Relevant answers to your frequent questions...

Combivent, Ipratropium/Albuterol (generic): Frequently Asked Questions

What is the advantage of combining albuterol and ipratropium?

A clinical trial has proven that the 2 medicines together work better than either alone. The total DuoNeb ® dose is 3.0 mL. An equivalent dose of the 2 medicines separately is 5.5 mL. * *DuoNebŽ unit dose is 3.0 mL total volume vs 2.5 mL ipratropium unit dose and 3.0 mL albuterol for 5.5 mL total volume.

If a pharmacist is mixing or “compounding” albuterol and ipratropium, should the pharmacist still use J7621?

No, J7621 is only used for compounded drugs that are prepared by the manufacturer. In cases where the pharmacist is mixing the two drugs together, the supplier will need to bill the drugs using code J7619 for albuterol and J7644 for ipratropium with the appropriate modifier – KP, or KQ as described in the Nebulizer LCD

How are albuterol HFA inhalers the same as albuterol CFC inhalers?

Albuterol HFA inhalers are used in the same way as albuterol CFC inhalers and give the same dose of albuterol as the CFC inhalers. Albuterol HFA inhalers are safe and effective for the same FDA approved uses: treatment or prevention of bronchospasm in patients with reversible obstructive airway disease, including asthma and chronic obstructive pulmonary disease (COPD).
Source: www.fda.gov

Do HFA albuterol inhalers work as well as CFC albuterol inhalers?

Yes . HFA albuterol inhalers have been proven to work just as well as CFC albuterol inhalers for the treatment or prevention of bronchospasm (difficulty breathing) associated with conditions like asthma and COPD. In fact, the FDA studied HFA inhalers extensively before approving them and making the decision to ban CFC inhalers.

How are albuterol HFA inhalers different from albuterol CFC inhalers?

CFCs are used as propellants (spray) to move the albuterol medicine out of the inhaler so patients can breathe the medicine into their lungs. HFAs are a different type of propellant (spray). The albuterol and levalbuterol HFA inhalers have a different propellant called hydrofluoroalkane (HFA). Albuterol HFA and albuterol CFC inhalers may taste and feel different. The force of the spray may feel softer from albuterol HFA than from albuterol CFC inhalers. Each of the HFA inhalers is different (see table below). ...
Source: www.fda.gov

Is it only for Albuterol inhalers?

The Trigger Guard was designed for use with fast acting rescue inhalers, because it is necessary that they be available to the patient at all times, and are therefore more susceptible to accidental discharge. However, you may wish to use the clip with your other MDIs. Again, check with your pharmacist if you are unsure of the fit.

When will albuterol CFC inhalers be gone?

Albuterol CFC inhalers will not be sold in the United States after December 31, 2008. The company that makes albuterol CFC inhalers is expected to stop making albuterol CFC inhalers before then. People who are using albuterol CFC inhalers should talk with their health care professional now about switching to an albuterol HFA inhaler. There are enough albuterol HFA inhalers for everyone who needs them.
Source: www.fda.gov

Why is cleaning and priming my albuterol HFA inhaler important?

Cleaning the inhaler to prevent clogging and properly priming the albuterol HFA inhaler are very important to make sure that the medicine sprays from the inhaler so you can breathe it into your lungs. Each albuterol HFA inhaler comes with directions for washing, drying the mouthpiece (part that goes in your mouth) and priming. There are some differences between brands of inhalers, so you will need to follow the directions that come with each inhaler.
Source: www.fda.gov

Why are albuterol CFC inhalers being phased out?

The phase out of albuterol CFC inhalers is due to an international agreement called the Montreal Protocol on Substances that Deplete the Ozone Layer . CFCs are harmful to the environment because they decrease the protective ozone layer above the Earth.
Source: www.fda.gov

Are salbutamol and albuterol the same drug?

Ventolin is the brand name of salbutamol, which is the WHO (World Health Organization) recommended name for the medication. Unfortunately, in the US this same drug is called albuterol, leading to endless confusion. In fact, it's one of the few drugs in which the brand name stays the same from country to country, while the chemical name changes! Ventolin is made in the U.S. by Allen & Hanburys, and Proventil is the same drug manufactured by Schering. ...

How will the rule affect my access to albuterol MDIs?

HHS/FDA is committed to ensuring an orderly transition to the HFA albuterol MDIs, over the next three years. HHS/FDA is also committed to ensuring these products will be available to populations that need them. Currently, there are three non-ODS albuterol MDIs marketed-Proventil HFA (marketed by Schering –Plough), Ventolin HFA (marketed by GlaxoSmithKline) and a similar product from IVAX. ...
Source: www.fda.gov

What should I do if I have problems with my albuterol HFA inhaler?

First, remember that the force of the spray from the albuterol HFA may feel different. Make sure you wash, dry, and prime the inhaler as described in the directions that come in each package. If you have problems using your albuterol HFA inhaler, talk to your healthcare professional as a different product may be right for you.
Source: www.fda.gov

What hydrofluoroalkane inhalers (HFA) (non-CFC albuterol inhalers) are available?

There are three albuterol HFA inhalers that FDA has approved as safe and effective: ProAir (albuterol sulfate) HFA Inhalation Aerosol Proventil HFA (albuterol sulfate) Inhalation Aerosol Ventolin (albuterol sulfate) HFA Inhalation Aerosol Also available is Xopenex HFA (levalbuterol tartrate) Inhalation Aerosol that contains the active form of albuterol and does the same thing as albuterol. Patients in the United States have been using HFA inhalers safely and effectively since 1998.
Source: www.fda.gov

Albuterol side effects in kids: What's normal?

http://www.mayoclinic.com/print/albuterol-side-effects/AN01065/METHOD=print Asthma medications: Know your options http://www.mayoclinic.com/print/asthma-medications/AP00008/METHOD=print Asthma and Children - A Guide to Coping http://www.healthyroadsmedia.org/english/Files/flv/engast.htm

Can albuterol be taken while taking salmeterol?

Yes. Quoting from the Product Information Sheet that comes with the Serevent (salmeterol) inhaler, manufactured by Allen & Hanburys: "Serevent Inhalation Aerosol should not be used more frequently than twice daily (morning and evening) at the recommend dose. When prescribing Serevent Inhalation Aerosol, patients must be provided with a short-acting, inhaled beta2-agonist (e.g., albuterol) for treatment of symptoms that occur despite regular twice-daily (morning and evening) use of Serevent. ...

_ARE THERE ENOUGH HFA ALBUTEROL INHALERS TO REPLACE THE CFC ALBUTEROL INHALERS?

"As we decrease supply of CFC-based albuterol inhalers, we will increase the supply of PROVENTIL HFA inhalers. We expect that we will have the capacity to provide our historical volume of albuterol inhalers. "Schering-Plough is working with the FDA to help ensure patients have an uninterrupted supply of inhalers during this transition from the CFC to HFA propelled albuterol inhalers.

What conditions had to be met for albuterol MDIs to no longer be considered “essential use”?

Under 21 CFR 2.125, several criteria must be met for a listed product to be considered no longer essential. These criteria are the following: Sufficient non-ODS alternatives are available with the same indications and approximate level of convenience; There is adequate post-marketing data for the alternative products. ...
Source: www.fda.gov

What is HHS/FDA’s advice to patients who use albuterol MDIs?

It is important that patients who use albuterol CFC MDIs talk with their doctors about the phase-out of the CFC products to establish the timing and manner of their move to HFA albuterol MDIs or other product/medication. This final rule goes into effect in about 40 months, and even when in effect, will not mean that albuterol MDIs will no longer be available, just that they will change. ...
Source: www.fda.gov

What will be the long-term effect of this phase-out on the price and availability of albuterol products for asthma and COPD patients?

HHS/FDA carefully thought through the rule and the effective date to assure availability of albuterol HFA products would not be an issue throughout this three-year transition. Currently, the HFA albuterol products are more expensive than the generic albuterol CFC inhalers. Three current HFA products will compete in the market place as CFC products are withdrawn, and the long-term effect of this rule on price is not certain. ...
Source: www.fda.gov

What programs will be in place to help patients get the albuterol MDI they need, since the albuterol HFA MDI currently cost 20 dollars more per MDI than the generic CFC MDIs?

HHS/FDA is encouraged that the manufacturers of the three HFA products are implementing programs to help assure access to these albuterol MDIs for patients for whom price could be a significant barrier to access to this important medicine. These programs include MDI giveaways, coupons for reducing the price paid and patient-assistance programs based on financial need.
Source: www.fda.gov

Should I use Albuterol every day to help my asthma?

Many patients think it is okay to use Albuterol on a daily basis for their asthma symptoms of wheezing, chest tightness, or shortness of breath. Albuterol is not intended to be used on a frequent basis,though. In fact, Albuterol is often called a “rescue inhaler” because it is used to relieve a sudden onset of asthma symptoms. ...

Does the drug Accolate alone or in combination with aerobid,serevent and albuterol cause lack of libido and fatigue?

ot usually, check your liver functions however. Loss of Libido [posted 11/11/98]

Are there any differences between how I should use the new HFA albuterol inhalers and my old CFC?

Yes. There are some simple yet important differences between the new HFA inhalers and the old CFC ones. HFA inhalers need to be primed and cleaned differently and more often than CFC ones. They can get clogged if you don't care for your device, so it's very important that you clean the mouthpiece under warm running water at least once a week. Each of the 4 available HFA rescue inhalers is different, so you'll need to make sure you understand exactly how to use and care for whichever one your doctor prescribes for you. ...

I was used to my older CFC inhaler. Can I just continue filling prescriptions for CFC albuterol instead of transitioning to a new HFA inhaler?

No . CFC inhalers are no longer permitted to be produced in the United States as of December 31, 2008, and their supply will eventually disappear. Talk with your healthcare provider about your concerns. He or she may be able to help you choose the right device for you and help you get comfortable with your new inhaler. In only a short time, you will not miss your CFC inhaler at all!

If there have been alternatives to albuterol MDIs containing ODSs for several years, why did HHS/FDA not act sooner?

There are many reasons for this. One of the criteria for beginning the process of finding a drug to no longer be an essential use of CFCs is that there must be adequate post-marketing experience with the alternative(s). Ventolin HFA, the second product necessary for beginning this process for albuterol, only began marketing in 2002. ...
Source: www.fda.gov

_DOES THE BAN ON CFCS APPLY TO ALL MANUFACTURERS OF ALBUTEROL INHALERS?

"The U.S. Food and Drug Administration (FDA) has issued a Final Rule requiring all manufacturers to phase out CFCs in albuterol containing products by December 31, 2008. "In fact, the U.S. is currently the only country that continues to use CFC albuterol inhalers. Every albuterol inhaler used in the United States must use an environmentally friendly propellant by the end of December 31, 2008. " _WHEN SCHERING-PLOUGH STOPS MANUFACTURING CFC ALBUTEROL INHALERS, HOW QUICKLY WILL THE SUPPLY BE DEPLETED? ...
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