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

Itraconazol Generis

Active Ingredient:
Itraconazole
Origin:
EU

Itraconazol Generis (Itraconazole)

Itraconazole, the active ingredient in Itraconazol Generis, is an azole antifungal presented as an oral formulation for oral use. It treats systemic fungal infections such as aspergillosis, candidiasis, histoplasmosis, blastomycosis and sporotrichosis in adult patients.

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

Manufacturer / TM Owner

Generis Farmacêutica, S.A.

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Indications & Clinical Uses

Itraconazole is used to treat fungal infections that involve the systemic or mucosal pathways.

  • Aspergillosis: effective in treating invasive disease caused by Aspergillus species.
  • Candidiasis (oropharyngeal and esophageal): clears infection and relieves symptoms.
  • Histoplasmosis: controls disseminated infection and prevents progression.
  • Blastomycosis: eradicates Blastomyces dermatitidis infection.
  • Sporotrichosis: resolves cutaneous and disseminated disease.

How It Works

  • Itraconazole inhibits the fungal enzyme lanosterol 14α-demethylase, a cytochrome P450 isoform, which blocks the conversion of lanosterol to ergosterol. This disruption impairs fungal cell membrane synthesis, leading to increased membrane permeability and inhibition of fungal growth.

Side Effects

Common side effects are generally mild and reversible.

Common Side Effects

  • Nausea: mild to moderate stomach upset.
  • Headache: transient cranial discomfort.
  • Rash: skin irritation or mild erythema.

Serious or Rare Side Effects

  • Hepatic toxicity: elevated liver enzymes or hepatitis.
  • Severe skin reactions: Stevens‑Johnson syndrome or toxic epidermal necrolysis.
  • Congestive heart failure: fluid retention and reduced cardiac function.
  • Arrhythmias: irregular heart rhythms.
  • Visual disturbances: blurred vision or photophobia.
  • Severe hypotension: sudden drop in blood pressure.

Precautions & Warnings

Before initiating therapy, consider the following safety measures.

  • Liver function monitoring: assess hepatic enzymes before and during treatment.
  • Drug interactions: review concomitant medications that affect CYP3A4 metabolism.
  • Cardiac assessment: avoid use in patients with existing heart failure.
  • Pregnancy and lactation: prescribe only when benefit outweighs potential risk; safety data are limited.
  • Renal impairment: adjust dosing in severe renal dysfunction.
  • Store at ambient temperature: keep below 25°C in the original container, protect from moisture.

Avoid Interactions

Itraconazole has several notable drug interactions that require attention.

Major Interactions (Avoid)

  • Rifampin: strong enzyme inducer that markedly reduces itraconazole exposure.
  • Ketoconazole: competitive inhibition may increase itraconazole toxicity.
  • St. John’s wort: potent CYP3A4 inducer that lowers therapeutic effectiveness.

Moderate Interactions (Monitor Closely)

  • Calcium channel blockers (e.g., amlodipine): may raise plasma concentrations of itraconazole.
  • Statins (e.g., simvastatin): increased risk of myopathy; monitor dosage and symptoms.
  • Proton pump inhibitors: can decrease itraconazole absorption; observe clinical response.

Frequently Asked Questions

Itraconazol Generis contains itraconazole, an azole antifungal indicated for the treatment of systemic mycoses such as aspergillosis, invasive candidiasis (including oropharyngeal and esophageal forms), histoplasmosis, blastomycosis, and sporotrichosis. It is prescribed for adult patients with confirmed fungal infections where oral therapy is appropriate.

Itraconazole blocks the fungal enzyme lanosterol 14α-demethylase, a member of the cytochrome P450 family. By inhibiting this enzyme, the drug prevents the synthesis of ergosterol, an essential component of fungal cell membranes, leading to membrane destabilisation and inhibition of fungal growth.

The dosage of Itraconazol Generis is determined by the prescribing clinician based on the specific infection, severity, patient weight, renal and hepatic function, and other individual factors. Healthcare professionals set the appropriate regimen and duration according to clinical guidelines.

Safety data for itraconazole in pregnancy and lactation are limited, and the product is classified as having an unknown pregnancy category. It should only be used when the potential benefit justifies the potential risk to the fetus or infant, and the decision must be made by a qualified healthcare provider.

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

Itraconazole is a triazole antifungal that offers broader coverage against molds such as Aspergillus compared with fluconazole, a fluoro‑triazole primarily effective against yeasts. Itraconazole has a longer half‑life and higher tissue penetration, but it also carries a higher risk of hepatic and cardiac adverse effects, requiring more careful monitoring.

Store the product at ambient temperature, preferably below 25 °C, in its original packaging to protect it from moisture and light. Keep the container tightly closed and out of reach of children. Do not refrigerate or freeze the oral formulation, as temperature extremes may affect stability.

Itraconazol Generis is administered orally, usually with food or a full glass of water to enhance absorption. The tablet or capsule should be swallowed whole and not crushed or chewed unless specifically instructed by a healthcare professional. Follow the prescriber’s directions regarding timing and duration of therapy.

Serious risks include hepatic toxicity (elevated liver enzymes, hepatitis), severe skin reactions such as Stevens‑Johnson syndrome, congestive heart failure or worsening of existing heart failure, and significant drug‑drug interactions that can lead to arrhythmias or myopathy. Patients should report any unexplained jaundice, rash, shortness of breath, or swelling promptly.

Itraconazol Generis should be avoided in patients with known hypersensitivity to itraconazole or any azole antifungal, those with uncontrolled heart failure, and individuals taking contraindicated medications such as strong CYP3A4 inducers (e.g., rifampin, St. John’s wort). Caution is also advised for patients with severe hepatic impairment.

Published by

GNH India Pharmaceuticals Limited

Licensed pharmaceutical supplier

Last updated:

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