Itraconazole GPO

Itraconazole GPO

itraconazole

Manufacturer:

GPO

Distributor:

GPO
Concise Prescribing Info
Contents
Itraconazole
Indications/Uses
Susceptible fungal infections in immunocompromised & immunocompetent patients including blastomycosis & histoplasmosis; aspergillosis (in patients intolerant/refractory to amphotericin B), & onychomycosis of the toenail & fingernail (in nonimmunocompromised patients).
Dosage/Direction for Use
Adult 100-400 mg/day. Doses >200 mg/day are given in 2 divided doses. Max dose: 400 mg/day. Aspergillosis, invasive (salvage therapy) 200-400 mg/day for 6-12 wk. Aspergillosis, allergic (ABPA, sinusitis) 200 mg/day in conjunction w/ corticosteroids. Blastomycosis 200 mg tid for 3 days, then 200 mg bid for 6-12 mth. Brain abscess: Cerebral phaeohyphomycosis (dematiaceous) 200 mg bid for at least 6 mth. Coccidioidomycosis 200 mg bid. Histoplasmosis 200 mg tid for 3 days, then 200 mg bid. Mild to moderate histoplasmosis 200 mg tid for 3 days, then 200 mg once daily for 6-12 wk. Progressive disseminated or chronic cavitary pulmonary histoplasmosis ≥12 mth. Long-term suppression therapy: 200 mg/day. Meningitis: Coccidioides 400-800 mg/day. Onychomycosis 200 mg once daily for 12 consecutive wk. Alternative "pulse-dosing" may be considering for fingernail involvement only: 200 mg bid for 1 wk; repeat 1-wk course after 3-wk off-time. Pneumonia: Coccidioides Mild-moderate: 200 mg bid, coccidioides, HIV-positive (focal pneumonia) 200 mg tid for 3 days, then 200 mg bid. Protothecal infection 200 mg once daily for 2 mth. Sporotrichosis: Lymphocutaneous 100-200 mg/day for 3-6 mth, osteoarticular & pulmonary 200 mg bid for 1-2 yr. Patients w/ renal impairment (CrCl <10 mL/min) 50% of normal dose. Continuous renal replacement therapy/Hemodialysis 200 mg every 12 hr for 4 doses, then 200 mg every 24 hr.
Administration
Should be taken with food: Take immediately after a full meal.
Contraindications
Hypersensitivity. Concurrent administration w/ cisapride, dofetilide, ergot derivatives, levomethadyl, lovastatin, midazolam (oral), nisoldipine, pimozide, quinidine, simvastatin, or triazolam; treatment of onychomycosis (or other non-life-threatening indications) in patients w/ evidence of ventricular dysfunction, heart failure or a history of heart failure. Pregnancy.
Special Precautions
Transient or permanent hearing loss. Patients w/ risk factors for heart failure (COPD, renal failure, edematous disorders, ischemic or valvular disease). Patients w/ preexisting hepatic impairment. Monitor liver function closely. Not recommended for patients w/ active liver disease, elevated liver enzymes or prior hepatotoxic reactions to other drugs. Discontinue or reassess use if signs or symptoms of heart failure occur during treatment. Cystic fibrosis. Not recommended for treatment of onychomycosis in patients w/ ventricular dysfunction or history of heart failure. Concurrent use w/ Ca channel blockers; concurrent use w/ nisoldipine, cisapride, pimozide, quinidine, dofetilide or levomethadyl, ergot derivatives, lovastatin, midazolam, simvastatin & triazolam are contraindicated. Hepatic & renal impairment. Use effective contraception during & for 2 mth following treatment. Pregnancy & lactation.
Adverse Reactions
Nausea, diarrhea. Edema, HTN, chest pain; fever, headache, fatigue, dizziness, depression; rash, pruritus; hypokalemia; vomiting, abdominal pain, constipation; abnormal liver function tests; rhinitis, cough, dyspnea, pneumonia, sinusitis, increased sputum; increased diaphoresis.
Drug Interactions
Increased plasma conc & risk of serious adverse CV effects of antiarrhythmic agents (digoxin, disopyramide, quinidine, dofetilide). Increased plasma conc & risk of toxicty of antilipemic agents (HMG-CoA reductase inhibitors eg, statins). Increase plasma conc of maraviroc. Possible pharmacokinetic interactions w/ antiretroviral agents (HIV PIs eg, atazanavir, darunavir, fosamprenavir, indinavir, lopinavir, nelfinavir, ritonavir, saquinavir, tipranavir). Decreased plasma conc & AUC w/ efavirenz. Possible decreased conc w/ etravirine & nevirapine. Pharmacokinetic interaction & potential serious adverse CV effects w/ antihistamines (astemizole, terfenadine). May increase plasma conc of benzodiazepines (alprazolam, diazepam, midazolam, triazolam). Possible increased conc of Ca-channel blockers (nifedipine, nisoldipine, felodipine, verapamil); carbamazepine, cilostazol, corticosteroids, eletriptan, ergot alkaloids, fentanyl (potential for fatal resp depression), pimozide, phosphodiesterase type 5 inhibitors (sildenafil, tadalafil, vardenafil).
MIMS Class
Antifungals
ATC Classification
J02AC02 - itraconazole ; Belongs to the class of triazole and tetrazole derivatives. Used in the systemic treatment of mycotic infections.
Presentation/Packing
Form
Itraconazole GPO cap 100 mg
Packing/Price
10 × 10's
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