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 dosage form for systemic use. It treats a range of susceptible fungal infections, including systemic candidiasis, dermatophyte infections, blastomycosis and histoplasmosis, in adult patients. The drug exerts its effect by inhibiting fungal sterol synthesis, thereby limiting growth of pathogenic yeasts and molds.

GNH India supplies Ketoconazole Esteve as a licensed, GDP‑compliant international pharmaceutical supplier serving hospitals, transplant centres, oncology centres, pharmacies, clinics, and research institutions worldwide.

Manufacturer / TM Owner

Esteve Pharmaceuticals, S.A.

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Indications & Clinical Uses

  • Ketoconazole is used to treat fungal infections by targeting organisms that are susceptible to imidazole antifungal therapy.
  • Systemic candidiasis: eradication of invasive Candida species.
  • Dermatophyte infections: clearance of skin and nail infections caused by dermatophytes.
  • Blastomycosis: treatment of pulmonary and disseminated Blastomyces dermatitidis infection.
  • Histoplasmosis: management of acute and chronic Histoplasma capsulatum disease.
  • Other susceptible fungal infections: therapy for rare or resistant fungal pathogens as indicated.

How It Works

  • Ketoconazole inhibits the fungal cytochrome P450 14α‑demethylase enzyme, blocking the conversion of lanosterol to ergosterol. This disruption of sterol synthesis compromises the integrity of the fungal cell membrane, leading to impaired growth and eventual death of susceptible yeasts and molds.

Side Effects

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

Common Side Effects

  • Nausea and vomiting.
  • Abdominal discomfort or pain.
  • Headache.
  • Rash or pruritus.
  • Elevated liver enzymes.

Serious or Rare Side Effects

  • Hepatotoxicity, including severe liver injury.
  • Adrenal insufficiency due to inhibition of steroid synthesis.
  • QT interval prolongation and cardiac arrhythmias.

Precautions & Warnings

  • Before initiating therapy, clinicians should consider several safety measures.
  • Monitor liver function: obtain baseline and periodic hepatic enzyme tests.
  • Assess for drug interactions: review concomitant CYP450 substrates and inhibitors.
  • Avoid in patients with known hypersensitivity to imidazole antifungals.
  • Use with caution in individuals with cardiac disease or electrolyte disturbances.
  • Store at room temperature: keep in the original container, protect from moisture.

Avoid Interactions

Ketoconazole has a notable interaction profile that requires careful management.

Major Interactions (Avoid)

  • CYP3A4 substrates (e.g., certain statins): increased risk of toxicity.
  • CYP2C9 substrates (e.g., warfarin): enhanced anticoagulant effect.
  • Ergot alkaloids: risk of severe vasospasm and ischemia.

Moderate Interactions (Monitor Closely)

  • Oral contraceptives: reduced hormonal efficacy.
  • Antacids or H2 blockers: decreased ketoconazole absorption.
  • Rifampin: lowered ketoconazole plasma concentrations.

Frequently Asked Questions

Ketoconazole Esteve is an oral imidazole antifungal indicated for the treatment of systemic candidiasis, dermatophyte infections of the skin and nails, blastomycosis, histoplasmosis, and other fungal infections that are susceptible to ketoconazole therapy.

Ketoconazole blocks the fungal cytochrome P450 14α‑demethylase enzyme, preventing conversion of lanosterol to ergosterol. This inhibition disrupts the fungal cell membrane, impairing growth and leading to cell death of susceptible yeasts and molds.

The dosage and duration of Ketoconazole Esteve are determined by the prescribing clinician based on the specific infection, patient weight, renal and hepatic function, and other clinical factors. No standardized dose is provided here.

Safety data for ketoconazole in pregnancy and lactation are limited. It is generally classified as contraindicated or to be used only when the potential benefit justifies the potential risk to the fetus or infant. Consultation with a healthcare professional is essential.

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 import documentation.

Ketoconazole belongs to the imidazole class, which differs from azoles like fluconazole or itraconazole in its broader spectrum against certain dermatophytes and systemic fungi, but it has a higher potential for liver toxicity and drug‑drug interactions. Choice of therapy depends on infection type, susceptibility patterns, and patient safety considerations.

Store the product at room temperature, below 25 °C, in the original packaging to protect it from moisture and light. Keep the container tightly closed and out of reach of children.

Ketoconazole Esteve is taken orally, usually with a full glass of water. It should be administered with food to enhance absorption, unless the prescribing information advises otherwise.

Serious risks include hepatotoxicity (potentially severe liver injury), adrenal insufficiency due to inhibition of steroid synthesis, and cardiac arrhythmias such as QT prolongation. Patients should be monitored for signs of liver dysfunction, abnormal fatigue, dizziness, or palpitations.

Ketoconazole should be avoided in individuals with known hypersensitivity to ketoconazole or other imidazole antifungals, in patients with severe liver disease, and in those taking medications that have a high risk of dangerous interactions, such as certain statins, ergot derivatives, or medications that prolong the QT interval.

Published by

GNH India Pharmaceuticals Limited

Licensed pharmaceutical supplier

Last updated:

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