Could you please clarify the appropriate daily dose to be considered for nitrosamine risk assessment when the maximum weekly dose is 600 mg?
Should the daily dose be calculated by dividing the weekly dose by 7 days, resulting in a daily dose of approximately 85.7 mg/day, or is there a different approach recommended according to current nitrosamine guidance?
Hi Sreedhar,
There is no specific Nitrosamine guidance available for calculating the MDD or determining the dosage.
The MDD depends on the dosing regimen. If a 600 mg dose is administered as a single dose, followed by a one-week interval before the next dose, the MDD should be considered as 600 mg.
However, if the total 600 mg dose is administered in divided doses over a one-week period, the MDD should be calculated based on the specific dosing regimen.
For further details on the applicable MDD values, you can refer to the relevant SmPC or drug label.