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

Itraconazole Sandoz Ltd

Active Ingredient:
Itraconazole
Origin:
EU

Itraconazole Sandoz Ltd (Itraconazole)

Itraconazole, the active ingredient in Itraconazole Sandoz Ltd, is an azole antifungal presented as an oral tablet for oral use. It treats a range of systemic and superficial fungal infections in adults and children as prescribed by a healthcare professional.

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

Manufacturer / TM Owner

Sandoz Ltd

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Indications & Clinical Uses

Itraconazole is an azole antifungal used to manage infections caused by susceptible fungi.

  • Dermatophyte infections: effective for skin, nail and hair infections caused by dermatophytes.
  • Candidiasis: treats oral, esophageal and systemic Candida infections.
  • Blastomycosis: used for severe or disseminated Blastomyces dermatitidis infection.
  • Histoplasmosis: indicated for acute and chronic Histoplasma capsulatum disease.
  • Sporotrichosis: employed in the management of cutaneous and disseminated Sporothrix schenckii infection.
  • Aspergillosis: used for invasive disease caused by Aspergillus species.

How It Works

  • Itraconazole inhibits the fungal cytochrome P450 enzyme lanosterol 14α‑demethylase, blocking the conversion of lanosterol to ergosterol. This disruption impairs the synthesis of ergosterol, a vital component of the fungal cell membrane, leading to increased membrane permeability and inhibition of fungal growth.

Side Effects

Common side effects are generally mild and may resolve with continued therapy.

Common Side Effects

  • Nausea
  • Vomiting
  • Abdominal pain or discomfort
  • Headache
  • Rash or pruritus
  • Altered taste sensation

Serious or Rare Side Effects

  • Hepatotoxicity, including severe liver injury
  • Stevens‑Johnson syndrome or toxic epidermal necrolysis
  • Cardiac failure or reduced left‑ventricular function
  • Severe visual disturbances such as blurred vision
  • Neutropenia or other significant blood dyscrasias
  • Acute adrenal insufficiency

Precautions & Warnings

Before initiating therapy, consider the following precautions.

  • Assess liver function: obtain baseline hepatic enzymes and monitor periodically.
  • Evaluate cardiac status: use caution in patients with existing heart failure.
  • Review concomitant medications: avoid drugs that may prolong QT interval.
  • Monitor for drug‑induced skin reactions: discontinue if severe rash develops.
  • 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 due to CYP3A4 inhibition and induction.

Major Interactions (Avoid)

  • Rifampin: markedly reduces itraconazole plasma concentrations.
  • St. John's wort: induces metabolism, lowering efficacy.
  • Ketoconazole: additive hepatotoxic risk when combined.
  • Macrolide antibiotics (e.g., erythromycin): may increase itraconazole levels leading to toxicity.
  • Other azole antifungals (e.g., fluconazole): can cause excessive itraconazole exposure.

Moderate Interactions (Monitor Closely)

  • CYP3A4 substrates such as midazolam, calcium‑channel blockers, and certain statins.
  • Warfarin: may enhance anticoagulant effect, requiring INR monitoring.
  • Proton‑pump inhibitors: can reduce absorption of itraconazole capsules.
  • Digoxin: increased serum concentrations may occur.
  • Antiretrovirals (e.g., protease inhibitors): may alter itraconazole levels.

Frequently Asked Questions

Itraconazole Sandoz Ltd is prescribed for a variety of fungal infections, including dermatophyte skin infections, oral and systemic candidiasis, blastomycosis, histoplasmosis, sporotrichosis, and invasive aspergillosis. The medication targets fungi that are susceptible to azole antifungal agents and is used under the direction of a qualified healthcare professional.

Itraconazole blocks the fungal enzyme lanosterol 14α‑demethylase, which is essential for converting lanosterol to ergosterol. By preventing ergosterol synthesis, the drug disrupts the integrity of the fungal cell membrane, leading to increased permeability and inhibition of fungal growth and replication.

The specific dose and duration of itraconazole therapy are determined by the prescribing clinician based on the type and severity of the infection, patient weight, renal and hepatic function, and other individual factors. Patients should follow the exact regimen provided by their healthcare provider.

Safety data for itraconazole in pregnancy and lactation are limited. It should only be used if the potential benefit justifies the potential risk to the fetus or infant. Women who are pregnant, planning to become pregnant, or breastfeeding should discuss alternatives and risks with their healthcare professional.

To place an order, submit an enquiry on the product page at gnhindia.com, specifying the required quantity. GNH India supplies hospitals, pharmacies, and procurement teams worldwide. After verification of trade or institutional credentials, the sales team will provide pricing, availability, shipping details (including any cold‑chain requirements), and necessary import documentation.

Itraconazole offers a broad spectrum of activity against many yeasts and molds and has a longer half‑life than some alternatives, allowing once‑daily dosing for certain indications. Compared with fluconazole, itraconazole provides better coverage for dermatophytes and some dimorphic fungi but may have a higher potential for drug interactions and liver‑related adverse effects.

Store the tablets at room temperature, preferably below 25 °C. Keep them in the original packaging to protect from moisture and light. Do not store in humid environments such as bathrooms, and keep out of reach of children.

Itraconazole Sandoz Ltd is taken orally, usually with food to enhance absorption, unless the prescribing information specifies otherwise. The tablets should be swallowed whole with a full glass of water and not chewed or crushed, unless a liquid formulation is prescribed.

Serious risks include hepatotoxicity, which may present as jaundice or elevated liver enzymes, and severe cardiac effects such as heart failure in susceptible patients. Rare but life‑threatening skin reactions like Stevens‑Johnson syndrome and toxic epidermal necrolysis can also occur. Patients should seek immediate medical attention if they notice signs of liver injury or severe skin rash.

Itraconazole is contraindicated in patients with known hypersensitivity to itraconazole or any azole antifungal. It should be avoided in individuals with severe liver disease, uncontrolled heart failure, or those taking medications that are strong inducers of CYP3A4 (e.g., rifampin, St. John's wort) without appropriate monitoring.

Published by

GNH India Pharmaceuticals Limited

Licensed pharmaceutical supplier

Last updated:

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