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

Itraconazol Heumann

Active Ingredient:
Itraconazole
Origin:
EU

Itraconazol Heumann (Itraconazole)

Itraconazole, the active ingredient in Itraconazol Heumann, is a triazole antifungal presented as an oral formulation for systemic use. It is employed to treat a range of serious fungal infections, including systemic candidiasis, invasive aspergillosis, onychomycosis and dermatophyte skin infections, primarily in adult patients.

GNH India supplies Itraconazol Heumann 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

Heumann Pharma Gmbh & Co. Generica Kg

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Indications & Clinical Uses

Itraconazole is indicated for several invasive and superficial fungal infections, targeting organisms that rely on ergosterol synthesis.

  • Dermatophyte infections: treats skin and nail infections caused by dermatophyte fungi, improving lesion clearance.
  • Onychomycosis: eradicates fungal infection of the nail plate, promoting regrowth of healthy nail.
  • Systemic candidiasis: combats invasive Candida species in bloodstream and internal organs, reducing mortality risk.
  • Invasive aspergillosis: effective against Aspergillus species in immunocompromised patients, aiding disease control.

How It Works

  • Itraconazole inhibits the fungal enzyme lanosterol 14α‑demethylase, a cytochrome P450 isoform essential for converting lanosterol to ergosterol. By blocking this step, the drug disrupts the synthesis of ergosterol, a critical component of fungal cell membranes, leading to increased membrane permeability and inhibition of fungal growth. The accumulation of toxic sterol intermediates further impairs fungal metabolism, while human cells are less affected due to lower affinity for the enzyme.

Side Effects

Itraconazole may cause a range of adverse reactions, varying from mild to severe, that should be monitored during therapy.

Common Side Effects

  • Nausea: mild to moderate gastrointestinal upset.
  • Vomiting: occasional episodes, often transient.
  • Abdominal pain: cramping or discomfort in the stomach area.
  • Headache: dull or throbbing pain, usually self‑limiting.
  • Rash: skin redness or itching without systemic involvement.
  • Elevated liver enzymes: mild, reversible increase in hepatic markers.

Serious or Rare Side Effects

  • Hepatotoxicity: severe liver injury, jaundice, or hepatitis.
  • Congestive heart failure: worsening of cardiac function, especially in patients with pre‑existing disease.
  • Severe liver injury: hepatic failure requiring medical intervention.
  • Arrhythmias: abnormal heart rhythms, including QT prolongation.
  • Visual disturbances: blurred vision or photopsia.
  • Anaphylaxis: rare, life‑threatening allergic reaction.

Precautions & Warnings

When prescribing itraconazole, clinicians should observe several precautionary measures to minimize risk and ensure safe use.

  • Monitor liver function: obtain baseline hepatic enzymes and repeat periodically during treatment.
  • Assess cardiac status: avoid use in patients with existing heart failure or significant ventricular dysfunction.
  • Review concomitant medications: identify drugs that may interact via CYP3A4 metabolism.
  • Evaluate hypersensitivity: discontinue if signs of allergic reaction such as rash or angioedema appear.
  • Pregnancy and lactation: use only if potential benefit justifies potential risk to fetus or infant.
  • Store at ambient temperature: keep in original container, protect from moisture and light.

Avoid Interactions

Itraconazole is metabolized by and can affect the activity of several cytochrome P450 enzymes, leading to important drug‑drug interactions.

Major Interactions (Avoid)

  • Rifampin: strong CYP3A4 inducer that markedly reduces itraconazole plasma concentrations.
  • Ketoconazole: additive hepatotoxic potential when combined with itraconazole.
  • St. John’s wort: herbal inducer that decreases itraconazole exposure and efficacy.

Moderate Interactions (Monitor Closely)

  • Erythromycin or clarithromycin: CYP3A4 inhibitors that can increase itraconazole levels, requiring dose adjustment.
  • Statins (e.g., simvastatin): increased risk of myopathy due to higher statin concentrations.
  • Antacids, H2‑blockers, or proton pump inhibitors: may reduce oral absorption of itraconazole, consider timing separation.

Frequently Asked Questions

Itraconazol Heumann contains itraconazole, a triazole antifungal indicated for the treatment of systemic candidiasis, invasive aspergillosis, onychomycosis, and dermatophyte skin infections. It is prescribed for adult patients with confirmed fungal infections where oral therapy is appropriate, and it works by inhibiting fungal cell membrane synthesis.

Itraconazole inhibits the fungal enzyme lanosterol 14α‑demethylase, a cytochrome P450 isoform required for converting lanosterol to ergosterol. Blocking this step prevents ergosterol formation, disrupting fungal cell membrane integrity and leading to impaired growth or death of the organism. Human cells are less affected because the drug has lower affinity for the human counterpart of the enzyme.

The dosage of itraconazole is individualized by the prescribing clinician based on the specific infection, severity, patient weight, renal and hepatic function, and potential drug interactions. Physicians determine the appropriate strength, frequency, and duration of therapy, and patients should follow the prescribed regimen exactly as instructed.

Safety data for itraconazole in pregnancy and lactation are limited. It is generally classified as contraindicated or to be used only when the potential benefit outweighs the risk to the fetus or infant. Women who are pregnant, planning pregnancy, or nursing should discuss alternative treatments with their healthcare provider before initiating therapy.

To place an order, submit an enquiry on the product page at gnhindia.com, specifying the required quantity of Itraconazol Heumann. 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 assistance with import documentation.

Compared with polyene agents such as amphotericin B, itraconazole offers oral administration and a more favorable safety profile, though it has notable drug‑interaction potential. Against newer azoles like voriconazole, itraconazole provides broader activity against dermatophytes and certain dimorphic fungi but may have lower bioavailability for some indications. Choice of therapy depends on infection type, patient comorbidities, and susceptibility patterns.

Itraconazol Heumann should be stored at ambient temperature, preferably below 25 °C, in its original packaging to protect it from moisture, light, and humidity. Keep the product out of reach of children and avoid storing it in bathrooms or other damp environments. Do not freeze the medication, and discard any tablets that appear discolored or damaged.

The medication is taken orally, usually with food or a full glass of water to enhance absorption. Patients should swallow the tablets whole and avoid crushing or chewing them unless specifically instructed by a healthcare professional. The exact dosing schedule, including frequency and duration, is determined by the prescriber based on the infection being treated.

Serious adverse events include hepatotoxicity, which may present as elevated liver enzymes or severe liver injury, and congestive heart failure due to negative inotropic effects. Rare but critical reactions such as severe allergic responses, arrhythmias, and visual disturbances have also been reported. Patients should be monitored regularly for liver function, cardiac status, and any signs of hypersensitivity throughout treatment.

Itraconazole is contraindicated in individuals with known hypersensitivity to itraconazole or any other azole antifungal. It should be avoided in patients with established heart failure, severe hepatic impairment, or those receiving medications that strongly induce its metabolism (e.g., rifampin) without appropriate dose adjustment. Pregnant or breastfeeding women should only use it when the therapeutic benefit justifies potential risks, and all decisions must be guided by a qualified healthcare professional.

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GNH India Pharmaceuticals Limited

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Last updated:

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