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 formulation for oral use. It treats a range of superficial and systemic fungal infections, including onychomycosis, aspergillosis, blastomycosis, and candidiasis, in adult patients as prescribed by a healthcare professional.

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

Stada Arzneimittel Gmbh

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Indications & Clinical Uses

Itraconazole belongs to the azole class and is used to manage fungal infections affecting the skin, nails, and internal organs.

  • Superficial mycoses: resolves skin and mucosal fungal infections such as tinea and oral candidiasis.
  • Systemic mycoses: treats deep‑seated infections including aspergillosis, blastomycosis, and disseminated candidiasis.
  • Onychomycosis: eradicates fungal infection of the toenails and fingernails, improving nail appearance and health.

How It Works

  • Itraconazole inhibits the fungal cytochrome P450 enzyme lanosterol 14α‑demethylase, a key step in ergosterol synthesis. By blocking ergosterol production, the drug disrupts the integrity of the fungal cell membrane, leading to increased permeability and ultimately cell death. This mechanism targets a broad spectrum of pathogenic fungi while sparing human cells due to selective enzyme affinity.

Side Effects

Adverse reactions may occur with itraconazole therapy and should be monitored.

Common Side Effects

  • Nausea
  • Abdominal pain
  • Headache
  • Rash

Serious or Rare Side Effects

  • Hepatotoxicity (elevated liver enzymes, hepatitis)
  • Severe skin reactions such as Stevens‑Johnson syndrome
  • Cardiac failure or worsening of existing heart failure

Precautions & Warnings

Before initiating itraconazole, clinicians should consider several safety measures.

  • Liver function monitoring: obtain baseline hepatic enzymes and repeat periodically.
  • CYP3A4 interactions: avoid concomitant use of strong inhibitors or inducers without adjustment.
  • Hypersensitivity: discontinue if signs of allergic reaction appear.
  • Cardiac risk: use with caution in patients with existing heart failure.
  • Pregnancy and lactation: safety not established; weigh benefits against potential risks.
  • Store at below 25°C: keep in the original packaging, protect from moisture and direct sunlight.

Avoid Interactions

Itraconazole has a notable interaction profile that requires careful management.

Major Interactions (Avoid)

  • Strong CYP3A4 inhibitors (e.g., ketoconazole, ritonavir) – may increase itraconazole levels.
  • Rifampin and other CYP3A4 inducers – may reduce efficacy.
  • St. John's wort – potent inducer that can markedly lower drug exposure.

Moderate Interactions (Monitor Closely)

  • Warfarin – may enhance anticoagulant effect, monitor INR.
  • Digoxin – increased serum concentrations possible.
  • Statins (especially simvastatin) – risk of myopathy, consider dose adjustment.
  • Oral contraceptives – efficacy may be reduced, advise alternative contraception.

Frequently Asked Questions

Itraconazol Stada contains itraconazole, an azole antifungal indicated for a variety of fungal infections. It is prescribed for superficial mycoses such as tinea and oral candidiasis, systemic infections like aspergillosis and blastomycosis, and nail infections (onychomycosis). The drug targets the underlying fungus, helping to clear the infection and prevent recurrence when used as directed by a healthcare professional.

Itraconazole works by inhibiting the fungal enzyme lanosterol 14α‑demethylase, which is essential for synthesising ergosterol, a key component of the fungal cell membrane. Disruption of ergosterol production compromises membrane integrity, leading to increased permeability and ultimately fungal cell death. This mechanism provides broad‑spectrum activity against many pathogenic yeasts and molds.

The appropriate dose of Itraconazol Stada is determined by the prescribing clinician based on the specific infection, its severity, patient weight, renal and hepatic function, and other individual factors. Dosage regimens can vary widely, ranging from short courses for superficial infections to prolonged therapy for systemic disease. Patients should follow the exact dosing instructions provided by their prescriber.

Safety data for itraconazole in pregnancy and lactation are limited, and the product is generally classified as contraindicated or to be used only if the potential benefit justifies the potential risk to the fetus. Women who are pregnant, planning to become pregnant, or breastfeeding should discuss alternatives and risk‑benefit considerations with their healthcare provider before initiating therapy.

To place an order, visit the product page on gnhindia.com and submit an enquiry specifying the required quantity of Itraconazol Stada. GNH India works with hospitals, pharmacies, and procurement teams worldwide, and will request verification of trade or institutional credentials. After confirmation, the team provides pricing, availability, shipping details (including any cold‑chain requirements), and assists with import documentation.

Itraconazol Stada belongs to the azole class, offering a broad spectrum of activity against yeasts and molds. Compared with older azoles like fluconazole, itraconazole has enhanced activity against certain molds (e.g., Aspergillus) and dermatophytes but may have a higher potential for drug‑drug interactions due to CYP3A4 inhibition. Clinicians choose itraconazole when its spectrum aligns with the pathogen and when its interaction profile can be managed.

Itraconazol Stada should be stored at temperatures below 25 °C (77 °F). Keep the product in its original packaging to protect it from moisture and direct sunlight. Do not store in bathrooms or near heat sources. Ensure the container is tightly closed when not in use to maintain stability and potency.

Itraconazol Stada is administered orally, typically as a tablet or capsule taken with food to enhance absorption. The exact route (e.g., with a full glass of water) and timing relative to meals are specified by the prescriber. Patients should not crush or chew the dosage form unless instructed, and they should follow any additional instructions regarding concomitant medications or dietary considerations.

Serious risks include hepatotoxicity, which may present as elevated liver enzymes or hepatitis, and severe skin reactions such as Stevens‑Johnson syndrome or toxic epidermal necrolysis. Cardiac failure or worsening of existing heart failure has also been reported. Patients should be monitored regularly for liver function, skin changes, and cardiac symptoms, and any concerning signs should prompt immediate medical evaluation.

Itraconazol Stada is contraindicated in individuals with known hypersensitivity to itraconazole or any component of the formulation. Patients with uncontrolled heart failure, severe hepatic impairment, or those taking strong CYP3A4 inducers (e.g., rifampin, St. John's wort) should avoid the drug unless a risk‑benefit assessment supports its use. Pregnant or breastfeeding women should consult their healthcare provider before initiating therapy.

Published by

GNH India Pharmaceuticals Limited

Licensed pharmaceutical supplier

Last updated:

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