Product image of Itraconazole Sandoz (Itraconazole) supplied by GNH India

Itraconazole Sandoz

Active Ingredient:
Itraconazole
Origin:
EU

Itraconazole Sandoz (Itraconazole)

Itraconazole, the active ingredient in Itraconazole Sandoz, is an azole antifungal presented as an oral dosage form for oral use. It treats systemic fungal infections such as blastomycosis, histoplasmosis, aspergillosis, candidiasis, and dermatophyte infections in adult patients. The drug is absorbed systemically and distributes to tissues where fungi reside, providing therapeutic concentrations.

GNH India supplies Itraconazole Sandoz as a licensed, GDP‑compliant international pharmaceutical supplier serving hospitals, pharmacies and clinics worldwide. Our global network ensures reliable sourcing, regulatory compliance, and timely delivery to meet the needs of healthcare providers across multiple regions.

Manufacturer / TM Owner

Sandoz

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Indications & Clinical Uses

Itraconazole is used to treat systemic fungal infections by targeting a broad range of pathogenic fungi.

  • Blastomycosis: effective therapy to eradicate Blastomyces dermatitidis infection.
  • Histoplasmosis: clears Histoplasma capsulatum from affected organs.
  • Aspergillosis: controls invasive disease caused by Aspergillus species.
  • Candidiasis: treats severe or disseminated Candida infections.
  • Dermatophyte infections: resolves deep or extensive skin fungal infections.

How It Works

  • Itraconazole inhibits the fungal enzyme lanosterol 14α‑demethylase, a key step in ergosterol synthesis. By blocking ergosterol production, the drug disrupts fungal cell membrane formation, leading to increased membrane permeability and inhibition of fungal growth and replication.

Side Effects

Common adverse reactions are generally mild and reversible.

Common Side Effects

  • Nausea: mild to moderate stomach upset.
  • Headache: transient cranial discomfort.
  • Diarrhea: loose stools occurring during therapy.
  • Elevated liver enzymes: mild increase in hepatic transaminases.

Serious or Rare Side Effects

  • Hepatotoxicity: severe liver injury requiring monitoring.
  • Congestive heart failure: fluid retention and reduced cardiac function.
  • Severe skin reactions: such as Stevens‑Johnson syndrome or toxic epidermal necrolysis.

Precautions & Warnings

Before initiating therapy, consider the following safety measures.

  • Liver function: assess baseline hepatic enzymes and monitor periodically.
  • Cardiac status: avoid in patients with existing congestive heart failure.
  • Drug interactions: review concomitant medications for potential CYP3A4 interactions.
  • Pregnancy and lactation: use only if potential benefit justifies potential risk.
  • Store at ambient temperature: keep below 25°C in the original container, protect from moisture and direct sunlight.

Avoid Interactions

Itraconazole has a notable interaction profile that requires careful management.

Major Interactions (Avoid)

  • Rifampicin: strong inducer of CYP3A4, markedly reduces itraconazole exposure.
  • St. John’s wort: herbal CYP3A4 inducer, decreases antifungal efficacy.
  • Certain antiretrovirals (e.g., efavirenz): may lower itraconazole levels.

Moderate Interactions (Monitor Closely)

  • Statins (e.g., simvastatin): increased risk of myopathy; consider dose adjustment.
  • Calcium channel blockers (e.g., verapamil): may raise itraconazole concentrations, monitor for toxicity.

Frequently Asked Questions

Itraconazole Sandoz is prescribed for systemic fungal infections such as blastomycosis, histoplasmosis, aspergillosis, severe candidiasis, and extensive dermatophyte infections. It targets the fungal cell membrane synthesis pathway, helping to clear the infection in adult patients.

Itraconazole blocks the fungal enzyme lanosterol 14α‑demethylase, which is essential for producing ergosterol, a key component of fungal cell membranes. Inhibiting ergosterol synthesis compromises membrane integrity, leading to inhibited growth and death of the fungus.

The specific dose and treatment duration are determined by the prescribing clinician based on the infection type, severity, patient weight, and renal or hepatic function. Patients should follow the exact regimen provided by their healthcare professional.

Safety data for itraconazole in pregnancy and lactation are limited. It should be used only if the potential benefit justifies any potential risk to the fetus or infant, and the decision must be made by a qualified healthcare provider.

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.

Compared with other azole antifungals, itraconazole offers a broad spectrum against many systemic fungi and has good tissue penetration. However, it has a higher potential for drug‑drug interactions due to CYP3A4 inhibition, which may be less pronounced with newer agents such as voriconazole or posaconazole.

Store the product at ambient temperature, preferably below 25 °C. Keep it in the original packaging, protect it from moisture and direct sunlight, and ensure the container is tightly closed to maintain stability.

Itraconazole Sandoz is taken orally, usually with food or a full glass of water to enhance absorption. The exact administration instructions, including whether to swallow whole or dissolve, depend on the specific dosage form supplied by the manufacturer.

Serious risks include hepatotoxicity, which may present as jaundice or elevated liver enzymes, and congestive heart failure due to fluid retention. Patients should be monitored for signs of liver dysfunction or worsening cardiac symptoms throughout therapy.

Individuals with known hypersensitivity to itraconazole or any azole antifungal should avoid the product. It is also contraindicated in patients with uncontrolled congestive heart failure and should be used with caution in those with significant liver impairment.

Published by

GNH India Pharmaceuticals Limited

Licensed pharmaceutical supplier

Last updated:

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