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

Itraconazol Sandoz

Active Ingredient:
Itraconazole
Origin:
EU

Itraconazol Sandoz (Itraconazole)

Itraconazole, the active ingredient in Itraconazol Sandoz, is an azole antifungal presented as an oral formulation for systemic use. It treats a range of systemic and superficial fungal infections in adult patients and is prescribed by qualified healthcare professionals.

GNH India supplies Itraconazol Sandoz as a licensed, GDP‑compliant international pharmaceutical supplier serving hospitals, transplant centres, oncology centres, pharmacies and clinics worldwide.

Manufacturer / TM Owner

Sandoz N.V.

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Indications & Clinical Uses

Itraconazole is an azole antifungal used to treat infections caused by susceptible fungi. It is indicated for several systemic mycoses:

  • Invasive aspergillosis: eradicates Aspergillus species in immunocompromised patients.
  • Blastomycosis: clears Blastomyces dermatitidis infection of lungs and skin.
  • Histoplasmosis: treats disseminated Histoplasma capsulatum disease.
  • Coccidioidomycosis: resolves Coccidioides immitis infection of respiratory tract.
  • Sporotrichosis: eliminates Sporothrix schenckii in cutaneous and disseminated forms.

How It Works

  • Itraconazole inhibits the fungal enzyme lanosterol 14α‑demethylase, a cytochrome P450 isoform essential for converting lanosterol to ergosterol. By blocking ergosterol synthesis, the drug disrupts fungal cell membrane integrity, leading to increased permeability and inhibition of fungal growth and replication.

Side Effects

Adverse reactions may occur with itraconazole therapy.

Common Side Effects

  • Nausea: mild to moderate stomach upset.
  • Vomiting: occasional emesis.
  • Abdominal pain: cramping or discomfort.
  • Headache: transient tension‑type headache.
  • Rash: mild skin erythema or pruritus.
  • Taste disturbance: altered or reduced taste perception.

Serious or Rare Side Effects

  • Hepatotoxicity: elevated liver enzymes or hepatitis.
  • Severe skin reactions: Stevens‑Johnson syndrome or toxic epidermal necrolysis.
  • Cardiac failure: worsening of pre‑existing heart conditions.
  • Visual disturbances: blurred vision or photophobia.
  • QT prolongation: potential arrhythmia risk.
  • Severe liver injury: hepatic failure requiring medical intervention.

Precautions & Warnings

Before initiating itraconazole, clinicians should consider several safety measures.

  • Assess liver function: obtain baseline hepatic enzymes.
  • Monitor cardiac status: avoid in patients with known heart failure.
  • Check for hypersensitivity: discontinue if allergic reaction occurs.
  • Review concomitant medications: avoid strong CYP3A4 inhibitors.
  • Adjust dose in hepatic impairment: follow clinical guidelines.
  • Store at room temperature: keep in the original container, protect from moisture and light.

Avoid Interactions

Itraconazole has a notable potential for drug‑drug interactions.

Major Interactions (Avoid)

  • Ketoconazole: combined azole therapy increases toxicity risk.
  • Rifampin: induces metabolism, markedly reducing itraconazole levels.
  • Ritonavir: potent CYP3A4 inhibitor leading to dangerous itraconazole accumulation.

Moderate Interactions (Monitor Closely)

  • Cimetidine: may increase itraconazole plasma concentrations.
  • Warfarin: enhanced anticoagulant effect requiring INR monitoring.

Frequently Asked Questions

Itraconazol Sandoz contains itraconazole, an azole antifungal indicated for systemic mycoses such as invasive aspergillosis, blastomycosis, histoplasmosis, coccidioidomycosis, and sporotrichosis, as well as certain superficial fungal infections. The drug works by targeting the fungal cell membrane, helping to clear the infection when prescribed by a qualified clinician.

Itraconazole blocks the fungal enzyme lanosterol 14α‑demethylase, a cytochrome P450 isoform required for ergosterol synthesis. Without ergosterol, the fungal cell membrane becomes unstable, leading to impaired growth and eventual death of the fungus. This mechanism is specific to fungi and does not affect human cells at therapeutic doses.

The exact dosage of Itraconazol Sandoz is determined by the prescribing healthcare professional based on the type and severity of the infection, patient weight, renal and hepatic function, and other clinical factors. Patients should follow the prescriber’s instructions and not adjust the dose without medical guidance.

Safety data for itraconazole in pregnancy are limited, and the drug is generally classified as contraindicated unless the potential benefit outweighs the risk. It is excreted in breast milk, so breastfeeding mothers should consult their physician before using Itraconazol Sandoz to assess potential risks to the infant.

To place an order, visit the product page on gnhindia.com, enter the required quantity, and submit the enquiry form. 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 necessary import documentation.

Itraconazole offers a broad spectrum of activity against many systemic fungi and has a longer half‑life than fluconazole, allowing once‑daily dosing for some indications. Compared with newer azoles like voriconazole, itraconazole may have fewer drug‑interaction concerns but can be less potent against certain molds. Choice of therapy depends on the specific pathogen, infection site, and patient factors.

Itraconazol Sandoz 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.

Itraconazol Sandoz is taken orally, usually with food to enhance absorption. The tablets or capsules should be swallowed whole with a full glass of water. Patients must follow the prescriber’s schedule and should not crush or chew the dosage form unless specifically instructed.

Serious risks include hepatotoxicity, severe skin reactions such as Stevens‑Johnson syndrome, cardiac failure in susceptible individuals, and QT interval prolongation that can lead to arrhythmias. Patients should be monitored for signs of liver injury, skin changes, or cardiac symptoms, and therapy should be stopped immediately if serious adverse events occur.

Itraconazol Sandoz is contraindicated in patients with known hypersensitivity to itraconazole or any azole antifungal, those with severe liver disease, and individuals taking strong CYP3A4 inducers such as rifampin. Caution is also advised for patients with existing heart failure or prolonged QT interval.

Published by

GNH India Pharmaceuticals Limited

Licensed pharmaceutical supplier

Last updated:

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