Product image of Itraconazolo Sandoz (Itraconazole) supplied by GNH India

Itraconazolo Sandoz

Active Ingredient:
Itraconazole
Origin:
EU

Itraconazolo Sandoz (Itraconazole)

Itraconazole, the active ingredient in Itraconazolo Sandoz, is a triazole antifungal presented as an oral tablet formulation for oral use. It is indicated for the treatment of a range of superficial and systemic mycoses caused by susceptible fungi in adult patients, including dermatophyte infections, onychomycosis, and invasive candidiasis.

GNH India supplies Itraconazolo Sandoz as a licensed, GDP‑compliant international pharmaceutical supplier serving hospitals, transplant centres, oncology centres, pharmacies and clinics worldwide.

Manufacturer / TM Owner

Sandoz S.P.A.

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Indications & Clinical Uses

  • Itraconazole is used to manage fungal infections across several disease categories.
  • Dermatophytosis (ringworm): reduces fungal growth and clears skin lesions.
  • Onychomycosis (nail fungus): promotes regrowth of healthy nail tissue.
  • Systemic mycoses such as blastomycosis, histoplasmosis, and sporotrichosis: eradicates invasive fungal infection.
  • Chronic pulmonary aspergillosis: controls fungal burden and improves respiratory symptoms.

How It Works

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

Side Effects

Adverse reactions may occur with itraconazole therapy.

Common Side Effects

  • Nausea
  • Headache
  • Abdominal pain or discomfort
  • Rash or mild skin irritation
  • Taste disturbance (dysgeusia)
  • Diarrhea

Serious or Rare Side Effects

  • Hepatotoxicity, including severe hepatitis
  • Severe skin reactions such as Stevens‑Johnson syndrome
  • Congestive heart failure or worsening of existing heart failure
  • Significant electrolyte disturbances, especially hypokalemia
  • Visual disturbances or blurred vision

Precautions & Warnings

  • Before initiating therapy, consider the following safety measures.
  • Liver function monitoring: assess baseline hepatic enzymes and repeat periodically.
  • Drug interaction review: evaluate concomitant medications for CYP3A4 substrates or inhibitors.
  • Cardiac assessment: avoid use in patients with known congestive heart failure.
  • Pregnancy and lactation: prescribe only if potential benefit outweighs risk.
  • Renal impairment: use with caution in severe renal dysfunction.
  • Store at ambient temperature: keep in the original container, protect from moisture and light.

Avoid Interactions

Itraconazole has several clinically relevant drug interactions.

Major Interactions (Avoid)

  • Strong CYP3A4 inducers (e.g., rifampin, carbamazepine): may markedly reduce itraconazole exposure.
  • Concomitant QT‑prolonging agents (e.g., quinidine, cisapride): increased risk of arrhythmia.
  • Potent CYP3A4 inhibitors (e.g., ketoconazole): may cause itraconazole toxicity.

Moderate Interactions (Monitor Closely)

  • Statins metabolized by CYP3A4 (e.g., simvastatin): monitor for myopathy.
  • Oral anticoagulants (warfarin): check INR more frequently.
  • Sulfonylurea hypoglycemics: observe for enhanced hypoglycemic effect.

Frequently Asked Questions

Itraconazolo Sandoz contains itraconazole, a triazole antifungal indicated for the treatment of superficial infections such as dermatophytosis and onychomycosis, as well as systemic mycoses including blastomycosis, histoplasmosis, sporotrichosis, and chronic pulmonary aspergillosis in adult patients.

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, leading to inhibited growth and eventual death of susceptible fungi.

The specific dose and treatment duration are determined by the prescribing clinician based on the type and severity of the fungal infection, patient weight, renal and hepatic function, and any concomitant medications. Patients should follow the prescriber’s instructions exactly.

Safety data for itraconazole in pregnancy and lactation are limited. It should only be used when the potential benefit to the mother outweighs any possible risk to the fetus or infant. Women who are pregnant, planning pregnancy, or breastfeeding should discuss alternatives with their healthcare provider.

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 (including any cold‑chain requirements), and necessary import documentation.

The most common alternative is fluconazole, another azole antifungal. Itraconazole has a broader spectrum against dermatophytes, dimorphic fungi, and some molds, while fluconazole is more active against Candida species and has fewer drug‑interaction concerns. Itraconazole’s longer half‑life allows once‑daily dosing for many indications, but it requires careful monitoring for hepatic and cardiac effects.

Store the product at ambient temperature, preferably below 25 °C. Keep it in the original packaging to protect it from moisture and light. Do not store in bathrooms or near heat sources, and keep out of reach of children.

Itraconazolo Sandoz is taken orally, usually with food or a full glass of water to enhance absorption. The tablet 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 hepatitis), severe skin reactions such as Stevens‑Johnson syndrome, congestive heart failure or worsening of existing heart failure, and significant electrolyte disturbances like hypokalemia. Patients should report any unexplained jaundice, rash, shortness of breath, or swelling promptly.

Itraconazolo Sandoz should be avoided in individuals with known hypersensitivity to itraconazole or any component of the formulation, patients with severe hepatic impairment, and those with established congestive heart failure. Caution is also advised for patients taking medications that strongly interact with CYP3A4.

Published by

GNH India Pharmaceuticals Limited

Licensed pharmaceutical supplier

Last updated:

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