Indications |
Oral Oesophageal candidiasis Adult: As oral liquid: 200 mg daily in 1 or 2 divided doses held in the mouth for 20 sec before swallowing. Double the dose in resistant infections. Oral Oral candidiasis Adult: As oral liquid: 200 mg daily in 1 or 2 divided doses held in the mouth for 20 sec before swallowing. Double the dose in resistant infections. Oral Prophylaxis of fungal infections in immunocompromised patients Adult: As oral liquid: 5 mg/kg daily in 2 divided doses. Oral Oropharyngeal candidiasis Adult: As capsule: 100 mg daily for 15 days. Oral Vulvovaginal candidiasis Adult: As capsule: 200 mg bid for 1 day. Oral Pityriasis versicolor Adult: As capsule: 200 mg daily for 7 days. Oral Tinea cruris Adult: As capsule: 100 mg daily for 15 days or 200 mg daily for 7 days. Oral Tinea corporis Adult: As capsule: 100 mg daily for 15 days or 200 mg daily for 7 days. Oral Nail fungal infections Adult: As capsule: 200 mg daily for 3 mth. Alternatively, pulse therapy with 200 mg bid for 7 days, repeated once for fingernail infections and twice for toenail infections after drug-free intervals of 21-days. Oral Systemic fungal infections Adult: As capsule: 100-200 mg once daily, increased to 200 mg bid for invasive or disseminated infections. For life-threatening infections: Loading dose of 200 mg tid for 3 days has been given. Oral Primary or secondary prophylaxis of infections in neutropenic or AIDS patients Adult: As capsule: 200 mg daily increased to 200 mg bid if necessary. Oral Tinea pedis Adult: As capsule: 100 mg daily for 30 days or 200 mg bid for 7 days Oral Tinea manuum Adult: As capsule: 100 mg daily for 30 days or 200 mg bid for 7 days Intravenous Systemic fungal infections Adult: 200 mg infused bid over 1 hr for 2 days. Maintenance: 200 mg daily. |
Contraindications |
Hypersensitivity to azole antifungals; pregnancy and lactation; hepatic disease. IV: CrCl: <30 ml/min. |
Warnings / Precautions |
Renal insufficiency; CHF, history of CHF, COPD; monitor liver function. |
Adverse Reactions |
Dyspepsia, abdominal pain, nausea, vomiting, diarrhoea; menstrual disorders; constipation, rash, pruritus, urticaria; angioedema, anaphylaxis. Increased liver enzyme values, jaundice, Stevens-Johnson syndrome, hypokalaemia. Potentially Fatal: Liver failure; heart failure; pulmonary oedema; CV disease. |
Drug Interactions |
Concentration increased by: clarithromycin, erythromycin, HIV protease inhibitors. Concentration decreased by: carbamazepine, phenobarbital, phenytoin, isoniazid, rifabutin, rifampin, nevirapine. Capsule absorption may be decreased by antacids, H2-receptor antagonists, proton pump inhibitors. Potentially Fatal: Itraconazole is an inhibitor of CYP3A4 and plasma concentrations of many drugs including ciclosporin, digoxin and warfarin may be increased. See Below for More itraconazole Drug Interactions |
Food Interactions |
Increase in absorption rate when capsule form is taken with or just after a meal; decreased when taken as a liquid in the presence of food. |
Mechanism of Actions |
Itraconazole decreases ergosterol biosynthesis by interfering with cytochrome P450 activity. This inhibits cell membrane function of susceptible fungi including Microsporum species, Trichophyton species, Candida species, Cryptococcus neoformans, Histoplasma capsulatum, Blastomyces dermatitidis and Paracoccidiodes brasiliensis. It also has antiprotozoal activity against Leishmania major. Absorption: Absorbed from the GIT, capsule enhanced by acidic gastric environment or when taken with food; oral liquid better absorbed during fasting state. Peak plasma concentrations are achieved after 1.5-5 hr. Distribution: Itraconazole is extensively bound (99.8%) to plasma protein. Widely distributed in skin, sebum, pus and other tissues and organs (higher concentrations compared to plasma). Small amounts are distributed in CSF and breast milk. Metabolism: Undergoes saturable hepatic metabolism (via cytochrome P450 isoenzyme CYP3A4); converted to hydroxyitraconazole (antifungal activity comparable to the parent drug) and other metabolites. Excretion: Via urine or bile (as inactive metabolites), via faeces (3-18% as unchanged), stratum corneum and hair (small amounts); not removed by dialysis. |
Administration |
Oral soln: Should be taken on an empty stomach. (Take on an empty stomach & refrain from eating for at least 1 hr after intake.) Cap: Should be taken with food. (Take immediately after a full meal.) |
Storage Conditions |
Intravenous: Store at ≤25°C. Protect from light and freezing. Oral: Store at 15-25°C. |
ATC Classification |
J02AC02 - itraconazole ; Belongs to the class of triazole derivatives. Used in the systemic treatment of mycotic infections. |
Storage |
Intravenous: Store at ≤25°C. Protect from light and freezing. Oral: Store at 15-25°C. |
Available As |
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Itraconazole
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Itraconazole Containing Brands
Itraconazole is used in following diseases
Drug - Drug Interactions of Itraconazole
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