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3.3 Instructions for use with Posaconazole Oral Suspension

The most frequently reported adverse reactions with an onset during the posaconazole intravenous phase of dosing with 300 mg once daily were diarrhea (32%), hypokalemia (22%), pyrexia (21%), and nausea (19%). These adverse reactions were consistent with those seen in studies with posaconazole oral suspension.

 Table 3: Dosing for Posaconazole Oral Suspension

Attention: Noxafil Oral Suspension and Delayed-
Release Tablets are NOT interchangeable due to
differences in the dosing of each formulation.

Shake posaconazole oral suspension well before use.

Noxafil is an azole antifungal agent indicated for:

Dose-proportional increases in plasma exposure (AUC) to posaconazole oral suspension were observed following single oral doses from 50 mg to 800 mg and following multiple-dose administration from 50 mg BID to 400 mg BID in healthy volunteers. No further increases in exposure were observed when the dose of the oral suspension increased from 400 mg BID to 600 mg BID in febrile neutropenic patients or those with refractory invasive fungal infections.

Dose-proportional increases in plasma exposure (AUC) to posaconazole oral suspension were observed following single oral doses from 50 mg to 800 mg and following multiple-dose administration from 50 mg BID to 400 mg BID in healthy volunteers. No further increases in exposure were observed when the dose of the oral suspension increased from 400 mg BID to 600 mg BID in febrile neutropenic patients or those with refractory invasive fungal infections.

Noxafil injection is indicated in patients 18 years of age and older.

The mean (%CV) [min-max] posaconazole oral suspension average steady-state plasma concentrations (Cav) and steady-state pharmacokinetic parameters in patients following administration of 200 mg TID and 400 mg BID of the oral suspension are provided in Table 14.

Posaconazole blocks the synthesis of ergosterol, a key component of the fungal cell membrane, through the inhibition of cytochrome P-450 dependent enzyme lanosterol 14α-demethylase responsible for the conversion of lanosterol to ergosterol in the fungal cell membrane. This results in an accumulation of methylated sterol precursors and a depletion of ergosterol within the cell membrane thus weakening the structure and function of the fungal cell membrane. This may be responsible for the antifungal activity of posaconazole.

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Noxafil injection must not be diluted with the following diluents:

Concomitant administration of posaconazole oral suspension with midazolam increases the midazolam plasma concentrations by approximately 5 fold. Increased plasma midazolam concentrations could potentiate and prolong hypnotic and sedative effects. Patients must be monitored closely for adverse effects associated with high plasma concentrations of midazolam and benzodiazepine receptor antagonists must be available to reverse these effects [see Drug Interactions].

Clinical Trial Safety Experience with Posaconazole Oral Suspension

Noxafil delayed-release tablets and oral suspension are not interchangeable due to the differences in the dosing of each formulation. Therefore, follow the specific dosage recommendations for each of the formulations. (, )

Advise patients to take Noxafil delayed-release tablets with food.

Noxafil injection, delayed-release tablets, and oral suspension are indicated for prophylaxis of invasive and infections in patients who are at high risk of developing these infections due to being severely immunocompromised, such as hematopoietic stem cell transplant (HSCT) recipients with graft-versus-host disease (GVHD) or those with hematologic malignancies with prolonged neutropenia from chemotherapy.

a) Brand name: NOXAFIL, by SCHERING.

Noxafil oral suspension is indicated for the treatment of oropharyngeal candidiasis, including oropharyngeal candidiasis refractory to itraconazole and/or fluconazole.

Posaconazole, SCH-56592, Noxafil-药 …

Noxafil delayed-release tablets and oral suspension are not to be used interchangeably due to the differences in the dosing of each formulation

Posaconazole (Noxafil): a new triazole antifungal agent

Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in clinical trials of posaconazole cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in practice. In clinical trials, the type of adverse reactions reported for posaconazole delayed-release tablets were generally similar to that reported in trials of posaconazole oral suspension.

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