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

Ketoconazole Biogaran

Active Ingredient:
Ketoconazole
Origin:
EU

Ketoconazole Biogaran (Ketoconazole)

Ketoconazole, the active ingredient in Ketoconazole Biogaran, is an azole antifungal presented as a topical formulation for skin application. It is used to treat fungal infections of the skin and scalp in adult and pediatric patients.

GNH India supplies Ketoconazole Biogaran as a licensed, GDP‑compliant international pharmaceutical supplier serving hospitals, pharmacies and clinics worldwide, with a focus on quality assurance, regulatory compliance and reliable cold‑chain logistics where required. Our distribution network reaches more than 50 countries, ensuring timely delivery to end‑users.

Manufacturer / TM Owner

Biogaran

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Indications & Clinical Uses

Ketoconazole is indicated for topical treatment of fungal skin conditions caused by dermatophytes and yeasts.

  • Seborrheic dermatitis: reduces scaling and erythema on the scalp and face.
  • Tinea corporis (body ringworm): clears lesions and prevents spread.
  • Tinea cruris (jock itch): alleviates itching and resolves infection.
  • Pityriasis versicolor: restores normal skin pigmentation by eliminating Malassezia species.

How It Works

  • Ketoconazole inhibits the fungal enzyme lanosterol 14α‑demethylase, a cytochrome P450 isoform essential for converting lanosterol to ergosterol. By blocking this step, the drug disrupts the synthesis of ergosterol, a critical component of fungal cell membranes, leading to increased membrane permeability and ultimately fungal cell death. The accumulation of toxic sterol intermediates further compromises fungal viability and enhances the antifungal effect.

Side Effects

Topical ketoconazole may cause local and, rarely, systemic adverse reactions.

Common Side Effects

  • Itching or pruritus at the application site.
  • Burning or stinging sensation.
  • Redness or erythema.
  • Dry or flaky skin.
  • Mild irritation or contact dermatitis.

Serious or Rare Side Effects

  • Severe allergic reaction such as anaphylaxis.
  • Stevens‑Johnson syndrome or toxic epidermal necrolysis.
  • Hepatic toxicity from systemic absorption.
  • Photosensitivity leading to exaggerated sunburn.
  • Secondary bacterial infection of the treated area.

Precautions & Warnings

When using Ketoconazole Biogaran, follow these safety measures.

  • Avoid application on broken skin: may increase systemic absorption.
  • Do not use with other topical irritants: risk of increased irritation.
  • Limit use to prescribed duration: prolonged use can lead to resistance.
  • Consult a healthcare professional if using concomitant systemic antifungals: possible drug interactions.
  • Store at ambient temperature: keep in original container, protect from moisture and light.

Avoid Interactions

Ketoconazole can interact with other medicines; consider the following.

Major Interactions (Avoid)

  • Systemic azole antifungals (e.g., itraconazole, fluconazole): additive CYP450 inhibition may increase systemic toxicity.
  • Oral corticosteroids: may mask signs of infection and increase systemic exposure.
  • Hepatotoxic drugs (e.g., acetaminophen, isoniazid): combined liver stress can raise risk of hepatic injury.

Moderate Interactions (Monitor Closely)

  • Topical corticosteroids: may reduce the antifungal efficacy of ketoconazole.
  • Other topical antifungals: concurrent use can increase local irritation.
  • Warfarin: theoretical increase in anticoagulant effect if systemic absorption occurs.

Frequently Asked Questions

Ketoconazole Biogaran is a topical azole antifungal indicated for the treatment of common skin fungal infections such as seborrheic dermatitis, tinea corporis (ringworm of the body), tinea cruris (jock itch), and pityriasis versicolor. It works by eliminating the fungi responsible for these conditions, helping to reduce 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. Inhibiting this pathway disrupts membrane integrity, causing increased permeability and cell death. The resulting loss of fungal cells leads to clinical improvement of the infection.

The dosage and frequency of Ketoconazole Biogaran are determined by the prescribing healthcare professional based on the specific infection, its severity, patient age, and other clinical factors. Patients should follow the prescriber’s instructions and the product label precisely; no universal dosing regimen is provided here.

Safety data for topical ketoconazole during pregnancy and lactation are limited. Healthcare providers generally weigh the potential benefits against any possible risks before prescribing. Women who are pregnant, planning to become pregnant, or breastfeeding should discuss the use of this product with their physician to make an informed decision.

To place an order, visit the product page on gnhindia.com and submit an enquiry with the required quantity. GNH India works with hospitals, pharmacies, and procurement teams worldwide, requesting verification of trade or institutional credentials. The sales team will then respond with pricing, availability, shipping details (including any cold‑chain requirements), and necessary import documentation.

Ketoconazole belongs to the azole class, which is effective against a broad spectrum of dermatophytes and yeasts. Compared with allylamine agents such as terbinafine, azoles have a slightly different mechanism and may be preferred for infections where yeasts predominate, like seborrheic dermatitis. Choice of therapy depends on the pathogen, site of infection, patient tolerance, and physician preference.

Ketoconazole Biogaran 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 to maintain stability and potency.

The product is applied topically to the affected skin area, usually once or twice daily as directed by the prescriber. Clean and dry the skin before application, spread a thin layer of the cream or ointment over the lesion, and gently rub it in. Hands should be washed after use unless they are the treatment site.

Although rare, serious adverse reactions can include severe allergic responses such as anaphylaxis, Stevens‑Johnson syndrome, toxic epidermal necrolysis, and systemic hepatic toxicity if significant absorption occurs. Patients should seek immediate medical attention if they experience widespread rash, blistering, fever, jaundice, or signs of an allergic reaction.

Ketoconazole Biogaran should be avoided in individuals with known hypersensitivity to ketoconazole or any component of the formulation. It is also contraindicated on extensive broken skin, in patients taking systemic azole antifungals without medical supervision, and in those with severe liver disease where systemic absorption could pose a risk.

Published by

GNH India Pharmaceuticals Limited

Licensed pharmaceutical supplier

Last updated:

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