Product image of Itragerm (Itraconazole) supplied by GNH India

Itragerm

Active Ingredient:
Itraconazole
Origin:
EU

Itragerm (Itraconazole)

Itraconazole, the active ingredient in Itragerm, is an azole antifungal presented as an oral formulation for oral use. It is employed to treat systemic mycoses and selected dermatophytosis and candidiasis infections in adult patients.

GNH India supplies Itragerm as a licensed, GDP‑compliant international pharmaceutical supplier serving hospitals, transplant centres, oncology centres, pharmacies and clinics worldwide. The company adheres to stringent quality standards and provides reliable logistics for global distribution.

Manufacturer / TM Owner

Isdin, S.A.

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Indications & Clinical Uses

  • Itraconazole is used to treat fungal infections across several disease categories.
  • Aspergillosis: effective in treating invasive disease caused by Aspergillus species.
  • Blastomycosis: clears systemic infection caused by Blastomyces dermatitidis.
  • Histoplasmosis: resolves disseminated histoplasma infection.
  • Sporotrichosis: manages cutaneous and systemic sporotrichal disease.
  • Dermatophytosis: eradicates skin infections caused by dermatophyte fungi.
  • Candidiasis: treats mucosal and systemic Candida infections.

How It Works

  • Itraconazole inhibits the fungal enzyme lanosterol 14α‑demethylase, a cytochrome P450 isoform responsible for converting lanosterol to ergosterol. By blocking this step, the drug prevents ergosterol synthesis, a critical component of the fungal cell membrane, leading to increased membrane permeability and inhibition of fungal growth. The inhibition is dose‑dependent and results in fungistatic activity against a broad spectrum of yeasts and molds.

Side Effects

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

Common Side Effects

  • Nausea: upset stomach and feeling of queasiness.
  • Headache: mild to moderate head pain.
  • Rash: skin redness or itching.
  • Elevated liver enzymes: mild increase in hepatic transaminases.

Serious or Rare Side Effects

  • Hepatotoxicity: severe liver injury, jaundice.
  • Congestive heart failure: fluid retention and worsening cardiac function.
  • Severe skin reactions: Stevens‑Johnson syndrome or toxic epidermal necrolysis.

Precautions & Warnings

When prescribing Itraconazole, clinicians should observe several precautionary measures to ensure patient safety.

  • Liver function monitoring: assess baseline and periodic hepatic enzymes.
  • Cardiac assessment: avoid use in patients with existing heart failure.
  • Drug interaction review: evaluate concomitant medications that affect CYP3A4.
  • Pregnancy and lactation: use only if benefits outweigh potential risks, as safety data are limited.
  • Hypersensitivity: discontinue if allergic reactions such as rash or anaphylaxis occur.
  • Store at ambient temperature: keep below 25 °C, retain in original packaging and protect from moisture.

Avoid Interactions

Itraconazole has a notable potential for drug‑drug interactions, primarily through CYP3A4 inhibition.

Major Interactions (Avoid)

  • Strong CYP3A4 inhibitors (e.g., ketoconazole, clarithromycin, ritonavir): may cause toxic itraconazole levels.
  • Drugs that prolong QT interval (e.g., quinidine, sotalol): increased risk of cardiac arrhythmia.
  • Certain anti‑arrhythmic agents (e.g., amiodarone): may lead to severe cardiac effects.

Moderate Interactions (Monitor Closely)

  • Statins metabolized by CYP3A4 (e.g., simvastatin, lovastatin): risk of myopathy, adjust dose.
  • Oral contraceptives: reduced efficacy, consider alternative contraception.
  • Antacids or proton pump inhibitors: may decrease itraconazole absorption, separate dosing times.

Frequently Asked Questions

Itragerm contains itraconazole, which is indicated for a range of fungal infections including systemic mycoses such as aspergillosis, blastomycosis, histoplasmosis and sporotrichosis, as well as skin infections like dermatophytosis and mucosal or systemic candidiasis. The drug is prescribed for adult patients when a broad‑spectrum azole antifungal is required.

Itraconazole blocks the fungal enzyme lanosterol 14α‑demethylase, a cytochrome P450 isoform needed to convert lanosterol into ergosterol. Without ergosterol, the fungal cell membrane cannot form properly, leading to increased permeability and inhibition of fungal growth. This mechanism provides fungistatic activity against many yeasts and molds.

The exact dose of Itragerm is set by the prescribing clinician based on the type and severity of the fungal infection, the patient’s weight, liver function, and any concomitant medications. Itraconazole dosing regimens vary widely, so patients should follow the specific instructions provided by their healthcare professional.

Safety data for itraconazole in pregnancy and lactation are limited, and the product is classified as having an unknown pregnancy category. It should be used only when the potential benefit justifies any possible risk to the fetus or infant. Women who are pregnant, planning pregnancy, or breastfeeding should discuss alternatives with their doctor.

To request Itragerm, submit an enquiry on the product page at gnhindia.com, specifying the required quantity. GNH India supplies hospitals, pharmacies and procurement teams worldwide, and will verify trade or institutional credentials before providing pricing, availability, shipping details (including any cold‑chain requirements) and necessary import documentation.

Compared with fluconazole, itraconazole offers a broader spectrum against molds such as Aspergillus and dimorphic fungi, but it has a higher potential for drug‑drug interactions due to strong CYP3A4 inhibition. It is generally more potent for systemic mycoses, while fluconazole is often preferred for uncomplicated Candida infections because of its simpler interaction profile.

Itragerm should be stored at ambient temperature, preferably below 25 °C (77 °F). Keep the product in its original container, protect it from moisture and direct sunlight, and avoid storing it in places where temperature fluctuations are common, such as near radiators or in a vehicle.

Itragerm is taken orally, usually as a tablet or capsule, and should be swallowed whole with a full glass of water. It can be taken with or without food, but consistent intake with respect to meals helps maintain stable absorption. Patients should not crush or chew the dosage form unless specifically instructed by a healthcare professional.

The most serious adverse effects of itraconazole include hepatotoxicity, which can present as jaundice or elevated liver enzymes, and congestive heart failure due to fluid retention. Severe cutaneous reactions such as Stevens‑Johnson syndrome or toxic epidermal necrolysis are rare but life‑threatening and require immediate medical attention.

Itragerm should be avoided in patients with known hypersensitivity to itraconazole or any azole antifungal, those with severe hepatic impairment, and individuals with existing congestive heart failure. Caution is also advised for patients taking medications that strongly interact with CYP3A4, as well as for pregnant or nursing women unless the benefits clearly outweigh the risks.

Published by

GNH India Pharmaceuticals Limited

Licensed pharmaceutical supplier

Last updated:

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