View the new ‘Fishing’ commercial!
The SYMBICORT "Fishing" advertising campaign will help raise awareness of COPD and
how treatment with SYMBICORT 160/4.5 for COPD may help.
- In patients with COPD, SYMBICORT 160/4.5 provided significant and sustained*
improvement in lung function, with a
majority of improvement occurring at 5 minutes.2,3†‡ SYMBICORT
is not a rescue medication and does not replace
fast-acting inhalers to treat acute symptoms.
We hope that you will consider SYMBICORT for your appropriate patients with COPD.
*Sustained improvement in lung function was demonstrated in a
12-month efficacy and safety study.
†In a serial spirometry subset, in patients taking SYMBICORT 160/4.5
(n=121), 66.98% of 1-hour postdose FEV1 improvement occurred at 5 minutes on day
of randomization, 82.84% at month 6, and 84.05% at end of treatment.
‡Results may vary.
1.SYMBICORT 160/4.5 Prescribing Information. Wilmington, DE: AstraZeneca, LP.
2. Rennard Sl, Tashkin DP, McElhattan J, et al. Efficacy and tolerability of budesonide/formoterol
in one hydrofluoroalkane pressurized metered-dose inhaler in patients with chronic
obstructive pulmonary disease: results from a 1-year randomized controlled clinical
3. Data on File. 1084400, AZPLP.
Important Safety Information, including Boxed warning
- WARNING: Long-acting beta2-adrenergic agonists (LABA), such as formoterol,
one of the active ingredients in SYMBICORT, increase the risk of asthma-related
death. A placebo-controlled study with another LABA (salmeterol) showed an increase
in asthma-related deaths in patients receiving salmeterol. This finding with salmeterol
is considered a class effect of LABA, including formoterol. Currently available
data are inadequate to determine whether concurrent use of inhaled corticosteroids
or other long-term asthma control drugs mitigates the increased risk of asthma-related
death from LABA. Available data from controlled clinical trials suggest that LABA
increase the risk of asthma-related hospitalization in pediatric and adolescent
- When treating patients with asthma, prescribe SYMBICORT only for patients not
adequately controlled on a long-term asthma control medication, such as an inhaled
corticosteroid or whose disease severity clearly warrants initiation of treatment
with both an inhaled corticosteroid and LABA. Once asthma control is achieved and
maintained, assess the patient at regular intervals and step down therapy (eg, discontinue
SYMBICORT) if possible without loss of asthma control, and maintain the patient
on a long-term asthma control medication, such as an inhaled corticosteroid. Do
not use SYMBICORT for patients whose asthma is adequately controlled on low- or
medium-dose inhaled corticosteroids
SYMBICORT is NOT a rescue medication and does NOT replace fast-acting inhalers to
treat acute symptoms.
It is possible that systemic corticosteroid effects such as hypercorticism and adrenal
suppression may occur, particularly at higher doses. Particular care is needed for
patients who are transferred from systemically active corticosteroids to inhaled
corticosteroids. Deaths due to adrenal insufficiency have occurred in asthmatic
patients during and after transfer from systemic corticosteroids to less systemically
available inhaled corticosteroids.
Patients who are receiving SYMBICORT should not use additional formoterol or other
LABA for any reason.
Due to possible immunosuppression, potential worsening of infections could occur.
A more serious or even fatal course of chickenpox or measles can occur in susceptible patients.
Excessive beta-adrenergic stimulation has been associated with central nervous system
and cardiovascular effects. SYMBICORT, like all products containing sympathomimetic
amines, should be used with caution in patients with convulsive disorders, thyrotoxicosis,
and cardiovascular disorders, especially coronary insufficiency, cardiac arrhythmias,
Beta-adrenergic agonist medications may produce hypokalemia and
hyperglycemia in some patients. As with other inhaled medications, paradoxical bronchospasm
may occur with SYMBICORT. Use with caution in patients with diabetes mellitus.
Long-term use of orally inhaled corticosteroids, such as budesonide, a component
of SYMBICORT, may result in a reduction in growth velocity and/or a loss of bone
Glaucoma, increased intraocular pressure, and cataracts have been reported following
the inhaled administration of corticosteroids, including budesonide, a component
In rare cases, patients on inhaled corticosteroids may present with systemic eosinophilic
SYMBICORT should be administered with caution to patients being treated with MAO
inhibitors or tricyclic antidepressants, or within
2 weeks of discontinuation of
such agents. Caution should also be exercised in patients on long-term ketoconazole
and other known potent CYP3A4 inhibitors.
Additional Information Specific to Asthma
The most common adverse reactions ≥3% reported in clinical trials included nasopharyngitis,
headache, upper respiratory tract infection, pharyngolaryngeal pain, sinusitis,
influenza, back pain, nasal congestion, stomach discomfort, vomiting, and oral candidiasis.
Additional Information Specific to COPD
- For patients with COPD, the approved dosage of SYMBICORT
is 160/4.5 mcg, 2 inhalations twice daily
- The most common adverse events ≥3% reported in COPD clinical trials included
nasopharyngitis, oral candidiasis, bronchitis, sinusitis, and upper respiratory
- Lower respiratory tract infections, including pneumonia, have been reported following
the inhaled administration of corticosteroids
- In 2 placebo-controlled SYMBICORT COPD clinical studies,
pneumonia did not occur with greater incidence in the SYMBICORT
160/4.5 group, compared with placebo, while the incidence of lung infections other
than pneumonia (eg, bronchitis) was higher for SYMBICORT
SYMBICORT is indicated for the treatment of asthma in patients 12 years and older
(also see Boxed WARNING).
SYMBICORT 160/4.5 is indicated for the maintenance treatment of airflow obstruction
in patients with chronic obstructive pulmonary disease (COPD), including chronic
bronchitis and emphysema.
SYMBICORT is NOT indicated for the relief of acute bronchospasm and should not be
initiated in patients during rapidly deteriorating or potentially life-threatening
episodes of asthma or COPD.
Please see full Prescribing
including Boxed WARNING.
You are encouraged to report negative side effects of prescription drugs to the
FDA. Visit www.FDA.gov/medwatch or call