"The US Food and Drug Administration (FDA) has expanded the indication for the short-acting beta-agonist albuterol sulfate inhalation powder (ProAir RespiClick, Teva) to children aged 4 to 11 years, the company announced today.
Instructions for Use
(COM beh vent - RES peh mat) (ipratropium bromide and albuterol) Inhalation Spray
For Oral Inhalation Only Do not spray COMBIVENT RESPIMAT into your eyes
Read this Instructions for Use before you start using COMBIVENT RESPIMAT and each time you get a refill. There may be new information. This information does not take the place of talking to your doctor about your medical condition or your treatment.
Use COMBIVENT RESPIMAT exactly as prescribed by your doctor. Do not change your dose or how often you use COMBIVENT RESPIMAT without talking with your doctor.
Tell your doctor about all of the medicines you take. COMBIVENT RESPIMAT may affect the way some medicines work and some other medicines may affect the way COMBIVENT RESPIMAT works. Do not use other inhaled medicines with COMBIVENT RESPIMAT without talking to your doctor.
The COMBIVENT RESPIMAT inhaler has a slow moving mist that helps you inhale the medicine.
Before your COMBIVENT RESPIMAT inhaler is used for the first time, the COMBIVENT RESPIMAT cartridge must be inserted into the COMBIVENT RESPIMAT inhaler and then primed. The instructions below show you how to prepare and prime the inhaler for first time use and how to use the inhaler for daily dosing.
Do not turn the clear base before inserting the cartridge.
The COMBIVENT RESPIMAT inhaler
Prepare For First Time Use
Step 1. With the orange cap closed, press the safety catch while pulling off the clear base. See Figure 1.
Be careful not to touch the piercing element located inside the bottom of the clear base.
Step 2. Write the discard by date on the label of the COMBIVENT RESPIMAT inhaler. The discard by date is 3 months from the date the cartridge is inserted into the inhaler. See Figure 2.
Step 3. Take the COMBIVENT RESPIMAT cartridge out of the box.
Push the narrow end of the cartridge into the inhaler. The base of the cartridge will not sit flush with the inhaler. About 1/8 of an inch will remain visible when the cartridge is correctly inserted. See Figure 3.
The cartridge can be pushed against a firm surface to ensure that it is correctly inserted. See Figure 3.
Do not remove the cartridge once it has been inserted into the inhaler.
Step 4. Put the clear base back into place. See Figure 4.
Do not remove the clear base again.
Your COMBIVENT RESPIMAT inhaler should not be taken apart after you have inserted the cartridge and put the clear base back.
Prime For First Time Use
The following steps are needed to fill the dosing system the first time you use it and will not affect the number of doses available. After preparation and initial priming, your COMBIVENT RESPIMAT inhaler will be able to deliver the labeled number of doses (120 or 60).
Proper priming of the inhaler is important to make sure the correct amount of medicine is delivered.
Step 5. Hold the COMBIVENT RESPIMAT inhaler upright, with the orange cap closed, to avoid accidental release of the dose. Turn the clear base in the direction of the white arrows on the label until it clicks (half a turn). See Figure 5.
Step 6. Flip the orange cap until it snaps fully open. See Figure 6.
Step 7. Point the COMBIVENT RESPIMAT inhaler toward the ground (away from your face). Press the dose release button. See Figure 7. Close the orange cap.
Repeat Steps 5, 6, and 7 until a spray is visible.
Once the spray is visible, you must repeat Steps 5, 6, and 7 three more times to make sure the inhaler is prepared for use.
Your COMBIVENT RESPIMAT inhaler is now ready to use.
These steps will not affect the number of doses available. After preparation and initial priming, your COMBIVENT RESPIMAT inhaler will be able to deliver the labeled number of doses (120 or 60).
Step A. Hold the COMBIVENT RESPIMAT inhaler upright with the orange cap closed, so you do not accidentally release a dose of medicine.
Turn the clear base in the direction of the white arrows on the label until it clicks (half a turn). See Figure A.
Step B. Flip the orange cap until it snaps fully open.
Breathe out slowly and fully, and then close your lips around the end of the mouthpiece without covering the air vents. See Figure B. Point your COMBIVENT RESPIMAT inhaler to the back of your throat.
While taking in a slow, deep breath through your mouth, press the dose release button and continue to breathe in slowly for as long as you can.
Hold your breath for 10 seconds or for as long as comfortable. Close the orange cap until you use your COMBIVENT RESPIMAT inhaler again.
Helpful Hints for Daily Dosing:
Using the COMBIVENT RESPIMAT inhaler requires 3 simple steps. A helpful way to remember the steps for Daily Dosing is to remember TOP:
Turn the clear base
Open the cap and close your lips around the mouthpiece
Press the dose-release button and inhale
If your COMBIVENT RESPIMAT inhaler has not been used for more than 3 days, spray 1 puff toward the ground to prepare the inhaler for use.
If your COMBIVENT RESPIMAT inhaler has not been used for more than 21 days, repeat Steps 5, 6, and 7 until a spray is visible. Then repeat Steps 5, 6, and 7 three more times to prepare the inhaler for use.
For more information or a video demonstration on how to use COMBIVENT RESPIMAT, go to www.combivent.com, or scan the code below. You may also call 1-800-542-6257 or (TTY) 1-800-459-9906 for further information about COMBIVENT RESPIMAT.
When should I get a new COMBIVENT RESPIMAT inhaler?
COMBIVENT RESPIMAT is available with 120 or 60 doses of medicine. One puff from COMBIVENT RESPIMAT equals one dose of medicine. The dose indicator shows approximately how much medicine is left. When the pointer enters the red area of the scale, there is enough medicine for 7 days (120 dose product) or 3 days (60 dose product). This is when you need to refill your prescription or ask your doctor if you need another prescription for COMBIVENT RESPIMAT Inhalation Spray.
Once the dose indicator has reached the end of the scale, all puffs have been used and the COMBIVENT RESPIMAT inhaler locks automatically. At this point, the base cannot be turned any further.
120 dose product
Throw away the COMBIVENT RESPIMAT inhaler 3 months after insertion of cartridge into inhaler, even if all the medicine has not been used, or when the inhaler is locked, whichever comes first.
60 dose product
Questions and Answers about
your COMBIVENT RESPIMAT inhaler
|What if...||Reason||What to do|
|I can not turn the base easily?||The COMBIVENT RESPIMAT inhaler is already prepared and ready to use.||The COMBIVENT RESPIMAT inhaler can be used as it is.|
|The COMBIVENT RESPIMAT inhaler is locked and all the medicine has been used.||Prepare and use a new COMBIVENT RESPIMAT inhaler.|
|I can not press the dose release button?||The clear base has not been turned.||Turn the clear base until it clicks (half a turn).|
|The clear base springs back after I have turned it and a small amount of moisture is released?||The clear base was not turned far enough.||Prepare the COMBIVENT RESPIMAT inhaler for use by turning the clear base until it clicks (half a turn).|
|I can turn the clear base past the point where it clicks?||Either the dose release button has been pressed, or the clear base has been turned too far.||With the orange cap closed, turn the clear base until it clicks (half a turn).|
How should I care for my COMBIVENT RESPIMAT inhaler?
Clean the mouthpiece, including the metal part inside the mouthpiece, with a damp cloth or tissue only, at least 1 time a week. Any minor discoloration in the mouthpiece does not affect your COMBIVENT RESPIMAT inhaler.
If the outside of your COMBIVENT RESPIMAT inhaler gets dirty, wipe it with a damp cloth.
How should I store my COMBIVENT RESPIMAT inhaler?
- Store COMBIVENT RESPIMAT at Room Temperature between 59°F to 86°F (15°C to 30°C).
- Do not freeze your COMBIVENT RESPIMAT cartridge and inhaler.
Keep your COMBIVENT RESPIMAT cartridge and inhaler out of the reach of children.
Last reviewed on RxList: 11/3/2014
This monograph has been modified to include the generic and brand name in many instances.
Additional Combivent Respimat Information
Report Problems to the Food and Drug Administration
You are encouraged to report negative side effects of prescription drugs to the FDA. Visit the FDA MedWatch website or call 1-800-FDA-1088.
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