Concise Prescribing Info
Vulvovaginal candidosis; pityriasis versicolor; dermatophytoses eg, tinea pedis, cruris, corporis & manuum; oropharyngeal candidosis; onychomycosis; histoplasmosis. Conditions when 1st-line therapy is inappropriate or proven ineffective ie, aspergillosis & candidosis; immunocompromised patients w/ cryptococcosis & in all patients w/ cryptococcosis of the CNS; maintenance therapy in AIDS patients to prevent relapse of underlying fungal infection. Prophylaxis of fungal infection during prolonged neutropenia.
Dosage/Direction for Use
Vulvovaginal candidiasis 200 mg bd for 1 day. Pityriasis versicolor 200 mg once daily for 7 days. Tinea corporis & cruris 100 mg once daily for 15 days or 200 mg once daily for 7 days. Tinea pedis & manuum 100 mg once daily for 30 days. Oropharyngeal candidosis 100 mg once daily for 15 days. Increase to 200 mg once daily in patients w/ AIDS or neutropenia. Onychomycosis (toenails w/ or w/o fingernail involvement) 200 mg once daily for 3 mth. Aspergillosis 200 mg once daily, increase to 200 mg bd in case of invasive or disseminated disease. Candidosis 100-200 mg once daily, increase to 200 mg bd in case of invasive or disseminated disease. Non-meningeal cryptococcosis 200 mg once daily. Cryptococcal meningitis 200 mg bd. Maintenance in AIDS 200 mg once daily. Prophylaxis in neutropenia 200 mg once daily. Histoplasmosis 200 mg once daily to 200 mg bd.
Should be taken with food: Must be taken immediately after meal.
Hypersensitivity. Coadministration w/ CYP3A4 metabolised substrates. Prolonged QT-interval & rare Torsades de pointes occurrence w/ CYP3A4 metabolised substrates eg, astemizole, bepridil, cisapride, dofetilide, levacetylmethadol (levomethadyl), mizolastine, pimozide, quinidine, sertindole & terfenadine; CYP3A4 metabolised HMG-CoA reductase inhibitors eg, atorvastatin, lovastatin & simvastatin; triazolam & PO midazolam; ergot alkaloids eg, dihydroergotamine, ergometrine (ergonovine), ergotamine & methylergometrine (methylergonovine); eletriptan; nisoldipine. Not for non-life threatening indications in patients receiving disopyramide or halofantrine; w/ evidence of ventricular dysfunction eg, CHF or a history of CHF except for the treatment of life-threatening or other serious infections. Women of childbearing potential. Pregnancy.
Special Precautions
Hypersensitivity to other azoles. Not for patients w/ history of CHF; patients w/ risk factors including cardiac diseases eg, ischemic & valvular heart disease, significant pulmonary disease, renal failure & other edematous disorders. Impaired absorption w/ reduced gastric acidity. Achlorhydria. Transient/permanent hearing loss may occur. Oral bioavailability may be decreased in some immunocompromised patients. Not recommended in patients w/ life-threatening systemic fungal infections. AIDS; discontinue if neuropathy occurs. Not for patients w/ rare hereditary problems of fructose intolerance, glucose-galactose malabsorption or sucrase-isomaltase insufficiency. Cross-resistance. Monitor liver function; patients should stop treatment immediately if anorexia, nausea, vomiting, fatigue, abdominal pain or dark urine occurs. Coadministration w/ Ca channel blockers; CYP3A4 inducers. Renal and hepatic impairment. Lactation. Not recommended in childn & in the elderly.
Adverse Reactions
Headache; abdominal pain, nausea. Potentially, toxic epidermal necrolysis, Stevens-Johnson syndrome, acute generalized exanthematous pustulosis, erythema multiforme, exfoliative dermatitis, leukocytoclastic vasculitis, alopecia, photosensitivity.
Drug Interactions
Impaired absorption w/ drugs that reduce gastric acidity. Decreased bioavailability leading to reduced efficacy w/ potent CYP3A4 inducers eg, antibacterials (INH, rifabutin, rifampicin), anticonvulsants (carbamazepine, phenobarb, phenytoin), antivirals (efavirenz, nevirapine). Increased bioavailability w/ potent CYP3A4 inhibitors eg, antibacterials (ciprofloxacin, clarithromycin, erythromycin), antivirals (ritonavir-boosted darunavir & fosemprenavir, indinavir, ritonavir). Increased plasma conc by itraconazole & corresponding advice: Contraindicated: levacetylmethadol (levomethadyl), methadone; disopyramide, dofetilide, dronedarone, quinidine; halofantrine; astemizole, mizolastine, terfenadine; ergot alkaloids [eg, dihydroergotamine, ergometrine (ergonovine), ergotamine, methylergometrine (methylergonovine)]; irinotecan; lurasidone, PO midazolam, pimozide, sertindole, triazolam; bepridil, felodipine; lercanidipine, nisoldipine; ivabradine, ranolazine; eplerenone; cisapride; lovastin, simvastatin; colchicine (in patients w/ renal or hepatic impairment). Not recommended: tamsulosin; fentanyl; rifabutin; rivaroxaban; carbamazepine; dasatinib, nilotinib, trabectedin; aliskiren; everolimus; salmeterol; vardenafil; colchicine. Use w/ caution: alfentanil, buprenorphine (IV & sublingual), oxycodone; digoxin; coumarins, cilostazol, dabigatran; repaglinide, saxagliptin; praziquantel; ebastine; eletriptan; bortezomib, busulphan, docetaxel, erlotinib, ixabepilone, lapatinib, trimetrexate, vinca alkaloids; alprazolam, aripiprazole, brotizolam, buspirone, haloperidol, midazolam IV, perospirone, quetiapine, ramelteon, risperidone; maraviroc, indinavir, ritonavir, saquinavir; nadolol; other dihydropyridines including verapamil; aprepitant, domperidone; budesonide, ciclesonide, ciclosporin, dexamethasone, fluticasone, methylprednisolone, rapamycin (sirolimus), tacrolimus, temsirolimus; atorvastatin; reboxetine; fesoterodine, imidafenacin, sildenafil, solifenacin, tadalafil, tolterodine; alitretinoin (oral formulations), cinacalcet, mozavaptan, tolvaptan.
MIMS Class
ATC Classification
J02AC02 - itraconazole ; Belongs to the class of triazole and tetrazole derivatives. Used in the systemic treatment of mycotic infections.
Eszol FC tab 100 mg
1 × 10's
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