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

Itraconazol Actavis

Active Ingredient:
Itraconazole
Origin:
EU

Itraconazol Actavis (Itraconazole)

Itraconazole, the active ingredient in Itraconazol Actavis, is a azole antifungal presented as an oral capsule for oral use. It treats systemic and superficial fungal infections in adults and children as prescribed.

GNH India supplies Itraconazol Actavis as a licensed, GDP-compliant international pharmaceutical supplier serving hospitals, transplant centres, oncology centres, pharmacies and clinics worldwide.

Manufacturer / TM Owner

Teva B.V

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Indications & Clinical Uses

Itraconazole is an azole antifungal that acts on a broad range of fungal pathogens, making it suitable for several clinical indications.

  • Dermatophytosis: resolves skin infections caused by dermatophyte fungi.
  • Onychomycosis: eradicates fungal infection of the nails.
  • Systemic mycoses (e.g., aspergillosis, blastomycosis, histoplasmosis): treats deep‑seated fungal diseases.
  • Candida infections: clears invasive or mucosal candidiasis.

How It Works

  • Itraconazole inhibits the fungal cytochrome P450 enzyme lanosterol 14α‑demethylase, preventing conversion of lanosterol to ergosterol. The resulting depletion of ergosterol disrupts the fungal cell membrane, leading to impaired cell growth and eventual death of the organism.

Side Effects

Adverse reactions may occur with itraconazole therapy.

Common Side Effects

  • Nausea: mild to moderate stomach upset.
  • Headache: transient cranial discomfort.
  • Abdominal pain: cramping or discomfort in the abdomen.
  • Rash: skin redness or itching.
  • Taste disturbance: altered or reduced 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 heart failure symptoms.
  • Visual disturbances: blurred vision or photopsia.
  • Severe allergic reactions: anaphylaxis or angioedema.
  • Acute pancreatitis: sudden abdominal pain with elevated enzymes.

Precautions & Warnings

Before initiating therapy, clinicians should consider several safety measures.

  • Liver function monitoring: assess baseline enzymes and repeat during treatment.
  • Drug interaction review: avoid concomitant strong CYP3A4 inhibitors.
  • Cardiac assessment: use cautiously in patients with existing heart failure.
  • Pregnancy risk: avoid use unless benefits outweigh potential risks.
  • Hypersensitivity: discontinue if allergic reaction occurs.
  • Store at below 25°C: keep in the original pack, protect from moisture.

Avoid Interactions

Itraconazole has a notable potential for drug‑drug interactions that require careful management.

Major Interactions (Avoid)

  • Strong CYP3A4 inhibitors (e.g., ketoconazole, ritonavir): may cause toxic itraconazole levels.
  • Certain statins (e.g., simvastatin): increased risk of myopathy.
  • Anti‑arrhythmics (e.g., quinidine): may lead to cardiac conduction abnormalities.

Moderate Interactions (Monitor Closely)

  • Rifampin and other CYP3A4 inducers: may reduce itraconazole efficacy.
  • Oral contraceptives: may decrease contraceptive effectiveness.

Frequently Asked Questions

Itraconazol Actavis contains itraconazole, an azole antifungal indicated for the treatment of dermatophytosis, onychomycosis, systemic mycoses such as aspergillosis, blastomycosis and histoplasmosis, and various Candida infections. It is prescribed by a qualified health professional based on the specific fungal infection and patient condition.

Itraconazole blocks the fungal enzyme lanosterol 14α‑demethylase, a key step in ergosterol synthesis. By preventing ergosterol formation, the drug disrupts the integrity of the fungal cell membrane, inhibiting growth and leading to cell death. This mechanism is effective against a wide range of yeasts and molds.

The dosage of itraconazole is individualized by the prescribing clinician according to the infection type, severity, patient weight, age, and renal or hepatic function. Dosing regimens can vary from a single daily dose to divided doses, and the prescriber determines the appropriate schedule and duration.

Itraconazole is classified as pregnancy category unknown, and its safety has not been established in pregnant or nursing women. Health professionals generally advise avoiding the drug during pregnancy and lactation unless the potential benefit justifies the potential risk to the fetus or infant.

To place an order, submit an enquiry on the product page at gnhindia.com, specifying the required quantity of Itraconazol Actavis. 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.

Itraconazole offers a broad spectrum of activity against dermatophytes, yeasts and molds, and it has a higher tissue penetration in skin, nails and lungs compared with fluconazole. However, it is metabolized by CYP3A4 and therefore has more potential for drug interactions than some newer azoles such as posaconazole.

Store the product at temperatures below 25 °C, in its original packaging, and protect it from moisture and direct sunlight. Do not expose the capsules to excessive heat or humidity, and keep them out of reach of children. Follow any additional handling instructions provided on the label.

Itraconazol Actavis is administered orally, typically as a capsule taken with food or a full glass of water to enhance absorption. The exact administration schedule, including whether it is taken once daily or divided doses, is determined by the prescribing clinician based on the infection being treated.

Serious adverse events include hepatotoxicity (elevated liver enzymes or liver failure), severe skin reactions such as Stevens‑Johnson syndrome, cardiac failure in patients with pre‑existing heart disease, and rare visual disturbances. Patients should report any signs of liver injury, rash, shortness of breath or vision changes promptly.

Itraconazole is contraindicated in individuals with known hypersensitivity to itraconazole or any azole antifungal, in patients with severe liver impairment, and in those taking strong CYP3A4 inducers that could markedly reduce drug exposure. Caution is also advised for patients with existing heart failure.

Published by

GNH India Pharmaceuticals Limited

Licensed pharmaceutical supplier

Last updated:

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