Product image of Itrac (Itraconazole) supplied by GNH India

Itrac

Active Ingredient:
Itraconazole
Origin:
EU

Itrac (Itraconazole)

Itraconazole, the active ingredient in Itrac, is an azole antifungal presented as an oral formulation for systemic use. Approved in the European Union, it treats a variety of fungal infections such as dermatophytosis, onychomycosis, systemic candidiasis and aspergillosis in adult patients.

GNH India supplies Itrac as a licensed, GDP‑compliant international pharmaceutical supplier serving hospitals, transplant centres, oncology centres, pharmacies and clinics worldwide. The product complies with EU GMP standards and is available for bulk and unit‑dose distribution across global markets.

Manufacturer / TM Owner

Belupo D.D.

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Indications & Clinical Uses

Itraconazole is an azole antifungal that interferes with ergosterol synthesis in pathogenic fungi.

  • Dermatophytosis: clears skin fungal infections and reduces lesion spread.
  • Onychomycosis: eradicates nail‑bed infection, allowing healthy nail regrowth.
  • Systemic candidiasis: treats invasive Candida infections in immunocompromised patients.
  • Aspergillosis: controls chronic pulmonary aspergillosis by suppressing fungal growth.

How It Works

  • Itraconazole inhibits the fungal cytochrome P450 enzyme lanosterol 14α‑demethylase, blocking conversion of lanosterol to ergosterol. This disruption compromises the integrity of the fungal cell membrane, leading to impaired growth and eventual cell death.

Side Effects

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

Common Side Effects

  • Nausea: mild gastrointestinal upset.
  • Headache: transient cranial discomfort.
  • Abdominal pain: intermittent stomach cramps.
  • Rash: mild skin erythema.

Serious or Rare Side Effects

  • Hepatotoxicity: elevated liver enzymes or hepatitis.
  • Cardiac failure: new or worsening congestive heart failure.
  • Severe hypersensitivity: anaphylaxis or Stevens‑Johnson syndrome.

Precautions & Warnings

When prescribing itraconazole, clinicians should consider several precautionary measures to ensure patient safety.

  • Liver function monitoring: assess baseline enzymes and repeat during therapy.
  • Drug interactions: review concomitant medications for CYP3A4 substrates.
  • Cardiac status: avoid in patients with existing heart failure.
  • Pregnancy and lactation: use only if benefits outweigh risks.
  • Renal impairment: adjust dose in severe cases if needed.
  • Store at ambient temperature: keep below 25 °C in original packaging, protect from moisture.

Avoid Interactions

Itraconazole has a notable interaction profile, primarily due to its inhibition of CYP3A4 enzymes.

Major Interactions (Avoid)

  • Rifampin: strong CYP3A4 inducer that reduces itraconazole exposure.
  • Carbamazepine: enzyme inducer leading to subtherapeutic levels.
  • St. John’s wort: herbal inducer that markedly decreases efficacy.

Moderate Interactions (Monitor Closely)

  • Statins (e.g., simvastatin): increased risk of myopathy; dose adjustment may be needed.
  • Calcium channel blockers (e.g., verapamil): may increase itraconazole levels; monitor for toxicity.

Frequently Asked Questions

Itrac contains itraconazole, which is prescribed for fungal infections such as dermatophytosis (skin fungus), onychomycosis (nail fungus), systemic candidiasis (invasive Candida infections), and chronic pulmonary aspergillosis. The medication targets the underlying fungus to halt disease progression.

Itraconazole blocks the fungal enzyme lanosterol 14α‑demethylase, a key step in ergosterol synthesis. Without ergosterol, the fungal cell membrane becomes unstable, leading to impaired growth and eventual cell death, thereby clearing the infection.

The dosage of Itrac is determined by the prescribing clinician based on the specific infection, patient weight, renal and hepatic function, and other clinical factors. Only a qualified health professional should set the dose and duration.

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

To request Itrac, 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.

Itrac belongs to the azole class, which generally offers oral convenience and broad-spectrum activity against yeasts and molds. Compared with polyenes (e.g., amphotericin B), azoles have fewer infusion‑related reactions but may have more drug‑interaction potential due to CYP3A4 inhibition.

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

Itrac is taken orally, usually with a full glass of water. The tablet or capsule should be swallowed whole and not chewed or crushed, unless the prescriber provides specific instructions for a different formulation.

Serious risks include hepatotoxicity, which may present as elevated liver enzymes or hepatitis, and cardiac failure, especially in patients with pre‑existing heart conditions. Severe hypersensitivity reactions such as anaphylaxis or Stevens‑Johnson syndrome can also occur and require immediate medical attention.

Patients with known hypersensitivity to itraconazole or any azole antifungal should not use Itrac. It is also contraindicated in individuals with uncontrolled heart failure, severe liver impairment, or those taking medications that strongly induce CYP3A4 without appropriate monitoring.

Published by

GNH India Pharmaceuticals Limited

Licensed pharmaceutical supplier

Last updated:

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