Human Health Division (HHD) Products
Product List by Generic Name
Itraconazole
Composition
Itracon 100 capsule: Each capsule contains Itraconazole pellets
equivalent to Itraconazole USP 100 mg.
Itracon 200 Tablet: Each film coated tablet contains Itraconazole USP
200 mg.
Pharmacology
Itracon is a preparation of Itraconazole, an orally active triazole
antifungal agent, having broad spectrum activity and 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.
Indication
Itracon 100 mg capsule: Tinea corporis, Tinea cruris, Tinea pedis,
Tinea manuum, Vulvovaginal candidiasis, Fungal keratitis, Pityriasis
versicolor, Oropharyngeal candidiasis, Onychomycosis, Histoplasmosis,
Systemic Infections: (Aspergillosis, Candidiasis and Cryptococcus
infection when other drugs are ineffective) Antifungal prophylaxis: To
prevent systemic fungal infection in severely neutropenic patients.
Itracon 200 mg tablet: It is an azole antifungal, indicated for the
treatment of onychomycosis of the toenail caused by Trichophyton
rubrum or T. mentagrophytes.
Dose & Administration
For oral use only
Tinea corporis, Tinea cruris : 100 mg daily for 2 weeks.
Tinea pedis, Tinea manuum : 100 mg daily for 4 weeks.
Vulvovaginal candidiasis : 200 mg twice daily for 1 day
Fungal keratitis : 200 mg daily for 3 weeks.
Pityriasis versicolor : 200 mg daily for 1 week.
Oropharyngeal candidiasis : 100 mg daily (200 mg for
immunocompromised patient
patients) for 15 days.
Onychomycosis: 200 mg daily for 3 months; or 200 mg twice daily for
7 days (course), subsequent courses to be repeated after 21 days
interval; fingernails 2 courses and toenails 3 courses.
Histoplasmosis: 200 mg 1-2 times daily.
Systemic Infections: (Aspergillosis, Candidiasis and Cryptococcus
infection when other drugs are ineffective) 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 100 mg daily.
Or as directed by the physician.
Contraindication
The drug is contraindicated in patients with 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.
Warnings and Precautions
Hepatic enzyme value should be monitored in patients with
pre-existing hepatic function abnormalities. It should also be monitored
periodically in all patients receiving continuous treatment for more than
one month or at any time a patient develops sign and symptoms
suggestive liver dysfunction.
Side Effects
Nausea, abdominal pain, dyspepsia, constipation, headache,
dizziness, raised liver enzymes, hepatitis, cholestatic jaundice,
peripheral neuropathy have been reported.
Use in Pregnancy and Lactation
Not recommended during pregnancy & lactation, unless otherwise
indicated by physician.
Use in Children & Adolescents
The efficacy and safety of Itraconazole capsule have not been
established in paediatric patients and adolescents.
Drug Interaction
Itraconazole inhibits the metabolism of Cyclosporine and Warfarin.
Interaction with Terfinadine, Phenobarbitone, Midazolam has been
reported.
Overdose
There is no experience of overdosage with itraconazole.
Storage
Store below 30°C, protected from light & in a dry place.
Keep all medicines out of the reach of children.
Packing
Itracon 100 capsule: Each box contains 6X4 capsules in Alu-Alu blister
pack and an insert.
Itracon 200 Tablet: Each box contains 2X10 tablets in Alu-Alu blister
pack and an insert.
