Noxafil

Noxafil

posaconazole

Manufacturer:

Merck Sharp & Dohme

Distributor:

Zuellig Pharma
Concise Prescribing Info
Contents
Posaconazole
Indications/Uses
Invasive aspergillosis in patients w/ disease refractory to amphotericin B or intolerant to these drugs. Fusariosis, zygomycosis, coccidioidomycosis, chromoblastomycosis & mycetoma in patients w/ disease refractory to other therapy or intolerant to other therapy. Prophylaxis of invasive fungal infections in patients w/ acute myelogenous leukaemia (AML) or myelodysplastic syndrome (MDS), haematopoietic stem cell transplant recipients & who are at high risk of developing these infections. Oral susp: Oropharyngeal candidiasis in immunocompromised adults.
Dosage/Direction for Use
Tab Refractory invasive fungal infections (IFI)/intolerant patient w/ IFI & prophylaxis of invasive fungal infection Loading dose: 300 mg bd on 1st day then 300 mg once daily thereafter. Duration of therapy: AML or MDS Prophylaxis should start several days before the anticipated onset of neutropenia & continue for 7 days after neutrophil count rises >500 cells/mm3. Oral susp Refractory IFI/intolerant patient w/ IFI 400 mg bd; administer 200 mg qds in patients w/ limited oral intake. Oropharyngeal candidiasis in HIV-infected patient Loading dose: 200 mg once daily on 1st day then 100 mg once daily for 13 days. Oropharyngeal candidiasis refractory to itraconazole or fluconazole in HIV-infected patient 400 mg bd. Prophylaxis of invasive fungal infections 200 mg tds.
Administration
Tab: May be taken with or without food: Swallow whole, do not crush/chew/break/dissolve. Oral susp: Should be taken with food: Take w/ a full meal or w/ a liqd nutritional supplement in patients who cannot eat a full meal.
Contraindications
Hypersensitivity. Co-administration w/ ergot alkaloids, HMG-CoA reductase inhibitors, terfenadine, astemizole, cisapride, pimozide, quinidine.
Special Precautions
Hypersensitivity to other azoles. Pro-arrhythmic conditions eg, congenital or acquired QTc prolongation, cardiomyopathy, sinus bradycardia, existing symptomatic arrhythmias. Monitor & correct electrolyte disturbances prior to & during therapy. Concomitant use w/ drugs known to prolong QTc interval, vincristine, adrenal steroid hormones. Severe hepatic & renal impairment. Women of childbearing potential must use effective contraceptive during & for at least 2 wk after therapy. Not to be used during pregnancy & lactation. Not to be used in childn <18 yr. Tab: Not for oropharyngeal candidiasis.
Adverse Reactions
Neutropenia; anorexia, electrolyte imbalance; dizziness, headache, paresthesia, somnolence; abdominal pain, diarrhoea, dyspepsia, flatulence, dry mouth, nausea, vomiting; elevated liver function tests; rash; asthenia, fatigue, fever.
Drug Interactions
Decreased Cmax & AUC by rifabutin, phenytoin, cimetidine, efavirenz, fosamprenavir. Increased plasma conc of terfenadine, astemizole, cisapride, pimozide, quinidine, vinca alkaloids (eg, vincristine & vinblastine), digoxin, HIV PIs. Ergotism w/ ergot alkaloids eg, ergotamine, dihydroergotamine. Elevated cyclosporine levels. Increased Cmax & AUC of tacrolimus, sirolimus, rifabutin, midazolam, simvastatin, HIV PIs (eg, atazanavir). Decreased glucose conc w/ sulfonylureas.
MIMS Class
ATC Classification
J02AC04 - posaconazole ; Belongs to the class of triazole derivatives. Used in the systemic treatment of mycotic infections.
Presentation/Packing
Form
Noxafil oral susp 40 mg/mL
Packing/Price
105 mL x 1's
Form
Noxafil MR tab 100 mg
Packing/Price
24's;96's
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