prescribing alert

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PRESCRIBING ALERT®
Dear Healthcare Professional,
At MPR we strive to bring you important drug information in a concise and timely fashion. In
keeping with this goal, we are pleased to bring you this PRESCRIBING ALERT about ProAir® HFA
(albuterol sulfate) Inhalation Aerosol, a product of Teva Respiratory, LLC.
ProAir HFA now has a built-in dose counter and offers a complete package of helpful features for
your patients. The new built-in dose counter helps your patients always know exactly how many
puffs are left in the canister and when it is time to refill their prescription.1
This PRESCRIBING ALERT highlights the helpful features, greater availability, and guideline
recommendations of the ProAir HFA red inhaler, making it the product to go to for your patients’ needs.
Indications
ProAir HFA (albuterol sulfate) Inhalation Aerosol is indicated in patients 4 years of age and older for
the treatment or prevention of bronchospasm with reversible obstructive airway disease and for the
prevention of exercise-induced bronchospasm.
Important Safety Information
• Inhaled albuterol sulfate can produce paradoxical bronchospasm that may be life-threatening.
It should be recognized that paradoxical bronchospasm, when associated with inhaled formulations,
frequently occurs with the first use of a new canister
• Fatalities have been reported in association with excessive use of inhaled sympathomimetic drugs in
patients with asthma
• ProAir HFA, as with all sympathomimetic amines, should be used with caution in patients with
cardiovascular disorders (especially coronary insufficiency, cardiac arrhythmias, and hypertension),
convulsive disorders, hyperthyroidism, and diabetes
• Potential drug interactions can occur with beta-blockers, diuretics, digoxin, or monoamine oxidase
inhibitors, and tricyclic antidepressants
• Do not exceed the recommended dose
• Adverse events, which occurred at an incidence rate of at least 3% with ProAir HFA, include
headache, tachycardia, pain, dizziness, pharyngitis, and rhinitis
Please see the full Prescribing Information for ProAir HFA.
Sincerely,
Madonna Krawczyk, PharmD
Director of Clinical Communications
MPR Custom Programs
Reference
1. ProAir HFA [prescribing information]. Horsham, PA: Teva Respiratory, LLC; May 2012.
130187 01/13
u MPR Prescribing Alert
ProAir® HFA
(albuterol sulfate) Inhalation Aerosol

Company: Teva Respiratory
Pharmacologic class: β2-agonist.
Active Ingredients: Albuterol sulfate 108 mcg/
inhalation metered-dose aerosol.
Indications: For the treatment or prevention of
bronchospasm with reversible obstructive airway
disease and for the prevention of exercise-induced
bronchospasm, in patients 4 years of age and older.
Dosing: <4yrs: not recommended. ≥4yrs: 2 inhalations
every 4–6 hrs as needed; 1 inhalation every 4 hrs may
suffice. Exercise-induced bronchospasm: 2 inhalations
15–30 minutes before exercise.
Warnings & Precautions: Discontinue if
paradoxical bronchospasm or cardiovascular effects
occur. Need for more doses may be a sign of
deterioration of asthma; reevaluate therapy. Consider
adding anti-inflammatory agents (eg, corticosteroids)
to therapeutic regimen. Caution in patients with
cardiovascular disease (eg, coronary insufficiency,
arrhythmias, hypertension). Avoid excessive use.
Caution in patients sensitive to sympathomimetic
drugs; discontinue immediately if immediate
hypersensitivity occurs. Monitor for hypokalemia
and changes in blood glucose.
Interactions: Oral sympathomimetics: not
recommended. Antagonized by β-blockers.
Caution with other drugs that may lower serum
potassium (eg, diuretics). Monitor digoxin. Avoid
MAOIs, tricyclics within 14 days (increased
cardiovascular effects).
Special Populations: Pregnancy (Cat.C). Nursing
mothers: use caution.
Adverse reactions: Headache, tachycardia, pain,
dizziness, pharyngitis, and rhinitis.
How Supplied: Inhalation aerosol—8.5 g
(200 inhalations)
[u] ProAir HFA now has a built-in dose
counter1
built-in dose counter
nP
atients will always know
• E xactly how many puffs are left in the
canister
• When it is time to refill their prescription
Indications
ProAir HFA (albuterol sulfate) Inhalation Aerosol
is indicated in patients 4 years of age and older for
the treatment or prevention of bronchospasm with
reversible obstructive airway disease and for the
prevention of exercise-induced bronchospasm.
Selected Safety Information
FPO
Counter numbers
turn red when it’s
time to refill 1
Source: ProAir HFA [prescribing information].1
• Do not exceed the recommended dose
Please see full Prescribing Information and the last page for
additional Important Safety Information.
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MPR Prescribing Alert
[u] ProAir® HFA (albuterol sulfate) may give patients more time to inhale each puff
ProAir HFA vs Ventolin ® HFA Plume
ProAir HFA
• ProAir HFA delivers a warmer, lower-impact,
longer-duration plume2
• The ProAir HFA plume is 55% less forceful
and lasts nearly 2.5 times longer than that
of Ventolin HFA 2
Ventolin HFA
Source: McCabe 2012. 2
[u] Reduce wasted medication by pro­v iding more time to use all 200 puffs3,4
ProAir HFA Expiration Dating
UP TO
12
UP TO
24
• ProAir HFA delivers long expiration dating
(up to 24 months), so patients get consistent
dosing for up to 2 years or 200 doses3
MONTHS 4
MONTHS 3
Ventolin HFA
ProAir HFA
Sources: Data on file3; Ventolin [prescribing information].4
[u] Offers a dose that is ready when your patients need it
nP
roAir HFA is designed to deliver flexibility and portability
nP
roAir HFA inhalers can be carried and stored in any position without affecting dose consistency1,5,6,*
*Just like all albuterol HFA inhalers, ProAir HFA should always be actuated, primed, and used in an upright position,
and must be stored at room temperature (between 59°F and 77°F).1
Selected Safety Information
• Potential drug interactions can occur with beta-blockers, diuretics, digoxin, or monoamine oxidase inhibitors,
and tricyclic antidepressants
Please see full Prescribing Information and the last page for
additional Important Safety Information.
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MPR Prescribing Alert
[u] May help insured patients pay less
nP
roAir® HFA (albuterol sulfate) has the widest, most preferred formulary coverage7
nC
overs 95% of insured patient lives, with preferred formulary coverage by more than 80% of
covered lives.7 As a result, more insured patients may pay less for their medication
Percentage of preferred formulary coverage
% Covered7
% Preferred7
ProAir HFA
95%
85%
Proventil® HFA
82%
38%
Ventolin HFA
90%
67%
Xopenex HFA®
82%
24%
®
• ProAir HFA has preferred
formulary coverage by more
than 80% of covered lives.7
As a result, more insured
patients may pay less for
their medication
Source: Fingertip Formulary Report, December 2012.7
[u] Guidelines for short-acting β 2 agonist use
n S hort-acting β2 agonists (SABAs) are indicated for the treatment or prevention of bronchospasm
with reversible obstructive pulmonary disease8
• Reversible obstructive pulmonary disease includes asthma, exercise-induced bronchospasm (EIB),
and chronic obstructive pulmonary disorder8,9
• SABAs bind to β2 adrenergic receptors to relax smooth muscle after adenylate cyclase activation
and increase cyclic AMP to antagonize further bronchoconstriction8
nC
urrently, SABAs are the most effective type of medication for relieving acute bronchospasm8
• The guidelines of the National Heart, Lung, and Blood Institute (NHLBI) recommends SABAs
• In addition, the NHLBI guidelines recommend the use of SABAs prior to exercise for the
as the preferred treatment of acute asthma symptoms and exacerbations (Evidence Level A)8
prevention of EIB (Evidence Level A)8
The NHLBI guidelines recommend that patients with asthma and EIB should have a SABA
inhaler available at all times.
Selected Safety Information
• Adverse events, which occurred at an incidence rate of at least 3% with ProAir HFA, include headache,
tachycardia, pain, dizziness, pharyngitis, and rhinitis.
Please see full Prescribing Information and the last page for
additional Important Safety Information.
(continued
(continued
on next
on page)
back)
MPR Prescribing Alert
Indications
ProAir® HFA (albuterol sulfate) Inhalation Aerosol is indicated in patients 4 years of age and older for the treatment
or prevention of bronchospasm with reversible obstructive airway disease and for the prevention of exercise-­
induced bronchospasm.
Important Safety Information
• Inhaled albuterol sulfate can produce paradoxical bronchospasm that may be life-threatening. It should be
recognized that paradoxical bronchospasm, when associated with inhaled formulations, frequently occurs
with the first use of a new canister
• Fatalities have been reported in association with excessive use of inhaled sympathomimetic drugs in
patients with asthma
• ProAir HFA, as with all sympathomimetic amines, should be used with caution in patients with cardiovascular
disorders (especially coronary insufficiency, cardiac arrhythmias, and hypertension), convulsive disorders,
hyperthyroidism, and diabetes
• Potential drug interactions can occur with beta-blockers, diuretics, digoxin, or monoamine oxidase inhibitors,
and tricyclic antidepressants
• Do not exceed the recommended dose
• Adverse events, which occurred at an incidence rate of at least 3% with ProAir HFA, include headache,
tachycardia, pain, dizziness, pharyngitis, and rhinitis
Please see full Prescribing Information.
References
1. ProAir HFA [prescribing information]. Horsham, PA: Teva Respiratory, LLC; May 2012.
2. McCabe JC, Koppenhagen F, Blair J, et al. ProAir HFA delivers warmer, lower-impact, longer-duration plumes containing higher
fine particle dose than Ventolin HFA. J Aerosl Med Pulm Drug Deliv. 2012;25(2):104-109.
3. F DA Letter [January 14, 2008]. Data on file. Teva Respiratory, LLC.
4. V
entolin HFA [package insert]. Research Triangle Park, NC: GlaxoSmithKline; 2009.
5. Everard ML, Devadason SG, Summers QA, et al. Factors affecting total and “respirable” dose delivered by a salbutamol metered
dose inhaler. Thorax. 1995;50(7):746-749.
6. Graham SJ, Ormsby ED, Lovering EG. Single spray drug content in a metered-dose aerosol formulation and a collection scheme
for content uniformity. Pharm Forum. 1992;18(6):4400-4403.
7. F ingertip Formulary Report, December 2012.
8. N
ational Heart, Lung, and Blood Institute. National Asthma Education and Prevention Program. Expert Panel Report 3: Guidelines
for the Diagnosis and Management of Asthma–Full Report 2007. National Institutes of Health; August 28, 2007.
9. G
lobal Initiative for Chronic Obstructive Lung Disease. Global Strategy for the Diagnosis, Management, and Prevention of Chronic
Obstructive Pulmonary Disease. Updated 2009.
ProAir® HFA is a registered trademark of Teva Respiratory, LLC.
The brands listed are the registered trademarks of their respective owners.
© 2013 Teva Respiratory, LLC.
130187
01/13