Product image of Itrakonazol Stada (Itraconazole) supplied by GNH India

Itrakonazol Stada

Active Ingredient:
Itraconazole
Origin:
EU

Itrakonazol Stada (Itraconazole)

Itraconazole, the active ingredient in Itrakonazol Stada, is a systemic azole antifungal presented as an oral formulation for systemic use. It treats a range of fungal infections, including dermatophytosis, candidiasis, and invasive molds, in adult patients as prescribed by a clinician.

GNH India supplies Itrakonazol Stada 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 regulatory support for import and distribution globally efficiently.

Manufacturer / TM Owner

Stada Arzneimittel Ag

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Indications & Clinical Uses

Itraconazole is used systemically to treat a variety of fungal infections affecting the skin, mucous membranes and internal organs.

  • Dermatophytosis: effective in treating skin and nail infections caused by dermatophyte fungi.
  • Candidiasis: used for oral, esophageal and systemic Candida infections.
  • Aspergillosis: indicated for invasive disease caused by Aspergillus species.
  • Blastomycosis: employed in the management of infections caused by Blastomyces dermatitidis.
  • Histoplasmosis: treats disseminated disease due to Histoplasma capsulatum.

How It Works

  • Itraconazole inhibits the fungal enzyme lanosterol 14α‑demethylase, a cytochrome P450 isoform, thereby blocking 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

Adverse reactions may occur with itraconazole therapy and vary in frequency and severity.

Common Side Effects

  • Nausea: mild to moderate gastrointestinal upset.
  • Headache: transient cranial discomfort.
  • Abdominal pain: cramping or discomfort in the stomach area.
  • Rash: skin erythema or mild itching.
  • Taste disturbance: altered or reduced taste perception.

Serious or Rare Side Effects

  • Hepatotoxicity: elevated liver enzymes or severe liver injury.
  • Cardiac failure: worsening of pre‑existing heart conditions.
  • Severe skin reactions: Stevens‑Johnson syndrome or toxic epidermal necrolysis.
  • Visual disturbances: blurred vision or photophobia.
  • Anaphylaxis: rare but potentially life‑threatening allergic reaction.

Precautions & Warnings

Before initiating therapy, clinicians should consider several safety measures.

  • Liver function monitoring: assess baseline enzymes and repeat during treatment.
  • Cardiac assessment: avoid in patients with known heart failure.
  • Drug hypersensitivity: discontinue if signs of allergic reaction appear.
  • Concomitant medications: review for agents that may increase itraconazole levels.
  • Pregnancy and lactation: use only if the potential benefit justifies the risk.
  • Store at ambient temperature: keep below 25°C in the original packaging, protected from moisture.

Avoid Interactions

Itraconazole has a notable potential for drug‑drug interactions due to CYP3A4 inhibition and other mechanisms.

Major Interactions (Avoid)

  • Strong CYP3A4 inhibitors (e.g., ketoconazole, clarithromycin, ritonavir): may cause toxic itraconazole levels.
  • Certain statins (simvastatin, lovastatin): increased risk of myopathy.
  • QT‑prolonging agents (e.g., quinidine, sotalol): heightened risk of cardiac arrhythmias.

Moderate Interactions (Monitor Closely)

  • CYP3A4 inducers (rifampin, carbamazepine, phenytoin): may reduce itraconazole efficacy.
  • Oral contraceptives: efficacy may be decreased, consider additional contraception.
  • Warfarin: monitor INR closely for potential anticoagulant effect changes.

Frequently Asked Questions

Itrakonazol Stada contains itraconazole, which is prescribed for a range of fungal infections such as dermatophytosis (skin and nail fungus), various forms of candidiasis, invasive aspergillosis, blastomycosis, and histoplasmosis. The specific indication depends on the clinical diagnosis made by a healthcare professional.

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 impaired growth and eventual death of the pathogen.

The dosage of Itrakonazol Stada is individualized by the prescribing clinician based on the type and severity of the infection, patient weight, liver function, and other clinical factors. Patients should follow the exact regimen provided by their healthcare provider.

The safety of itraconazole in pregnancy and lactation has not been definitively established. It should only be used if the potential benefit outweighs any possible risk to the fetus or infant, and this decision must be made by a qualified healthcare professional.

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 and any necessary import documentation.

Itraconazole offers a broad spectrum of activity against dermatophytes, yeasts and many molds, and it has a longer half‑life than fluconazole, allowing once‑daily dosing in some regimens. However, its absorption can be affected by gastric pH and it has a higher potential for drug interactions due to strong CYP3A4 inhibition.

Store Itrakonazol Stada at ambient temperature, preferably below 25 °C. Keep the product in its original packaging to protect it from moisture and light, and ensure the container is tightly closed when not in use.

Itrakonazol Stada is taken orally, usually with a full glass of water. The tablet or capsule should be swallowed whole and not crushed or chewed, unless the prescribing information specifies an alternative method for a particular formulation.

Serious adverse events include hepatotoxicity, which may present as elevated liver enzymes or liver failure, and cardiac complications such as worsening heart failure. Rare but severe skin reactions like Stevens‑Johnson syndrome and visual disturbances have also been reported.

Patients with known hypersensitivity to itraconazole or any azole antifungal should avoid the product. It is also contraindicated in individuals with severe liver disease, uncontrolled heart failure, or those taking medications that have a major interaction risk without appropriate monitoring.

Published by

GNH India Pharmaceuticals Limited

Licensed pharmaceutical supplier

Last updated:

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