Approved Uses for COPD
SYMBICORT 160/4.5 is for adults with COPD, including chronic bronchitis and emphysema.
You should only take 2 inhalations of SYMBICORT twice a day. Higher doses will not provide additional benefits.
Important Safety Information about SYMBICORT for COPD
Call your doctor if you notice any of the following symptoms: change in amount or color of sputum, fever,
chills, increased cough, or increased breathing problems. People with COPD may have a higher chance of pneumonia.
SYMBICORT may increase your risk of osteoporosis and some eye problems (cataracts or glaucoma). You should have
regular eye exams. Thrush in the mouth and throat may occur.
Tell your doctor if you have a heart condition or high blood pressure before taking SYMBICORT. Do not use
SYMBICORT with other long-acting-beta2-agonists for any reason. SYMBICORT does not replace
fast-acting inhalers for sudden symptoms.
Please see full Prescribing Information and discuss with your doctor.
(PDF — 437 KB)
Approved Uses for Asthma
Prescription SYMBICORT® (budesonide/formoterol fumarate dihydrate) is a controller medicine for the long-term maintenance treatment of asthma. SYMBICORT
is for people 12 years and older whose doctor has decided are not well controlled on another asthma-controller
medicine or who need two asthma-controller medicines. SYMBICORT is not for the treatment of sudden asthma
symptoms.
Important Safety Information about SYMBICORT for Asthma
What is the most important safety information I should know about SYMBICORT?
SYMBICORT contains formoterol, a long-acting beta2-agonist (LABA). Medicines containing LABAs may increase the chance of asthma-related death. So, SYMBICORT should be used only if your health care professional decides another asthma-controller medicine alone does not control your asthma or you need two controller medicines.
While taking SYMBICORT, never use another medicine containing a LABA.
What other important safety information should I know about SYMBICORT?
SYMBICORT won't replace rescue inhalers for sudden symptoms. Do not use SYMBICORT more than twice a day.
If you are taking SYMBICORT, see your health care professional if your asthma does not improve or gets worse.
Some people may experience increased blood pressure, heart rate, or change in heart rhythm. Tell your doctor if you have a heart condition or high blood pressure.
If you are switching to SYMBICORT from an oral corticosteroid, follow your doctor's instructions to avoid health risks when you stop using oral corticosteroids.
Avoid exposure to infections such as chicken pox or measles. Tell your health care professional immediately if you think you have been exposed.
Side Effects: In clinical studies, common side effects included nose and throat irritation, headache, upper respiratory tract infection, sore throat, sinusitis, and stomach discomfort.
Please see full Prescribing Information and discuss with your doctor.
(PDF - 437 KB)