Itraconazol Sandoz (Itraconazole)

Itraconazole is an azole antifungal used to treat infections caused by susceptible fungi.

• Superficial mycoses: effective against dermatophyte infections of skin, hair and nails.
• Systemic candidiasis: clears bloodstream and organ involvement caused by Candida species.
• Blastomycosis: treats pulmonary and disseminated infection caused by Blastomyces dermatitidis.
• Histoplasmosis: manages acute and chronic disease due to Histoplasma capsulatum.
• Aspergillosis: used for invasive disease caused by Aspergillus species.

• Itraconazole inhibits the fungal cytochrome P450 enzyme lanosterol 14α‑demethylase, a key step in ergosterol synthesis. By blocking this enzyme, the drug disrupts the formation of the fungal cell membrane, leading to increased membrane permeability and inhibition of fungal growth. The effect is fungistatic against most susceptible organisms and fungicidal at higher concentrations.

Itraconazole may cause a range of adverse reactions, varying from mild to severe.

Common Side Effects

• Nausea: mild to moderate stomach upset.
• Headache: transient cranial discomfort.
• Diarrhea: loose stools, often self‑limiting.
• Elevated liver enzymes: mild transaminase increase without symptoms.

Serious or Rare Side Effects

• Hepatotoxicity: severe liver injury, jaundice, or hepatitis.
• Congestive heart failure: fluid retention leading to worsening cardiac function.
• Severe skin reactions: Stevens‑Johnson syndrome or toxic epidermal necrolysis.

Before initiating itraconazole therapy, several safety considerations should be reviewed.

• Liver function monitoring: assess hepatic enzymes before treatment and periodically during therapy.
• Cardiac assessment: avoid use in patients with existing heart failure or significant ventricular dysfunction.
• Drug‑induced QT prolongation: evaluate baseline ECG in patients at risk for arrhythmias.
• Pregnancy and lactation: use only if potential benefit outweighs risk, as safety data are limited.
• Concomitant medications: review for potential interactions that may alter itraconazole levels.
• Store at ambient temperature: keep below 25 °C, retain in original packaging, protect from moisture and direct light.

Itraconazole interacts with several medicines; awareness of the interaction level guides clinical management.

Major Interactions (Avoid)

• Rifampicin: strong inducer reduces itraconazole exposure, compromising efficacy.
• St. John’s wort: herbal inducer markedly lowers plasma concentrations.
• Certain antiretrovirals (e.g., efavirenz): decrease itraconazole levels, risking treatment failure.

Moderate Interactions (Monitor Closely)

• Statins (simvastatin, lovastatin): increased risk of myopathy; dose adjustment may be needed.
• Calcium channel blockers (verapamil, diltiazem): may raise itraconazole levels, requiring monitoring.
• Proton pump inhibitors: can reduce absorption of itraconazole capsules, consider timing or alternative acid suppression.