ringworm), tinea cruris (jock itch), tinea pedis (athlete's foot), seborrheic dermatitis, and pityriasis versicolor. It works by eliminating the causative fungi on the skin.

Ketoconazole blocks the fungal enzyme lanosterol 14α‑demethylase, halting the synthesis of ergosterol, an essential component of fungal cell membranes. The resulting membrane disruption leads to fungal cell death, thereby clearing the infection.

The exact dosing schedule is determined by the prescribing healthcare professional. Generally, a thin layer is applied to the affected area once or twice daily for the duration specified by the clinician, which may vary based on the infection type and severity.

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 with their healthcare provider before using the product.

To place an order, 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.

Both ketoconazole and clotrimazole belong to the azole class and share a similar mechanism of inhibiting ergosterol synthesis. Ketoconazole often offers a broader spectrum against dermatophytes and yeasts, while clotrimazole is widely used for mild infections. Choice depends on the specific pathogen, infection site and clinician preference.

Store the product at temperatures below 25 °C in its original packaging. Keep it away from direct sunlight, moisture and excessive heat to maintain stability and potency.

Clean and gently dry the affected skin area. Apply a thin, even layer of the product to the lesion and surrounding skin, avoiding the eyes, mouth and open wounds. Wash hands after application unless treating the hands themselves.

Although rare, serious adverse reactions can include severe allergic responses such as anaphylaxis, Stevens‑Johnson syndrome or toxic epidermal necrolysis, and, with extensive use, hepatic toxicity. Immediate medical attention is required if signs of a severe reaction appear.

Individuals with a known hypersensitivity to ketoconazole or any component of the formulation should avoid use. It should also be avoided on broken, inflamed or severely damaged skin, and caution is advised for patients with significant liver disease.

Published by

GNH India Pharmaceuticals Limited

Licensed pharmaceutical supplier

Last updated:

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