Axita is used for the treatment of oropharyngeal candidiasis, vulvovaginal candidiasis, pityriasis versicolor, tinea pedis, tinea cruris, tinea corporis, tinea manuum, onychomycosis, histoplasmosis. It is indicated in the treatment of systemic candidiasis, aspergillosis, and cryptococcosis (including ... Read more Axita is used for the treatment of oropharyngeal candidiasis, vulvovaginal candidiasis, pityriasis versicolor, tinea pedis, tinea cruris, tinea corporis, tinea manuum, onychomycosis, histoplasmosis. It is indicated in the treatment of systemic candidiasis, aspergillosis, and cryptococcosis (including cryptococcal meningitis). It is also used for maintenance therapy in AIDS patients to prevent relapse of underlying fungal infections and in the prevention of fungal infection during prolonged neutropenia.
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. Being integral to the proper functioning of the cell membrane, inhibition of the synthesis of ergosterol leads to a cascade of abnormalities in permeability, membrane bound enzyme activity, and co-ordination of chitin synthesis leading to inhibition of growth, abnormal cell wall formation and accumulation of intracellular lipids and membranous vesicles. SUBA (Super Bio-available) technology is a novel technology for enhancing the bioavailability of poorly soluble drugs. This technology utilizes a solid dispersion of drug in a polymer that improves the dissolution of poorly soluble drugs compared to their normal crystalline form. SUBA technology Itraconazole is an orally active triazole antifungal drug that has demonstrated a broad spectrum of activity and favorable pharmacokinetic profile.
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For non-systemic fungal disease: Indication Dose & Duration Pityriasis versicolor Treatment doses : Children >4 weeks to <12 years old: Usual dose: 1.25-2 mg/kg/dose (to a maximum initial dose of 100 mg) given twice daily. Dose should be adjusted based on therapeutic drug monitoring. The dose may be increased to 5 mg/kg/dose (to a maximum initial dose of 100 mg) given twice daily for severe infections. The maximum daily dose may be increased based on therapeutic drug monitoring in discussion with the physicians. The dose should be rounded to the nearest 50 mg to facilitate administration. Children ≥12 years old: Usual dose: 50 mg to 100 mg once daily. Dose may be increased to 100 mg twice daily in severe infections. Prophylaxis doses : Children ≥2 years old: 2.5 mg/kg/dose given once daily (to a maximum initial dose of 200 mg daily). Dose should be adjusted based on therapeutic drug monitoring. Tinea corporis and tinea cruris Tinea pedis and tinea manuum Oropharyngeal Candidiasis Onychomycosis (toenails with or without fingernail involvement) For systemic fungal disease: Indication Dose & Duration Aspergillosis Treatment doses : Children >4 weeks to <12 years old: Usual dose: 1.25-2 mg/kg/dose (to a maximum initial dose of 100 mg) given twice daily. Dose should be adjusted based on therapeutic drug monitoring. The dose may be increased to 5 mg/kg/dose (to a maximum initial dose of 100 mg) given twice daily for severe infections. The maximum daily dose may be increased based on therapeutic drug monitoring in discussion with the physicians. The dose should be rounded to the nearest 50 mg to facilitate administration. Children ≥12 years old: Usual dose: 50 mg to 100 mg once daily. Dose may be increased to 100 mg twice daily in severe infections. Prophylaxis doses : Children ≥2 years old: 2.5 mg/kg/dose given once daily (to a maximum initial dose of 200 mg daily). Dose should be adjusted based on therapeutic drug monitoring. Candidiasis Non-meningeal Cryptococcosis Cryptococcal Meningitis Histoplasmosis
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 reported. On prolonged use hypokalaemia, oedema and hair loss reported.
Itraconazole is contraindicated in patients with known hypersensitivity to the drug or any ingredient in the formulation. Patients who have 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.
The drugs like terfenadine, astemizole, cisapride, HMG-CoA reductase inhibitors such as simvastatin, oral midazolam or triazolam should not be given concurrently with Axita. Significant interactions also observed during co-administration of rifampin, phenytoin, phenobarbital, digoxin, and calcium channel blockers. There is no experience of overdosage with Axita.
Absorption is impaired when gastric acidity is reduced. In patients receiving acid neutralizing medicines (e.g. aluminium hydroxide), these should be administered at least 2 hours after the intake of Axita. 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. It is therefore, advised to monitor liver function in patients receiving continuous treatment of more than one month.