Medication-info.com Search Menu

Budesonide Rectal (Pulmicort): Uses, Side Effects and Dosage

Updated:
Facts
Status:
Prescription (Rx)
Strength:
2 mg
Drug class:
Active ingredient:

Patient information: uses, side effects, how to take - Budesonide Rectal

Instructions for Use

Budesonide rectal foam

Read the Patient Information and Instructions for Use that comes with budesoniderectal foam before you start using it and each time you get a refill. There may be new information. This information does not take the place of talking to your healthcare provider about your medical condition or treatment. Talk to your healthcare provider if you have any questions.

Before using budesoniderectal foam, you should use the bathroom to empty your bowels.

You may use budesoniderectal foam while in a standing position, in a lying position, or in a sitting position (for example, while using the toilet).

Applicators should be used only 1 time. You should use a new applicator for each dose.

Figure A

Each kit contains (See Figure A):

  • Complete Prescribing Information
  • Patient Information and Instructions for Use
  • 2 canisters containing 14 doses each
  • 4 trays of single-use applicators (7 applicators per tray)
  • Applicator throw away (disposal) bags for use after each dose

Preparing to use budesoniderectal foam

Figure B

Step 1: Twist Safety Tab to Remove

Before the first use, remove the safety tab from

under the pump dome (See Figure B).

The canister cannot be used if safety tab is not removed.

Step 2: Attach the Applicator

The applicators are in a tray. Hold the tray firmly and pull to remove 1 applicator.

Push the applicator firmly onto the nozzle of the canister (See Figure C).

Each applicator is coated with a lubricant. If needed, you can apply an additional lubricant, such as Vaseline (petrolatum, petroleum jelly).

Figure C

Step 3: Align Notch to Nozzle

To unlock the canister, twist the dome on the top of the canister until the semicircular notch underneath the dome is in line with the nozzle (See Figure D).

Figure D

Step 4: Warm and Shake Canister

Warm the canister by holding it in your hands while shaking it vigorously for 10 to 15 seconds (See Figure E).

Figure E

Step 5: Turn the Canister Upside Down

Place your pointer finger (forefinger) on the top of pump dome and then turn the canister upside down (See Figure F).

The canister will only work properly when held with the pump dome pointing down.

Figure F

Step 6: Insert the Applicator into Rectum

Insert the applicator into your rectum as far as it is comfortable.

The easiest way to use budesonide rectal foam is to keep 1 foot on the floor and raise the other foot onto a firm surface such as a chair or stool (See Figure G).

Figure G

Step 7: Give a Dose of budesoniderectal foam

To give a dose of budesoniderectal foam, use your pointer finger (forefinger) to fully push down the pump dome 1 time and hold it for about 2 seconds in that position (See Figure H).

Figure H

Step 8: Release and Hold

Release finger pressure on the pump dome and hold the applicator in place for 10 to 15 seconds (See Figure I).

Figure I

Step 9: Remove the Applicator

(See Figure J)

The foam will still expand a little and may drop out of the applicator or anus.

Figure J

Step 10: Remove Applicator from Canister

Remove the applicator from the canister and place the used applicator in the applicator throw away (disposal) bag provided (See Figure K). Throw the applicator throw away (disposal) bag away in your household trash.

Figure K

Step 11: Twist Notch on Dome Away from Nozzle

To prevent loss of budesonide rectal foam from the canister between uses, turn the pump dome around so that the semicircular notch faces the opposite direction to the nozzle (See Figure L).

Wash your hands with soap and water after using the budesoniderectal foam. Try not to empty your bowels until the next morning.

Figure L

Distributed by:

Oceanside Pharmaceuticals, a division of

Bausch Health US, LLC

Bridgewater, NJ 08807 USA

Manufactured by:

ASM Aerosol-Service AG

Industriestrasse 11

CH-4313 Möhlin Switzerland

Product marketed and distributed under license from Dr. Falk Pharma.

© 2021 Bausch Health Companies Inc. or its affiliates

This Instructions for Use has been approved by the U.S. Food and Drug Administration.

Revised: 10/2021

9767800

EX00245

About this document

Source: FDA drug labeling via NLM DailyMed · Application number: NDA 205613 · View the label on DailyMed

Revision date stated in the text: October 2021

Found a mistake? Write to us via the contact page.

The information on this site does not replace the advice of a doctor or pharmacist.

Drug information for Budesonide Rectal

Rx or OTC
Prescription (Rx)?
  • This drug is available only with a prescription from a licensed healthcare provider.
  • Rx
Drug class Corticosteroid
Active ingredient Budesonide 2 mg
Dosage form Aerosol, foam
Route Rectal
Marketing status listed in the FDA NDC Directory
Company (applicant) SALIX
FDA approval NDA 205613New Drug Application (NDA) Approved October 7, 2014
Reference listed drug This is the reference listed drug (RLD) that generics are compared with.
Therapeutic equivalence (TE) code ABCodes starting with A mean the FDA rates the drug therapeutically equivalent to its reference drug (Orange Book).
Generics Uceris Rectal with the same TE code
Manufacturers 2 labelers list this drug on DailyMed
Packages (NDC)
Package
2 mg – 1 in 1 canister / 2 in 1 carton NDC 68682-658-02

Source: FDA drug labeling via NLM DailyMed, data as of October 31, 2026. FDA data (DailyMed, Orange Book, Drug Shortages, enforcement reports). Not a substitute for the advice of a doctor or pharmacist.