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

Itraconazol Aristo

Active Ingredient:
Itraconazole
Origin:
EU

Itraconazol Aristo (Itraconazole)

Itraconazole, the active ingredient in Itraconazol Aristo, is a triazole azole antifungal presented as an oral formulation for systemic use. Approved in the European Union, it treats a range of invasive and superficial fungal infections in adults and children when prescribed by a qualified healthcare professional.

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

Manufacturer / TM Owner

Aristo Pharma Gmbh (Art 57)

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Indications & Clinical Uses

  • Itraconazole is employed to treat systemic and localized fungal infections across several disease categories.
  • Blastomycosis: clears pulmonary and disseminated infection.
  • Histoplasmosis: resolves respiratory and disseminated disease.
  • Aspergillosis: treats invasive pulmonary forms.
  • Candidiasis (oropharyngeal and esophageal): eradicates mucosal infection.
  • Dermatophyte infections: eliminates skin and nail fungal disease.
  • Sporotrichosis: cures cutaneous and disseminated infection.

How It Works

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

Side Effects

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

Common Side Effects

  • Nausea or vomiting.
  • Abdominal discomfort or pain.
  • Headache.
  • Rash or mild skin irritation.
  • Altered taste sensation.
  • Diarrhea.

Serious or Rare Side Effects

  • Hepatotoxicity, including severe liver injury.
  • Stevens‑Johnson syndrome or toxic epidermal necrolysis.
  • Congestive heart failure exacerbation.
  • Visual disturbances such as blurred vision.
  • Anaphylactic reactions.
  • Severe electrolyte abnormalities.

Precautions & Warnings

  • Before initiating therapy, clinicians should consider several safety measures.
  • Liver function monitoring: assess hepatic enzymes before and during treatment.
  • Drug interaction review: evaluate concomitant CYP3A4 substrates and inhibitors.
  • Cardiac risk assessment: avoid use in patients with uncontrolled congestive heart failure.
  • Pregnancy and lactation: prescribe only when benefits outweigh potential risks.
  • Store below 25°C: keep in the original container, protect from moisture.

Avoid Interactions

Itraconazole interacts with many medicines; careful assessment is required.

Major Interactions (Avoid)

  • Rifampin: strong inducer that markedly reduces itraconazole exposure.
  • Ketoconazole: additive hepatotoxic potential.
  • St. John’s wort: potent CYP3A4 inducer, lowering efficacy.
  • Other azole‑resistant antifungals: may compromise therapeutic outcome.

Moderate Interactions (Monitor Closely)

  • CYP3A4 inhibitors (e.g., erythromycin, clarithromycin): may increase itraconazole levels.
  • Statins (e.g., simvastatin, lovastatin): heightened risk of myopathy.
  • Oral anticoagulants (warfarin): potential increase in INR.
  • Oral hypoglycemics: possible alteration of blood glucose control.

Frequently Asked Questions

Itraconazol Aristo contains itraconazole, an azole antifungal indicated for the treatment of systemic and localized fungal infections such as blastomycosis, histoplasmosis, aspergillosis, various forms of candidiasis, dermatophyte infections, and sporotrichosis. It is prescribed when a clinician determines that an azole agent is appropriate for the specific fungal pathogen and infection site.

Itraconazole blocks the fungal enzyme lanosterol 14α‑demethylase, a key step in ergosterol synthesis. By preventing ergosterol formation, the drug disrupts the integrity of the fungal cell membrane, leading to increased permeability, inhibition of growth, and ultimately fungal cell death.

The dosage of itraconazole is individualized by the prescribing healthcare professional based on the type and severity of the infection, patient weight, age, renal and hepatic function, and potential drug interactions. Only a qualified prescriber can determine the appropriate regimen.

Safety data for itraconazole in pregnancy and lactation are limited. The drug should be used only if the potential benefit to the mother outweighs any possible risk to the fetus or infant. Clinicians should discuss the risk‑benefit profile with the patient and consider alternative therapies when appropriate.

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 (including any cold‑chain requirements), and necessary import documentation.

Both itraconazole and fluconazole belong to the azole class, but itraconazole has a broader spectrum against molds such as Aspergillus and dimorphic fungi, whereas fluconazole is more active against many Candida species. Itraconazole also has a higher potential for drug‑drug interactions due to stronger CYP3A4 inhibition.

Store the product at temperatures below 25 °C, in its original packaging, and protect it from moisture and direct sunlight. Do not expose the tablets or capsules to excessive heat or humidity, and keep them out of reach of children.

Itraconazol Aristo is taken orally, usually with food or a full glass of water to enhance absorption. The exact administration instructions, including whether to take it with a high‑fat meal, are provided by the prescribing clinician and should be followed precisely.

Serious adverse events include hepatotoxicity (potentially leading to liver failure), severe skin reactions such as Stevens‑Johnson syndrome or toxic epidermal necrolysis, exacerbation of congestive heart failure, visual disturbances, and rare cases of anaphylaxis. Patients should be monitored closely for any signs of these conditions.

Itraconazole is contraindicated in patients with known hypersensitivity to itraconazole or any azole antifungal, and in individuals with uncontrolled congestive heart failure. Caution is also advised for patients with severe hepatic impairment, as the drug is metabolized by the liver.

Published by

GNH India Pharmaceuticals Limited

Licensed pharmaceutical supplier

Last updated:

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