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 tablet for oral use. It is indicated for the treatment of a range of systemic and localized fungal infections in adult and pediatric patients under medical supervision.

GNH India supplies Itraconazol Stada as a licensed, GDP‑compliant international pharmaceutical supplier serving hospitals, pharmacies and clinics worldwide. The company adheres to EU quality standards and provides reliable global logistics for qualified healthcare institutions, ensuring timely delivery and regulatory compliance across multiple markets.

Manufacturer / TM Owner

Laboratorio Stada, S.L.

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Indications & Clinical Uses

Itraconazole is used to treat systemic and localized fungal infections by targeting a broad spectrum of pathogenic fungi.

  • Blastomycosis: clears pulmonary and disseminated infection.
  • Histoplasmosis: resolves acute and chronic disease.
  • Aspergillosis: treats invasive and allergic forms.
  • Candidiasis (oropharyngeal and esophageal): eradicates mucosal lesions.
  • Dermatophytosis: eliminates skin and nail infections.
  • Sporotrichosis: cures cutaneous and lymphocutaneous disease.

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 formation, leading to increased membrane permeability and inhibition of fungal growth.

Side Effects

Side effects vary in frequency and severity.

Common Side Effects

  • Nausea: mild to moderate stomach upset.
  • Headache: transient cranial discomfort.
  • Diarrhea: loose stools, usually self‑limiting.
  • Abdominal pain: cramping or discomfort.
  • Rash: mild skin irritation or erythema.
  • Elevated liver enzymes: mild, often reversible.

Serious or Rare Side Effects

  • Hepatotoxicity: severe liver injury, jaundice, or hepatitis.
  • Congestive heart failure: fluid retention and reduced cardiac function.
  • Severe skin reactions: Stevens‑Johnson syndrome or toxic epidermal necrolysis.
  • Visual disturbances: blurred vision or photophobia.
  • Anaphylaxis: rare systemic allergic reaction.

Precautions & Warnings

Before initiating therapy, consider the following precautions.

  • Liver function monitoring: assess baseline enzymes and repeat during treatment.
  • Cardiac assessment: avoid in patients with existing heart failure.
  • Drug interactions: review concomitant medications for CYP3A4 substrates.
  • Pregnancy and lactation: evaluate risk‑benefit ratio; use only if clearly needed.
  • Renal impairment: adjust dose if severe kidney dysfunction is present.
  • Store below 25°C: keep in the original pack, protect from moisture.

Avoid Interactions

Itraconazole has a notable interaction profile that requires careful management.

Major Interactions (Avoid)

  • Rifampin: reduces itraconazole plasma levels, compromising efficacy.
  • St. John’s wort: induces metabolism, leading to subtherapeutic concentrations.
  • Certain antiarrhythmics (e.g., amiodarone): may cause serious cardiac effects.

Moderate Interactions (Monitor Closely)

  • Statins (e.g., simvastatin): increased risk of myopathy.
  • Benzodiazepines (e.g., midazolam): enhanced sedation.
  • Proton pump inhibitors: may decrease absorption of itraconazole.

Frequently Asked Questions

Itraconazol Stada is prescribed for a variety of systemic and localized fungal infections, including blastomycosis, histoplasmosis, aspergillosis, candidiasis of the mouth and esophagus, dermatophytosis of the skin and nails, and sporotrichosis. The drug targets the fungal cell membrane synthesis pathway, helping to clear the infection when used under medical supervision.

Itraconazole blocks the fungal enzyme lanosterol 14α‑demethylase, a key step in the production of ergosterol, an essential component of fungal cell membranes. By inhibiting ergosterol synthesis, the drug compromises membrane integrity, leading to impaired fungal growth and eventual eradication of the pathogen.

The dosage of Itraconazol Stada is determined by the prescribing clinician based on the specific infection, patient age, weight, renal and hepatic function, and other individual factors. Only a qualified healthcare professional can set the appropriate regimen and duration of therapy.

Safety data for itraconazole in pregnancy and lactation are limited. The drug should only be used if the potential benefit justifies any potential risk to the fetus or infant. Healthcare providers will evaluate the risk‑benefit profile for each patient and advise accordingly.

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 the necessary import documentation.

Itraconazol Stada belongs to the azole class, offering broad‑spectrum activity against many yeasts and molds. Compared with older agents like fluconazole, itraconazole has enhanced activity against Aspergillus and certain dimorphic fungi, though it may have a higher potential for drug‑drug interactions due to CYP3A4 inhibition.

Store Itraconazol Stada at temperatures below 25 °C, in its original packaging, and protect it from moisture and direct sunlight. Maintaining these conditions helps preserve the tablet’s potency and stability throughout its shelf life.

Itraconazol Stada is taken orally, usually with food to improve absorption. The tablets should be swallowed whole with a full glass of water and not crushed or chewed, unless the prescribing information specifies an alternative method.

The most serious adverse events include hepatotoxicity, which can manifest as elevated liver enzymes, jaundice or hepatitis, and congestive heart failure due to fluid retention. Patients should be monitored for signs of liver dysfunction or worsening cardiac symptoms during therapy.

Itraconazol Stada is contraindicated in patients with known hypersensitivity to itraconazole or any azole antifungal. It should also be avoided in individuals with severe liver disease, uncontrolled heart failure, or when taking medications that have a major interaction risk, such as rifampin or St. John’s wort.

Published by

GNH India Pharmaceuticals Limited

Licensed pharmaceutical supplier

Last updated:

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