Noxafil Dosage/Direction for Use

Non-Interchangeability between Noxafil Modified Release Tablets and Noxafil Oral Suspension: Noxafil modified release tablets and oral suspension are not to be used interchangeably due to the differences in the dosing of each formulation. Therefore, follow the specific dosage recommendations for each of the formulations.
MR Tablet: Noxafil modified release tablets may be taken without regard to food intake.
Noxafil modified release tablets are intended for oral administration only.
Noxafil modified release tablets should be swallowed whole, and not be divided, crushed, or chewed.
Important Administration Instructions for Noxafil Modified Release Tablet and Noxafil Oral Suspension: The prescriber should follow the specific dosing instructions for each formulation. The modified release tablet and oral suspension are not to be used interchangeably due to the differences in the dosing of each formulation.
MR Tablet: Coadministration of drugs that can decrease the plasma concentrations of posaconazole should generally be avoided unless the benefit outweighs the risk. If such drugs are necessary, patients should be monitored closely for breakthrough fungal infections (see Interactions).
Oral Suspension: Shake well before use.
Refractory Invasive Fungal Infections (IFI)/Intolerant Patients with IFI: MR Tablet: Loading dose of 300 mg (three 100 mg tablets) twice a day on the first day, then 300 mg (three 100 mg tablets) once a day thereafter.
Duration of therapy should be based on the severity of the underlying disease, recovery from immunosuppression, and clinical response.
Oral Suspension: NOXAFIL should be administered at a dose of 400 mg (10 mL) twice a day with a meal or 240 mL of nutritional supplement. Dividing the dose further to 200 mg (5 mL) four times a day has been shown to enhance exposure to posaconazole, particularly in patients who have limited oral intake. Increasing the total daily dose above 800 mg does not further enhance the exposure to posaconazole. (See Pharmacology under Actions.)
Prophylaxis of Invasive Fungal Infections: The duration of therapy is based on recovery from neutropenia or immunosuppression. For patients with acute myelogenous leukaemia or myelodysplastic syndromes, prophylaxis with Noxafil should start several days before the anticipated onset of neutropenia and continue for 7 days after the neutrophil count rises above 500 cells per mm³.
MR Tablet: Loading dose of 300 mg (three 100 mg tablets) twice a day on the first day, then 300 mg (three 100 mg tablets) once a day thereafter.
Oral Suspension: NOXAFIL should be administered at a dose of 200 mg (5 ml) three times a day.
Each dose of NOXAFIL should be administered with a meal, or with a nutritional supplement in patients who cannot tolerate food, to enhance exposure.
Duration of therapy should be based on the severity of the patient's underlying disease, recovery from immunosuppression, and clinical response.
There are limited pharmacokinetic data in patients with severe gastrointestinal dysfunction (such as severe diarrhoea). Patients who have severe diarrhoea or vomiting should be monitored closely for breakthrough fungal infections.
Use in renal impairment: No dose adjustment is required for renal dysfunction and posaconazole is not significantly renally eliminated, an effect of severe renal insufficiency on the pharmacokinetics of posaconazole is not expected and no dose adjustment is recommended. (See Pharmacology under Actions.)
MR Tablet: Due to variability in exposure, patients with severe renal impairment should be monitored closely for breakthrough fungal infections.
Use in hepatic impairment: There are limited pharmacokinetic data in patients with hepatic insufficiency; therefore, no recommendation for dose adjustment can be made. In the small number of subjects studied who had hepatic insufficiency, there was an increase in half-life with a decrease in hepatic function. (See Pharmacology under Actions.)
Use in Children: Safety and efficacy in children and adolescents below the age of 18 years have not been established. Therefore, posaconazole is not recommended for use in patients below 18 years of age.
Use in the Elderly: No dosage adjustment is recommended for elderly patients. (See Pharmacology under Actions.)
Oral Suspension: Oropharyngeal Candidiasis in HIV-infected patients: NOXAFIL should be administered as a loading dose of 200 mg (5 mL) once a day on the first day, then 100 mg (2.5 mL) once a day for 13 days.
Oropharyngeal Candidiasis refractory to itraconazole or fluconazole in HIV-infected patients: NOXAFIL should be administered at a dose of 400 mg (10 mL) twice a day.