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Uceris

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Uceris

Indications
Dosage
How Supplied

INDICATIONS

UCERIS rectal foam is indicated for the induction of remission in patients with active mild to moderate distal ulcerative colitis extending up to 40 cm from the anal verge.

DOSAGE AND ADMINISTRATION

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.

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.

HOW SUPPLIED

Dosage Forms And Strengths

UCERIS rectal foam is formulated as an emulsion which is filled into an aluminum canister with an aerosol propellant. It is available in 1 strength: 2 mg budesonide per metered dose.

Storage And Handling

UCERIS rectal foam is supplied as a kit containing 2 aerosol canisters with 28 PVC applicators coated with paraffin lubricant for administration of the foam (NDC 65649-651-03). Each canister (NDC 65649-651-02) is labeled with a net weight of 33.4g and contains 14 metered doses.

Storage

Store at 20-25°C (68-77°F); excursions permitted to 15 -30°C (59 -86°F). [See USP Controlled Room Temperature].

Handling

UCERIS rectal foam contains a flammable propellant. Do not have the canister burned after use and do not spray contents directly towards flames.

  • Do not expose to heat or store at temperatures above 120°F (49°C).
  • Flammable. Avoid fire, flame, or smoking during and immediately following administration.
  • Contents under pressure. Do not puncture or incinerate.

DO NOT REFRIGERATE.

UCERIS (budesonide) rectal foam is marketed by Salix Pharmaceuticals, Inc., Raleigh, NC 27615 under license from Dr. Falk Pharma. Issued 10/2014

Last reviewed on RxList: 11/17/2014
This monograph has been modified to include the generic and brand name in many instances.

Indications
Dosage
How Supplied
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