Product image of Niddazol (Itraconazole) supplied by GNH India

Niddazol

Active Ingredient:
Itraconazole
Origin:
EU

Niddazol (Itraconazole)

Itraconazole, the active ingredient in Niddazol, is an azole antifungal presented as an oral formulation for systemic use. It is employed to treat a range of fungal infections, including invasive mycoses, candidiasis and dermatophytosis, in adult patients requiring prescription therapy.

GNH India supplies Niddazol 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. All shipments are handled through regulated channels to ensure compliance with local regulations.

Manufacturer / TM Owner

Stada Arzneimittel Ag

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Indications & Clinical Uses

Itraconazole is an azole antifungal used to treat systemic and superficial fungal infections.

  • Systemic mycoses (e.g., aspergillosis, blastomycosis, histoplasmosis): eradicates invasive fungal organisms and improves clinical outcomes.
  • Candidiasis: treats oral, esophageal and systemic Candida infections, reducing fungal burden.
  • Dermatophytosis: resolves skin and nail infections caused by dermatophyte fungi, promoting lesion healing.

How It Works

  • Itraconazole inhibits the fungal cytochrome P450 enzyme lanosterol 14α‑demethylase, blocking the conversion of lanosterol to ergosterol. This disruption impairs fungal cell membrane synthesis, leading to increased membrane permeability and inhibition of fungal growth and replication.

Side Effects

Common Side Effects

  • Nausea: mild to moderate stomach upset.
  • Headache: transient cranial discomfort.
  • Rash: skin erythema or pruritus.
  • Taste disturbance: altered taste perception.

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.
  • Visual disturbances: blurred vision or photophobia.

Precautions & Warnings

Itraconazole requires careful clinical monitoring before and during therapy.

  • Hepatic function: assess baseline liver enzymes and monitor periodically.
  • Renal function: evaluate kidney status, especially in patients with concomitant nephrotoxic drugs.
  • Drug interactions: review all concomitant medications for CYP3A4 involvement.
  • Pregnancy and lactation: avoid unless benefits outweigh potential risks.
  • Store at ambient temperature: keep in the original container, protect from moisture and light.

Avoid Interactions

Itraconazole has several clinically significant drug interactions.

Major Interactions (Avoid)

  • Rifampin: induces metabolism, markedly lowering itraconazole exposure.
  • Ketoconazole: combined hepatotoxic risk; avoid co‑administration.
  • St. John’s wort: strong CYP3A4 inducer, reduces efficacy.

Moderate Interactions (Monitor Closely)

  • Warfarin: may increase anticoagulant effect; monitor INR.
  • Simvastatin: increased statin levels raise risk of myopathy; consider dose adjustment.

Frequently Asked Questions

Niddazol contains itraconazole, an azole antifungal indicated for the treatment of systemic mycoses such as aspergillosis, blastomycosis and histoplasmosis, as well as for candidiasis and dermatophytosis affecting skin, nails and mucous membranes.

Itraconazole blocks the fungal enzyme lanosterol 14α‑demethylase, a cytochrome P450 isoform essential for converting lanosterol to ergosterol. By preventing ergosterol synthesis, the drug disrupts fungal cell‑membrane integrity, inhibiting growth and leading to cell death.

The appropriate dose of Niddazol is determined by the prescribing clinician based on the specific infection, patient weight, renal and hepatic function, and other individual factors. No fixed regimen is provided here.

Safety data for itraconazole in pregnancy and lactation are limited. The product should be avoided unless the potential therapeutic benefit justifies the possible risk to the fetus or infant, and the decision must be made by a qualified health professional.

To request Niddazol, 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.

Compared with fluconazole, another azole antifungal, itraconazole (Niddazol) has a broader spectrum against molds such as Aspergillus and offers better activity for certain dimorphic fungi. However, itraconazole has more potential for drug‑drug interactions and requires monitoring of liver function.

Niddazol should be stored at ambient temperature, preferably below 25 °C, in its original packaging to protect it from moisture and light. Keep the product out of reach of children and avoid storing in humid or excessively hot environments.

Niddazol is administered 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 adverse events include hepatotoxicity (elevated liver enzymes or liver injury), severe skin reactions such as Stevens‑Johnson syndrome, cardiac failure in patients with pre‑existing heart disease, and visual disturbances. Prompt medical attention is required if any of these occur.

Niddazol is contraindicated in individuals with known hypersensitivity to itraconazole or any azole antifungal. It should also be avoided in patients with severe hepatic impairment and in those taking contraindicated medications that strongly induce CYP3A4, such as rifampin.

Published by

GNH India Pharmaceuticals Limited

Licensed pharmaceutical supplier

Last updated:

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