Itraclean

Itraconazole

Composition:

Itraclean 100 mg Capsule: Each capsule contains Itraconazole IR pellets equivalent to Itraconazole USP 100 mg.

Pharmacology:

Itraconazole is a triazole antifungal drug that has broad spectrum activity in fungal infections. Itraconazole inhibits Cytochrome P-450 dependent enzymes resulting in impairment of the biosynthesis of ergosterol, a major component of the cell membrane of yeast and fungal cells. It affects membrane-bound enzyme activity and causes abnormalities in permeability, leading to inhibition of growth, abnormal cell wall formation and structural degeneration of the fungal organism.

Indications:

Itraconazole is indicated for the treatment of:

• Tinea corporis

• Tinea cruris

• Tinea pedis

• Tinea manuum

• Pityriasis versicolor

• Aspergillosis

• Onychomycosis

• Oropharyngeal candidiasis

• Histoplasmosis

• Systemic candidiasis

• Systemic aspergillosis

• Cryptococcosis, including cryptococcal meningitis

• Maintenance therapy in AIDS patients to prevent relapse of underlying fungal infections

• Prevention of fungal infection during prolonged neutropenia

Dosage & Administration:

Recommended dosage schedule of Itraclean Capsule:

• Tinea corporis, Tinea cruris: 100 mg once daily for 15 days or 200 mg once daily for 7 days.

• Tinea pedis, Tinea manuum: 100 mg once daily for 30 days.

• Onychomycosis: Either 200 mg daily for 3 months or 200 mg twice daily for 7 days, with subsequent courses repeated after a 21-day interval. Fingernails require two courses and toenails require three courses.

• Pityriasis versicolor: 200 mg once daily for 7 days.

• Oropharyngeal candidiasis: 100 mg once daily for 15 days. Increase to 200 mg once daily for 15 days in AIDS or neutropenic patients because of impaired absorption.

• Systemic candidiasis: 100–200 mg once daily for 3–7 months. Increase to 200 mg twice daily in case of invasive or disseminated disease.

• Vulvovaginal candidiasis: 200 mg twice daily for 1 day.

• Aspergillosis: 200 mg once daily for 2–5 months. Increase to 200 mg twice daily in case of invasive or disseminated disease.

• Systemic cryptococcosis including cryptococcal meningitis: 200 mg twice daily for 2–6 months.

• Histoplasmosis: 200 mg once daily to twice daily for 8 months.

• Maintenance in AIDS: 200 mg once daily until immune recovery.

• Prophylaxis in neutropenia: 200 mg once daily until immune recovery.

Contraindications:

Itraconazole is contraindicated in patients with known hypersensitivity to the drug or any ingredient in the formulation. Patients with severe hepatic disease are not advised to take Itraconazole. It is not advisable to use the drug in patients taking rifampin, which appears to initially inhibit and then enhance the metabolism of Itraconazole.

Warning & Precaution:

Absorption is impaired when gastric acidity is reduced. In patients receiving acid-neutralizing medicines such as aluminium hydroxide, these should be administered at least 2 hours after the intake of Itraconazole. The drug should be administered after a full meal. Rarely, cases of hepatitis and jaundice have been reported, mainly in patients treated for longer than one month. Therefore, it is advised to monitor liver function in patients receiving continuous treatment for more than one month.

Side Effects:

Nausea, abdominal pain, dyspepsia, constipation, headache, dizziness, raised liver enzymes, menstrual disorders, allergic reactions including pruritus, rash, urticaria and angioedema, hepatitis and cholestatic jaundice, peripheral neuropathy and Stevens-Johnson syndrome have been reported. On prolonged use, hypokalaemia, oedema and hair loss have been reported.

Drug Interactions:

Drugs like terfenadine, astemizole, cisapride, HMG-CoA reductase inhibitors such as simvastatin, oral midazolam or triazolam should not be co-administered with Itraconazole. Rifampin, phenytoin, phenobarbital, digoxin and calcium channel blockers may affect the metabolism or efficacy of Itraconazole.

Use in Pregnancy & Lactation:

Itraconazole is contraindicated in pregnancy. Breastfeeding while receiving Itraconazole is not recommended.

Overdose:

Itraconazole is not removed by dialysis. In the event of accidental overdosage, supportive measures should be employed. Activated charcoal may be given if considered appropriate.

Storage:

Store below 30°C, protected from light and moisture. Store in a dry and cool place. Keep out of reach of children.

Packing:

Itraclean 100 mg Capsule: Each box contains 30 capsules in Alu-Alu blister pack.