Agencia Lei Va Hong
Concise Prescribing Info
Treatment of invasive aspergillosis, fusariosis, chromoblastomycosis & mycetoma, coccidioidomycosis, zygomycosis, oropharyngeal candidiasis. Prophylaxis of invasive fungal infections in patients receiving remission-induction chemotherapy & hematopoietic stem cell transplant recipients.
Dosage/Direction for Use
Refractory invasive fungal infections (IFI)/intolerant patients w/ IFI 400 mg (10 mL) bd, or 200 mg (5 mL) qds in patient who cannot tolerate meal or nutritional supplement. Oropharyngeal candidiasis Loading dose: 200 mg (5 mL) once daily on 1st day, then 100 mg (2.5 mL) once daily for 13 days. Prophylaxis of invasive fungal infections 200 mg (5 mL) tds.
Should be taken with food: Take w/ a meal or w/ a nutritional supplement in patients who cannot tolerate food.
Hypersensitivity. Co-administration w/ ergot alkaloids; CYP3A4 substrates (terfenadine, astemizole, cisapride, pimozide, halofantrine or quinidine); HMG-CoA reductase inhibitors (simvastatin, lovastatin & atorvastatin).
Special Precautions
Hypersensitivity to other azoles. Reports of abnormal liver function tests &/or clinical hepatitis; cholestasis or hepatic failure. Consider discontinuation in case of signs & symptoms consistent w/ liver disease. Patients w/ congenital or acquired QTc prolongation, cardiomyopathy, sinus bradycardia, existing symptomatic arrhythmias. Monitor & correct electrolyte disturbances (eg, K, Mg or Ca levels) prior to & during therapy. GI dysfunction (eg, severe diarrhoea). Concomitant use w/ vincristine, rifamycin antibacterials (rifampicin, rifabutin), certain anticonvulsants (phenytoin, carbamazepine, phenobarb, primidone), efavirenz & cimetidine. Glucose-galactose malabsorption. May potentially affect driving or operating machinery. Hepatic impairment. Women of childbearing potential have to use effective contraception during treatment. Pregnancy & lactation. Adolescents & childn <18 yr.
Adverse Reactions
Nausea. Neutropenia; electrolyte imbalance, anorexia, decreased appetite, hypokalaemia, hypomagnesaemia; paresthesia, dizziness, somnolence, headache, dysgeusia; HTN; vomiting, abdominal pain, diarrhoea, dyspepsia, dry mouth, flatulence, constipation, anorectal discomfort; raised liver function tests (increased ALT, AST, bilirubin, alkaline phosphatase, GGT); rash, pruritis; pyrexia (fever), asthenia, fatigue.
Drug Interactions
Increased plasma conc w/ P-gp inhibitors (eg, verapamil, ciclosporin, quinidine, clarithromycin, erythromycin). Decreased plasma conc w/ P-gp inducers (eg, rifampicin, rifabutin, certain anticonvulsants). Decreased Cmax & AUC w/ rifabutin; efavirenz; fosamprenavir; phenytoin; cimetidine. Reduction in bioavailability may occur w/ H2 receptor antagonists (eg, famotidine, ranitidine) & other proton-pump inhibitors (eg, omeprazole). Increased exposure (AUC) of IV midazolam. Increased plasma conc of CYP3A4 substrates (eg, terfenadine, astemizole, cisapride, pimozide, halofantrine or quinidine); ergot alkaloids (ergotamine & dihydroergotamine); HMG-CoA reductase inhibitors (eg, simvastatin, lovastatin & atorvastatin); vinca alkaloids (eg, vincristine & vinblastine); digoxin. Increased Cmax & AUC of rifabutin; tacrolimus; sirolimus; HIV PIs (eg, atazanavir). Increased conc of ciclosporin. May prolong sedation effect of benzodiazepines metabolised by CYP3A4 (eg, midazolam, triazolam, alprazolam). Ca channel blockers metabolised through CYP3A4 (eg, diltiazem, verapamil, nifedipine, nisoldipine). Decreased glucose conc w/ glipizide.
MIMS Class
ATC Classification
J02AC04 - posaconazole ; Belongs to the class of triazole derivatives. Used in the systemic treatment of mycotic infections.
Noxafil oral susp 40 mg/mL
105 mL x 1's
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