Important Administration Instructions for NOXAFIL Delayed Release Tablet and Oral Suspension: Non-Interchangeability between NOXAFIL Delayed Release Tablets and NOXAFIL Oral Suspension: The prescriber should follow the specific dosing instructions for each formulation. The tablet and oral suspension are not to be used interchangeably due to the differences in the dosing of each formulation.
NOXAFIL Delayed Release Tablets: NOXAFIL Delayed Release Tablets may be taken without regard to food intake.
NOXAFIL Delayed Release Tablets should be swallowed whole, and not be divided, crushed, or chewed. (See Table 3.)
Click on icon to see table/diagram/image
NOXAFIL Oral Suspension: NOXAFIL Oral Suspension should be administered with a meal, or with 240 ml of a nutritional supplement to enhance the oral absorption and to ensure adequate exposure. The oral suspension must be shaken well before use. (See Table 4.)
Click on icon to see table/diagram/image
Use in renal impairment: No dose adjustment is required for renal dysfunction and NOXAFIL is not significantly renally eliminated, an effect of severe renal insufficiency on the pharmacokinetics of NOXAFIL is not expected and no dose adjustment is recommended.
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.
Use in children: Safety and efficacy in children below the age of 13 years have not been established.