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

Ketoconazole Esteve

Active Ingredient:
Ketoconazole
Origin:
EU

Ketoconazole Esteve (Ketoconazole)

Ketoconazole, the active ingredient in Ketoconazole Esteve, is an imidazole antifungal presented as an oral formulation for systemic use. It inhibits fungal sterol synthesis and is employed to treat systemic mycoses such as blastomycosis, histoplasmosis and coccidioidomycosis, as well as dermatophytosis and seborrheic dermatitis in adult patients.

GNH India supplies Ketoconazole Esteve as a licensed, GDP‑compliant international pharmaceutical supplier serving hospitals, transplant centres, oncology centres, pharmacies and clinics worldwide, ensuring quality, regulatory compliance and reliable logistics for global distribution throughout.

Manufacturer / TM Owner

Esteve Pharmaceuticals, S.A.

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Indications & Clinical Uses

Ketoconazole is an imidazole antifungal that acts on a broad spectrum of fungal pathogens.

  • Systemic fungal infections: Effective in treating blastomycosis, histoplasmosis and coccidioidomycosis.
  • Dermatophytosis: Reduces skin lesions caused by dermatophyte species.
  • Seborrheic dermatitis: Controls Malassezia‑related scalp and skin inflammation.

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 key component of fungal cell membranes, leading to increased membrane permeability and inhibition of fungal growth. The accumulation of toxic methylated sterol intermediates further impairs fungal metabolism and replication. This selective action spares human cells because the target enzyme is absent in mammalian cholesterol synthesis pathways.

Side Effects

Ketoconazole may cause a range of adverse reactions, varying from mild to severe.

Common Side Effects

  • Nausea: mild stomach upset.
  • Headache: transient cranial pain.
  • Abdominal pain: discomfort in the stomach area.
  • Diarrhea: loose stools.
  • Rash: skin irritation or redness.
  • Elevated liver enzymes: mild hepatic enzyme increase.

Serious or Rare Side Effects

  • Hepatotoxicity: severe liver injury or failure.
  • Severe allergic reaction: anaphylaxis, swelling, or breathing difficulty.
  • QT prolongation: cardiac rhythm disturbance.
  • Thrombocytopenia: low platelet count.
  • Stevens‑Johnson syndrome: severe skin blistering.
  • Adrenal insufficiency: cortisol production impairment.

Precautions & Warnings

Before prescribing ketoconazole, clinicians should consider several precautionary measures to minimize risk.

  • Liver function monitoring: assess baseline and periodic hepatic enzymes.
  • Drug interactions review: evaluate concomitant use of CYP3A4 substrates.
  • Pregnancy and lactation: avoid use unless benefits outweigh risks.
  • Pre‑existing cardiac conditions: monitor QT interval in at‑risk patients.
  • Alcohol consumption: advise limiting alcohol to reduce hepatotoxic risk.
  • Store at ambient temperature: keep below 25 °C in original packaging, protect from moisture.

Avoid Interactions

Ketoconazole interacts with several medicines; awareness of the interaction level guides clinical decisions.

Major Interactions (Avoid)

  • CYP3A4 substrates: increased plasma levels of drugs such as midazolam, cyclosporine.
  • Statins (lovastatin, simvastatin): heightened risk of myopathy and rhabdomyolysis.
  • Anticoagulants (warfarin): potentiated anticoagulant effect.

Moderate Interactions (Monitor Closely)

  • CYP2C9 substrates: altered levels of drugs like phenytoin.
  • Hormonal contraceptives: reduced efficacy, consider backup method.
  • QT‑prolonging agents: additive risk of cardiac arrhythmia.

Frequently Asked Questions

Ketoconazole Esteve is an oral imidazole antifungal indicated for the treatment of systemic fungal infections such as blastomycosis, histoplasmosis and coccidioidomycosis, as well as for dermatophytosis and seborrheic dermatitis caused by susceptible fungal species.

Ketoconazole blocks the fungal enzyme lanosterol 14α‑demethylase, preventing the conversion of lanosterol to ergosterol. This disruption impairs fungal cell‑membrane formation, leading to increased permeability, inhibition of growth, and ultimately fungal cell death.

The dosage of ketoconazole is individualized by the prescribing clinician based on the specific infection, patient weight, renal and hepatic function, and other clinical factors. No fixed dose is provided here; the prescriber determines the appropriate regimen.

Safety data for ketoconazole in pregnancy and lactation are limited. It is generally avoided unless the potential benefit justifies the potential risk to the fetus or infant. Women who are pregnant, planning pregnancy, or breastfeeding should discuss alternatives with their healthcare provider.

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

Ketoconazole belongs to the imidazole class, which primarily inhibits fungal sterol synthesis. Compared with azole alternatives such as fluconazole, ketoconazole has a broader spectrum against certain systemic mycoses but may have a higher risk of hepatic toxicity and drug‑drug interactions, requiring careful monitoring.

Ketoconazole oral tablets should be stored at ambient temperature, preferably below 25 °C. Keep the product in its original container, protect it from moisture and direct sunlight, and ensure the packaging remains sealed until use.

Ketoconazole is administered orally, usually as a tablet or capsule, and should be taken with food or a full glass of water to improve absorption. Patients must follow the prescribing clinician’s instructions regarding timing, duration of therapy, and any necessary laboratory monitoring.

The most serious adverse events include hepatotoxicity, severe allergic reactions such as anaphylaxis, QT‑interval prolongation leading to cardiac arrhythmias, and rare but life‑threatening skin reactions like Stevens‑Johnson syndrome. Prompt medical attention is required if any of these symptoms develop.

Ketoconazole is contraindicated in patients with known hypersensitivity to the drug or other imidazole antifungals, those with severe hepatic impairment, and individuals taking medications that are strong CYP3A4 substrates where interaction cannot be managed. Caution is also advised for patients with pre‑existing cardiac conduction abnormalities.

Published by

GNH India Pharmaceuticals Limited

Licensed pharmaceutical supplier

Last updated:

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