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 systemic mycoses and certain dermatologic fungal infections in adult patients.
GNH India supplies Ketoconazole Esteve as a licensed, GDP‑compliant international pharmaceutical supplier serving hospitals, pharmacies and clinics worldwide.

Manufacturer / TM Owner

Esteve Pharmaceuticals, S.A.

1
Pack/s
This product is added to your enquiry list

Request a Quote

Please fill out the form below and our team will get back to you shortly with pricing and further information.

A minimum order value applies. Our team will confirm the exact amount or quantity after reviewing your requirements.

Indications & Clinical Uses

Ketoconazole is an imidazole antifungal used to treat fungal infections that affect internal organs or the skin.

  • Systemic mycoses: eradicates deep‑seated fungal infections such as blastomycosis, histoplasmosis, and coccidioidomycosis.
  • Dermatophytosis (when oral therapy is required): clears skin infections caused by dermatophyte fungi.
  • Seborrheic dermatitis (off‑label oral use): reduces scalp inflammation and flaking associated with Malassezia overgrowth.

How It Works

  • Ketoconazole inhibits the fungal enzyme lanosterol 14α‑demethylase, a key cytochrome P450 isoform required for ergosterol synthesis. By blocking ergosterol production, the drug disrupts fungal cell‑membrane integrity, leading to increased permeability and ultimately cell death. This mechanism is selective for fungi, providing antifungal activity across a broad spectrum of yeasts and molds.

Side Effects

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

Common Side Effects

  • Nausea: mild to moderate stomach upset.
  • Vomiting: occasional expulsion of stomach contents.
  • Abdominal pain: discomfort or cramping in the abdomen.
  • Diarrhea: loose stools occurring during therapy.
  • Headache: transient head pain.
  • Rash: mild skin erythema or itching.

Serious or Rare Side Effects

  • Hepatotoxicity: elevated liver enzymes or liver injury.
  • Adrenal insufficiency: suppression of cortisol production.
  • Severe allergic reaction (anaphylaxis): rapid onset of hives, swelling, and breathing difficulty.
  • QT prolongation: potential cardiac rhythm disturbance.

Precautions & Warnings

Ketoconazole requires careful monitoring and specific safety measures.

  • Liver function monitoring: assess hepatic enzymes before and during treatment.
  • Drug interaction vigilance: avoid concomitant use with strong CYP3A4 inhibitors.
  • Hypersensitivity avoidance: discontinue if allergic reactions develop.
  • Cardiac caution: monitor patients with known QT prolongation risk.
  • Pregnancy safety unknown: use only if benefits outweigh potential risks.
  • Store at room temperature: keep in the original container, protect from moisture and direct sunlight.

Avoid Interactions

Ketoconazole interacts with several medications, necessitating dose adjustments or avoidance.

Major Interactions (Avoid)

  • Strong CYP3A4 inhibitors (e.g., itraconazole, clarithromycin): may increase ketoconazole levels.
  • CYP2C9 inhibitors (e.g., fluconazole): can raise plasma concentrations.
  • Drugs that prolong QT interval (e.g., quinidine): risk of cardiac arrhythmia.
  • Rifampin or other CYP inducers: markedly reduce ketoconazole efficacy.

Moderate Interactions (Monitor Closely)

  • Oral contraceptives: reduced hormonal effectiveness, consider alternative contraception.
  • Warfarin: potential alteration of INR, monitor coagulation status.
  • Statins (e.g., simvastatin): increased risk of myopathy, adjust dose if needed.

Frequently Asked Questions

Ketoconazole Esteve is prescribed for systemic fungal infections such as blastomycosis, histoplasmosis, and coccidioidomycosis, as well as for dermatophytosis when oral therapy is needed. It may also be used off‑label for severe seborrheic dermatitis. The drug targets the underlying fungal organisms to achieve clinical cure.

Ketoconazole blocks the fungal enzyme lanosterol 14α‑demethylase, a cytochrome P450 isoform essential for converting lanosterol to ergosterol. Without ergosterol, the fungal cell membrane becomes unstable, leading to increased permeability and cell death. This mechanism provides broad‑spectrum activity against yeasts and molds.

The specific dose and treatment duration of Ketoconazole Esteve are determined by the prescribing clinician based on the infection type, severity, patient weight, renal and hepatic function, and other individual factors. Healthcare professionals tailor the regimen to achieve optimal therapeutic outcomes.

The safety of ketoconazole in pregnancy and lactation has not been definitively established. It is classified as pregnancy category unknown, and use is generally reserved for situations where the potential benefit justifies any possible risk to the fetus. Breastfeeding mothers should consult their physician before use.

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, and will request verification of trade or institutional credentials. After confirmation, the team provides pricing, availability, shipping details (including any cold‑chain requirements), and necessary import documentation.

Ketoconazole belongs to the imidazole class and is distinguished by its oral formulation and broad activity against systemic and cutaneous fungi. Compared with newer azoles such as itraconazole or voriconazole, ketoconazole has a higher potential for hepatic toxicity and drug‑drug interactions, but remains a cost‑effective option for many indications when monitored appropriately.

Ketoconazole Esteve should be stored at room temperature, below 25 °C, in its original packaging. Protect the product from moisture, excessive heat, and direct sunlight to maintain stability and potency throughout its shelf life.

Ketoconazole Esteve is taken orally, usually with food or a full glass of water to improve absorption and reduce gastrointestinal irritation. The exact administration schedule—once daily, twice daily, or as directed—depends on the prescriber’s instructions and the specific infection being treated.

The most serious risks include hepatotoxicity, which can manifest as elevated liver enzymes or liver failure, and adrenal insufficiency due to inhibition of steroid synthesis. Additionally, severe allergic reactions such as anaphylaxis and cardiac arrhythmias from QT prolongation require immediate medical attention.

Ketoconazole Esteve is contraindicated in patients with known hypersensitivity to ketoconazole or any imidazole antifungal. It should also be avoided in individuals with severe liver disease, uncontrolled cardiac arrhythmias, or those taking medications that strongly interact and cannot be safely managed. Clinical judgment determines suitability.

Published by

GNH India Pharmaceuticals Limited

Licensed pharmaceutical supplier

Last updated:

Disclaimer

At GNH India, we aim to provide information that is expert-reviewed, accurate, and reliable. However, all content on this platform is intended for general informational purposes only and does not constitute professional medical advice, diagnosis, or treatment. While efforts are made to maintain accuracy and currency, the information may contain errors, omissions, or may not reflect the latest developments. Always consult a qualified healthcare professional regarding any medical concerns.

All product names, brand names, trademarks and registered trademarks displayed on this website are the property of their respective owners. This website and its operator are not affiliated with, endorsed by, or authorized by any such trade mark owners unless expressly stated. Any reference to product names or trademarks is made solely for descriptive and informational purposes. No commercial relationship, sponsorship, approval, or association with any trademark owner should be inferred. Information provided herein does not constitute promotion, advertising, or an offer for sale of any medicinal product and is intended solely for general informational purposes.

All trademarks and brand names displayed on this website are used strictly in accordance with the provisions of the Trade Marks Act, 1999, specifically Sections 30 and 30(1) governing fair use. Trademark ownership has been accurately attributed under the "Manufacturer/ TM Owner" section in compliance with statutory requirements.

Ordering Process

Simple, Secure, and Seamless

Learn how our streamlined ordering process guarantees fast, compliant, and reliable access to essential medicines worldwide.

Quote request form

01

Submit Quote Request Form

Tell us what medications you need by filling out our simple form and uploading a valid document.

Price estimate review

02

We Review & Send Estimate

Our licensed pharmacists will verify your details and provide you with a detailed cost estimate.

Secure payment

03

Confirm & Make Payment

Discuss any queries, approve the estimate, and complete your payment.

Worldwide delivery

04

Get Delivered

Your medicines, safely packed and delivered to your door or nearest airport — hassle-free.

Quality You Can Trust

Our internationally recognized certifications underscore our commitment to safety, quality, and excellence.