DOSAGE AND ADMINISTRATION
| Indication | Dose and Duration of therapy |
|---|
| Prophylaxis of Invasive Fungal Infections | 200 mg (5 mL) three times a day. The duration of therapy is based on recovery from neutropenia or immunosuppression. |
| Oropharyngeal Candidiasis | Loading dose of 100 mg (2.5 mL) twice a day on the first day, then 100 mg (2.5 mL) once a day for 13 days. |
| Oropharyngeal Candidiasis Refractory to itraconazole and/or fluconazole | 400 mg (10 mL) twice a day. Duration of therapy should be based on the severity of the patient's underlying disease and clinical response. |
Each dose of NOXAFIL should be administered with a full meal or with a liquid nutritional supplement in patients who can not eat a full meal. (See CLINICAL PHARMACOLOGY.)
To enhance the oral absorption of posaconazole and optimize plasma concentrations:
- Each dose of NOXAFIL Oral Suspension should be administered with a full meal or liquid nutritional supplement. For patients who can not eat a full meal or tolerate an oral nutritional supplement, alternative antifungal therapy should be considered or patients should be monitored closely for breakthrough fungal infections.
- Patients who have severe diarrhea or vomiting should be monitored closely for breakthrough fungal infections.
- Co-administration 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 CLINICAL PHARMACOLOGY, Drug Interactions.)
Shake NOXAFIL® Oral Suspension well before use.
A measured dosing spoon is provided, marked for doses of 2.5 mL and 5 mL.
It is recommended that the spoon is rinsed with water after each administration and before storage.
Renal Insufficiency
No dose adjustment is recommended for patients with renal dysfunction. However, the range of the posaconazole AUC estimates was highly variable (CV=96%) in subjects with severe renal insufficiency as compared to that in the other renal impairment groups (CV<40%). Due to the variability in exposure, patients with severe renal impairment should be monitored closely for breakthrough IFIs. (See CLINICAL PHARMACOLOGY.)
Hepatic Insufficiency
The pharmacokinetic data in subjects with hepatic impairment was not sufficient to determine if dose adjustment is necessary in patients with hepatic dysfunction. It is recommended that posaconazole be used with caution in patients with hepatic impairment. (See CLINICAL PHARMACOLOGY and WARNINGS.)
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