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

Itrakonazol Actavis

Active Ingredient:
Itraconazole
Origin:
EU

Itrakonazol Actavis (Itraconazole)

Itraconazole, the active ingredient in Itrakonazol Actavis, is a azole antifungal presented as an oral formulation for systemic use. It treats a range of deep‑tissue and cutaneous fungal infections in adult patients.

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

Manufacturer / TM Owner

Actavis Group Ptc Ehf.

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Indications & Clinical Uses

Itrakonazol Actavis is an azole antifungal used to manage systemic and localized fungal infections.

  • Aspergillosis: eradicates invasive Aspergillus species and prevents disease progression.
  • Blastomycosis: clears Blastomyces dermatitidis infection in pulmonary and disseminated forms.
  • Histoplasmosis: resolves Histoplasma capsulatum infection, especially in immunocompromised hosts.
  • Coccidioidomycosis: treats Coccidioides immitis/posadasii infections of the lungs and other sites.
  • Dermatophytosis: eliminates skin‑surface dermatophyte infections resistant to other agents.
  • Onychomycosis: improves nail‑plate involvement caused by dermatophytes and yeasts.

How It Works

  • Itraconazole inhibits the fungal cytochrome P450 enzyme lanosterol 14α‑demethylase, blocking 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.
  • Abdominal pain: cramping or discomfort in the abdomen.
  • Diarrhea: loose stools occurring intermittently.
  • Rash: mild skin irritation or erythema.
  • Elevated liver enzymes: mild increases in hepatic transaminases.

Serious or Rare Side Effects

  • Hepatotoxicity: severe liver injury requiring monitoring.
  • Congestive heart failure: fluid retention and reduced cardiac output.
  • Severe skin reactions: Stevens‑Johnson syndrome or toxic epidermal necrolysis.
  • QT prolongation: potential cardiac arrhythmias.
  • Visual disturbances: blurred vision or photopsia.
  • Hepatic failure: rare but life‑threatening liver dysfunction.

Precautions & Warnings

Itrakonazol Actavis requires careful monitoring and patient assessment before and during therapy.

  • Liver function monitoring: check transaminases before initiation and periodically thereafter.
  • Cardiac assessment: evaluate for heart failure history prior to use.
  • Drug interaction review: assess concomitant CYP3A4 substrates and inhibitors.
  • Renal impairment caution: adjust therapy in severe kidney disease.
  • Hypersensitivity avoidance: discontinue if allergic reactions occur.
  • Store at room temperature: keep in the original pack, protect from moisture and direct sunlight.

Avoid Interactions

Itrakonazol Actavis can alter the plasma concentrations of several co‑administered drugs.

Major Interactions (Avoid)

  • Simvastatin and other strong CYP3A4 substrates: risk of severe myopathy.
  • Rifampin: potent inducer that reduces itraconazole exposure.
  • Ketoconazole: additive CYP3A4 inhibition leading to toxicity.

Moderate Interactions (Monitor Closely)

  • Warfarin: may increase anticoagulant effect, monitor INR.
  • Oral contraceptives: efficacy may be reduced, advise backup method.
  • Digoxin: possible increase in serum levels, observe for toxicity.

Frequently Asked Questions

Itrakonazol Actavis contains itraconazole, an azole antifungal indicated for systemic mycoses such as aspergillosis, blastomycosis, histoplasmosis, coccidioidomycosis, as well as cutaneous infections like dermatophytosis and onychomycosis.

Itraconazole blocks the fungal enzyme lanosterol 14α‑demethylase, a cytochrome P450 isoform, preventing ergosterol synthesis. Without ergosterol, the fungal cell membrane becomes defective, inhibiting growth and leading to cell death.

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

Safety data for itraconazole in pregnancy and lactation are limited. It should only be used if the potential benefit justifies the potential risk to the fetus or infant, and the decision must be made by a qualified healthcare professional.

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 and any required import documentation.

Compared with other azoles, itraconazole offers a broad spectrum against dimorphic fungi and dermatophytes and has a longer half‑life, allowing once‑daily dosing in many regimens. However, it has a higher potential for drug‑drug interactions than newer agents such as posaconazole.

Store Itrakonazol Actavis at room temperature, below 25 °C, in the original container. Keep the product away from moisture, heat, and direct sunlight to maintain stability.

Itrakonazol Actavis is taken orally, usually with food or a full glass of water to enhance absorption. The exact administration schedule, including whether it should be taken with an acidic beverage, is determined by the prescriber.

Serious risks include hepatotoxicity, congestive heart failure, severe skin reactions such as Stevens‑Johnson syndrome, and QT‑interval prolongation. Patients should be monitored for signs of liver injury, cardiac symptoms, and unusual skin changes.

Patients with known hypersensitivity to itraconazole or any azole antifungal, those with existing severe heart failure, or individuals taking contraindicated medications that cause dangerous interactions should avoid using Itrakonazol Actavis.

Published by

GNH India Pharmaceuticals Limited

Licensed pharmaceutical supplier

Last updated:

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