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Indications

Itraconazole is indicated in-

  • Tinea corporis, Tinea cruris, Tinea pedis, Tinea manus,
  • Vulvovaginal candidiasis,
  • Fungal keratitis,
  • Pityriasis versicolor,
  • Oropharyngeal candidiasis,
  • Onychomycosis,
  • Histoplasmosis,
  • Systemic Infections: (Aspergillosis, Candidiasis and Cryptococcus when other drugs are effective)
  • Antifungal prophylaxis: To prevent systemic fungal infection in severely neutropenic patients.

Pharmacology

Itraconazole is an orally active triazole antifungal agent, having broad-spectrum activity and a favourable pharmacokinetic profile. Itraconazole inhibits cytochrome p-450 dependent enzymes resulting in impairment of the biosynthesis of ergoesterol, a major component of the cell membrane of yeast and fungal cells.

Dosage And Administration

Tinea corporis, Tinea cruris: 100 mg daily for 2 weeks.

Tinea pedis, Tinea manus: 100 mg daily for 4 weeks.

Vulvovaginal candidiasis: 200 mg twice daily for 1 day or 200 mg daily for 3 days.

Fungal keratitis: 200 mg daily for 3 weeks.

Pityriasis versicolor: 200 mg daily for 1 week.

Oropharyngeal candidiasis: 100 mg daily (200 mg for AIDS patients) for 15 days.

Onychomycosis: 200 mg daily for 3 months; or 200 mg twice daily for 7 days (course), subsequent courses repeated after 21 day interval; fingernails 2 courses and toenails 3 courses.

Histoplasmosis: 200 mg 1-2 times daily.

Systemic Infections: (Aspergillosis, Candidiasis and Cryptococcus when other drugs are effective) 200 mg once daily, increased in invasive or in cryptococcal meningitis to 200 mg twice daily.

Antifungal prophylaxis: To prevent systemic fungal infection in severely neutropenic patients: 100mg daily. Or as directed by the physician.

Interaction

Itraconazole inhibits the metabolism of Cyclosporine and Warfarin. Interaction with Terfenadine, Phenobarbitone, Midazolam has been reported.

Contraindications

The drug is contraindicated in patients with a known history of hypersensitivity to it. The drug is also contraindicated in pregnant women and patients with known severe hepatic disease. It is also contraindicated with Rifampicin therapy.

Side Effects

Nausea, abdominal pain, dyspepsia, constipation, headache, dizziness, raised liver enzymes, hepatitis, cholestatic jaundice, peripheral neuropathy have been reported.

Pregnancy And Lactation

Not recommended during pregnancy & lactation, unless otherwise indicated by the physician.

Precautions And Warnings

Hepatic enzyme value should be monitored in patients with preexisting hepatic function abnormalities. It should also be done periodically in all patients receiving continuous treatment for more than one month or at any time a patients develops sign and symptoms suggestive liver dysfunction.

Overdose Effects

There is no experience of overdosage with itraconazole.

Therapeutic Class

Drugs for subcutaneous and mycoses

Use in special populations

The efficacy and safety of the Itraconazole capsule have not been established in pediatric patients.

Storage Conditions

Store below 30°C, away from light & in a dry place. Keep out of the reach of children.