Product image of Itraconazole Focus Pharmaceuticals Ltd (Itraconazole) supplied by GNH India

Itraconazole Focus Pharmaceuticals Ltd

Active Ingredient:
Itraconazole
Origin:
EU

Itraconazole Focus Pharmaceuticals Ltd (Itraconazole)

Itraconazole, the active ingredient in Itraconazole Focus Ltd, is an azole antifungal presented as an oral formulation for systemic use. It treats a range of fungal infections in adults and children, including skin, nail and deep organ infections.

GNH India supplies Itraconazole Focus Ltd 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 sourcing for global healthcare providers. Its distribution network ensures timely delivery across diverse regulatory environments.

Manufacturer / TM Owner

Focus Pharmaceuticals Limited

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Indications & Clinical Uses

Itraconazole is used to treat fungal infections affecting the skin, nails and internal organs.

  • Dermatophytosis: effective in clearing skin infections caused by dermatophyte fungi.
  • Onychomycosis: promotes regrowth of healthy nail tissue by eradicating nail‑plate fungal invasion.
  • Systemic mycoses (e.g., blastomycosis, histoplasmosis, coccidioidomycosis): provides systemic antifungal activity for deep‑seated infections.

How It Works

  • Itraconazole inhibits the fungal enzyme lanosterol 14α‑demethylase, a cytochrome P450 isoform responsible for converting lanosterol to ergosterol. By blocking this step, the drug disrupts ergosterol synthesis, compromising the integrity of the fungal cell membrane and leading to inhibited growth and eventual cell death. Its high affinity for the fungal enzyme results in prolonged intracellular concentrations, enhancing therapeutic effect.

Side Effects

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

Common Side Effects

  • Nausea or vomiting
  • Abdominal pain or dyspepsia
  • Diarrhea
  • Headache
  • Rash or pruritus
  • Elevated liver enzymes (asymptomatic)

Serious or Rare Side Effects

  • Hepatotoxicity with jaundice
  • Severe skin reactions such as Stevens‑Johnson syndrome
  • Cardiac failure or arrhythmias
  • Visual disturbances
  • Peripheral edema
  • Anaphylactic reactions

Precautions & Warnings

When prescribing itraconazole, clinicians should consider several safety precautions to minimize risk.

  • Liver function monitoring: assess baseline enzymes and repeat during therapy.
  • Drug‑interaction review: avoid concomitant use with strong CYP3A4 inhibitors or inducers.
  • Cardiac assessment: caution in patients with heart failure or arrhythmias.
  • Pregnancy and lactation: use only if potential benefit outweighs risk; discuss with obstetrician.
  • Patient counseling: advise on taking with food to enhance absorption and report any rash.
  • Store at ambient temperature: keep below 25 °C in original packaging, protect from moisture.

Avoid Interactions

Itraconazole interacts with several medicines due to its effect on cytochrome P450 enzymes and transport proteins.

Major Interactions (Avoid)

  • Strong CYP3A4 inhibitors (e.g., ketoconazole, clarithromycin): may cause toxic itraconazole levels.
  • Strong CYP3A4 inducers (e.g., rifampicin, carbamazepine): may reduce efficacy.
  • Certain statins (e.g., simvastatin, lovastatin): increased risk of rhabdomyolysis.
  • Digoxin: elevated serum concentrations.
  • Sildenafil: heightened hypotensive effect.

Moderate Interactions (Monitor Closely)

  • Anticoagulants (warfarin): monitor INR for potential increase.
  • Anticonvulsants (phenytoin, phenobarbital): may lower itraconazole exposure.
  • HIV protease inhibitors (ritonavir): may alter plasma levels.
  • Calcium channel blockers (verapamil): possible additive cardiac effects.
  • Oral contraceptives: reduced effectiveness, advise backup method.

Frequently Asked Questions

Itraconazole is an azole antifungal prescribed to treat infections such as dermatophytosis (skin fungus), onychomycosis (nail fungus), and systemic mycoses including blastomycosis, histoplasmosis and coccidioidomycosis. It is used in both adult and pediatric patients when a broad‑spectrum oral antifungal is required.

Itraconazole blocks the fungal enzyme lanosterol 14α‑demethylase, a key step in ergosterol synthesis. By preventing ergosterol formation, the drug destabilises the fungal cell membrane, inhibiting growth and eventually causing cell death. Its selective action targets fungi while sparing human cholesterol pathways.

The specific dose of itraconazole is determined by the prescribing clinician based on the infection type, severity, patient weight, renal and hepatic function, and other individual factors. Healthcare professionals set the regimen and duration according to current clinical guidelines.

Safety data for itraconazole during pregnancy and lactation are limited. It should only be used when the potential benefit justifies any possible risk to the fetus or infant. Physicians should discuss the risk‑benefit profile with the patient and consider alternative therapies when appropriate.

To request itraconazole, 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.

Compared with fluconazole, another azole antifungal, itraconazole has a broader spectrum against dermatophytes and certain systemic fungi but may have more drug‑interaction potential due to stronger CYP3A4 inhibition. Choice between them depends on the pathogen, infection site, patient comorbidities and interaction profile.

Itraconazole 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 bathrooms or other humid environments.

Itraconazole is taken orally, usually with food to improve absorption. The tablet or capsule should be swallowed whole with a full glass of water. Patients should follow the prescribing clinician’s instructions regarding timing, meal composition and any required therapeutic drug monitoring.

Serious risks include hepatotoxicity (liver injury), severe skin reactions such as Stevens‑Johnson syndrome, cardiac failure or arrhythmias, visual disturbances, and rare cases of anaphylaxis. Patients should report any unexplained jaundice, rash, shortness of breath, or vision changes to their healthcare provider promptly.

Itraconazole is contraindicated in individuals with known hypersensitivity to the drug or any azole antifungal. Patients with severe liver impairment, uncontrolled heart failure, or those taking contraindicated medications (e.g., strong CYP3A4 inducers) should avoid its use unless a specialist determines that benefits outweigh risks.

Published by

GNH India Pharmaceuticals Limited

Licensed pharmaceutical supplier

Last updated:

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