Budesonidedosage

The recommended dosage is 1 metered dose administered twice daily for 2 weeks followed by 1 metered dose administered once daily for 4 weeks.

For rectal administration only.

Warm the canister in the hands while shaking it vigorously for 10 to 15 seconds prior to use.

2.1 Recommended

Dosage The recommended dosage regimen is 1 metered dose administered rectally twice daily for 2 weeks followed by 1 metered dose administered rectally once daily for 4 weeks.

2.2 Administration

Instructions Advise patients:

UCERIS rectal foam is only to be applied rectally. It is not for oral use.

Before using UCERIS rectal foam, use the bathroom to empty your bowels.

Each applicator is coated with a lubricant. If additional lubrication is needed, petrolatum or petroleum jelly can also be used.

Warm the canister in the hands while shaking it vigorously for 10 to 15 seconds prior to use.

UCERIS rectal foam can be used in a standing, lying or sitting position (e.g., while using the toilet).

Apply UCERIS rectal foam in the morning and the evening for the first 2 weeks of treatment; then once daily in the evening for the next 4 weeks. When applied in the evening, use immediately prior to bedtime. Try not to empty your bowels again until the next morning.

Avoid concomitant use of CYP3A4 inhibitors (e.g., ketoconazole, grapefruit juice) during treatment with UCERIS rectal foam.