Product image of Itrabene (Itraconazole) supplied by GNH India

Itrabene

Active Ingredient:
Itraconazole
Origin:
EU

Itrabene (Itraconazole)

Itraconazole, the active ingredient in Itrabene, is a azole antifungal presented as a oral formulation for oral use. It treats systemic and localized fungal infections in adults and children as prescribed by a healthcare professional.

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

Manufacturer / TM Owner

Teva B.V

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Indications & Clinical Uses

Itraconazole is used to treat a range of deep‑tissue and superficial fungal infections by inhibiting ergosterol synthesis.

  • Blastomycosis: eradicates the causative Blastomyces dermatitidis and resolves pulmonary and disseminated disease.
  • Histoplasmosis: clears Histoplasma capsulatum infection, improving respiratory and systemic symptoms.
  • Aspergillosis: controls invasive Aspergillus species, reducing tissue invasion and mortality.
  • Systemic Candidiasis: eliminates Candida spp. from bloodstream and internal organs.
  • Dermatophytosis: treats skin‑surface dermatophyte infections, promoting lesion healing.
  • Sporotrichosis: combats Sporothrix schenckii, preventing spread along lymphatic channels.

How It Works

  • Itraconazole inhibits the fungal enzyme lanosterol 14α‑demethylase (CYP51), a key step in ergosterol biosynthesis. By blocking this pathway, the drug depletes ergosterol, a vital component of fungal cell membranes, leading to increased membrane permeability and ultimately fungal cell death or growth inhibition.

Side Effects

Adverse reactions to itraconazole vary from mild to severe and should be monitored during therapy.

Common Side Effects

  • Nausea: mild to moderate stomach upset.
  • Vomiting: occasional emesis.
  • Abdominal pain: cramping or discomfort.
  • Headache: transient dull pain.
  • Rash: skin redness or itching.
  • Taste disturbance: altered taste perception.

Serious or Rare Side Effects

  • Hepatotoxicity: elevated liver enzymes or liver injury.
  • Severe skin reactions: Stevens‑Johnson syndrome or toxic epidermal necrolysis.
  • QT prolongation: cardiac rhythm disturbances.
  • Hepatic failure: rare but life‑threatening liver dysfunction.
  • Anaphylaxis: acute allergic response requiring emergency care.

Precautions & Warnings

When prescribing itraconazole, clinicians should consider several safety measures.

  • Liver function monitoring: assess baseline and periodic hepatic enzymes.
  • Drug interaction vigilance: review concomitant medications for CYP3A4 substrates.
  • Cardiac assessment: avoid in patients with known QT prolongation.
  • Hypersensitivity caution: discontinue if allergic reactions occur.
  • Renal impairment use: adjust dosing in severe kidney disease.
  • Store at ambient temperature: keep below 25°C in the original container, protect from moisture and light.

Avoid Interactions

Itraconazole has a broad interaction profile that requires careful management.

Major Interactions (Avoid)

  • Strong CYP3A4 inhibitors (e.g., ketoconazole, ritonavir): may cause toxic itraconazole levels.
  • Certain statins (simvastatin, lovastatin): increased risk of rhabdomyolysis.
  • Anti‑arrhythmic agents (quinidine, amiodarone): heightened cardiac toxicity.
  • HIV protease inhibitors (indinavir): unpredictable plasma concentrations.
  • Macrolide antibiotics (clarithromycin): elevated itraconazole exposure.

Moderate Interactions (Monitor Closely)

  • CYP3A4 substrates (midazolam, cyclosporine): may require dose adjustment.
  • Calcium channel blockers (verapamil, diltiazem): monitor for enhanced effects.
  • Oral contraceptives: reduced efficacy, advise alternative contraception.
  • Warfarin: possible increased anticoagulant effect, check INR.
  • Antifungal combination therapy: assess for additive toxicity.

Frequently Asked Questions

Itrabene, containing itraconazole, is prescribed for systemic and localized fungal infections such as blastomycosis, histoplasmosis, aspergillosis, systemic candidiasis, dermatophytosis, and sporotrichosis. It is used when a broad‑spectrum azole antifungal is indicated.

Itraconazole blocks the fungal enzyme lanosterol 14α‑demethylase (CYP51), preventing the synthesis of ergosterol, an essential component of the fungal cell membrane. This disruption leads to increased membrane permeability and inhibits fungal growth or causes cell death.

The dosage of Itrabene is determined by the prescribing clinician based on the specific infection, severity, patient weight, age, and renal or hepatic function. Only a qualified healthcare professional should set the appropriate regimen.

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, and the decision must be made by a qualified prescriber after a thorough risk assessment.

To request Itrabene, 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.

Itraconazole offers a broad spectrum of activity against many yeasts and molds and has a longer half‑life than fluconazole, allowing once‑daily dosing for some indications. However, it has a higher potential for drug‑drug interactions due to strong CYP3A4 inhibition, which may require more careful monitoring.

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

Itrabene is taken orally, usually with food or a full glass of water to enhance absorption. The exact administration instructions, including timing relative to meals, are provided by the prescribing clinician.

Serious risks include hepatotoxicity, severe skin reactions such as Stevens‑Johnson syndrome, and cardiac effects like QT prolongation. Patients should be monitored for signs of liver injury, rash, or arrhythmia, and therapy should be stopped immediately if these occur.

Itrabene is contraindicated in patients with known hypersensitivity to itraconazole or any azole antifungal, and in those with pre‑existing severe liver disease or uncontrolled cardiac arrhythmias. Clinicians should also avoid use in patients taking medications that have a contraindicated interaction with itraconazole.

Published by

GNH India Pharmaceuticals Limited

Licensed pharmaceutical supplier

Last updated:

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