FMES - Florida Educational Medical Services

FMES NEWSLETTER: FDA Approves Combivent Respimat Inhalation Spray (Avail. Oct. 2012)

Issue 71 - 10/9/2012

Combivent Respimat (ipratropium bromide and albuterol sulfate)Inhalation Spray

 Combivent Inhalation Aerosol will not be available after December 31, 2013. 

What is Combivent Respimat? 
Combivent Respimat is a suitable alternative for patients who are currently using Combivent (ipratropium bromide and albuterol sulfate) Inhalation Aerosol.  Combivent Inhalation Aerosol is being phased out because it contains chlorofluorocarbons (CFCs).  CFCs are chemical compounds that decrease the ozone layer.  As a result, Combivent Inhalation Aerosol will not be available after December 31, 2013. 

Combivent Respimat does not contain CFCs.

The COMBIVENT RESPIMAT cartridge contains 120 puffs (equal to 120 doses of medicine) after you prepare your inhaler for the first use. There is enough medicine for 30 days when it is used as 1 puff 4 times a day. No shaking or spacer required.

-------------------------INDICATIONS AND USAGE-------------

COMBIVENT RESPIMAT Inhalation Spray is a combination of an anticholinergic and beta-adrenergic indicated for:

• Patients with chronic obstructive pulmonary disease (COPD) on a

regular aerosol bronchodilator who continue to have evidence of

bronchospasm and who require a second bronchodilator.

---------------------DOSAGE FORMS AND STRENGTHS--------

• Inhalation spray: 20 mcgipratropium bromide (monohydrate) and

100 mcg albuterol (equivalent to 120 mcg albuterol sulfate) per actuation with the COMBIVENT RESPIMAT inhaler.

The COMBIVENT RESPIMAT inhaler

Prepare For First Time Use

Figure 1

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.

Figure 2

Step 2. Write the discard bydate 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.

Figure 3

Step 3. Take the COMBIVENTRESPIMAT 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.

Figure 4

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 120 doses.

Proper priming of the inhaler is important to make sure the correct amount of medicine is delivered.

Figure 5

Step 5. Hold the COMBIVENTRESPIMAT inhaler upright, with the orange cap closed, to avoid accidental release ofthe dose. Turn the clear base in the direction of the white arrows on the label until it clicks (half a turn). See Figure 5. 

Figure 6

Step 6. Flip the orange cap until it snaps fully open.  See Figure 6.

Figure 7

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 120 doses.

Daily Dosing

Figure A

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.

Figure B

 

Step B. Flip the orange capuntil it snaps fully open.

Breathe out slowly and fully, and then close your lips around the end of the mouth piece 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.

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.

When should I get anew COMBIVENT RESPIMAT inhaler?

The COMBIVENT RESPIMAT inhaler contains 120 puffs, equal to 120 doses. 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. 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 120 puffs have been used and

the COMBIVENT RESPIMAT inhaler locks automatically. At this point, the base cannot

be turned any further.

For more information or a video demonstration on how to use COMBIVENT RESPIMAT, go to www.combivent.com.

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