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

Itraconazol Stada

Active Ingredient:
Itraconazole
Origin:
EU

Itraconazol Stada (Itraconazole)

Itraconazole, the active ingredient in Itraconazol Stada, is an azole antifungal presented as an oral dosage form for systemic use. It treats a range of superficial and systemic fungal infections in adult patients, including onychomycosis, candidiasis and invasive mycoses.
GNH India supplies Itraconazol Stada as a licensed, GDP‑compliant international pharmaceutical supplier serving hospitals, transplant centres, oncology centres, pharmacies and clinics worldwide.

Manufacturer / TM Owner

Stadapharm Gmbh

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Indications & Clinical Uses

Itraconazole is an azole antifungal that targets a broad spectrum of fungal diseases.

  • Systemic mycoses: effective for blastomycosis, histoplasmosis, aspergillosis and other deep fungal infections.
  • Onychomycosis: clears fungal nail infections by eradicating the causative dermatophytes.
  • Candidiasis: resolves mucosal and invasive Candida infections, including oropharyngeal and esophageal forms.

How It Works

  • Itraconazole inhibits the fungal enzyme lanosterol 14α‑demethylase, a cytochrome P450 isoform essential for converting lanosterol to ergosterol. By blocking ergosterol synthesis, the drug disrupts fungal cell membrane integrity, leading to increased permeability and inhibition of fungal growth and replication.

Side Effects

Common Side Effects

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

Serious or Rare Side Effects

  • Hepatotoxicity: elevated liver enzymes or liver injury.
  • Severe skin reactions: Stevens‑Johnson syndrome or toxic epidermal necrolysis.
  • Cardiac failure: worsening of pre‑existing heart conditions.
  • QT prolongation: potential arrhythmia risk.
  • Anaphylaxis: rare but life‑threatening allergic response.
  • Severe liver injury: jaundice, hepatic failure.

Precautions & Warnings

Itraconazol Stada requires careful clinical monitoring to minimize risks.

  • Liver function monitoring: obtain baseline tests and repeat periodically during therapy.
  • Drug interaction review: assess concomitant medications for CYP3A4 involvement.
  • Cardiac risk assessment: avoid in patients with existing heart failure.
  • Pregnancy considerations: prescribe only when benefits outweigh potential fetal risks.
  • Renal impairment: evaluate need for dose adjustment in severe kidney disease.
  • Store at ambient temperature: keep in original packaging, protect from moisture and direct sunlight.

Avoid Interactions

Itraconazol Stada may interact with several medicines; clinicians should evaluate each combination.

Major Interactions (Avoid)

  • Rifampin: induces metabolism, markedly reducing itraconazole exposure.
  • Ketoconazole: additive hepatotoxic potential when co‑administered.
  • St. John's Wort: strong CYP3A4 inducer, decreasing itraconazole levels.

Moderate Interactions (Monitor Closely)

  • CYP3A4 inhibitors (e.g., erythromycin, clarithromycin): may increase itraconazole concentrations.
  • CYP3A4 substrates (e.g., statins, calcium channel blockers): monitor for toxicity.
  • Warfarin: itraconazole can enhance anticoagulant effect, requiring INR surveillance.

Frequently Asked Questions

Itraconazol Stada contains itraconazole, an azole antifungal indicated for the treatment of systemic mycoses such as blastomycosis, histoplasmosis and aspergillosis, as well as superficial infections like onychomycosis and various forms of candidiasis. It is prescribed for adult patients when a broad‑spectrum systemic antifungal is required.

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

The specific dose of Itraconazol Stada is determined by the prescribing clinician based on the infection type, severity, patient weight, renal and hepatic function, and other individual factors. Healthcare professionals tailor the regimen to achieve optimal therapeutic outcomes while minimizing adverse effects.

Safety data for itraconazole in pregnancy are limited, and the drug should be used only if the potential benefit justifies the potential risk to the fetus. It is excreted in breast milk, so breastfeeding mothers should discuss alternatives with their healthcare provider before use.

To request Itraconazol Stada, 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.

Itraconazole generally has a broader spectrum against molds such as Aspergillus and dimorphic fungi, whereas fluconazole is more active against Candida species but less effective for many systemic mycoses. Itraconazole also has a higher potential for drug‑drug interactions due to strong CYP3A4 inhibition.

Store Itraconazol Stada at ambient temperature, preferably below 25 °C. Keep the product in its original container, protect it from moisture and direct sunlight, and ensure the packaging remains tightly closed until use.

Itraconazol Stada is taken 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.

Serious risks include hepatotoxicity, severe skin reactions such as Stevens‑Johnson syndrome, cardiac failure in patients with pre‑existing heart disease, and QT‑interval prolongation that may lead to arrhythmias. Patients should be monitored for signs of liver injury, rash, or cardiac symptoms during therapy.

Itraconazol Stada is contraindicated in patients with known hypersensitivity to itraconazole or any azole antifungal, in those with severe liver impairment, and in individuals with a history of ventricular dysfunction or uncontrolled heart failure. Caution is also advised for patients taking strong CYP3A4 inducers.

Published by

GNH India Pharmaceuticals Limited

Licensed pharmaceutical supplier

Last updated:

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