Budesonide Inhalation Suspension (Page 7 of 7)

PATIENT INSTRUCTIONS FOR USE

Important:

Budesonide inhalation suspension is only for use with a jet nebulizer machine. Make sure you know how to use your jet nebulizer machine before your child uses budesonide inhalation suspension.

Budesonide inhalation suspension is a liquid that is turned into a mist by a nebulizer and inhaled into the lungs.

The face mask should be properly adjusted to optimize delivery and to avoid exposing the eyes to the nebulized medication. Corticosteroid effects on the skin can be avoided if the face is washed after the use of a face mask.

1. Budesonide inhalation suspension comes in a sealed protective aluminium foil envelope.

  • Do not open the sealed pouch until you are ready to use a dose of budesonide inhalation suspension.
  • Open the sealed foil envelope and take out the single-dose ampule.

2.Gently shake the budesonide inhalation suspension ampule using a circular motion as shown in Figure 1.

Figure 1

pi-figure-1

3. Hold the budesonide inhalation suspension ampule upright without squeezing the ampule and open by twisting off the top as shown in Figure 2.

Figure 2

pi-figure-2

4. Place the open end of the budesonide inhalation suspension ampule into the nebulizer cup (reservoir) and slowly squeeze all of the medicine from the ampule into the nebulizer medicine cup as shown in Figure 3. Throw away the empty ampule.

Figure 3

pi-figure-3

5. Use your jet nebulizer as directed.

Distributed by:
Ritedose Pharmaceuticals, LLC Columbia, SC 29203 USA

08/2021

RPIN0125

PACKAGING PRINCIPAL DISPLAY PANEL

carton-front
(click image for full-size original)

BUDESONIDE INHALATION SUSPENSION budesonide inhalation suspension suspension
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:76204-018(NDC:68180-984)
Route of Administration RESPIRATORY (INHALATION) DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
BUDESONIDE (BUDESONIDE) BUDESONIDE 0.5 mg in 2 mL
Inactive Ingredients
Ingredient Name Strength
SODIUM CITRATE, UNSPECIFIED FORM
POLYSORBATE 80
SODIUM CHLORIDE
EDETATE DISODIUM
ANHYDROUS CITRIC ACID
WATER
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:76204-018-01 1 POUCH in 1 CARTON contains a POUCH (76204-018-11)
1 NDC:76204-018-11 30 AMPULE in 1 POUCH This package is contained within the CARTON (76204-018-01) and contains a AMPULE
1 5 mL in 1 AMPULE This package is contained within a POUCH (76204-018-11) and a CARTON (76204-018-01)
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA210897 12/01/2021
Labeler — Ritedose Pharmaceuticals, LLC (968062294)
Establishment
Name Address ID/FEI Operations
The Ritedose Corporation 837769546 analysis (76204-018), manufacture (76204-018), pack (76204-018), label (76204-018), repack (76204-018)

Revised: 06/2022 Ritedose Pharmaceuticals, LLC

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